Lev Gerlovin, vice president in the Life Sciences Practice at Charles River Associates (CRA), and Pascale Diesel former vice president in the Life Sciences Practice at CRA, discuss how pharma companies are changing their strategies when it comes to cell and gene therapies.

In recent years, drug development has been transitioning from a one pill fits all approach to a focus on more targeted and personalised therapies, including many cell and gene therapies. These innovative treatments often bring the promise of high efficacy and even curative benefit and, in many cases, are options for patients with diseases that previously had limited or no treatments available. With several cell and gene therapies now approved and many more advancing toward late-stage clinical development, patient communities and healthcare systems are rapidly recognising their potential benefits, whilst pharmaceutical companies are considering opportunities including mergers, acquisitions, licensing agreements, and partnerships. The deal-making landscape for cell and gene therapies is already very active and positioned to grow exponentially in the years ahead.

While the pace of deal-making is accelerating, the unique qualities of cell and gene therapies are also requiring dealmakers on both sides to consider some innovative and previously untried strategies designed to optimise returns and reduce risk. They are structuring deals to address many factors, including the lack of commercial benchmarks for these products and limited long-term safety and efficacy data often associated with cell and gene therapies. We conducted an analysis of more than 30 deals executed in the cell and gene therapy sector recently and compared them to deals executed for monoclonal antibodies (mAbs) between 1999-2013. Emerging cell and gene therapies are often considered magic bullets in the treatment of many serious diseases a claim that was applied to many mAbs when they were first introduced to the market about 20 to 25 years ago and the level of interest in deal-making for these therapies is a reflection of the level of optimism companies have regarding their clinical and commercial potential. Findings from our analysis show that the pace of deal-making in cell and gene therapy is faster and occurring much earlier in the drug development process compared to deals seen in the past for breakthrough therapies including mAbs.

When the first mAb was approved in the mid-1980s, deal-making interactions were mostly limited to collaborations and licensing agreements between smaller biotechnology firms. It took more than 20 years for big pharma to become significantly interested in mAbs and start proactively pursuing deals for these drugs. Conversely, deals within the cell and gene therapy sector have shown a much faster uptake, quickly growing in momentum since approval of the first cell and gene therapies in the early 2010s. More than 50 cell and gene therapy-related partnerships and investments were established between 2010-2016, with big pharma involved in many deals from the beginning. In one example, Novartis initiated a collaboration with GenVec in 2010 for clinical development of adeno-based gene therapies a deal worth potentially $213 million (excluding royalties). That same year Novartis also formed a strategic alliance with GlaxoSmithKline and the Telethon Institute of Gene Therapy to pursue additional gene therapy research and development.

Larger pharmaceutical companies such as Novartis seem more eager to embrace cell and gene therapies compared to prior innovative therapies including mAbs, but the types and values of related deals are evolving compared to what has historically been seen. While the largest mAb deals were often characterised by the acquisitions of late-stage and marketed products, which present more robust data and potentially lower risk to acquisition or licensing partners, most major cell and gene therapy acquisitions involve product pipelines, platform technologies, and manufacturing capabilities rather than one single product. Larger pharmaceutical companies are also targeting earlier stage opportunities, with a higher proportion of partnerships involving Phase 1 or even preclinical stage assets. For example, Pfizer established a collaboration deal with Spark Therapeutics for the development and potential commercialisation of a Phase 1/2 gene therapy for the treatment of haemophilia B and also acquired Bamboo Therapeutics based on a promising gene therapy portfolio including one Phase 1 and several preclinical assets for the treatment of rare diseases impacting the nervous system.

As more companies work to establish a presence in this sector, both larger and smaller companies now often prefer innovative licensing and collaborative agreements, whereas the majority of deals executed for mAbs were straightforward mergers or acquisitions. Given that cell and gene therapy development is still in its nascent stages and many stakeholders, including payers, have questions related to their long-term clinical benefit and budget impact, the fact that mergers or acquisitions are deemed less attractive is unsurprising. Innovative partnerships can be a lower risk option for licensors or investors who want to expand their cell and gene therapy portfolios without assuming full financial responsibility. Partnership and licensing deals can also help reduce the risk of possible disruptions in business operations and productivity, which often occur following M&A deals and the subsequent restructuring of company resources and teams.

The opportunity to access complementary business capabilities is another factor that is driving interest in innovative licensing and collaborative agreements. With licensing arrangements, a licensor might be seeking a partner who can offer specialised expertise in a specific indication whereas a licensee might see the benefit of collaborating with a company with technical abilities or assets that align with their own product pipeline. The partnership between Neurocrine Bioscience and Voyager Therapeutics reflects this type of synergistic collaboration, where Neurocrine provides expertise in central nervous system (CNS) drug development as well as financial support for the clinical development of gene therapies for Parkinson's disease and Friedreichs ataxia. In return, Neurocrine gains the opportunity to co-commercialise and potentially obtain global rights to portfolio-compatible therapies.

As new cell and gene therapies emerge and others progress to late-stage clinical development and regulatory approval, most industry stakeholders anticipate that both the structure and value of deals in the sector will mature. Companies will exercise the option to follow up on previous collaborative deals, punctuating the space with potentially massive exclusive licensing agreements and acquisitions.

*The views expressed herein are the authors and not those of Charles River Associates (CRA) or any of the organisations with which the authors are affiliated.The authors wish to acknowledge the contributions ofSil Collins and Alex Davidto this article.

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How pharma companies are shifting deal strategies for cell and gene therapies - EPM Magazine

Recommendation and review posted by Bethany Smith

Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer. While most children respond well to chemotherapy, some experience resistant or relapsed disease. Building on an immunotherapy treatment called CAR T cell therapy, Dr. Nabil Ahmed and his colleagues from multiple institutions were able to engineer a new fighter T cell that more effectively targeted leukemia cells in preclinical studies.

Chimeric antigen receptor (CAR) T cell therapy, a form of immunotherapy, was developed to help children for whom chemotherapy was not enough, said Ahmed, associate professor of pediatrics, section of hematology-oncology at Baylor College of Medicine and Texas Childrens Hospital. He is the senior author of the findings published by Dr. Kristen Fousek and colleagues in the journal Leukemia.

CAR T cell therapy uses a patients T cells, a type of immune cell that is usually involved in fighting cancer. Several research groups have genetically engineered patients T cells to express a CAR molecule to recognize CD19, a protein (antigen) found on leukemia cells. When these CAR T cells are introduced back into the patient, they can attack the cancer more effectively. Although initial treatment using CAR T cells offered impressive initial results, nearly half of the patients who received the therapy later relapsed because the cancer adapted to the attack by not producing the target protein CD19 anymore. As a result of this adaptation, the cancer became invisible to the engineered T cells.

Looking to improve this promising immunotherapy, Ahmed collaborated with Dr. Hisham Abdel-Azim, an investigator in the Saban Research Institute of Childrens Hospital Los Angeles and co-corresponding author, to study the pattern of target change before and after treatment with CD19 CAR T cells. Accordingly, Fousek, then a graduate student in Ahmeds laboratory at the Center for Cell and Gene Therapy, engineered a T cell that targets not only CD19, but also two other proteins found on leukemia cells, CD20 and CD22.

Its like using a trident to attack the cancer instead of a spear, said Ahmed, who also is a member of Baylors Dan L Duncan Comprehensive Cancer Center.

The team used this three-pronged weapon against leukemia cells in preclinical studies and developed new methods to monitor how well it worked.

The new CAR T cells, named TriCAR T cells, targeting CD19/20/22 were significantly more effective than T cells that target CD19 alone. When the leukemia cells stopped producing CD19 and were no longer visible to CD19 CAR T cells, TriCAR T cells were still effective.

TriCAR T cells bind to more cancer cells and these connections are much stronger, said Abdel-Azim.

We studied the behavior of individual TriCAR T cells in the laboratory of Dr. Varadarajan at the University of Houston; the new TriCAR T cells are more effective serial killers of leukemia, Ahmed said.

Although a clinical trial will be needed before the new TriCAR T cell therapy could be used on patients, the early lab results suggest a path that could be significantly more effective in battling resistant leukemia.

See the publication to find the complete list of authors, their affiliations and sources of support for this project.

By Ana Mara Rodrguez, Ph.D.

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Trading a spear for a trident is promising in the fight against leukemia - Baylor College of Medicine News

Recommendation and review posted by Bethany Smith

Latest market study on Gene Therapy Market to 2027 Global Analysis and Forecasts By Cell Type (Somatic Gene Therapy, Germline Gene Therapy); By Application (Genetic Disorder, Cancer, Neurological Disorder, and Others). Global Gene Therapy Market Status and Future Forecast 2020-2027. The Insight Partners evaluating the market, highlighting opportunities, risk side analysis, and leveraged with strategic and tactical decision-making support. The study provides information on market trends and development, drivers, capacities, technologies, and on the changing investment structure of the Global Gene Therapy Market. Some of the key players profiled in the study are Sangamo Therapeutics, Inc., bluebird bio, Inc., uniQure N.V., AveXis, Inc., Vineti, Solid Biosciences., Spark Therapeutics, Inc., CHIMERON BIO, RENOVA THERAPEUTICS, HORAMA S.A., etc.

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MARKET INTRODUCTION

Gene therapy is the introduction of DNA into a patient to treat a genetic disease or a disorder. The newly inserted DNA contains a correcting gene to correct the effects of a disease, causing mutations. Gene therapy is a promising treatment for genetic diseases and also includes cystic fibrosis and muscular dystrophy. Gene therapy is a suitable treatment for infectious diseases, inherited disease and cancer.

MARKET DYNAMICS

The growth of the gene therapy market is regulated due to various reason which includes the rapid involvement of synthetically modified gene to treat various diseases, it helps in designing the personalized medicine, rise in the research and development of the gene therapy among the others. The gene therapy requires less doses of medicines and is one time treatment, this factor is likely to show growth opportunity for gene therapy market in coming near future.

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MARKET SCOPE

The Global Gene Therapy Market Analysis to 2027 is a specialized and in-depth study of the biotechnology industry with a special focus on the global market trend analysis. The report aims to provide an overview of gene therapy market with detailed market segmentation by cell type, application and geography. The global gene therapy market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading gene therapy market players and offers key trends and opportunities in the market.

MARKET SEGMENTATION

The gene therapy market is segmented based on cell type as, somatic gene therapy and germline gene therapy. The application segment is classified as genetic disorder, cancer, neurological disorder and others. The cancer segment is expected to grow in coming years as the need of gene correction is must as the gene corrector is introduced to produce a another gene or to inhibit the expression of another gene or to disturb the activity of another gene.

The report analyzes factors affecting gene therapy market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the gene therapy market in these regions.

Strategic Points Covered in Table of Content of Global Gene Therapy Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Gene Therapy market

Chapter 2: Exclusive Summary the basic information of the Gene Therapy Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Gene Therapy

Chapter 4: Presenting the Gene Therapy Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Evaluating the leading manufacturers of the Gene Therapy market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 6: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

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Gene Therapy Market Segmented by Region/Country: North America, Europe, Global, Middle East & Africa, and Central & South America

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Gene Therapy Market: Study Navigating the Future Growth Outlook | Sangamo Therapeutics, Inc., bluebird bio, Inc., uniQure NV - Science In Me

Recommendation and review posted by Bethany Smith

The Gene Therapy Products market report is an important element which gains demand from all corners of the globe. It provides product overview and highlights of product and application segments of the global market including price, revenue, sales, sales growth rate, and market share by product. Primary and secondary research methodologies have been employed for a detailed study to generate this report. This report performs SWOT analysis of major key players of Healthcare industry based on strengths, weaknesses, opportunities and threats as well as companys internal & external environments. To generate this world-class Gene Therapy Products Market report, the combination of best industry insight, practical solutions, talent solutions and latest technology have been used.

With this Gene Therapy Products market research report, it becomes easy to save and reduce time, that would be otherwise required for entry-level research, by identifying the growth, size, leading players and segments in the global Gene Therapy Products market. The report suggests that the market has shown rapid development in the current and past years and is going to progress with continuing growth in the upcoming years. For this report, market analysts have studied the various products in the market and offered an even-handed opinion about the factors that are likely to drive the market or restrain it.

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Global gene therapy products market is set to witness a substantial CAGR in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Rising cancer cases and unused potential for emerging markets are the major factors for the growth of this market.

Few of the major competitors currently working in the globalgene therapy products marketareAdaptimmune., Anchiano Therapeutics, bluebird bio, Inc., CELGENE CORPORATION, GlaxoSmithKline plc., Merck KGaA, Novartis AG, Achieve Life Sciences, Inc., Spark Therapeutics, Inc., Abeona Therapeutics, Inc, Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis, Inc., CRISPR Therapeutics, Intellia Therapeutics, Inc and Gilead Sciences,Inc. among others.

Market Definition:Global Gene Therapy Products Market

Gene therapy or human gene therapy is a process which is used to modify gene for the treatment of any disease. Plasmid DNA, bacterial vector, human gene editing technology and viral vectors are some of the most common type of gene therapy products. The main aim of the gene therapy is to replace the dysfunctional genes. Somatic and germline are some of the most common type of the gene therapy.

Complete report on Global Gene Therapy Product Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Segmentation: Global Gene Therapy Products Market

Gene Therapy Products Market : By Product

Gene Therapy Products Market : By Application

Gene Therapy Products Market : ByGeography

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Key Developments in the Gene Therapy Products Market:

Gene Therapy Products Market Drivers

Gene Therapy Products Market Restraints

Competitive Analysis: Gene Therapy Products Market

Global gene therapy products market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of gene therapy products market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key questions answered in the report :-

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Gene Therapy Products Market Sees Astonishing Growth in 2020. Major Players are Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis Inc. -...

Recommendation and review posted by Bethany Smith

HER2-positive breast cancer may be a misnomer, according to a growing body of evidence that one of the most widely recognized oncogenes, HER2, may not be the primary driver of the disease. The research, which comes from several groups including Genentech, makers of the prevailing anti-HER2 treatment, has researchers questioning whether current clinical guidelines for classifying and treating breast cancer may be off the mark. New classification schemes may better identify those patients more likely to benefit from anti-HER2 treatment, or point to therapies that might be more effective.

HER2 is short for human epidermal growth factor receptor 2. Researchers discovered HER2 breast cancer in the 1980s. Too many copies of the HER2 gene or its overexpression appeared to cause an especially aggressive form of the disease. By the late 90s, a drug called Herceptin that targeted the HER2 receptor, sped into the clinic on the US Food and Drug Administrations new fast-track status. As Dana-Farber Cancer Institute oncologist Harold Burstein put it a couple of years ago, HER2 breast cancer, once the most feared type of the disease, had gone from worst to first, largely because of Herceptin.

After analyzing multiple, published genomic data sets, researchers at Genentech, which makes Herceptin, reported in 2018 that there was no evidence that HER2 amplification represents a breast cancer subtype.

About 14 percent of breast cancers are HER2-positive, a diagnosis largely based on immunohistochemical staining to reveal an overabundance of HER2 receptors spanning the cancer cells membranes, with ambiguous cases decided by testing for an abnormally high HER2 gene copy number. The American Society of Clinical Oncology recommends Herceptin as the first-line treatment for HER2-positive breast cancer. In the US, tens of thousands of patients receive Herceptin each year. Recently, however, researchersincluding those from Herceptin maker Genentechhave begun to reconsider the HER2-positive subtype.

In the HER2-centric model of breast cancer, highly dysregulated HER2 signaling drives uncontrolled cell growth. HER2-positive breast cancers carry as many as 50 copies of the HER2 gene, compared with just two in noncancerous cells, and the gene can be highly expressed, leading to HER2 protein levels as much as 40- to 100-fold higher than normal.

