The first company to win a Food and Drug Administration authorization for a CRISPR-based product is now, less than two months later, looking to develop an on-site diagnostic for Covid-19.

Cambridge, Massachusetts-based Sherlock Biosciences said Wednesday that it would partner with binx health, based in Boston, to develop a point-of-care test for Covid-19 using CRISPR technology. Sherlock received an emergency use authorization for its CRISPR-based Covid-19 test kit on May 7, becoming the first company ever to get a regulatory nod for a product using the gene-editing platform.

The companies will use Sherlocks CRISPR technology and binxs molecular testing system, called io, to develop a way to test for Covid-19 in retail and similar settings.

This collaboration with binx health to advance our Sherlock diagnostic platform and offer an accurate, point-of-care test is the next critical step in combating the global Covid-19 crisis, Sherlock CEO Rahul Dhanda said in a statement. We are also excited to explore with binx how to utilize the io platform to bring accurate and affordable testing to hospitals, urgent care centers and other healthcare facilities for a range of diagnostic tests beyond Covid-19.

Testing for Covid-19 whether RT-PCR or serological relies on samples being sent to central laboratories from the point of care, meaning it can take several days before patients learn whether or not they have the disease days in which they could still spread the virus if they do not self-isolate. That has led to an interest in point-of-care testing. However, the Food and Drug Administration has come under fire for granting an emergency use authorization for one rapid test, Abbotts ID NOW, amid reports that it is delivering inaccurate results.

Sherlock was co-founded by Broad Institute scientist Feng Zhang, one of the pioneers of CRISPR technology. Another company, South San Francisco, California-based Mammoth Biosciences whose technology is based on the research of fellow CRISPR pioneer Jennifer Doudna of the University of California Berkeley is partnered with GlaxoSmithKline to develop a CRISPR-based Covid-19 diagnostic.

Photo: jxfzsy, Getty Images

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The Herald

John CumbersSherlock Biosciences is partnering with binx health to not only bring to market the first point-of-care CRISPR product but also take the first step toward a new paradigm in health and diagnostics.

On January 4, 2018, Boston was shut down by a blizzard, but Rahul Dhanda was on a mission. A few months prior, the veteran of the diagnostics industry had gotten a call from David WaltHarvard professor and scientific founder of biotech heavyweight Illuminaabout a potential startup company Walt was exploring with synthetic biology pioneers Feng Zhang and Jim Collins. Despite the weather, Dhanda, in his business jacket and snow pants, trudged through two feet of snow to pitch his vision for that company to its founders. The day ended with dinner and one takeaway: Lets do it.

That company is Sherlock Biosciences, and just two years after that fateful January day, it received the first FDA Emergency Use Authorization for its CRISPR-based Covid-19 test, and was named a Technology Pioneer by the World Economic Forum.

Today, Sherlock announced that it has partnered with binx health to scale the rapid diagnostic test for point-of-care settings ranging from doctors offices to grocery stores. It represents not only the first point-of-care CRISPR product to come to market, but the first step toward a new paradigm in health and diagnostics.

Sherlocks namesake diagnostics platform, Specific High-sensitivity Enzymatic Reporter unLOCKing, is a technique that uses CRISPR to identify highly specific genetic sequences. Its the perfect tool for diagnosing Covid-19 by the presence of the novel coronavirus, which is discernible by its specific RNA sequence. The CRISPR system is adapted from the bacterial immune system and is best known for its ability to edit genes. Typically, CRISPR uses a piece of guide RNA as a WANTED poster to seek out a target gene of interest, which is then snipped by its enzymatic partner, the Cas9 molecular scissors.

The incredible precision of CRISPR has revolutionized gene editing. That same specificity also makes it a powerful tool for diagnostics, which is vital in fighting pandemics. While SHERLOCK does not utilize Cas9, it employs the same underlying principle of enzymatic molecular scissors. Guide RNA strands serve as scouts for a specific sequence of genetic material. When the guide meets the virus, the enzymatic scissors are activated and chop up a reporter-probe-quencher sequence, generating a fluorescent signal that shows the presence of the virus.