But after analyzing multiple, published genomic datasets, researchers at Genentech reported in 2018 that there was no evidence that HER2 amplification (and, by extension, HER2 overabundance) represents a breast cancer subtype at all. HER2 amplification by itself seemed to have a negligible influence on the expression of genes thought to be mediated by the HER2 signaling. Rather, HER2 amplification was associated with upregulation of genes governed by androgen receptor (AR) signaling, which orchestrates the actions of testosterone and related hormones and is often boosted in breast cancer. This link between HER2 amplification and AR signaling suggests the androgen receptor may play a bigger role in the disease than previously recognized.

Other researchers have similarly reevaluated breast cancers using transcriptional profiles that look at gene expression across the genome, rather than focusing on individual genes thought to have large effect. The resulting subtypes require a more nuanced view of HER2 or dont include HER2 at all.

[T]he whole state of subdividing and classifying breast cancers is in a state of flux, says Larry Norton, a medical oncologist at Memorial Sloan Kettering Cancer Center who played a key role in the clinical trials establishing HER2-positive breast cancer as a subtype and Herceptin as the first drug for treating it. Were in a molecular era now, so we think we know more.

The conventional view of HER2 breast cancer that guides current clinical practice has been under pressure for some time. While most researchers remain convinced that HER2 is a clear driver of some breast cancers, Herceptin by itself struggled to knock down HER2-positive tumors in early clinical trials. It was the synergy with [the chemotherapy drug] paclitaxel that really put the drug on the map, says Norton, who was involved in the early trials of the combination therapy. Had we focused in on trastuzumab [Herceptin] as a single agent . . . the drug would have been abandoned.

Norton was the senior author of the published trial that led to FDA approval of Herceptin for advanced breast cancer in 1998. However, that trial did not actually demonstrate that the combination of Herceptin and paclitaxel, a type of chemotherapy drug known as a taxane, was superior to paclitaxel alone in increasing survival. Only when the data were combined with separate trial arms testing non-taxane chemotherapy with and without Herceptin did the researchers see a statistically significant difference in survival.

In addition, the two trials that led to Herceptins 2006 approval for early breast cancer later cast doubt on HER2 as a biomarker for response to the drug. A 2007 reanalysis of one of the trials found no statistical interaction between patients HER2 status and whether they benefitted from Herceptin. A similar reanalysis of the second trial corroborated this result: [Herceptin] benefit seemed independent of HER2 amplification, the researchers wrote in their report.

In 2000, a group at the Stanford University School of Medicine used state-of-the-art microarray technology to propose molecular subtypes of breast cancer based on the expression of more than 8,000 genes in biopsies from 42 patients. While the researchers identified a molecular signature for a HER2-based subtype, it wasnt strictly based on overabundance of the HER2 receptor or high HER2 copy numbers in the genome. Rather, they used the expression patterns from nearly 500 genes as indicators of the activation of the HER2 signaling pathway.

Breast cancer tissue stained for HER2 using antibody clone IHC002

The new subtype, which the team later dubbed HER2-enriched (HER2E), fractured the HER2 classification: a tumor might be HER2-positive based on the classical methods but not show evidence of HER2-mediated signaling activity at the transcriptional level. Only 47 percent of HER2-amplified tumors are HER2E, a concordance the 2018 paper from Genentech calls remarkably weak. Margaret Gatti-Mays of the National Cancer Institute estimates that 30 percent to 40 percent of tumors classified as HER2E tumors are not clinically HER2-positive.

A number of research groups have found no HER2-based subtype at all. In a 2005 paper, Richard Iggo, then at the Swiss Institute for Experimental Cancer Research, and colleagues performed experiments similar to those that had identified the molecular subtypes put forward by the Stanford researchers in 2000. Iggos team found that the previously discovered HER2 group did not appear to be defined by HER2, but by genes that looked like they might be related to androgen signaling, says Iggo, now at INSERM and the University of Bordeaux in France.

Similarly, in their 2018 study from Genentech, Anneleen Daemen and Gerard Manning found that AR activity is a key part of the HER2E subtype. HER2-enriched is not HER2-driven, per se. Its rather the androgen signaling, says Daemen, now head of translational medicine at ORIC Pharmaceuticals. You have androgen signaling that is massively on . . . and that is regardless of whether the HER2-enriched tumor is also HER2-positive or not.

Gerard Tarulli, an endocrinology researcher at the University of Melbourne who was not involved in the study, explains that this may be because the androgen receptor can play a role similar to the estrogen receptor (ER), which, in the most common form of breast cancer, drives tumor growth. In HER2E tumors, AR signaling is thought to replace ER as the driver, with the androgen receptor almost physically substituting for the presence of the estrogen receptor, says Tarulli.

Iggo and his colleagues called for the HER2E subtype to be renamed molecular apocrine to reflect a pathology very different from a HER2-centric model of disease, one that appears to involve signaling by AR and perhaps other pathways as well. The thing thats slightly disappointing for me, says Iggo, [is that] rather than changing the name . . . [the Stanford team] just said HER2-enriched, which perpetuates the idea that [HER2 amplification] defines a biological subtype.

Daemen agrees. When they originally defined these subtypes, they should not have used the word HER2-enriched because thats misleading, she says. [The nomenclature is] so ingrained in the research thats happening for breast cancer that people really hold on to it. . . . The field at large has not questioned those subtypes or deviated from them as much as is happening in other fields or other cancer types. The Stanford team did not respond to The Scientists request for comment.

Which subtypes are real is a very difficult question, says Tarulli. One recently published breast cancer scheme includes seven types, three of which could be considered subsets of the traditional HER2-positive categorization, while yet another research group has proposed 10 molecular subtypes, including one that pertains to HER2-type disease.

According to Daemen, her work was closely followed by the clinicians and the biomarker scientists who were running trials in breast and gastric cancers. I worked closely with the clinical teams at Genentech at that time to see if we could explain why some patients in our trials were not responding as well to anti-HER2 agents because of AR expression, for example. However, Daemen left Genentech last fall and says, to my knowledge, there is no additional research that is being undertaken [at the company] as a result of this. Genentech spokesperson Kayla Bruneau says that the company did not have any researchers available to discuss the [Daemen and Manning] paper at this time.

For now, clinical practice continues in strict adherence to the HER2-positive subtype as classically defined. HER2 receptor overabundance or HER2amplification has been validated as a biomarker of clinical effect for HER2-targeting therapies, Gatti-Mays says in a statement emailed to The Scientist. But the diversity of subtypes churned out by recent molecular analyses has thrown the field for a loop.

We thought that there should be some underlying molecular characteristic that is shared by all the HER2-positive breast tumors, and that turned out not to be the case, says Daemen. This absence of HER2-related biology in HER2-positive tumors seems to clash with how targeted therapies, including anti-HER2 treatments, are thought to work, namely, by interrupting a well-understood, cancer-driving pathway.

If you can demonstrate that adding a HER2 enrichment analysis in terms of clinical decision-making improves patient outcomes, then that classification needs to go in.

Gerard Tarulli, University of Melbourne

HER2E in particular is gaining traction as a possible subtype to consider for eventual clinical use. According to a meta-analysis published earlier this year, HER2E patients show a stronger clinical benefit from anti-HER2 therapies than other molecular subtypes. Tarulli says the inclusion of HER2E in future clinical trials of anti-HER2 therapies makes a lot of sense, because now were understanding more about the mechanisms behind what [HER2] is doing.

Once clinical trial data start rolling in, researchers can make a more informed decision, he says. If you can demonstrate that adding a HER2 enrichment analysis in terms of clinical decision-making improves patient outcomes, then that classification needs to go in. Tarulli also says that for HER2E patients, inhibiting both the androgen receptor and HER2 makes a lot of sense and will probably increase the effect of both. The authors of the meta-analysis did not respond to a request for comment.

Daemen disagrees with using HER2E to decide who gets anti-HER2 therapy, which can have heart-related side effects, in a clinical trial. If you were to base treatment decisions on the HER2-enriched label of a tumor, you would do harm, rather, in patients that lack HER2 amplification.

HER2E is an interesting subgroup, agrees Gatti-Mays, but [m]ore information is needed about the long-term clinical outcomes of these HER2E patients.

Still, earlier conceptions might be falling away, Norton says. The simplistic notionHER2 is a signaling molecule, you blockade, stop the signaling, so you get apoptosis rather than going into cell division[that] all makes sense, but it could be wrong.

Robert Fortner is a freelance journalist based in Portland, Oregon. Email him atrobertwfortner@gmail.comor follow him on Twitter@robertfortner1.

Read more from the original source:
Who Benefits from Herceptin and Other Anti-HER2 Cancer Therapies? - The Scientist

Recommendation and review posted by Bethany Smith

RANCHO CORDOVA, Calif., April 13, 2020 /PRNewswire/ --ThermoGenesis Holdings, Inc.(Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that its joint venture, ImmuneCyte Life Sciences, Inc., has completed the acquisition of worldwide intellectual property for developing fully human antibody therapeutics for COVID-19. The acquired intellectual property includes four high-affinity monoclonal antibody drug candidates against SARS-CoV-2 (the virus causing COVID-19) and tools for screening and quantifying efficacy of such neutralizing antibodies. These high-affinity neutralizing monoclonal antibodies were obtained from the screening of enriched B cell libraries from individuals who have recently recovered from COVID-19 (i.e. from convalescent whole blood). The technologies were originally developed by a research team affiliated withEast China Normal University, one of the most prestigious universities in China. The acquisition includes an undisclosed upfront cash payment and low double-digit future revenue sharing for the monoclonal antibody drug candidates under development. ThermoGenesis currently holds approximately 19% of the equity of ImmuneCyte.

There are currently no regulatory approved vaccine or drug therapies for COVID-19. Current estimates are that a vaccine for emergency use may be available by early 2021. Convalescent plasma therapy is an exploratory approach that involves giving patients an infusion of plasma from people who have recovered from COVID-19. ThermoGenesis is developing a convalescent plasma strategy for COVID-19 with its SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit, which, together with ImmuneCyte's newly acquired technologies, can quickly identify individuals who have developed protective immunity against the virus, and then, using ThermoGenesis' proprietary cell processing platform, allows for the simultaneous isolation of convalescent plasma and immune cells for potential anti-COVID-19 antibody development.

The key effectors in convalescent plasma are neutralizing antibodies, which can block the entrance of the virus into the cells, thus achieving its anti-viral effects. Purified neutralizing polyclonal and monoclonal antibodies could be safer and more potent and are expected to have much higher efficacy than convalescent plasma. With the acquisition of these key intellectual property technologies, ImmuneCyte will be further engaged in the development of anti-COVID-19 polyclonal and monoclonal neutralizing antibodies for COVID-19 treatment.

"The technologies acquired from a team associated with the world's leading institute in biological research will allow us to spearhead our antibody drug development against COVID-19," Chris Xu, Ph.D, Chairman and Chief Executive Officer of ThermoGenesis, commented, "Given the gravity of the situation, both ThermoGenesis and ImmuneCyte are rapidly mobilizing our respective expertise and resources to fight against the pandemic. The acquisition of the new technologies by ImmuneCyte, along with ThermoGenesis' established proprietary technologies in the automated cellular processing field, will allow us to develop highly efficient processing methods for making convalescent plasma and pursue the development of fully human polyclonal and monoclonal antibody therapies against COVID-19."

About ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc. develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpressplatform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit:www.thermogenesis.com.

About ImmuneCyte Life Sciences, Inc.

ImmuneCyte, a joint venture which is 19% owned by ThermoGenesis, is one of the first U.S. based immune cell banks to develop and commercialize immunological products and services. The Company provides clients the opportunity to bank their own immune cells when the cells are "healthy and unaffected" as a future resource for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes a proprietary CAR-TXpress platform, a GMP compliant close-system capable of automated separating and cryopreserving different components from blood, simultaneously. For more information about ImmuneCyte Life Sciences Inc., please visit: http://www.immunecyte.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect the current expectations of ThermoGenesis concerning future events and results. Forward-looking statements based on ThermoGenesis' current assumptions, expectations and beliefs are generally identifiable by use of words "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue," or similar expressions and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. Such forward-looking statements involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, market and other conditions, as well as those risk factors discussed in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") as well as other documents that may be filed by ThermoGenesis from time to time with the SEC, which are available atwww.sec.gov. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Company Contact:Wendy Samford916-858-5191ir@thermogenesis.com

Investor Contact:Paula Schwartz,Rx Communications917-322-2216pschwartz@rxir.com

View original content:http://www.prnewswire.com/news-releases/thermogenesis-announces-its-immunecyte-joint-venture-acquires-key-technologies-to-develop-fully-human-polyclonal-and-monoclonal-antibody-therapeutics-for-covid-19-301039184.html

SOURCE ThermoGenesis Holdings, Inc.

Link:
ThermoGenesis Announces Its ImmuneCyte Joint Venture Acquires Key Technologies to Develop Fully Human Polyclonal and Monoclonal Antibody Therapeutics...

Recommendation and review posted by Bethany Smith

GERMANTOWN, Md., April 13, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS), a pioneering, global biotech company committed to lowering costs, accelerating commercialization, and transforming the delivery of cell and gene therapies (CGTs), announces it has entered into an agreement to acquire the assets of Tamir Biotechnology, Inc, including ranpirnase, TamirBios broad spectrum anti-viral platform. The acquisition will be completed for total stock and cash consideration valued at approximately $19 million, based on the value of the stock at closing. Orgenesis plans to combine ranpirnase with its co-developed Bioxome technology for enhanced payload delivery directly to cells.

TamirBio is a clinical stage anti-viral therapeutics company engaged in the discovery and development of a new class of prophylactic and therapeutic drugs for the treatment of viruses and other pathological conditions. TamirBios lead asset, ranpirnase, a ribonuclease (RNase), is a member of the superfamily of enzymes that catalyze the degradation of RNA, and mediate several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death. Therefore, it is a potential candidate for the development of therapeutics for life-threatening diseases, including viral and autoimmune diseases, that require anti-proliferative and apoptotic properties.

TamirBios first target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. The companys lead asset, topical ranpirnase, was evaluated in a phase I/II clinical trial targeting genital warts. The phase I/II study demonstrated clear clinical effect of ranpirnase. Additional clinical trials are currently being planned.

Orgenesis and TamirBio plan to combine ranpirnase with Bioxomes, which have demonstrated the ability to fuse with cell membranes and deliver an intracellular cargo, in a similar manner to natural exosomes. Bioxomes can carry selected therapeutic cargo inside the target cells when loaded with predesignated genetic material, proteins, signaling molecules and drugs, as these mimic the natural membrane fusion capacity of exosomes. Orgenesis and TamirBio believe the combination of the two platforms will result in enhanced efficacy and anti-viral results.

Vered Caplan, CEO of Orgenesis, said, Combining TamirBios broad antiviral platform, ranpirnase, with Bioxomes could result in an enhanced payload delivery into cells. In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway. We believe combining ranpirnase with the Bioxome platform has the potential to become a potent and powerful combination given the natural intracellular trafficking abilities of Bioxomes. We look forward to testing a variety of additional anti-viral therapies in the near future.

We are honored to combine forces with Orgenesis to advance this powerful platform, stated, Jamie Sulley, President of TamirBio. Ranpirnase has already demonstrated preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS. Not only do we believe Orgenesis will help advance ranpirnase through the clinic using their global development platform, but by combining ranpirnase with the Bioxome technology, we believe we can deliver ranpirnase through a more effective delivery mechanism.

About OrgenesisOrgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: http://www.orgenesis.com.

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citybizlist : Washington DC : Orgenesis To Acquire Assets of Tamir Biotechnology - Citybizlist Real Estate

Recommendation and review posted by Bethany Smith

New York, April 14, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Bioinformatics Market Research Report by Product , by Application , by End User - Global Forecast to 2025" - https://www.reportlinker.com/p05881705/?utm_source=GNW

The Global Bioinformatics Market is expected to grow from USD 14,086.57 Million in 2019 to USD 32,672.24 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 15.05%.

Market Segmentation & Coverage:This research report categorizes the Bioinformatics to forecast the revenues and analyze the trends in each of the following sub-markets:

On the basis of Product, the Bioinformatics Market is studied across Bioinformatics Platform, Bioinformatics Service, and Knowledge Management Tool. The Bioinformatics Platform further studied across Sequence Alignment Platforms, Sequence Analysis Platforms, Sequence Manipulation Platforms, and Structural & Functional Analysis Platforms. The Bioinformatics Service further studied across Data Analysis Services, Database & Management Services, and Sequencing Services. The Knowledge Management Tool further studied across Generalized Knowledge Management Tools and Specialized Knowledge Management Tools.

On the basis of Application, the Bioinformatics Market is studied across Agriculture, Chemoinformatics, Genomics, Medicine, Metabolomics, Microbial Genome Applications, Molecular Phylogenetics, Proteomics, and Transcriptomics.

On the basis of End User, the Bioinformatics Market is studied across Academics, Agricultural Bioinformatics, Animal Bioinformatics, Clinical Diagnostics, Drug Development, Environmental Bioinformatics, Forensic Bioinformatics, Gene Therapy, Medical Bioinformatics, Molecular Medicine, and Reproductive Biotechnology.

On the basis of Geography, the Bioinformatics Market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region is studied across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region is studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region is studied across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Company Usability Profiles:The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Bioinformatics Market including ABM Inc, Accelrys Inc., Agilent Technologies Inc, BGI Group, Biomax Informatics AG, DNASTAR, Eurofins Scientific, Illumina Inc., Partek Incorporated, Perkinelmer, Inc., QIAGEN Bioinformatics, Sophia Genetics, Thermo Fisher Scientific, Waters Corporation, and WuXi NextCODE..

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Bioinformatics Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as:1. What is the market size and forecast of the Global Bioinformatics Market?2. What are the inhibiting factors and their impact analysis shaping the Global Bioinformatics Market during the forecast period?3. What is the competitive position if vendors in the Global Bioinformatics Market?4. How Porters Five Forces define the Global Bioinformatics Market landscape?5. What are the technology trends and regulatory frameworks in the Global Bioinformatics Market?6. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Bioinformatics Market?7. What is the competitive strategic window for opportunities in the Global Bioinformatics Market?8. What are the modes and strategic moves considered suitable for entering the Global Bioinformatics Market?Read the full report: https://www.reportlinker.com/p05881705/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The Global Bioinformatics Market is expected to grow from USD 14,086.57 Million in 2019 to USD 32,672.24 Million by the end of 2025 at a Compound...

Recommendation and review posted by Bethany Smith

Latest Study on Industrial Growth ofGlobal Gene Editing Technologies Market2019-2025. A detailed study accumulated to offerLatest insights about acute features of the Gene Editing Technologies market. The report contains different market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market. It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary and SWOT analysis.

The Major Players Covered in this Report: Thermo Fisher Scientific, Merck, Sangamo Therapeutics, Lonza, Transposagen Biopharmaceuticals, Editas Medicine, CRISPR Therapeutics & Agilent Technologies

Gene Editing Technologies Market Study guarantees you to remain / stay advised higher than your competition. With Structured tables and figures examining the Gene Editing Technologies, the research document provides you a leading product, submarkets, revenue size and forecast to 2025. Comparatively is also classifies emerging as well as leaders in the industry.Click To get SAMPLE PDF (Including Full TOC, Table & Figures)

This study also covers company profiling, specifications and product picture, sales, market share and contact information of various regional, international and local vendors of Global Gene Editing Technologies Market. The market opposition is frequently developing greater with the rise in scientific innovation and M&A activities in the industry. Additionally, many local and regional vendors are offering specific application products for varied end-users. The new merchant applicants in the market are finding it hard to compete with the international vendors based on reliability, quality and modernism in technology.

Read Detailed Index of full Research Study at @https://www.htfmarketreport.com/reports/1606682-global-gene-editing-technologies-market

The titled segments and sub-section of the market are illuminated below:

In-depth analysis of Global Gene Editing Technologies market segments by Types: , Double Strand Break Repair, Engineered Nucleases & Clustered Regularly Interspaced Short Palindromic Repeats

In-depth analysis of Global Gene Editing Technologies market segments by Applications: Gene Therapy & Eradicating Diseases

Major Key Players of the Market: Thermo Fisher Scientific, Merck, Sangamo Therapeutics, Lonza, Transposagen Biopharmaceuticals, Editas Medicine, CRISPR Therapeutics & Agilent Technologies

Regional Analysis for Global Gene Editing Technologies Market:North America (United States, Canada and Mexico)Europe (Germany, France, UK, Russia and Italy)Asia-Pacific (China, Japan, Korea, India and Southeast Asia)South America (Brazil, Argentina, Colombia etc.)Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Furthermore, the years considered for the study are as follows:Historical year 2013-2017Base year 2018Forecast period** 2018 to 2023 [** unless otherwise stated]

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players.

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Guidance of the Global Gene Editing Technologies market report:

Detailed considerate of Gene Editing Technologies market-particular drivers, Trends, constraints, Restraints, Opportunities and major micro markets. Comprehensive valuation of all prospects and threat in the Global Gene Editing Technologies market. In depth study of industry strategies for growth of the Gene Editing Technologies market-leading players. Gene Editing Technologies market latest innovations and major procedures. Favorable dip inside Vigorous high-tech and market latest trends remarkable the Market. Conclusive study about the growth conspiracy of Gene Editing Technologies market for forthcoming years.

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1. A comprehensive summary of several area distributions and the summary types of popular products in the Gene Editing Technologies Market.2. You can fix up the growing databases for your industry when you have info on the cost of the production, cost of the products, and cost of the production for the next future years.3. Thorough Evaluation the break-in for new companies who want to enter the Gene Editing Technologies Market.4. Exactly how do the most important companies and mid-level companies make income within the Market?5. Complete research on the overall development within the Gene Editing Technologies Market that helps you elect the product launch and overhaul growths.

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Detailed TOC of Gene Editing Technologies Market Research Report-

Gene Editing Technologies Introduction and Market Overview Gene Editing Technologies Market, by Application [Gene Therapy & Eradicating Diseases]

Gene Editing Technologies Industry Chain Analysis Gene Editing Technologies Market, by Type [, Double Strand Break Repair, Engineered Nucleases & Clustered Regularly Interspaced Short Palindromic Repeats]

Industry Manufacture, Consumption, Export, Import by Regions (2013-2018) Industry Value ($) by Region (2013-2018)

Gene Editing Technologies Market Status and SWOT Analysis by Regions

Major Region of Gene Editing Technologies Marketi) Global Gene Editing Technologies Salesii) Global Gene Editing Technologies Revenue & market share Major Companies List Conclusion

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

About Author:HTF Market Report is a wholly owned brand of HTF market Intelligence Consulting Private Limited. HTF Market Report global research and market intelligence consulting organization is uniquely positioned to not only identify growth opportunities but to also empower and inspire you to create visionary growth strategies for futures, enabled by our extraordinary depth and breadth of thought leadership, research, tools, events and experience that assist you for making goals into a reality. Our understanding of the interplay between industry convergence, Mega Trends, technologies and market trends provides our clients with new business models and expansion opportunities. We are focused on identifying the Accurate Forecast in every industry we cover so our clients can reap the benefits of being early market entrants and can accomplish their Goals & Objectives.

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Gene Editing Technologies Market Major Technology Giants in Buzz Again | Merck, Sangamo Therapeutics, Lonza - Science In Me

Recommendation and review posted by Bethany Smith

Jack PriceMIT Press2020288 pp.Purchase this item now

In the late 19th century, the Spanish neuroanatomist Santiago Ramn y Cajal documented, in exquisite detail, the fantastical, uncharted landscapes of the human brain. The ornate cellular structures he drew were, according to Cajal, fragile and irreplaceable. Brain cells, he stated, may die and cannot be regenerated. Cajal then threw down the gauntlet, asserting that it was the job of the science of the future to change, if possible, this harsh decree.

Jack Prices engaging bookThe Future of Brain Repairdetails past, present, and future attempts to address Cajals formidable challenge. In so doing, it provides a vibrant and compelling guide to the important and rapidly evolving fields of stem cellbased therapies and brain repair, which together, he believes, are poised to deliver unprecedented changes to the management of brain diseases.

Unlike the diverse blood cells generated throughout life by specialized stem cells in bone marrow, the two known brain stem cell typestucked into the underside of the dentate gyrus of the hippocampus and surrounding the ventricles of the forebrain in the subependymal zonedifferentiate into a much more restricted set of cells. This intrinsic lack of versatility, coupled with the fact that brain cells are postmitotic and consequently unable to divide, underlies the brains inability to efficiently repair itself.

Two broad strategies for repair are suggested. The first would be to bypass endogenous neural stem cells by introducing non-native brain cells. The second would be to coax native cells into a different set of behaviors.

Parkinsons disease, a progressive movement disorder caused by the incremental destruction of dopaminergic neurons, has provided a fertile testing ground for the first strategy. The first human neural transplantation experiments conducted during the 1980s, which used dopamine-producing cells from human fetal brain cells or from patients own adrenal medullas, failed to meet expectations. It appeared as if not any old cells would do. Although a proof of concept for the feasibility of such approaches was provided, a more precisely defined and renewable source of donor cells was lacking, as was an accompanying robust and affordable commercial-scale manufacturing process.

In the 1990s, researchers showed that neural progenitor cells could be cultured as neurospheresballs of cells that maintain self-replication and multipotency over protracted durations. This discovery led, in 2006, to the first human neural stem cell transplant in a group of children with Batten disease, a rare neurodegenerative disorder. The results, again, were disappointing: the overall survival of treated patients showed no discernible improvement over that of untreated patients. Similar studies in patients with ischemic stroke have proved more promising, but researchers suspect improvements in these cases resulted from the grafts secretion of neuroprotective proteins rather than from cell replacement.

Two other innovations, however, have the potential to address Cajals regenerative vision. The first is our ability to culture embryonic stem cells (ES cells) to produce billions of pluripotent stem cells, which are, in turn, capable of producing every cell type in the human body. Therapies derived from ES cells have been shown to be highly effective in animal models of Parkinsons disease, with evidence suggesting that the transplanted neurons exert their effect by synthesizing dopamine.

The second innovation issues from the work of Shinya Yamanaka, who demonstrated in 2006 that terminally differentiated cells of any type can be reprogrammed into induced pluripotent stem cells (iPSCs) through the administration of just four transcription factors. iPSCs may then be converted into select cell types using different transcription factor cocktails.

Although not without complicationsextended culture of iPSCs has been shown, for example, to result in mutations in P53 and other oncogenesES cells and iPSCs have the potential to transform the science of brain repair and regenerative medicine by enabling the generation and therapeutic deployment of relevant neuronal subtypes in a scalable and low-cost manner. These cells have the additional advantage of retaining the capacity to build new tissues from scratch.

Perhaps most interesting, however, is the recent convergence of pluripotent stem cells with gene editing. Together, these technologies offer the possibility of augmenting natural neural stem cell behavior.

ACKNOWLEDGMENTSThe reviewer is a shareholder of Sangamo Therapeutics.

The reviewer is the executive vice president of research and development at Sangamo Therapeutics, Brisbane, CA, USA.

Original post:
Stem cell therapies slowly gain traction as viable treatments for brain disorders - Science Magazine

Recommendation and review posted by Bethany Smith

EL SEGUNDO, Calif.--(BUSINESS WIRE)-- NantKwest, Inc. (NASDAQ: NK) and ImmunityBio, Inc., clinical-stage immunotherapy companies within the NantWorks family of companies, today announced they are in active discussions with the U.S. Food and Drug Administration (FDA) for vaccines and therapeutics to combat COVID-19.

Leveraging ImmunityBios expertise in vaccine development and natural killer cell activation, with a broad platform of immunomodulators currently in clinical trials for cancer and infectious diseases, and NantKwests extensive experience in off-the-shelf, cell-based therapeutics, the companies are combining their resources to design and develop therapeutics and vaccines for COVID-19.

Were in a race against time, but I am confident that, as a result of the incredible hard work the NantKwest, ImmunityBio, and the global scientific communities are undertaking, we will find effective therapeutics and vaccines against this coronavirus, said Patrick Soon-Shiong, M.D., Chairman & CEO of NantKwest and ImmunityBio.

Therapeutics:

The biological, immunological, and physiological status of the patients medical state should inform the treatment strategy to reverse the infectivity and tissue damage caused by this virus. ImmunityBio and NantKwest have developed immunomodulator regimens for COVID-19 based on the biological stage of the patients infection - from the mild, moderate to the severe or critically ill state.

In the mild-to-moderate stage of infection, we believe that the patients infection and viral load could be mitigated with natural killer (NK) and T cell stimulation. Hence, in this early-moderate stage of the disease, we are proposing clinical trials of N-803 alone, and a second trial of haNK alone, or haNK combined with convalescent plasma, said Dr. Soon-Shiong.

Investigational New Drug (IND) applications with the FDA for these trials are pending. ImmunityBios Il-15 superagonist N-803 is currently being used in clinical trials for other indications and has achieved Breakthrough Therapy Designation from the FDA[1] for the treatment of BCG-unresponsive non-muscle invasive bladder carcinoma in situ (NMIBC-CIS) patients. It has also demonstrated encouraging results in lowering the viral load in SHIV-infected monkeys[2], as announced last month at the Annual Conference on Retroviruses and Opportunistic Infections (CROI)[3].

In patients requiring ventilatory support in the severe state of COVID-19 disease, we are exploring the use of bone marrow-derived allogenic mesenchymal stem cells (BM-Allo-MSC) to mitigate the cytopathic storm, said Dr. Soon-Shiong.

NantKwest has proprietary isolation and expansion methods for growing MSCs and is using ImmunityBios automated, closed system (GMP-in-a-Box) to safely and rapidly grow these stem cells from a bone marrow cell bank in approximately 7-9 days. NantKwest has filed an IND with the FDA and anticipates beginning trials in Q2 2020.

Vaccines: Developing a platform for both initial immunizations and subsequent booster injections

First generation Adenovirus platforms (Ad5) currently in use are disadvantaged by inducing adenovirus neutralizing antibodies, thus limiting multiple doses and reducing the immune response to the antigen of interest. ImmunityBio has overcome this obstacle through the development of a second generation Ad5 platform. Through multiple deletions in the adenovirus genome, this next generation platform establishes a vector that is immunologically quiet as it relates to adenovirus protein production in the host dendritic cell and enables this same Ad5 vector to serve both as a prime and a boost treatment, even in patients with pre-existing adenovirus immunity. This second-generation Ad5 [E1-, E2b-, E3- deleted] platform has demonstrated safety in Phase I and Phase II studies in immunosuppressed cancer patients.

Furthermore ImmunityBio has extensive infectious disease experience with this second generation Ad5 platform and has published several peer-reviewed articles on studies demonstrating humoral and cell mediated immunity in H1N1 Influenza[4], HIV[5], SIV[6], Lassa Fever[7], Chikungunya, and Zika virus infections.

While development of therapies is urgently needed in this crisis, as urgent is the need to develop a vaccine with long-lasting cell-mediated immunity. Developing vaccines in the time of pandemics requires novel approaches and the use of modernized genomics, molecular dynamics, and vectors that are proven to induce cell-mediated immunity, with mass scale production capabilities. In 2009, with the H1N1 crisis, the scientific team developing this second generation Ad5 platform demonstrated that such a vaccine for the H1N1 pandemic could be developed in six weeks from identification of the H1N1 sequence. This experience in 2009 allows ImmunityBio to respond as rapidly as possible to the COVID-19 pandemic, continued Dr. Soon-Shiong. I view the spike (S) protein and the nucleocapsid (N) protein as the equivalent of a neoantigen in cancer. A recent study by the National Cancer Institute (NCI) in patients with advanced cancer, published in The Oncologist[8] reported positive evidence that this platform could induce antigen-specific T cell immunity, even in the face of previous adenoviral immunity, said Dr. Soon-Shiong. Together with our scientific collaborators at the NCI, we have recently published evidence[9] that the Ad5 platform can successfully induce cell-mediated immunity following the administration of Ad5-Neoantigens, with total remission of the tumor in pre-clinical models. Based on these findings, we are hopeful that the Ad platform could induce a similar immune response to this novel Coronavirus antigen.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in phase I clinical trials in Canada and Europe, as well as in multiple phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells as well as other therapeutics as part of the NANT Cancer Vaccine platform as a cancer treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

About ImmunityBio

ImmunityBio, Inc. is a privately-held immunotherapy company with a broad portfolio of biological molecules at clinical stages of development. The companys goals are to employ this portfolio to activate endogenous natural killer and CD8+ T cells in the fields of cancer and infectious disease. Specifically, ImmunityBios goal is to develop a memory T-cell cancer vaccine to combat multiple tumor typeswithout the use of high-dose chemotherapy. Regarding infectious disease, ImmunityBio is addressing HIV, influenza, and the coronavirus.

ImmunityBios first-in-human platform of technologies has enabled it to achieve one of the most comprehensive, late-stage clinical pipelines, activating both the innate (natural killer cell) and adaptive immune systems. The product pipeline includes an albumin-linked chemotherapeutic (Aldoxorubicin), a novel IL-15 cytokine superagonist (N-803), checkpoint inhibitors, macrophage polarizing peptides, bi-specific fusion proteins targeting TGFb and IL-12, adenovirus, and yeast vaccine therapies targeting tumor-associated antigens and neoepitopes.

In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to N-803 for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC). Other indications currently at registration-stage trials include BCG-unresponsive papillary bladder cancer, first- and second-line lung cancer, and metastatic pancreatic cancer.

ImmunityBios goal is to develop therapies, including vaccines, for the prevention and treatment of HIV, influenza, and the coronavirus SARS-CoV-2.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that ImmunityBio will be successful in improving the treatment of various diseases, including, but not limited to the novel coronavirus and cancer. Risks and uncertainties related to this endeavor include, but are not limited to, the companys beliefs regarding the success, cost and timing of its development activities and clinical trials.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

[1]: ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in NMIBC December 4, 2019 https://www.businesswire.com/news/home/20191204005300/en/ImmunityBio-Granted-FDA-Breakthrough-Therapy-Designation-N-803

[2]: ImmunityBio Announces Durable Virus Control of SHIV Without Anti-Retroviral Therapy (ART) by Activating NK and Memorty T Cells with N-803, an IL-15 Superagonist March 10, 2020 https://immunitybio.com/immunitybio-announces-durable-virus-control-of-shiv-without-anti-retroviral-therapy-by-activating-nk-and-memory-t-cells-with-n-803-an-il-15-superagonist/

[3]: Combination IL-15 Therapy in a SHIV NHP Model Presented at Conference on Retroviruses and Opportunistic Infections (CROI) March 8-11, 2020 Boston, Massachusetts http://www.croiconference.org/sessions/combination-il-15-therapy-shiv-nhp-model

[4]: Prevention of Influenza Virus Shedding and Protection from Lethal H1N1 Challenge Using a Consensus 2009 H1N1 HA and NA Adenovirus Vector Vaccine. Vaccine. 2011 Sep 16; 29(40): 70207026. Published 2011 Aug 5. doi: 10.1016/j.vaccine.2011.07.073

[5]: Induction and Comparison of SIV Immunity in Ad5 Nave and Ad5 Immne Non-Human Primates Using an Ad5 [E1-, E2b-] Based Vaccine. Vaccine. 2011 Oct 19;29(45):8101-7. doi: 10.1016/j.vaccine.2011.08.038. Epub 2011 Aug 22.

[6]: Control of SIV Infection and Subsequent Induction of Pandemic H1N1 Immunity in Rhesus Macaques Using an Ad5 [E1-, E2b-] Vector Platform.Vaccine. 2012 Nov 26; 30(50): 72657270. Published 2012 Oct 2. doi: 10.1016/j.vaccine.2012.09.058

[7]: Adenoviral Vector-Based Vaccine is Fully Protective Against Lethal Lassa Fever Vhallenge in Hartley Guinea Pigs. Vaccine..2019 Oct 23;37(45):6824-6831. doi: 10.1016/j.vaccine.2019.09.030. Epub 2019 Sep 24.

[8]: A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer. The Oncol. doi:10.1634/theoncologist.2019-0608

[9]: Efficient Tumor Clearance and Diversified Immunity Through Neoepitope Vaccines and Combinatorial Immunotherapy. Cancer Immunology Research July 2019 DOI: 10.1158/2326-6066.CIR-18-0620

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NantKwest and ImmunityBio Announce Therapeutics and Vaccines for Combatting COVID-19; Clinical Trials Anticipated to Begin This Quarter - BioSpace

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Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Set to Witness an Uptick during 2017 to 2025 - Science In Me

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The coronavirus pandemic has gripped all countries and infected more than half a million people around the world, so far. Some 100,000 people have also lost their lives to the virus. In Iran, too, all national plans have been drawn up while taking the epidemic into consideration.

The Royan Research Institute, which is a distinguished scientific centre in Iran, is naturally expected to adopt innovative measures in order to boost the societys health at a time when the country is gripped by the coronavirus outbreak. One of the measures for which the research centre is known is its cell-therapy capacity. Recently, Royan has taken action to tap into its cell-therapy potential to fight COVID-19.

Head of the research centre Abdolhossein Shahverdi has, in an interview, weighed in on the measures adopted by the institute to fight the coronavirus, namely the establishment of a molecular diagnostic laboratory.

The Royan Institute has good experience in the field of cell science, he said.

Given that the Royan Research Centre has the necessary infrastructure, we felt that we should tap into its potentialities to help tackle the ordeal which has gripped the country, he added.

Of course, treatments offered by the Royan Institute has, so far, been mostly related to infertility or cell-therapy for hardly curable diseases; however, there was good infrastructure at Roya, and with reliance on this very infrastructure, we began to put into service a molecular diagnosis lab in cooperation with the Ministry of Health and Medical Education to serve as a backup coronavirus diagnosis laboratory, he said.

One of the problems that develop in patients infected with the coronavirus is that their lungs are affected, and these problems may result in subsequent complications. So far, good treatment methods have been used for COVID-19 patients in Iran by drawing on Chinas experience in fighting the coronavirus as well as the findings of medical institutes inside Iran. In addition, a large percentage of patients have recovered using these very methods and returned to the bosom of their families.

he Royan Research Institute has experience in the field of cell therapy and using Mesenchymal stem cells (MSCs). The institute has a record of treating different illnesses using cell therapy. Mesenchymal stem cells are among good cells used in cell therapy and play a role in moderating reactions by the immune system and healing damaged tissue. The research institute has received initial licenses from the Ministry of Health and Medical Treatment to use MSCs. By drawing on its experience in cell therapy and its treatment record in that regard, the Royan Institute has taken the first step in developing a treatment for coronavirus patients through cell therapy and stem cells in cooperation with other hospitals and the Tehran University of Medical Sciences.

In this treatment method, MSCs are used. One of the sources of these cells are umbilical cord blood cells or marrow cells, he noted.

In the past, we had used these cells to treat some incurable illnesses such as cartilage and bone diseases, and we achieved good results, said the director of the institute.He expressed hope the treatment method will successfully pass the stage of clinical tests and prove useful in treating coronavirus patients.

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Stem-Cell-Therapy Proves Effective in Treating COVID-19 - Iran Front Page - IFP News

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In this special edition of the CURE Talks Cancer podcast, we teamed up with our sister publication OncLive on Air to speak with a patient-doctor duo on myeloproliferative neoplasms.

BY Kristie L. Kahl and Gina Columbus

MPNS essential thrombocythemia, myelofibrosis and polycythemia vera begin with an abnormal change, or mutation, in a stem cell in the bone marrow, which leads to an overproduction of any combination of white cells, red cells and platelets.

In this special edition of the CURE Talks Cancer podcast, we teamed up with our sister publication OncLive on Air to speak with a patient-doctor duo on the disease.

Learn more from Dr. Ruben A. Mesa, director of the Mays Cancer Center at UT Health San Antonio MD Anderson, and Antje Hjerpe, a patient diagnosed with essential thrombocythemia in 1992. The pair discuss myeloproliferative neoplasms what they are, how theyre treated and how patients can talk to their doctors to be their own best advocates.

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Patient-Doctor Duo: The Basics of Myeloproliferative Neoplasms - Curetoday.com

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More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients

Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites

Phase 2b/3 trial - First hospital cleared to enroll patients beginning today

VANCOUVER, Washington, April 13, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Companys trials.

Patient enrollment in the Companys two clinical trials and Emergency Investigational New Drug (EIND) is as follows:

-- More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA). -- Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen. -- As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available. -- First site cleared to enroll patients in Phase 2b/3 beginning today.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3...

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In early April, about four months after a new, highly infectious coronavirus was first identified in China, an international group of scientists reported encouraging results from a study of an experimental drug for treating the viral disease known as COVID-19.

It was a small study, reported in the New England Journal of Medicine, but showed that remdesivir, an unapproved drug that was originally developed to fight Ebola, helped 68% of patients with severe breathing problems due to COVID-19 to improve; 60% of those who relied on a ventilator to breathe and took the drug were able to wean themselves off the machines after 18 days.

Repurposing drugs designed to treat other diseases to now treat COVID-19 is one of the quickest ways to find a new therapy to control the current pandemic. Also in April, researchers at Vanderbilt University enrolled the first patients in a much-anticipated study of hydroxychloroquine. Its already approved to treat malaria and certain autoimmune disorders like rheumatoid arthritis and lupus but hasnt been studied, until now, against coronavirus. Yet the medication has become a sought-after COVID-19 treatment after first Chinese doctors, and then President Trump touted its potential in treating COVID-19. The data from China is promising but not conclusive, and infectious disease experts, including Trumps coronavirus task force scientific advisor Dr. Anthony Fauci, arent convinced its ready for prime time yet in Americas emergency rooms and intensive care units.

But doctors facing an increasing flood of patients say they dont have time to wait for definitive data. In a survey of 5,000 physicians in 30 countries conducted by health care data company Sermo, 44% prescribed hydroxychloroquine for their COVID-19 patients, and 38% believed it was helping. Such off-label use in using a drug approved to treat one disease to treat another is allowed, especially during a pandemic when no other therapies are available. A similar percentage said remdesivir was very or extremely effective in treating COVID-19. (Although remdesivir is not approved for treating any disease, the Food and Drug Administration granted special authorization for doctors to use it to treat the sickest COVID-19 patients.)

That explains the unprecedented speed with which the hydroxychloroquine studyand others like itare popping up around the world. There are no treatments proven to disable SARS-CoV-2, the virus that causes the disease, which means all the options scientists are exploring are still very much in the trial-and-error stage. Still, they are desperate for anything that might provide even a slim chance of helping their patients survive, which is why studies are now putting dozens of different therapies and a handful of vaccines to the test. The normal road to developing new drugs is often a long oneand one that frequently meanders into dead ends and costly mistakes with no guarantees of success. But given the speed at which SARS-CoV-2 is infecting new hosts on every continent across the globe, those trials are being ushered along at a breakneck pace, telescoping the normal development and testing time by as much as half.

The newly launched Vanderbilt study, led by the National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health, will enroll more than 500 people who have been hospitalized with COVID-19 and randomly assign them to receive hydroxychloroquine or placebo. It would be the first definitive trial to test whether hydroxychloroquine should be part of standard therapy for treating COVID-19, and its lead scientist expects results in a few months.

The sense of urgency is pushing other researchers at academic institutes as well as pharmaceutical companies to turn to their libraries of thousands of approved drugs or compounds that are in early testing and screening to see if any can disable SARS-CoV-2. Because these are either already approved and deemed safe for people, if any emerge as possible anti-COVID-19 therapies, companies could begin testing them in people infected with the virus within weeks. Other teams are mining recovered patients blood for precious COVID-19-fighting immune cells, and because the virus seems to attack the respiratory system, scientists are also finding clever ways to stop it from compromising lung tissue.

These are all stop-gap measures, however, since ultimately, a vaccine against COVID-19 is the only way to arm the worlds population against new waves of infection. Established pharmaceutical powers like Johnson & Johnson, Sanofi and Glaxo SmithKline are racing shoulder-to-shoulder to with startups using new technology to develop dozens of potential new vaccines, with the hope of inoculating the first people next yearnone too soon before what public health officials anticipate might be another season of either the same, or potentially new, coronavirus.

We know these viruses reside in animal species, and surely another one will emerge, says Dr. David Ho, director of the Aaron Diamond AIDS Research Center and professor of medicine at Columbia University, who is heading an effort to screen antiviral drug compounds for new COVID-19 treatments. We need to find permanent solutions to treating them, and should not repeat the mistake that once an epidemic wanes, interest and political will and funding also wanes.

Its an old-school approach that dates back to the late 19th century, but the intuitive logic behind using plasma from recovered patientstechnically called convalescent plasmaas a treatment might still apply today. Plasma treatments have been used with some success to treat measles, mumps and influenza. The idea is to use immune cells extracted from the blood of people who have recovered from COVID-19 and infuse them into those who are infected, giving them passive immunity to the disease, which could at least minimize some of its more severe symptoms.

Its part of a broader range of tactics that utilize the bodys own immune response as a molecular North Star for charting the course toward new treatments. And by far, antibodies against the virus are the most abundant and efficient targets, so a number of pharmaceutical and biotechnology companies are concentrating on isolating the ones with the strongest chance of neutralizing SARS-CoV-2.

In late March, New York Blood Center became the first U.S. facility to start collecting blood from recovered COVID-19 patients specifically to treat other people with the disease. Doctors at New Yorks Mount Sinai Health System are now referring recovered (and willing) patients to the Blood Center, which collects and processes the plasma and provides the antibody-rich therapy back to hospitals to treat other COVID-19 patients.. Its not clear yet whether the practice will work to treat COVID-19, but the Food and Drug Administration (FDA) is allowing doctors to try the passive immunity treatment in the sickest patients on a case by case basis, as long as they apply for permission to use or study the plasma an investigational new drug. If we can passively transfuse antibodies into someone who is actively sick, they might temporarily help that person fight infection more effectively, so they can get well a little bit quicker, says Dr. Bruce Sachais, chief medical officer at New York Blood Center Enterprises.