When run in the lab, Sherlocks diagnostic process produces results in under an hour. The companys new partnership with binx will scale the technology and bring the testing time down to as little as 20 minutes.

binxs FDA-approved and point-of-care testing system, binx io, is an easy-to-use desktop-sized instrument that has already made waves in testing for sexually transmitted infections. With its single-use cartridge system and the SHERLOCK platform installed, a binx io unit can analyze nasal swab samples and report a detected or not detected result for the novel coronavirus in under 30 minutes.

The speed and performance of binx io makes it incredibly competitive and best-in-class, says Dhanda. The decrease in time and increase in performance of SHERLOCK in conjunction with binxs platform creates an incredibly powerful way to manage the pandemic. By providing diagnostic screening in everyday locations, binx and Sherlock are meeting a need for Covid-19 testing that remains highly urgent months into this pandemic, especially as case counts continue to rise in the United States.

Pivoting to conquer a pandemicThe team at Sherlock recognized early this year that the health crisis unfolding in China would soon become a global threat. Within a matter of days, the Board of Directors made a unanimous and resounding decision to alter course to combat Covid-19. Sherlocks scientists responded with an inspiring demonstration of commitment, adaptability, and creativity. This quick turnaround to mitigate such a pressing problem speaks to the vast potential of Sherlock as a company.

Never in my career have I worked at a company able to pivot so quickly in the way we have with this technology to work on Covid-19, remarked Dhanda. Everyone here is smart enough to do something else, but theyre here because they want to be scientists making an impact and they believe in making a difference in healthcare. I was impressed with how we went from vision to implementation almost overnight, and how quickly that happened really speaks to the culture of the company.

In commercializing the worlds first FDA-authorized CRISPR product, we are learning about the value of rapid, rigorous execution for realizing the translational potential of engineering biology, adds Dr. Jim Collins. Our team at Sherlock Biosciences was remarkable in their demonstrated ability to go beyond ideas, concepts and academic papers, to a developed, authorized Covid-19 diagnostic test that is supported by extensive data and strong corporate partnerships.

The logistics side of the equationsupply chain, distribution, partners, regulatory compliance, and morealso seemed to fall into place in response to the Sherlock teams sheer drive and resilience. These were potential hurdles that Dhanda, in a pre-pandemic world, had given himself two years to overcome, but the swift repurposing of research also catalyzed delivery to market. The result has been a profound ripple effect throughout the diagnostics space.

Reimagining diagnostics, screening populationsTo date, Americas approach to Covid-19 testing has followed general trends in diagnostics. The scarcity of Covid-19 tests has forced healthcare providers to triage potential patients, prioritizing symptomatic individuals to confirm likely positive cases. While valuable and necessary, it is rare for these diagnostic results to make a difference in clinical care for patients, nor does such limited testing help researchers understand this deceptively complicated disease in a variety of populations.

The high-throughput testing facilitated by SHERLOCK and binx is an incredible way to deliver results that were inconceivable even five years agowere breaking the mold, says Dhanda. We tend to make decisions based on limited access to resources, and diagnostics have always been rationed. Covid-19 has just put a magnifying glass on that. But the unique restrictions placed on this industry start to fall away when we have new ways of getting results.

For Dhanda and Sherlock, the answerfor Covid-19 and beyondis moving away from reactive triage testing and towards broad-based screening, which allows researchers to better understand how a disease behaves in people and spreads throughout a population. Sherlock is uniquely poised to continue facilitating this shift to broad-based screening. In addition to the CRISPR-based SHERLOCK, the companys other technological cornerstone is the cell-free synthetic biology platform INSPECTR (Internal Splint-Pairing Expression Cassette Translation Reaction). INSPECTR shows great promise in the at-home testing market, thanks to its low cost, room temperature, and modular implementation..

[INSPECTR and SHERLOCK] are highly programmablewe can direct these tools towards anything wed like, explains Dhanda.