The biggest drawback to this approach, however, is the limited supply of antibodies. Each recovered donor has different levels of antibodies that target SARS-CoV-2, so collecting enough can be a problem, especially if the need continues to surge during an ongoing pandemic. At the Maryland-based pharmaceutical company Emergent BioSolutions, scientists are trying to overcome this challenge by turning to a unique source of plasma donors: horses. Their size makes them ideal donors, says Laura Saward, head of the companys therapeutic business unit. Scientists already use plasma from horses to produce treatments for botulism (a bacterial infection), and have found that the volume of plasma the animals can donate means each unit can treat more than one patient (with human donors, at this point, one unit of plasma from a donor can treat one patient). Horses plasma may also have higher concentrations of antibody, so the thought is that a smaller dose of equine plasma would be effective in people because there would be higher levels of antibody in smaller doses, says Saward. By the end of the summer, the company expects its equine plasma to be ready for testing in people.

Scientists are also looking for other ways to generate the virus-fighting antibodies produced by COVID-19 patients. At Regeneron, a biotechnology firm based in New York, researchers are turning to mice bred with human-like immune systems and infected with SARS-CoV-2. Theyre searching hundreds of antibodies these animals produce for the ones that can most effectively neutralize the virus. By mid-April, the company plans to start manufacturing the most powerful candidates and prepare them (either solo or in combination) for human testingboth in those who are already infected, as well as in healthy people, to protect from getting infected in the first place, like a vaccine.

Its not just people and animals that can produce antibodies. Scientists now have the technology to build what are essentially molecular copying machines that can theoretically churn out large volumes of the antibodies found in recovered patients. At GigaGen, a San Francisco-based biotech startup founded by Stanford University professor Dr. Everett Meyer, scientists are identifying the right antibodies from recovered COVID-19 patients and hoping to use them as a template for synthesizing new ones, in a more consistent and efficient way so a handful of donors could potentially produce enough antibodies to treat millions of patients. What GigaGens technology does is almost Xerox copy a big swath of the human repertoire of antibodies, and then takes those copies and grows it in cells [in the lab] to manufacture more antibodies outside of the human body, says Meyer. So we can essentially keep up with the virus. If all goes well and the FDA gives its green light, the company intends to start testing their antibody concoctions in COVID-19 patients early next year.

Researchers at Rockefeller University are following another clue from the human bodys virus-fighting defenses. They discovered in 2017 that human cells make a protein called LY6E that can block a viruss ability to make copies of itself. Working with scientists at the University of Bern in Switzerland and the University of Texas Southwestern Medical Center, they found that mice genetically engineered to not produce the protein became sicker, and were more likely to die after infection with other coronaviruses, including SARS and MERS, compared to mice that were able to make the protein. If the mice have the protein they pretty much survive, says John Schoggins, associate professor of microbiology at the University of Texas. If they dont have it, they dont survivebecause their immune system cant control the virus. While these studies havent yet been done on SARS-CoV-2, given its similarity to the original SARS virus, theres hope a therapy based on LY6E might be useful.

Ideally, Schoggins is hoping to start testing LY6Es potential in infected human lung cells, which SARS-CoV-2 appears to target for disease. The closest mouse model for coronavirus, created to study the original SARS virus, has been retired since research on that virus dwindled after cases wanted following the 2003 outbreak. There wasnt the need to keep the mouse around, and that tells us a lot about the state of our research, says Schoggins. We dont really work on thing unless everyones hair is on fire.

Its not just immune cells that make good targets for new drugs. Other companies are looking at broader immune-system changes triggered by stressduring cancer, for example, or infection with a new virus like SARS-CoV-2that end up making it easier for a virus to infect cells. Drugs that inhibit these stress-related changes would act like molecular gates slamming shut on the cells that viruses are trying to infect.

Because SARS-CoV-2 preferentially attacks lung tissue and causes cells in the respiratory tract to launch a hyperactive immune response, researchers are exploring ways to tame that aggressive response by dousing those cells with a familiar gas: nitric oxide, often used to relax blood vessels and open up blood flow in hospital patients on ventilators who have trouble breathing. While working on a new, portable system for delivering nitric oxide developed by Bellerophon Therapeutics to treat a breathing disorder in newborns, Dr. Roger Alvarez, an assistant professor of medicine at University of Miami, got the idea that the gas might be helpful for COVID-19 patients as well. One symptom of the viral infection is low oxygen levels in the lungs, and nitric oxide is ideally designed to grab more oxygen molecules from the air with each breath and feed it to the lungs. With this system, patients dont need to be in the ICU [Intensive Care Unit] at all, he says. The patient can be in a regular hospital bed, or even at home. So you save the cost of the ICU and from a resource standpoint, you save on needing nursing care, respiratory therapists and other ICU monitoring.

In theory, if this system could be used for COVID-19 patients with moderate symptoms, it could keep those patients from needing a ventilatora huge benefit in the current context where ventilator shortages are one of the biggest threats to the U.S. health care system. So far, Alvarez has received emergency use authorization from the FDA to test a version of his system on one COVID-19 patient at the University of Miami Health System. That patient improved and is ready to go home. Its great news and gives me the information to say that this appears at least safe to study further, he says, which is what he plans to do with the first small trial of nitric oxide for COVID-19 at his hospital.

When it comes to developing a new antiviral treatment, it doesnt always pay to start from scratch. There are dozens of drugs that have become life-saving therapies for one disease after their developers accidentally discovered that the medications had other, equally useful effects. Viagra, for example, was originally explored as a heart disease drug before its unintended effect in treating erectile dysfunction was discovered, and gabapentin was developed as an epilepsy drug, but is now also prescribed to control nerve pain.

Within weeks of COVID-19 cases spiking to alarming levels in China, researchers at Gilead in Foster City, Cal., saw an opportunity. A drug the company had developed against Ebola, remdesivir, had shown glimmers of hope in controlling that virus in the laband also showed promise as a tool to treat coronaviruses like those that caused SARS and MERS. In fact, says Merdad Parsey, chief medical officer of Gilead, We knew in the test tube that remdesivir had more activity against coronaviruses like SARS and MERS than against Ebola. So it wasnt entirely surprising that when the company began testing it in people during last years Ebola outbreak in the Democratic Republic of Congo, the results were disappointing. The early studies against Ebola werent as encouraging in people as they were in animals. So we were basically on hold with the drug, waiting to see if there would be another [Ebola] outbreak to see if we could test it earlier in the infection, says Parsey.

Then COVID-19 happened. As the infection roared through Wuhan, Chinathe original epicenter of the diseaseresearchers there reached out to Gilead, knowing that the company had released data suggesting that remdeisivir had strong antiviral effects in lab studies against coronaviruses. They launched two studies of the drug in the sickest patients.

In mid-January, a man in Everett, Wash., who had recently visited Wuhan, checked into a clinic after a few days of feeling sick. He quickly went from having a fever and cough to having difficulty breathing because of pneumonia. Concerned that the man was worsening by the day, his doctor contacted the U.S. Centers for Disease Control; suspecting this might be a case of COVID-19and knowing there was no proven treatment for the infectionexperts at the agency suggested he try an experimental therapy, remdesivir.

The CDC team felt relatively confident about the drugs safety, if not its effectiveness, since Gilead had studied it extensively in animal models and, in the early trials in people, it didnt lead to any serious side effects and appeared safe. They were also aware of the companys promising data with human cells against the original SARS.

For the Washington patient, the experimental drug might be a lifesaver. A day after receiving remdesivir intravenously, his fever dropped, and he no longer needed supplemental oxygen to breathe. About two weeks after entering the hospital, he was discharged to self-isolate for several more days at home.

That set off a rush for remdesivir as cases in the U.S. went from a trickle to a flood, and doctors grasped for anything to treat quickly declining patients. Gilead initially offered the drug on a compassionate use basis, a process that allows companies, with the FDAs permission, to provide unapproved drugs currently being studied to patients who need them as a last resort. These programs are designed for one-off uses, and companies usually receive two to three requests a month from doctors . But in this case, Gilead was flooded with requests for remdesivir at the beginning of March. And because each one is evaluated on a case-by-case basis to ensure that each patient is eligible and that the potential risks of trying an untested drug dont outweigh the benefits, a backlog developed and the company couldnt respond to the requests in a timely way, says Parsey. So on March 30, Gilead announced it would no longer provide remdesivir through that program but through an expanded access program instead. Doctors can get access to the drug for their COVID-19 patients via dozens of clinical trials of remdesivir, two of which Gilead initiated. One is focused on patients with mild symptoms and one involves those with severe symptoms. The National Institutes of Health is currently heading another large study of the drug, at multiple centers around the country.

Finding a new purpose for existing drugs is ideal; they are likely already proven safe and their developers have a substantial dossier of information on how the drugs work. Thats what happened with hydroxychloroquine, a malaria drug developed after the parasite that causes the illness became resistant to the chloroquine, a drug discovered during World War II and since used widely to fight the disease. As researchers studied hydroxychloroquine in the lab in recent decades , they learned it can block viruses, including coronaviruses, from infecting cells. In lab studies, when researchers infected human cells with different viruses and then bathed them in hydroxychloroquine, those cells could generally stop viruses like influenza, SARS-CoV-2, and the original SARS virus, another type of coronavirus, from infecting the cells. The problem is that what happens in the lab often doesnt predict what happens in a patient, says Dr. Otto Yang, from the department of microbiology, immunology and molecular genetics at the David Geffen School of Medicine at the University of California Los Angeles. In fact, in the case of influenza, the drug wasnt as successful in stopping infection in animals or in people. Similarly, when scientists brought hydroxychloroquine out of the lab and tested it in people, the drug failed to block infection with HIV and dengue as well.

Thats why doctors are approaching hydroxychloroquine with healthy skepticism when it comes to COVID-19 and are only using it on the sickest patients with no other options. Doctors at a number of hospitals, including Johns Hopkins, the University of California Los Angeles, and Brigham and Womens, for example, are starting to use hydroxychloroquine to treat patients with severe COVID-19 symptoms when they dont improve on current supportive treatments. Its not ideal, but If someone is sick in the ICU you try everything possible you can for that person, says Dr. David Boulware, a professor of medicine at the University of Minnesota, who is conducting a study of hydroxychloroquine effectiveness both in treating those with severe disease and in protecting health people from infection.

Other researchers are attempting to trace the same path with other repurposed drugs, including a flu treatment from Toyama Chemical, a pharmaceutical division of the Japanese conglomerate Fujifilm, called favipiravir, which Chinese researchers used to treat patients with COVID-19. More rigorous studies of both remdesivir and favipirivir against SARS-CoV-2 are ongoing; all researchers can say at this point is that they are worth studying further, and that they appear to be safe.

Even cancer drugs are showing promise as COVID-19 treatments, not by neutralizing the virus but by healing the damage infection does to the immune system. The Swiss pharmaceutical giant Novartis, for example, has ruxolitinib (sold under the trade name Jakavi), which was approved by the FDA in 2011 to treat a number of different cancers, and is designed to tamp down an exaggerated immune responsewhich can be caused by both tumor cells and a virus. In the case of SARS-CoV-2, a hyperactive immune response can trigger breathing problems, called a cytokine storm, that require extra oxygen therapy or mechanical ventilation. In theory, ruxolitinib could suppress this virus-caused cytokine storm. Novartis is making its drug available on an emergency use basis for doctors willing to try it on their sickest patients.

Eli Lilly is also testing one of its anti-inflammatory drugs, baricitinib, in severe COVID-19 patients. Like ruxolitinib, baricitinib interferes with the revved up signalling among immume cells that can trigger the inflammatory cytokine storm. According to president of Lilly Bio-Medicines Patrik Jonsson, there are even early hints from case studies of doctors treating COVID-19 patients that the drug may target the virus too, which could mean that it helps to lower the viral load in infected patients. The company is working with NIAID to confirm whether this is the case in a more rigorous study of severe COVID-19 patients, and expects to see results by summer.

It wasnt immediately obvious that baricitinib could potentially treat COVID-19; it took an artificial intelligence effort by UK-based BenevolentAI to scour existing medical literature and descriptions of drug structures to identify baricitinib as a possible therapy.

Such machine learning-based techniques are making the search for new therapies far more efficient than ever before. Chloroquine, hydroxychloroquines parent, came out of a massive war-time drug discovery effort in the 1940s, when governments and pharmaceutical companies combed through existing drug libraries for promising new ways to treat malaria. With computing power that is orders of magnitude greater now, its now possible to single out not just existing drugs with antiviral potential, but entirely new ones that may have gone unnoticed.

When Sumit Chanda first heard of the mysterious pneumonia-like illnesses spiking in Wuhan, China, he had an eerie feeling that the world was about to face a formidable viral foe. He had spent his entire career studying all the clever and devilish ways that bacteria, viruses and pathogens find hospitable hosts and then take up residence, oblivious to how much illness, disease and devastation they may cause. And as director of the immunity and pathogenesis program at Sanford Burnham Prebys Medical Discovery Institute in San Diego, Chanda knew that if the mystery illness striking in China was indeed caused by a new virus or bacteria, then doctors would need new ways to treat itand quickly.

So, he and his team started canvassing a 13,000 drug library, which is funded by the Bill and Melinda Gates Foundation and created by Scripps Research. Our strategy is to take existing drugs and see if they might have any efficacy as an antiviral to fight COVID-19, he says. The advantage of this approach is that you can shave years upon years off the development process and the studies on safety. We want to move things quickly into [testing] in people. In a matter of weeks, he has narrowed down the list of potential coronavirus drug candidates, and because these are already existing drugs and approved for treating other diseases, they are relatively safe, and can quickly be tested in people infected with SARS-CoV-2.

Chandas team isnt the only one taking advantage of this approach. Researchers at numerous pharmaceutical companies, biotech outfits and academic centers are screening their libraries of drugsboth approved and in developmentfor any anti-COVID-19 potential.

At Columbia University, Dr. David Ho, who pioneered ways of creating cocktails of drugs to make them more potent against HIV, is scouring a different library of virus-targeting drugs to pluck out ones that could be effective against SARS-CoV-2. Altogether, he has some 4,700 drugs (approved and in development) to look through, and he believes there is a strong chance of finding something that might be effective against not just SARS-CoV-2 but any other coronavirus that might pop up in coming years. The key, says Ho, is to be prepared for the next outbreak so the work on finding antiviral drugs doesnt have to start from scratch. We know these viruses reside in animal species, he says. We predict in the coming decade there will be more [outbreaks]. And we need to find permanent solutions. We should not repeat the mistake we made after SARS and after MERS, that once the epidemic wanes, the interest and the political will and the funding also wanes. If we had followed through with the work that had begun with SARS, we would be so much better off today.

But today, we are in the midst of a pandemic, and scientists are eager to leave no potentially promising technology untried. Banking on the growing body of science looking at how newborn babies are able to avoid life-threatening infections in their first days in the world, researchers at New Jersey-based Celularity are investigating how placental cells, rich with immune cells that protect the baby in utero, might also become a source of immune defense therapy against COVID-19. Its part of a broader strategy of cell-based treatments that scientists are beginning to explore for treating cancer as well as infectious disease.

On April 1, the company received FDA clearance for its placental cell treatment, based on a group of immune cells called natural killer cells that circulate in the placenta, and are designed to protect the developing fetus from infection. They are programmed to recognize red flags typically sent up by cells infected with viruses like SARS-CoV-2, and destroy them. After the 2002-2003 SARS epidemic, researchers in China found that people who had more severe symptoms of that disease also had deficient populations of natural killer cells.