An at-home Covid-19 test through INSPECTR, while not yet a reality, is just one of many possibilities for the platform. INSPECTRs single-base specificity and rapid results could allow for crucial differentiation between influenza variants, drastically reduce the spread of infectious disease, add value to oncology, and even revolutionize non-medical industries such as agriculture and industrial testing. Much remains to be seen, but one thing is for certainwith the diagnostics market on the cusp of a transformation, Sherlock Biosciences is the company to watch.- Forbes

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A New 20-Minute Covid-19 Test Will Use CRISPR Gene Editing Technology To Deliver Results At The ... - The Herald

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ZUG, Switzerland and CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, today announced the pricing of an underwritten public offering of 6,428,572 common shares at a public offering price of $70.00 per share. In addition, the underwriters have a 30-day option to purchase up to an additional 964,285 common shares at the public offering price less the underwriting discount. CRISPR Therapeutics anticipates its gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, to be approximately $450.0 million, excluding any exercise of the underwriters option to purchase additional shares. The offering is expected to close on or about July 6, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the offering. Canaccord Genuity, William Blair, SunTrust Robinson Humphrey and Roth Capital Partners are acting as co-managers for the offering.

The common shares will be offered and sold pursuant to the Companys previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the SEC) on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on June 29, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SECs website at http://www.sec.gov. A copy of the final prospectus supplement may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at prospectus_department@jefferies.com.

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding CRISPR Therapeutics anticipated public offering. The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, such as the expected closing date, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the offering. These and other risks and uncertainties are described in greater detail in the section entitled Risk Factors in CRISPR Therapeutics Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on February 12, 2020, the prospectus supplement related to the public offering and other filings that CRISPR Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent CRISPR Therapeutics views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CRISPR Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

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Investor Contact:Susan Kim+1-617-307-7503susan.kim@crisprtx.com

Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167reides@wcgworld.com

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CRISPR Therapeutics Announces Pricing of Public Offering of Common Shares - Yahoo Finance

Recommendation and review posted by Bethany Smith

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Major Players Are:

Thermo Fisher Scientific Inc, Cellecta Inc, GeneCopoeia Inc, GenScript Corporation, Merck KGaA, New England Biolabs Inc, Horizon Discovery Group, Origene Technologies Inc, Agilent Technologies Inc and Integrated DNA Technologies Inc

Market Segmentation:

Segmentation on the basis of product: Library, Plasmids and Vectors, Proteins, Others (Control Kits and gRNA). Segmentation on the basis of application: Biological Research, Agricultural Biotech, Industrial Biotech, Therapeutics and Drug Discovery

Regions & Countries Mentioned In The CRISPR Technology Market Report:

North America ( United States)

Europe ( Germany, France, UK)

Asia-Pacific ( China, Japan, India)

Latin America ( Brazil)

The Middle East & Africa

Some of the questions related to the CRISPR Technology market addressed in the report are:

With the developing demand, how are market players aligning their activities to fulfill the demand?

Which place has the most favorable regulatory rules to conduct commercial enterprise in the present CRISPR Technology market?

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At present, which organization has the very best market share in the CRISPR Technology market?

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Table of Contents

Outlook of the CRISPR Technology Market: This section covers the key manufacturers, market segments, study aim and analysis of market size for the 2020-2029 forecast period.

Presumption and Growth Trends Highlighted until 2029: This prospects based on 3 section such as growth rate of key producers, industry trends, and manufacturing estimation.

CRISPR Technology Player Market Share: This consist player production, revenue, and price calculation at the side of other chapters, such as growth plans and mergers and acquisitions, products include with the aid of top players and served areas and headquarters distribution.

Market size: Size of the market includes analysis of price, market share of the production value and market share of production.

Company profiles: Here, new entrants and leading players in the CRISPR Technology market are analysed based on gross margin, revenue, sales area, vital products, price and production.

CRISPR Technology Analysis of the market value chain and sales channel: Covering analysis of distributor, value chain, customer and sales channel.

Market forecast: In this part of the report, the analyst have targeted on the forecast of the value of production, the forecast of consumption by region, the forecast of production by region, the forecast of manufacturing and earnings and the regional forecast.