The FDA green light means the company can launch a small human study using placental natural killer cells against COVID-19. Dr. Robert Hariri, Celularitys founder and CEO, wants to test them first in people who are infected, to see if they can stop the infection from getting worse. Our approach is to flatten the immunologic curve, he says. Our hope is to decrease the size of the viral load and keep it below the threshold of serious symptomatic disease until the patients own immune system can be revved up and respond. If those studies are encouraging, then the company will look at how natural killer cells might be used to pre-charge the immune system to prevent infection with SARS-CoV-2 in the first place.

As effective and critical as these therapies might be, they are a safety net for the best weapon against an infectious disease: a vaccine.

The main reason that a new virus like SARS-CoV-2 has such free license to infect hundreds of thousands of people around the world is because its an entirely new enemy for the human immune system making the planets population an open target for infection. But a vaccine that can prime the body to build an army of antibodies and immune cells trained to recognize and destroy the coronavirus would act as an impenetrable molecular fortress blocking invasion and preventing disease.

Unfortunately, vaccines take time to developyears, if not decades. Scientists at Johnson & Johnson are currently working on a vaccine using fragments of the SARS-CoV-2 spike protein, an easy protein target that sprinkles the surface of the virus like a crown (hence the name coronavirus, from the Latin for crown). The company loads the viral gene for the spike protein into a disabled common-cold virus vector that delivers the genetic material to human cells. The immune system then recognizes the viral fragments as foreign and deploys defensive cells to destroy it. In the process, the immune system learns to recognize the genetic material of the virus, so when the body is confronted by the actual virus, its ready to attack.

Given the manufacturing requirements to build the vaccine, and the studies in animals needed to get a hint of whether the vaccine will work, however, J&Js project is unlikely to come to fruition until mid-2021. We plan to have the first data on the vaccine before the end of the year, says Paul Stoffels, chief science officer at J&J. I would hope that in the first half of next year, we should be able to get vaccines ready for people in high risk groups like health care workers on the front lines.

That timeline is already accelerated quite a bit compared to vaccine research in non-pandemic contexts. But new technology that doesnt require a live transport system could shrink the time to human tests even further. Working with the National Institute of Allergy and Infectious Diseases, Moderna Therapeutics, a biotech based in Cambridge, Mass., developed its mRNA vaccine in a record 42 days after the genetic sequence of the new coronavirus was released in mid January. Its system turns the human body into a living lab to churn out the viral proteins that activate the immune system.

Researchers at Moderna hot wired the traditional vaccine-making process by packing their shot with mRNA, the genetic material that comes from DNA and makes proteins. The viral mRNA is encased in a lipid vessel that is injected into the body. Once inside, immune cells in the lymphatic system process the mRNA and use it like a genetic beacon to attract immune cells that can mount toxic responses against the virus. Our vaccine is like the software program for the body, says Dr. Stephen Hoge, president of Moderna. So which then goes and makes the [viral] proteins that can generate an immune response.

Because this method doesnt involve live or dead virusesall it requires is a lab that can synthesize the correct genetic viral sequencesit can be scaled up quickly since researchers dont have to wait for viruses to grow. Almost exactly two months after the genetic sequence of SARS-CoV-2 was first published by Chinese researchers, the first volunteer received an injection of the Moderna vaccine. The companys first study of the vaccine, which will include 45 healthy participants, will monitor its safety. Hoge is already gearing up to produce hundreds and thousands of more doses to prepare for the next stage of testing, which will enroll hundreds of people, most likely those at high risk of getting infected, like health care workers.

If those results arent as promising as health experts hope, there are other innovative options in the works. At the University of Pittsburgh, scientists who had been developing a vaccine against the original SARS virus have switched to making a shot against the new one. Their technology involves hundreds of microneedles in a band-aid like patch that deliver parts of the coronavirus protein directly into the skin. From there, the foreign viral proteins are swept into the blood and into the lymph system, where immune cells recognize them as invaders and develop antibodies against them. After seeing animals inoculated with their vaccine develop strong antibodies against SARS-CoV-2, the team is ready to submit an application to the FDA to begin testing in people.

Whats different about these new coronavirus efforts is the fact that they arent all designed to control SARS-CoV-2 alone. Recognizing that this coronavirus is the third in recent decades to cause pandemic disease, scientists are focusing on building therapies, including vaccines, that can quickly be adapted to target different coronaviruses that might emerge in coming years. We hope these new technologies become the kinds of things we build in our tool kits that as humans will allow us to respond in a much more accelerated way to the next pandemic, says Modernas Hoge. Because we expect continuing threats from viruses in the future.

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Vaccines, Antibodies and Drug Libraries. The Possible COVID-19 Treatments Researchers Are Excited About - TIME

Recommendation and review posted by Bethany Smith

publication date: Apr. 14, 2020

By Matthew Bin Han Ong

This story is part of The Cancer Letters ongoing coverage of COVID-19s impact on oncology. A fulldirectory of our coverage is availablehere.

In spite of disruptions caused by the coronavirus pandemic, NCI continues to review grants, disburse funds, and support extramural research, said NCI Director Ned Sharpless.

I really wont sugarcoat our present circumstances. This epidemic is bad, and its going to continue to be bad for a while, especially the next few weeks, Sharpless said April 9 in an emergency virtual meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board. We have suspended lab operations on campus and we have stopped all non-essential activities.

But I want to reiterate right now, from an extramural funding point of view, we are fully operational. But, no doubt, things have gotten more complicated, and we have received many, many questions from our investigators about grants, lab suspensions, and what this all means for them.

When we do reach uniform agreement about these funding policies, the NCI is fully committed to disseminating that information as quickly as possible through blogs, our website, Twitter streams, etc.

Thus far, two lessons for U.S. health care and oncology can be derived:

Weve shown that, in a meaningful way, we can take care of patients via telehealth, and I predict cancer patients are going to like this in the future, Sharpless said. Another area where Ive seen a real example of something that, I think, will last after the pandemic, for the good, is the fact that the government can, when it needs to, move really quickly.

We have been involved in complex multi-agency endeavors, but weve been able to really cut through a lot of the process and the usual steps to launch large, innovative, complex research efforts in a matter of days.

The institute, with its research capabilities, has a moral obligation to be involved in the U.S. national response to the pandemic, Sharpless said.

NCI has a long and storied history of intramural virology research, from Doug Lowy and John Schiller and Harold Varmus, to Bob Gallo, to Sam Broderpathbreaking, groundbreaking work on HPV and HIV and RNA tumor virusesand to not use the virology expertise at the NCI during the current pandemic would seem to be a missed opportunity, Sharpless said.

NCI is finalizing plans to use its clinical trials networks to administer a compassionate use protocol for distribution of tocilizumab, a drug that blocks the inflammatory protein IL-6. Under the institutes protocol, the drug will be made available to cancer patients at institutions that are not participating in Genentechs phase III trial of the drug (The Cancer Letter, April 10, 2020).

Other updates at NCI include:

Enrollment of the first patient in a CD33 CAR T trial, a collaboration between the institute and the Childrens Hospital of Philadelphia; and

Appointment of Dan Gallahan as director of the Division of Cancer Biology.

On March 27, Congress passed a $2 trillion coronavirus relief package, the Coronavirus Aid, Relief and Economic Security (CARES) Act. The bill appropriates pandemic response funds in the following amounts: $4.3 billion for CDC, $945.4 million for NIH, $80 million for FDA, and $200 million for CMS (The Cancer Letter, March 27, 2020).

The Congress has done some stuff for coronavirus, Sharpless said. Most probably relevant for the NIH is phase 3, the CARES Act, which provided significant new money for the NIH as well as the FDA and CDC, and it alsoan issue Im sure very important to many of the board membersprovided significant funding for hospitals, given the massive drop in revenues some hospitals are seeing with the cessation of elective surgeries and that type of issue.

Normalcy will return, Sharpless assured the advisory boards.

Im here to tell you well get through this, he said. And this is going to be a tough period for the NCI, for cancer research, but it will come to an end.

Sharplesss remarks to BSA and NCAB follow:

Welcome to our first-ever virtual joint board meeting. This is an emergency meeting that I called to discuss the NCIs response to the coronavirus pandemic. Thank you to all of you for making time. The pandemic has no doubt scrambled your schedules and I really appreciate your being available on short notice. NCI really needs your advice on some complex issues.

Well have talks by Doug Lowy, Dafna [Bar-Sagi] and Jim [Doroshow], and in a closed session Dinah [Singer] will have some further remarks. As noted, there will be time for discussion after the remarks, this is a vital part of todays meeting. Im sure we will all be saying many times today, Could you please all mute? as with my experience with prior WebExs.

One thing I want to make clear from the outset is that this is an emergency meeting to discuss the NCI response to the pandemic. And, necessarily, were going to be talking a lot about the coronavirus pandemic, but I want to make very clear right now that the primary focus of the National Cancer Institute is on cancer research and cancer care. That is our primary focus for now and forever. And this meeting will not supplant other scheduled NCAB or BSA meetings where we will continue to talk more about usual NCI business in those meetings.

Id like to reiterate the points on the slide here that cancer research and cancer care remain job number one at NCI, even though our operations have been somewhat disrupted by the pandemic. And even during these difficult times, I think we are still making progress toward our mission of reducing cancer suffering.

But today is an emergency meeting to talk about a crisis that has gripped our nation and disrupted our work. And Im sure many of you would agree the National Cancer Institute has to be involved in the pandemic response. NCI has unique research capabilities and capacities, so, to help in this complex situation, we believe, is a moral obligation.

First off, the NCI has a long and storied history of intramural virology research, from Doug Lowy and John Schiller and Harold Varmus, to Bob Gallo to Sam Broderpathbreaking, groundbreaking work on HPV and HIV and RNA tumor virusesand to not use the virology expertise at the NCI during the current pandemic would seem to be a missed opportunity.

Also, the Frederick National Lab, which the NCI administers in collaboration with [the National Institute of Allergy and Infectious Diseases], has unique capabilities and resources that are really tailor-made for an emergency situation like this. The facilities at the Frederick Lab are quite exceptional, like the cryo-EM facility and the serology lab that can be useful and deployed in the current pandemic.

Frederick National Lab has unique contracting authorities that allow it to move very quickly to set up new research as needed. And it has the ability to form robust collaborative relationships, both with extramural scientists as well as industry. And so for these reasons its really well suited to take on the coronavirus pandemic. And Doug Lowy will be talking about many of the ways weve been using Frederick National Lab in conjunction with NIAID during the present crisis.

And then, lastly, the NCI supports the worlds best scientists bar none, and through our extramural funding programs, and thats through our networks and our individual investigator-initiated grants, and these individuals have tremendous research capabilities and skills that can be very useful in a pandemic. So, not to involve the extramural fundees would seem, also, a missed opportunity. And we have heard a lot from you on this question.

Ive had many conversations and emails with cancer center directors and scientists, with clinicians, with trainees at the various cancer centers about what you can do to work on the coronavirus pandemic and how the NCI can support those efforts. And thank you for giving us that feedback, and thank you for volunteering your expertise. In short, because of these reasons and others, we believe the NCI has important contributions to make during the coronavirus pandemic.

Just as the pandemic, no doubt, has changed operations at your institution, it has radically changed how the NIH and the NCI operate. Were still able to keep research going while complying with physical distancing. One of our awesome WebExs is to do a senior weekly leadership meeting by this format and how well that works. We have suspended lab operations on campus and we have stopped all non-essential activities.

But the clinical center is still operationaltreating patients, including cancer patients, with lifesaving therapies. It has reduced elective procedures and has taken in some COVID-19 patients, but it still continues to work, and NCI staff work there under, as you can imagine, difficult circumstances.

In order to reconfigure a 3,000-personnel organization with thousands of contractors in such a rapid capacity is really a challenge, but Ive been thrilled and impressed by how much weve been able to do, even virtually. Im also very excited to see how cross-government collaborations have sprung up in a very rapid and direct manner, both across the NIH and the rest of federal government.

In the last few weeks, the NCI has started very important mutual research efforts with NIAID, with [the National Institute of Biomedical Imaging and Bioengineering], with [the National Heart, Lung, and Blood Institute], and with the Aging Institute. We are also working very intimately with other federal agencies, including the FDA, the CDC, BARDA, and other parts of the HHS.

One other point Ill make is that although the pandemic has disrupted operations, I believe we will take some very valuable and meaningful things from this experience. Some of the changes that are being inflicted upon us may actually lead to some good overall.

Two important examples: the first, I believe telehealth is here to stay. Weve shown that, in a meaningful way, we can take care of patients via telehealth, and I predict cancer patients are going to like this in the future. Theyre going to like the ability to see their doctor sometimes virtually, rather than in person.

And by the way, I will mention now that this is a tremendous pop-sci research opportunity. If youre studying implementation science, your moment has arrived, because a thing like this where weve gone from nobody using telehealth to a large part of the country using telehealthin, really, a couple of daysis a tremendous change in our practice, and really will lead to some great research, I believe.

Another area where Ive seen a real example of something that, I think, will last after the pandemic, for the good, is the fact that the government can, when it needs to, move really quickly. We have been involved in complex multi-agency endeavors, but weve been able to really cut through a lot of the process and the usual steps to launch large, innovative, complex research efforts in a matter of days.

Jim Doroshow will talk about some of the clinical trials the NCI has recently stood up. I think these are some of the fastest trials that weve ever gotten started at the NCI in our history, and Doug Lowy will talk about many of the efforts at Frederick National Lab, including a serology effort theyre working with the FDA, it just has to be seen to be believed what theyve started in just a few weeks (The Cancer Letter, April 10, 2020).

We also wont cover everything the NCI is doing. It is just too much. We really have too many activities in this space, so I wont really talk about our work with BARDA or what were doing in the SBIR program with small companies that work on coronavirus, or a very interesting set of collaborations with the NIBIB on a novel data platform that is aimed to help people get back to work.

But we will focus on a few of the more visible efforts in later talks. I hope that as life gets back to normal, we in the federal government can take these lessons were learning from the pandemic about how to do business differently and that will help cancer research in the future.

Im pleased to report that the NCIs Cancer Information Service, 1800-4-CANCER is fully operational and has been up continuously throughout the pandemic, even though its gone remote. Weve already received hundreds of inquiries related to the coronavirus, as of yesterday. Most of the questions from cancer patients for their loved ones involve questions about risk and whether they are considered immunocompromised, whether their cancer puts them in increased risk.

As you can imagine, the nature of calls to 1800-4-CANCER really has changed during the pandemic. We get questions now like, Should I go to my doctor? Can I get my scheduled chemotherapy? Can I get a blood transfusion? Im sure your institutions are dealing with these same questions. The Cancer Information Service is a highly visible service of the NCI that we provide for patients and it is moving along rapidly and working fully in a full capacity, even during the pandemic.

Weve also produced some new key resources for patients and caregivers. A few examples are shown here. So, we stood up a coronavirus page with information for people with cancer as of March 13, that website has already received more than 60,000 visits. Its the fourth most-visited page on our website. In addition, we have also stood up a coronavirus page targeted to researchers as of March 25, and that website has received 1,400 visits and well provide these links in the material for the meeting and they can also be easily accessed from cancer.gov.

In addition, were trying to maintain really strong communications to our research community. Theres been lots of internal communications. I did a virtual town hall meeting using the similar format to this that had 4,000 live attendees.

Here, Im highlighting some of our external communications efforts: weve done cancer.gov websites, as I mentioned, weve had several blogs, weve done social media through many of our Twitter accounts, including the highly popular NCI Director account.

We really want people to understand whats going on with grants and other funding matters. I had an NCI Bottom Line blog post on NCI funding during the coronavirus pandemic thats received 5,500 visits since its publication on March 23, and it has some useful information for extramural fundees, and I commend it to all of you.