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The vaccine from Pfizer and BioNTech has shown potential in human trials. In a small trial, participants developed higher levels of COVID-19 antibodies than typically seen in infected people. (Reuters)

Sherlock Biosciences has partnered with Binx Health to scale its CRISPR-enabled COVID-19 test. The company plans to make the test available at the point-of-care and in other places like grocery stores, making it the first CRISPR product to come to market. (Forbes)

Submit a cover design for MM&Ms Hall of Femme issue. Design a cover that celebrates the inspirational women who are leading the industry, raising their voices and exerting their influence to make real change happen to enter the contest. The deadline is July 31. (MM&M)

Some government COVID-19 research contracts do not require the drug to be affordable. A report found some contracts allowed companies to bypass laws that ensure taxpayer-funded treatments or vaccines are affordable. (STAT)

Drug companies are suing to block a Minnesota insulin law. The law, which was to go into effect Wednesday, would allow patients to get insulin for $35 and was intended to stop people from rationing the drug because they couldnt afford it. (STAT)

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Five things for pharma marketers to know: Thursday, July 2, 2020 - Roundup - MM&M - Medical Marketing and Media

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Base editing, a new player in the gene editing arena, could have an important role in the development of immune-based cell therapies to treat solid tumors. Using cell therapies, such as CAR-T cells, in solid tumors remains challenging: the current word on the street is that such chimeric antigen receptors (CARs) will need multiple gene modifications to make them efficient and it is in this space that base editing could have a substantial advantage.Immune-cell-based therapy is an exciting cell therapy approach to treat cancer where the natural defenses of a patients immune system are used to target and kill cancer cells. Hopes were high following the initial FDA approvals of the first autologous CAR-T therapies for Novartis KYMRIAH (Aug 2017) and Gilead/Kite Pharmas YESCARTA (Oct 2017), both for blood-based cancers, but translating these successes into solid tumors remains a challenge. This is a consequence of the complexity and heterogeneity of solid tumors together with the immune inhibitory nature of the tumor microenvironment.For T cell-based therapies to work, the patient is treated with modified T cells that are rendered capable of identifying and killing tumor cells and, through this, generating a wider immune response against the tumor. Two key approaches used to modify T cells are through expressing a T cell receptor (TCR) known to target the tumor cell or a CAR. Other approaches include using and/or modifying natural killer cells, gamma delta cells or tumor infiltrating lymphocytes. It is not clear which approach will provide the most effective treatment option and in fact it might be that each tumor type responds better to one approach or to a combination of approaches. Irrespective of the approach, it is clear that the current therapies all face similar challenges; the risk of graft vs host disease (GvHD), a lack of durable remissions, on-target or off-target toxicity and cytokine release syndrome.Another layer of complexity for T cell-based therapies lies with the source of T cellsusing the patients own (autologous T cells), or a donor or iPSC-derived T cells (allogeneic). Each approach has advantages and challenges. Briefly, autologous treatments are attractive because they mitigate the risk of immune rejection and GvHD when infused back into the patient. However, they require a complex manufacturing process that necessitates specialist equipment local to the patient to enable the isolation of their T cells followed by rapid manufacture to transform them into engineered T cells ready to infuse back into the patient. At all points during this manufacturing pipeline, the product must be kept sterile and tracible to ensure the correct cells are transfused back into the correct patient. The allogeneic T cells approach is appealing because of the possibility that these could be engineered to be universal donor cells (suitable for all or most patients). Such cells can be manufactured in bulk and administered to multiple patients all over the world. This bulk manufacturing would attract cost-savings once a critical mass of therapy is reached. It could also allow for engineered T cells to be available on-tap to any patient, a game-changer for particular patients whose own T cell count is either too low for engineering, or that transduce poorly with the engineered construct during manufacture. The challenge for allogeneic T cell therapies is the ability to generate cloaked T cells that do not provoke an immune-response in the patient, as this could kill the engineered T cells after transplantation such that they have no efficacy or potentially lead to the death of the patient as a result of a disseminated cytokine storm. Despite these challenges, in April 2019 the US Food and Drug Administration (FDA) approved the first allogeneic CAR-T for investigational use in patients with multiple myeloma and more are expected to follow.To try and achieve a stealth allogeneic T cell that flies under the radar of the patients immune system, genetic engineering is key. Although T cells can be engineered to express a specific TCR or CAR, additional genetic changes are required to provide a cloak of invisibility, prolong the survival of the cells in the patient and enable them to function in an immune suppressive tumor microenvironment. From a simplistic point of view, one could view the modified CAR or TCR as a sat nav, with the T cell being the engine. You need both to get to your destination and, if youre able to improve your engine, its possible the outcome could be achieved faster and in a more reliable fashion. There are several gene knockouts or gene knockdowns that are seen as a natural first step to improving the properties of engineered allogeneic T cells and these are summarized in the table below:As there are multiple gene knockout options, a gene engineering technology capable of making multiple gene edits with as few off-target effects as possible is needed. Indeed, it is conceivable that an effective allogeneic T cell-based therapy might require ten or more gene edits.This prompts the question What is the best gene editing platform or technology to support multiple gene edits? On the surface of it, and owing to its phenomenal adoption in research labs worldwide over the past decade, most currently use the gene editing approach provided by CRISPR-Cas9. CRISPR was first commercialized in 2012 and quite staggeringly made its debut in a clinical trial for cell therapy in June 2016. Although CRISPR is an efficient gene editing tool, its mode of action of generating double-strand breaks in the DNA could be a source of concern. DNA double-strand breaks, which tend to be repaired by the cells repair machinery in an error prone fashion, can cause unintended changes in the genome of engineered cells. Although there are methods for minimizing these off-target effects when single genes are targeted, targeting multiple genes in one cell all at the same time could lead to genome-altering insertions, deletions and/or chromosomal translocations. The impact of this on a patient could be that the cell therapy is effective but the off-target genetic changes lead to deleterious side-effects, impacting patient recovery and potentially survival. Well-known alternatives to CRISPR include transcription activator-like effector nucleases (TALENS) and zinc finger nucleases (ZFN). These approaches have slightly different safety profiles to CRISPR and while optimized for single gene edits or knockouts, multiple gene knockouts still present a challenge for these technologies. Freedom to operate using these technologies in the therapeutics space can also be challenging, particularly for start-up and biotech companies.The potential deleterious impact of off-target effects, particularly for multiple gene edits has opened the door to a newcomer on the gene engineering scene: base editing. This technology first gained prominence from peer-reviewed papers published by researchers from Harvard University.1 Others, such as Rutgers University, have also developed base editing platforms.2 In brief, base editing uses a deaminase enzyme to make a specific base pair change in the DNA. The base pair alteration can either be an A to G or a C to T depending on which deaminase is used. Importantly, the CRISPR-Cas system is used to guide the deaminase to the base pair that is going to be altered, but in this version of CRISPR-Cas, a DNA double-strand break is not made, meaning that the off-target effects with base editing in terms of insertions, deletions or translocations should be substantially reduced.On the surface, this crucial characteristic makes base editing an excellent choice of gene editor for cell therapyit can be used to specifically knock-out multiple genes through the introduction of stop codons or splice site disruptions with limited capacity to introduce substantial, large-scale chromosomal abnormalities. However, as base editing was first published in May 2016,1 substantial research is required to understand fully the utility of base editing in the therapeutic space and to appreciate its advantages and challenges compared with standard gene editing approaches, such as CRISPR-Cas, TALENs and ZFNs.As is somewhat expected of a fashionable area for scientific research, the gene editing space does not stand-still for very long: Prime editing has followed hot on the heels of base editing. Unlike base editing, which makes changes to specific base pairs in the DNA, prime editing allows changes to be made to a run of base pairs by forcing the cell to use a DNA copying system that exists naturally in cells as part of the DNA repair mechanism. Initial data suggest3 that prime editing has higher off-target effects compared with base editing, in terms of introducing insertions and deletions, and more work is needed to understand the comparison and utility of base editing vs. prime editing. It will be interesting to see how prime editing evolves over the months and years within the cell and gene therapy space.Although cell therapy has demonstrated its potential for driving complete remissions in some patients with hematological cancers, the next big step is to translate these early successes into patients with solid tumors. However, due to the complexity of solid tumors, this is not a simple or straight-forward process and multiple factors need to be considered. While the sat nav in the form of an engineered TCR or CAR is crucial, the T cell engine could be the natural starting point for improving efficacy in patients with solid tumors, as could the use of allogeneic rather than autologous approaches. The multiple edits that will be needed to deliver a stealth, engineered, allogeneic off-the-shelf T cell are only now being investigated in earnest and it could be that the new kid on the block, base editing, provides a compelling route forward.References1. Komor, A.C., Kim, Y.B., Packer, M.S., Zuris, J.A. and Liu, D.R. (2016). Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage. Nature, 533(7603), 420424. Doi:10.1038/nature179462. Horizon Discovery to provide access to novel base editing technology, January 2020;https://horizondiscovery.com/en/news/2020/Horizon-Discovery-to-provide-access-to-novel-base-editing-technology (accessed May 2020)3. Anzalone, A.V., Randolph, P.B., Davis, J.R., et al. (2019). Search-and-replace genome editing without double-strand breaks or donor DNA. Nature, 576(7785), 149157. doi:10.1038/s41586-019-1711-4Dr. Jonathan Frampton is a business development professional who has been working for Horizon Discovery for the past 9 years and currently as their Corporate Development Partner. He is always scouting for exciting novel technology that could complement Horizons already extensive gene engineering toolkit. In addition to this he works closely with Horizons partners to manage out-licensing opportunities.