Also, Oliver Bogler has written a Bottom Line blog post about training grant issues, K awards, and F awards, and T awards and their deadlines and their reporting requirements, and how the NCI is going to handle those issues. Thats up now, and I commend it to all of you. In summary, were trying to maintain communications to all our stakeholders, NCI employees, researchers, caregivers, and most importantly, patients throughout the time of the pandemic.

The coronavirus has really affected how we do business at the NCI and, no doubt, how you do business at your institutions. But I want to reiterate right now, from an extramural funding point of view, we are fully operational. We are up and running, we can review grants, we can disburse funds, we can do what we normally need to do to support the extramural research community. But, no doubt, things have gotten more complicated, and we have received many, many questions from our investigators about grants, lab suspensions, and what this all means for them.

Cancer center directors, trainees, postdocs, integrated research programs, individual scientists have all been asking us lots of questions and Ive listed some of the key issues here, like deadlines for applications and the use of funds and flexibility around reporting requirements and extensions for training periods. And let me say, I provided some material in advance from the Office of Extramural Research, Mike Lauers office at the NIH, that has a lot of really great information in that document, recently updated and is current, and I commend it to all of you, because it talks about a lot of these issues in detail.

Certainly, we can talk about any one of these more in a Q&A, if theres interest. But I will say, as a general principle, the NCI is trying to provide maximal flexibility to investigators so they can get their important work done during this crisis. We really want to avoid work stoppages, we want to avoid layoffs, we want to avoid a loss of the research capacity for cancer research in the United States.

Although, it has to be acknowledged that the policies we adopt at the NCI have to fit within policies of the greater federal government, we cannot really go it alone on extramural grant policies, as what we do has to agree with what the NIH and other grant making organizations within the federal government do.

But when we do reach uniform agreement about these funding policies, the NCI is fully committed to disseminating that information as quickly as possible through blogs, our website, Twitter streams, etc.

Its also important to note that we have a number of funding opportunities both not related to coronavirus, and I think those are out and probably familiar to many of you, and we also expect to have some coronavirus-related funding opportunities appearing soon, so please stay tuned for that.

We have some good news from a leadership point of view here at the NCI. Dan Gallahan, after being acting director of the Division of Cancer Biology for a while, has now become the director of the Division of Cancer Biology. We have really benefited from Dans leadership, and NCI is very lucky to have Dan in this role, which is tremendously important for the NCI. I would like to give a round of virtual applause for Dan Gallahan. Hey, alright, that worked!

I would also like to thank Dinah Singer, who held this position prior to Dan. She has now moved to become the deputy director of the NCI, and as I mentioned, well be hearing from Dinah later on some important topics related to the NCIs extramural programs.

It is clear that Congress is extremely interested in our activities during the coronavirus pandemic. This is a hearing that was held on March 4that was like a month agoLabor-HHS subcommittee for the House Appropriations Committee, where there were a lot of questions about how the United States is responding. Doesnt this really seem like a lifetime ago? I mean, here we all were, packed in a room, close together, not wearing masks, talking to each other. I had hair back then, that was a while ago.

Sitting beside me, by the way, is Americas most famous scientist, Tony Fauci [director of NIAID]. I think Tony and I have had a very close working relationship my entire time at the NCI, but it has really gotten a lot closer, because of the joint NIAID-NCI activities during the pandemic, and I think the nation as a whole is so lucky to have Tonys leadership during this time. He is a remarkable American institution.

At this hearing, as you can imagine, there was a tremendous amount of questions about the coronavirus and the pandemic, but also this is the subcommittee, I remind you, chaired by Rosa DeLauro (D-CT) and Tom Cole (R-OK).

There was a lot of interest in cancer research. That group is very committed to cancer science and we had some great discussions about cancer research, paylines, pediatric cancer, clinical trials and many other topics. So, while Congress is very interested in coronavirus for the moment, they are consistently also very interested in supporting cancer research as they have done generously for a while.

I would say this congressional interest since this March 4 hearing has significantly even further intensified. Over the last week alone, I have spoken with, I think, maybe three or four senators and representatives about NCI activities related to the pandemic, and also with various staff for the House and the Senate, and these conversations really continue.

The Congress has done some stuff for coronavirus. Shown here are three fairly large supplemental spending packages that have moved rapidly through Congress to support a number of things regarding science and patient care, and the American economy. Most probably relevant for the NIH is phase 3, the CARES Act, which provided significant new money for the NIH as well as the FDA and CDC, and it alsoan issue Im sure very important to many of the board membersprovided significant funding for hospitals, given the massive drop in revenues some hospitals are seeing with the cessation of elective surgeries and that type of issue.

Another thing we just learned recently is the FDA position regarding the CARES Act, which has a provision that all Americans can get testing for the coronavirus. And as I said, the FDA interprets that to mean both RT-PCR testing for the coronavirus as well as serologic IgG, IgM antibody testing for the coronavirus. This has very significant implications for the Frederick National Lab serology effort that Doug Lowy will be talking about later. Theres also talk, Im sure many of you heard, about the possibility of a fourth supplemental spending bill. Should that happen, there is a good chance, I think, that there will be funding in that for the NIH and for the clinical center.

I really couldnt resist, as I said, even though you know its a lot of coronavirus going on around here right now, cancer really does continue at a brisk pace despite all the measures being taken to mitigate the pandemic, and I just wanted to highlight a few of those examples. These are things that have just happened in the last few weeks to give everyone a sense of how things are still moving along in the cancer research enterprise.

So, one about which Im very excited is we enrolled our first patient on our CD33 CAR T trial. This is a trial for young adults and children with acute leukemia that has relapsed or refractory. And this is a first-in-man trial of a new CAR antigen and that reflects the work of Nirali Shah and collaborators at CHOP.

And thats all important, but what is particularly remarkable at this trial in my mind is that the cells were made at our new Frederick National Lab facilities. So, that cellular therapies facility is open for business now.

We have a vision of doing several types of highly personalized cancer therapy for patients at Frederick National Lab, and I think the cellular program is just the beginning of that. So, Id really like to congratulate Jim Doroshow and the Frederick National Lab team for getting this facility up and running so quickly.

The facility can make the CAR T cells there, and then ship them to a participating clinical trial site, in this case CHOP. And this technical advance is great news for kids and adults with leukemia, but I think well see it spread to other CAR T trials soon.

This is a paper that came out from the intramural program from [Division of Cancer Epidemiology and Genetics] about a week or two ago, also with collaborators at NIA and CDC, and this shows a very strong association of steps per day with all-cause mortality.

So, people who get 12,000 steps per day have a lower all-cause mortality than people who get 8,000 steps per day, who have a lower all-cause mortality than people who get 4,000 steps per day.

When Im sheltering in place during a pandemic, this issue is really key. Ive been trying to get out of the house to get my steps in, not just for my all-cause mortality, but for my mental health, and this great study was led by Chuck Matthews and others in DCEG.

This is a wonderful story 30 years in the making, 30 years of intramural research at the NIH about the use of selumetinib in NF1. It started with a fresh faced young geneticist named Francis Collins, who, while faculty at the University of Michigan, along with others, first discovered the gene NF1 that is mutated in this congenital pediatric cancer predisposition syndrome. And then people like Doug Lowy and others figured out what NF1 does from a biochemical standpoint and its role in Ras/MEK signaling.

And then a lot of studies, a number, over a decade of studies in the intramural program to try and address NF1 in patients. And those were largely led by Brigitte Widemann pictured here. And finally, after a lot of things that didnt work, recently the NCI and Brigitte have developed this therapy that is really a notable success. Its published recently in the New England Journal. This is not a cure for neurofibromatosis, but its incredibly meaningful for patients and vastly improves their quality of life. I really want to take my hat off to the people in the pediatric oncology grants who have developed this over so many years.

Theres just too much great science in the extramural community to mention it all and its so rapid and staggering in its output. I thought I would show one slide that I particularly liked, which is a story from my old friend Sean Morrisons lab showing this interesting relationship between metastasis and melanoma spread.

Metastasis is one of the great unsolved riddles of cancer research, and I think science like this that helps us understand the cellular basis of that process is really, really key, and is a good example of why basic research is what really moves the needle, in my opinion, for cancer patients over the long term.

And this is why Ive been such a fierce defender of the RPG pool my entire time, because it produces great basic science like this, and I believe someday were going to be able to prevent metastasis because of studies in this vein.

So, let me close now. I really wont sugarcoat our present circumstances. This epidemic is bad, and its going to continue to be bad for a while, especially the next few weeks. This period of waiting for some normalcy to return has made me think a lot about what it was like when I was a leukemia doctor.

In leukemia, in acute leukemia, you give patients a big bolus of chemotherapy, and then you wait four to six weeks for them to recover their bone marrow and go home. And induction chemotherapy, as many of you know, involves a lot of waiting and a lot of anxiety, hoping for a return to a more normal time.

And this period now reminds me a lot of waiting for bone marrow to return and the inpatient service while were waiting for this pandemic to abate. And in particular, Ive been thinking about a former patient from that time. He was an English professor who taught undergrads English literature, and hed gotten his induction chemotherapy, and was waiting in that hospital for his bone marrow to recover, so he could go home.

Now, a little-known fact is that I was an English major for about a month, as an undergraduate, before I realized how much writing an English major entails, and then I switched to become a math major. But Ive always loved literature, and Ive always taken the chance to learn from my patients. So, when I would come in every morning with my huge team of residents, medical students and pharmacists to round on this patient, we would always ask him for some great thought from English literature to summarize his day.

Original post:
Sharpless: NCI is fully operational, we have a moral obligation to help in the COVID-19 pandemic response - The Cancer Letter

Recommendation and review posted by Bethany Smith

Why Young People Should Not Take AAS

Adapted from the r/steroids Wiki

Nandrolone has been reported to induce psychiatric side effects such as aggression and depression. Adolescence represents an extremely sensitive neurodevelopmental period to influence by detrimental effects.

Side Effects of Drugs Annual (2015)

AAS use by teenagers is a primary concern because of the potential side effects where remodeling of the brain and behavioral maturation occurs.

Journal of Behavioral Processes (2015)

Until you're around the age of 25, your brain and endocrine system are still developing. This should be obvious as you are still going through the end of puberty, getting acne, etc. During this time period, supplementing with exogenous hormones is extremely dangerous.

Taking anything before you are completely finished with puberty can have negative side effects. While you are maturing, your brain, organs, and cells are consistently gauging the overall development of your body. When you introduce a foreign substance, you risk your bodys ability to truly judge how far along your maturation is, resulting in the possibility of premature shutdown or stunting your growth and development processes.

Natural Blast

Your body is already pumping out blast levels of testosterone as part of the natural course of late adolescence. It's the highest that it's ever going to be in your lifetime.

Why prematurely shut that down and ruin a great thing? You're essentially on free steroids right now. Don't take that opportunity for granted and abort your own physiological development by injecting additional variables that short-circuit the whole equation.

Sides

There's a serious potential for long-term side effects. People oft-say I've stopped growing, so it's okay. No: it's not okay. The rest of you hasn't finished developing yet. There are many other potential side effects besides simply your growth plates. Here are a few.

Brain Function, Memory, Alzheimers Disease

It's well known that hormones play a role in the development of cognitive brain function. Your neuroendocrine system is still developing until the age of 25. Adding external hormones when your brain is still developing can stunt normal development and maturation.

Many steroids are neurotoxic.

They lead to depression, memory loss and learning difficulties.

They cause longstanding dysfunction in brain reward systems.

They give rise to the accumulation of amyloid plaques, which leads to Alzheimers.

Do you really want to add these variables to a still-growing and developing brain? How can you know many years down the road there won't be even more problems?

Cancer, Liver, Kidney Disease

You hear all the time teenagers say Well my friends it and they got big and nothing happened to them. Really? How do you know? Have they been to a doctor and had their liver and kidney values checked? Just because a person looks okay on the outside, doesn't mean that they don't already host serious problems on the inside. If treated improperly or in an untimely manner, liver and kidney damage can prove to be fatal.

Premature Closing of Growth Plates

This one is the most known about. Even if you think you've stopped growing, there still is a potential for height increase over time. Scientists have found that growth plates don't fuse completely in some cases until individuals are past 22. Don't be deterred just because you haven't grown taller in awhile. You grow out as well as up. Do you want broader shoulders, or do you want to stay stuck with what you've got now?

Impotence

Your neuroendocrine system is still developing. Supplementing with hormones while you are still growing can potentially cause permanent impotence and fertility issues in teenagers. When you add testosterone, estrogen and a wealth of other synthetic androgens to your body it can cause problems with your normal testicular growth and function. Remember, some of these effects are more than just temporary.

Gyno, or Bitch Tits

Androgen usage in teens increases the risk of gyno. Gyno has already been known to happen naturally in many teenagers because of fluctuating hormones. When you add more hormones to the mix, you dramatically increase the problems. Remember once you have gyno, it's very hard to get rid of. Unless you take the proper precautions up front, you'll have to resort to surgery and go under the knife.

Hair Loss, Acne, Prostate Dysfunction

All of these can be accelerated and aggravated with exogenous androgen use.

Have you seen a 20-year old already going bald?

What about permanent scarring from severe cystic acne?

How about being unable to use the bathroom due to the excruciating pain involved in the process? It's not pretty.

Don't think it can't happen to you.

References

A few references.

Trenbolone neurotoxicity:

Deca, or Nandrolone, is eleven times more damaging to blood vessels than Testosterone. It causes longstanding changes in the brain reward system, affects learning and memory, and induces genetic damage across multiple organ systems.

Nandrolone impaired spatial learning and memory, and this effect was not rescued by exercise. The harmful effects of ND and other AAS on learning and memory should be taken into account when athletes decide to use AAS for performance or body image improvement.

Adapted from the r/steroids Wiki

Originally posted here:
[Discussion] Dealing with shitty male genetics. : steroids

Recommendation and review posted by Bethany Smith

A team of researchers from eight institutions in China and the U.S. has offered a fresh insight into why 85 patients died of multiple organ failure after suffering severe COVID-19.

All individuals whose data the team studied received care at either the Hanan Hospital or the Wuhan Union Hospital between January 9 and February 15, 2020.

The researchers came from the Chinese Peoples Liberation Army General Hospital in Beijing, and the University of California Davis and six other institutions.

Their study uncovered a series of factors that the majority of these patients shared.

The study has been published by the American Journal of Respiratory and Critical Care Medicine.

The majority were older malesThe research team was able to access and analyze the deceased patients medical histories, including whether they had any underlying, chronic conditions.

The researchers were also able to find out what symptoms the patients experienced once they had contracted the virus and access information from laboratory tests and CT scans.

They also accessed information about the medical treatment they received while in the hospitals.

They found that 72.9% of those who died with COVID-19 were male, with a median age of 65.8 years and underlying chronic conditions, such as heart problems or diabetes.

The greatest number of deaths in our cohort were in males over 50 with noncommunicable chronic diseases, the investigators note.

They found that 72.9% of those who died with COVID-19 were male, with a median age of 65.8 years and underlying chronic conditions, such as heart problems or diabetes. The greatest number of deaths in our cohort were in males over 50 with noncommunicable chronic diseases, the investigators note.

We hope that this study conveys the seriousness of COVID-19 and emphasises the risk groups of males over 50 with chronic comorbid conditions, including hypertension (high blood pressure), coronary heart disease, and diabetes, they have commented.

The team also notes that, among the 85 patients whose records it analyzed, the most common COVID-19 symptoms were fever, shortness of breath, and fatigue.

Some important observationsIn terms of other potentially relevant information, the research team found that 81.2% of the study individuals had very low eosinophil [a type of white blood cells, which are specialized immune cells that help fight infection] counts on admission.