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Cell Therapy For Solid Tumors - Contract Pharma

Recommendation and review posted by Bethany Smith

Wall Street brokerage firm analysts have placed aBuy rating on shares of CRISPR Therapeutics AG (:CRSP). Using the following ratings scale: 1.0 Strong Buy, 2.0 Buy, 3.0 Hold, 4.0 Sell and 5.0 Strong Sell, analysts have an average recommendation of 2.30 on the shares. Based on a recent trade, the shares are hovering around $72.50 which, according to analysts, yield significant upside potential to the $75.88 consensus target price.

When it comes to investing in the equity market, discipline can play a major role in achieving ones goals. A few bad moves can send the investors confidence spiraling. Acting purely on emotion can lead to impulsive decisions that may cause the losses to pile up. Creating a solid plan and following through with the plan can help investors stay on track and focus on the proper details. Markets are constantly going up and down and the investing ride can sometimes be a bumpy one. Being able to see the big picture and focus on the important data can help keep the investor tuned in to the right channel. Investors who expect to jump into the market and immediately start raking in the profits may find out fairly quickly that trading without a plan can be a recipe for defeat.

Although the investing process is fairly straightforward, securing consistent returns in the stock market is not easy. Throwing hard earned money at un-researched investments can eventually lead the investor down the road to ruin. Every individual investor may have different goals when starting out. Aligning these goals with a specific plan can create a solid foundation for the future. Nobody can predict what the future will hold, but being aware of market conditions can be a great asset when attempting to navigate the terrain while mitigating risk. Once the vision of the individual investor is clear, the road to sustaining profits may be much easier to travel.

As company earnings reports continue to roll in, investors will be watching to see which companies hit their numbers for the last reporting period. Investors will also be watching which sectors are reporting the best earnings numbers. A positive overall earnings season could mean that the stock market could keep climbing. Many investors may be cautious with the market trading at current levels. Even though the gloom and doom prognosticators are out in full force, investors have to do the research and decide for themselves which way they believe the market will move in the next couple of months.

One of the most important factors that investors look at when examining stocks is the consistency of earnings results. When the quarterly earnings report is released, investors watch closely to see if the company is performing up to expectations. A company that fails to meet projections may see large price swings following the report. Of course one bad quarter may not signal trouble, but a company that continually disappoints during earnings season may need to be further examined to help figure out what is going on. Experienced investors will closely watch stock price movements before and after earnings events in order to gain a truer understanding of how the market is reacting to the reports.

Earnings estimates can also be manipulated, as the analysts are inclined to minimize them so that it increases the chances that a stock will beat the artificially lowered estimate in order to get inexperienced investors to buy.

RSI

CRISPR Therapeutics AG (:CRSP)s shares may have a significant upside to the consensus target of75.88, but how has it been performing relative to the market? The stocks price is 72.50 and their relative strength index (RSI) stands at 60.88. RSI is a technical oscillator that shows price strength by comparing upward and downward movements. It indicates oversold and overbought price levels for a stock.

Individual investors often strive to create a solid strategy before trying to take on the market. Setting up realistic, attainable goals, may be a good place for the amateur to start. There are many different approaches that the investor can take when getting into the stock market. Some investors will try to follow strategies that have worked for others in the past. Sometimes this will work, and sometimes it will not. Markets and economic landscapes are constantly changing. A strategy that worked yesterday may not work again tomorrow. Investors who put in the time to do the necessary homework may find themselves much better off when the market decides to rear its ugly head at some point down the road.

CRISPR Therapeutics AG (:CRSP) shares are moving-1.35% trading at $72.50 today.

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Analyst Activity Update on CRISPR Therapeutics AG (:CRSP) - Pineville

Recommendation and review posted by Bethany Smith

Analytical Research has added a new report to their increasing litany of reports titled Testosterone undecanoate Market Report. The new study encompasses valuable insights using a variety of graphs, tables and figures that explores opportunities, trends and drivers surrounding the Testosterone undecanoate industry.

HNY Research projects that the Testosterone undecanoate market size will grow from XXX in 2019 to XXX by 2025, at an estimated CAGR of XX. The base year considered for the study is 2019, and the market size is projected from 2020 to 2025.

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By Market Players:Bayer AG, Endo Pharmaceuticals, Merck Sharp & Dohme, Taro Pharmaceutical, Cipla, Zhejiang Xianju Pharmaceutical, Zhejiang Medicine Co.

By ApplicationPrimary hypogonadism, Hypogonadotropic hypogonadism, Late-onset hypogonadism

By TypeInjection, Oral

The prime objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

Brief about Testosterone undecanoate Market Report with [emailprotected] https://www.arcognizance.com/report/2020-2025-global-and-regional-testosterone-undecanoate-industry-production-sales-and-consumption-status-and-prospects-professional-market-research-report

Points Covered in The Report:The points that are discussed within the report are the major market players that are involved in the market such as manufacturers, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. The historical data from 2014 to 2019 and forecast data from 2020 to 2025.The growth factors of the market is discussed in detail wherein the different end users of the market are explained in detail.Data and information by manufacturer, by region, by type, by application and etc, and custom research can be added according to specific requirements.The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Reasons to PurchaseTo gain insightful analyses of the market and have comprehensive understanding of the global market and its commercial landscape.Assess the production processes, major issues, and solutions to mitigate the development risk.To understand the most affecting driving and restraining forces in the market and its impact in the global market.Learn about the market strategies that are being adopted by leading respective organizations.To understand the future outlook and prospects for the market.Besides the standard structure reports, we also provide custom research according to specific requirements.

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Table of Content

Chapter One: Industry Overview

Chapter Two: Major Segmentation (Classification, Application and etc.) Analysis

Chapter Three: Production Market Analysis

Chapter Four: Sales Market Analysis

Chapter Five: Consumption Market Analysis

Chapter Six: Production, Sales and Consumption Market Comparison Analysis

Chapter Seven: Major Manufacturers Production and Sales Market Comparison Analysis