Among the complications that the patients experienced while hospitalised with COVID-19, some of the most common were respiratory failure, shock, acute respiratory distress syndrome, and cardiac arrhythmia, or irregular heartbeat.

As part of their treatment, the majority received antibiotics, antivirals, and glucocorticoids, and some received intravenous immunoglobulins (also known as antibodies), or interferon alpha-2b, which is also a stimulant for the immune response.

Yet, the researchers note, the effectiveness of medications, such as antivirals or immunosuppressive agents, against COVID-19 is not completely known.

Based on their observations, the authors indicate that treatments, including combinations of antimicrobial drugs, did not appear to have much of a positive effect.

Perhaps our most significant observation is that while respiratory symptoms may not develop until a week after presentation, once they do there can be a rapid decline, as indicated by the short duration between time of admission and death (6.35 days on average) in our study, they write.

They also suggest that having abnormally low levels of eosinophils a condition known as eosinophilopenia may correlate with a greater risk of severe outcomes in people who have contracted SARS-CoV-2.

While they hope that their current findings may help other doctors better understand and prepare for fighting COVID-19, the researchers nevertheless urge the global scientific community to keep on recording all possible information about people receiving care for this new illness.

Our study, which investigated patients from Wuhan, China, who died in the early phases of this pandemic, identified certain characteristics, the researchers say, yet as the disease has spread to other regions, the observations from these areas may be the same, or different.

They continue: Genetics may play a role in the response to the infection, and the course of the pandemic may change as the virus mutates, as well.

Since this is a new pandemic that is constantly shifting, we think the medical community needs to keep an open mind as more and more studies are conducted.

*Originally published by Medical News Today

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Insight: What those dying of COVID-19 have in common - P.M. News

Recommendation and review posted by Bethany Smith

Global Genetic Testing for Consumers (DTC) Market Size, Status and Forecast 2020-2026

In 2019, the global Genetic Testing for Consumers (DTC) market size was US$ xx million and it is expected to reach US$ xx million by the end of 2026, with a CAGR of xx% during 2021-2026.

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Top key players @ Mapmygenome, Karmagenes, Helix OpCo LLC, Full Genome Corporation, FamilytreeDNA (Gene By Gene), Easy DNA, Color Genomics, MyHeritage, Living DNA, Identigene, Ancestry, 23andMe, Pathway Genomics, and Genesis Healthcare

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TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendix

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Global Genetic Testing for Consumers (DTC) Market Size Industry Research Report, Growth Trends and Competitive Analysis 2020-2025 - Science In Me

Recommendation and review posted by Bethany Smith

The Predictive Genetic Testing market report aims to offer an extensive overview of the market with broad segmentation on the basis of products, services, application, as well as regional overview. In addition, the Predictive Genetic Testing market report also provides a complete analysis of the global market trends that are influencing the global market over the forecast period. Moreover, the global Predictive Genetic Testing market is likely to witness a significant growth over the forecast period.

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Global Predictive Genetic Testing Market 2020: Development Trends, Application, Capabilities and Technologies, Expert's Analysis & Competitive...

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Progressive Report On Male Hypogonadism Market By Growth, Demand & Opportunities & Forecast To 2025 | Astrazeneca Plc., Eli Lilly and Company...

Recommendation and review posted by Bethany Smith

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Male Hypogonadism Market 2020: Insights and Regional Forecast to 2026 TRUX Route Management Systems, Soft-Pak, Cairn Applications, 21st Century...

Recommendation and review posted by Bethany Smith

Complete study of the global Testosterone Cypionate market is carried out by the analysts in this report, taking into consideration key factors like drivers, challenges, recent trends, opportunities, advancements, and competitive landscape. This report offers a clear understanding of the present as well as future scenario of the global Testosterone Cypionate industry. Research techniques like PESTLE and Porters Five Forces analysis have been deployed by the researchers. They have also provided accurate data on Testosterone Cypionate production, capacity, price, cost, margin, and revenue to help the players gain a clear understanding into the overall existing and future market situation.

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Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Testosterone Cypionate industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Testosterone Cypionate market include _Pfizer, Cipla, Sun Pharmaceutical, Teva, Perrigo, Hikma Pharmaceuticals

Key questions answered in the report:

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TOC

Table of Contents 1 Testosterone Cypionate Market Overview1.1 Product Overview and Scope of Testosterone Cypionate1.2 Testosterone Cypionate Segment by Type1.2.1 Global Testosterone Cypionate Sales Growth Rate Comparison by Type (2021-2026)1.2.2 200 mg/mL1.2.3 100 mg/mL1.3 Testosterone Cypionate Segment by Application1.3.1 Testosterone Cypionate Sales Comparison by Application: 2020 VS 20261.3.2 Primary hypogonadism1.3.3 Hypogonadotropic hypogonadism1.3.4 Late-onset hypogonadism1.4 Global Testosterone Cypionate Market Size Estimates and Forecasts1.4.1 Global Testosterone Cypionate Revenue 2015-20261.4.2 Global Testosterone Cypionate Sales 2015-20261.4.3 Testosterone Cypionate Market Size by Region: 2020 Versus 2026 2 Global Testosterone Cypionate Market Competition by Manufacturers2.1 Global Testosterone Cypionate Sales Market Share by Manufacturers (2015-2020)2.2 Global Testosterone Cypionate Revenue Share by Manufacturers (2015-2020)2.3 Global Testosterone Cypionate Average Price by Manufacturers (2015-2020)2.4 Manufacturers Testosterone Cypionate Manufacturing Sites, Area Served, Product Type2.5 Testosterone Cypionate Market Competitive Situation and Trends2.5.1 Testosterone Cypionate Market Concentration Rate2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue2.5.3 Market Share by Company Type (Tier 1, Tier 2 and Tier 3)2.6 Manufacturers Mergers & Acquisitions, Expansion Plans2.7 Primary Interviews with Key Testosterone Cypionate Players (Opinion Leaders) 3 Testosterone Cypionate Retrospective Market Scenario by Region3.1 Global Testosterone Cypionate Retrospective Market Scenario in Sales by Region: 2015-20203.2 Global Testosterone Cypionate Retrospective Market Scenario in Revenue by Region: 2015-20203.3 North America Testosterone Cypionate Market Facts & Figures by Country3.3.1 North America Testosterone Cypionate Sales by Country3.3.2 North America Testosterone Cypionate Sales by Country3.3.3 U.S.3.3.4 Canada3.4 Europe Testosterone Cypionate Market Facts & Figures by Country3.4.1 Europe Testosterone Cypionate Sales by Country3.4.2 Europe Testosterone Cypionate Sales by Country3.4.3 Germany3.4.4 France3.4.5 U.K.3.4.6 Italy3.4.7 Russia3.5 Asia Pacific Testosterone Cypionate Market Facts & Figures by Region3.5.1 Asia Pacific Testosterone Cypionate Sales by Region3.5.2 Asia Pacific Testosterone Cypionate Sales by Region3.5.3 China3.5.4 Japan3.5.5 South Korea3.5.6 India3.5.7 Australia3.5.8 Taiwan3.5.9 Indonesia3.5.10 Thailand3.5.11 Malaysia3.5.12 Philippines3.5.13 Vietnam3.6 Latin America Testosterone Cypionate Market Facts & Figures by Country3.6.1 Latin America Testosterone Cypionate Sales by Country3.6.2 Latin America Testosterone Cypionate Sales by Country3.6.3 Mexico3.6.3 Brazil3.6.3 Argentina3.7 Middle East and Africa Testosterone Cypionate Market Facts & Figures by Country3.7.1 Middle East and Africa Testosterone Cypionate Sales by Country3.7.2 Middle East and Africa Testosterone Cypionate Sales by Country3.7.3 Turkey3.7.4 Saudi Arabia3.7.5 U.A.E 4 Global Testosterone Cypionate Historic Market Analysis by Type4.1 Global Testosterone Cypionate Sales Market Share by Type (2015-2020)4.2 Global Testosterone Cypionate Revenue Market Share by Type (2015-2020)4.3 Global Testosterone Cypionate Price Market Share by Type (2015-2020)4.4 Global Testosterone Cypionate Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Global Testosterone Cypionate Historic Market Analysis by Application5.1 Global Testosterone Cypionate Sales Market Share by Application (2015-2020)5.2 Global Testosterone Cypionate Revenue Market Share by Application (2015-2020)5.3 Global Testosterone Cypionate Price by Application (2015-2020) 6 Company Profiles and Key Figures in Testosterone Cypionate Business6.1 Pfizer6.1.1 Corporation Information6.1.2 Pfizer Description, Business Overview and Total Revenue6.1.3 Pfizer Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.1.4 Pfizer Products Offered6.1.5 Pfizer Recent Development6.2 Cipla6.2.1 Cipla Testosterone Cypionate Production Sites and Area Served6.2.2 Cipla Description, Business Overview and Total Revenue6.2.3 Cipla Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.2.4 Cipla Products Offered6.2.5 Cipla Recent Development6.3 Sun Pharmaceutical6.3.1 Sun Pharmaceutical Testosterone Cypionate Production Sites and Area Served6.3.2 Sun Pharmaceutical Description, Business Overview and Total Revenue6.3.3 Sun Pharmaceutical Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.3.4 Sun Pharmaceutical Products Offered6.3.5 Sun Pharmaceutical Recent Development6.4 Teva6.4.1 Teva Testosterone Cypionate Production Sites and Area Served6.4.2 Teva Description, Business Overview and Total Revenue6.4.3 Teva Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.4.4 Teva Products Offered6.4.5 Teva Recent Development6.5 Perrigo6.5.1 Perrigo Testosterone Cypionate Production Sites and Area Served6.5.2 Perrigo Description, Business Overview and Total Revenue6.5.3 Perrigo Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.5.4 Perrigo Products Offered6.5.5 Perrigo Recent Development6.6 Hikma Pharmaceuticals6.6.1 Hikma Pharmaceuticals Testosterone Cypionate Production Sites and Area Served6.6.2 Hikma Pharmaceuticals Description, Business Overview and Total Revenue6.6.3 Hikma Pharmaceuticals Testosterone Cypionate Sales, Revenue and Gross Margin (2015-2020)6.6.4 Hikma Pharmaceuticals Products Offered6.6.5 Hikma Pharmaceuticals Recent Development 7 Testosterone Cypionate Manufacturing Cost Analysis7.1 Testosterone Cypionate Key Raw Materials Analysis7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price Trend7.1.3 Key Suppliers of Raw Materials7.2 Proportion of Manufacturing Cost Structure7.3 Manufacturing Process Analysis of Testosterone Cypionate7.4 Testosterone Cypionate Industrial Chain Analysis 8 Marketing Channel, Distributors and Customers8.1 Marketing Channel8.2 Testosterone Cypionate Distributors List8.3 Testosterone Cypionate Customers 9 Market Dynamics9.1 Market Trends9.2 Opportunities and Drivers9.3 Challenges9.4 Porters Five Forces Analysis 10 Global Market Forecast10.1 Global Testosterone Cypionate Market Estimates and Projections by Type10.1.1 Global Forecasted Sales of Testosterone Cypionate by Type (2021-2026)10.1.2 Global Forecasted Revenue of Testosterone Cypionate by Type (2021-2026)10.2 Testosterone Cypionate Market Estimates and Projections by Application10.2.1 Global Forecasted Sales of Testosterone Cypionate by Application (2021-2026)10.2.2 Global Forecasted Revenue of Testosterone Cypionate by Application (2021-2026)10.3 Testosterone Cypionate Market Estimates and Projections by Region10.3.1 Global Forecasted Sales of Testosterone Cypionate by Region (2021-2026)10.3.2 Global Forecasted Revenue of Testosterone Cypionate by Region (2021-2026)10.4 North America Testosterone Cypionate Estimates and Projections (2021-2026)10.5 Europe Testosterone Cypionate Estimates and Projections (2021-2026)10.6 Asia Pacific Testosterone Cypionate Estimates and Projections (2021-2026)10.7 Latin America Testosterone Cypionate Estimates and Projections (2021-2026)10.8 Middle East and Africa Testosterone Cypionate Estimates and Projections (2021-2026) 11 Research Finding and Conclusion 12 Methodology and Data Source12.1 Methodology/Research Approach12.1.1 Research Programs/Design12.1.2 Market Size Estimation12.1.3 Market Breakdown and Data Triangulation12.2 Data Source12.2.1 Secondary Sources12.2.2 Primary Sources12.3 Author List12.4 Disclaimer*

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Testosterone Cypionate Market Size, Key Trends, Challenges and Standardization, Research, Key Players, Economic Impact and Forecast to 2026|Pfizer,...

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ENGLEWOOD, CO / ACCESSWIRE / April 13, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today the launch of Regoxidine, an over-the-counter foam formulation of minoxidil available for use by both men and women. Regoxidine is indicated for hair treatment and regrowth and is available through the company's recently acquired, wholly-owned subsidiary Innovus Pharmaceuticals. Regoxidine is a branded alternative to hair regrowth treatment Rogaine.

Regoxidine is available for purchase through the product's website regoxidine.com. The product is also available through its Beyond Human marketing and sales platform and through Amazon. Over 11 million Americans purchased and used hair regrowth products in 2019.

Regoxidine for Men and Regoxidine for Women are the second and third FDA-approved, over-the-counter drugs Innovus Pharmaceuticals has launched to date following the launch of FlutiCare (fluticasone propionate 50 mcg nasal spray) in 2017. FlutiCare is indicated to treat nasal and allergy-related symptoms.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are excited about the launch of Regoxidine OTC and the expansion of our consumer health product portfolio. Regoxidine represents the first consumer product launch since completing the merger between Aytu and Innovus, and the consumer health team will continue its focus on developing and launching new products that address large segments of consumers. Through the expansion of the over-the-counter product portfolio, and the growth of our existing prescription and consumer healthcare products, we anticipate continued revenue growth with strong contribution from both of Aytu's business segments, expected to accelerate our path to profitability."

About Regoxidine 5% Minoxidil Foam for Men and Women

Regoxidine is a topical foam containing 5% minoxidil that is approved by the FDA as a hair regrowth treatment and is used to grow hair on the top of the scalp. The active ingredient is 5% minoxidil and is comparable to the Rogaine* line of similar products from Johnson & Johnson. The product comes in a 60g canister and will be sold as a 90-day supply for men and as a 120-day supply for women. Regoxidine is available as a foam for men and women.

The American Hair Loss Association (AHLA) reported that more than 95% of hair loss is caused by androgenetic alopecia. Also, approximately 35 million men and 21 million women 35 years of age and older experience hair loss. The 5% minoxidil market segment of the hair regrowth treatment market is projected to grow more than 4.5% annually through 2024. According to Global Market Insights the US market is valued at $0.5 billion with approximately 50 million retail units sold. The 5% foam products are the newest means of minoxidil delivery and are proven to be more effective against androgenic alopecia among men than other minoxidil formulations.

For more information visit http://www.regoxidine.com

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

*Rogaine is a trademark of Johnson & Johnson.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/584684/Aytu-BioScience-Consumer-Health-Subsidiary-Launches-RegoxidineR-an-FDA-Approved-Hair-Regrowth-Treatment-Foam-that-Contains-5-Minoxidil-and-Targets-Over-11-Million-US-Consumers-Who-Purchased-Hair-Regrowth-Products-in-2019

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Aytu BioScience Consumer Health Subsidiary Launches Regoxidine(R), an FDA Approved Hair Regrowth Treatment Foam that Contains 5% Minoxidil and Targets...

Recommendation and review posted by Bethany Smith