Chapter Eight: Competition Analysis by Players

Chapter Nine: Marketing Channel Analysis

Chapter Ten: New Project Investment Feasibility Analysis

Chapter Eleven: Manufacturing Cost Analysis

Chapter Twelve: Industrial Chain, Sourcing Strategy and Downstream Buyers

List of Table and Figure

Figure Product PictureTable 2014-2019 Major Types Market Sales Volume And Market ShareFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateFigure 2014-2019 Sales Volume And Growth RateTable 2014-2019 Capacity, Production, Capacity Utilization Rate, Ex-Factory Price, Revenue, Cost, Gross And Gross MarginFigure 2014-2019 Capacity, Production And Growth RateFigure 2014-2019 Capacity, Production And Capacity Utilization Rate continued

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Note: Our report does take into account the impact of corona virus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

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Testosterone undecanoate Market 2020 | What Will Be the Market Size and the Growth Rate Analysis by 2025? - Cole of Duty

Recommendation and review posted by Bethany Smith

Human chorionic gonadotropin (hCG) hails from the group of gonadotropin hormones and is normally delivered by the placenta. hCG hormone plays an essential job after the development of the embryo, and subsequently has increased huge footing throughout the years for the treatment of fruitlessness in ladies and men.

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By Therapeutic Area

By Technology

By End User

Growth in the frequency of male hypogonadism among the aged populace is the key factor driving the market development. Moreover, increment in footing picked up by hCG among healthcare experts and patients would enhance the market development. However, alerts and admonitions gave by the FDA relating to the symptoms of hCG treatment is anticipated to hamper the development of the market.

North America was the significant income contributor in 2017 and is foreseen to keep up its predominance all through the figure time frame.

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Advancements in treatments in healthcare is boosting the Human Chorionic Gonadotropin (HCG) Market - Day Web Chronicle

Recommendation and review posted by Bethany Smith

With this new market research report namelyGlobal Hormone Replacement Therapy Market Growth 2020-2025we are accomplishing our aim of providing our clients an in-depth analysis of the global market. The report features a comprehensive analysis and enlightens market dynamics that provide a holistic picture of the global Hormone Replacement Therapy industry. The report offers knowledge about the industry competitors, growth potential, potentially disruptive trends, industry product innovations, market size value/volume (regional/country level, industry segments), and market share of top players/products. Growth figures are demonstrated between the forecast time-span using industrial facts and figures. The study comprises an analysis of market growth, consumption volume, market trends, and business price structures throughout the forecast amount from 2020 to 2025.

Some of the major Hormone Replacement Therapy market players are:Eli Lilly, Abbott, Pfizer, Novo Nordisk, Merck KGaA, AbbVie, Teva, Mylan, Novartis, Bayer, Roche, ANI Pharmaceuticals, Ipsen, TherapeuticsMD, Endo International,

NOTE:Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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Recent Industry Trend:

The report shows the profiles of various prominent players in the global Hormone Replacement Therapy market. Different strategies implemented by these vendors have been analyzed and studied to gain a competitive edge, create unique product portfolios, and increase their market share. The report also throws light on major global industry vendors including essential vendors consist of both new and well-known players. Different strategies implemented by these vendors have been analyzed. The key insights have been covered to deliver a realistic overview of the industry, covering global Hormone Replacement Therapy market manufacturers data, i.e. shipment, price, revenue, gross profit, business distribution, etc.

Following are the major regions considered for the analysis of the market: Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries)

Most important types of products covered in this report are: Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone Hormone

Most widely used downstream fields of market covered in this report are: Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other

Major Aspects Widely Described In The Report Are:

All segments of the global Hormone Replacement Therapy market have been covers in this study. The report highlights the competitive status of key players within the projection timeline while focusing on their portfolio and regional expansion. The research report segments the geographical spectrum of this industry. The report provides market dynamics scenarios, along with growth opportunities of the market in the years to come.

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This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Marketsandresearch.biz is a leading global Market Research agency providing expert research solutions, trusted by the best. We understand the importance of knowing what global consumers watch and buy, further using the same to document our distinguished research reports. Marketsandresearch.biz has worldwide presence to facilitate real market intelligence using latest methodology, best-in-class research techniques and cost-effective measures for worlds leading research professionals and agencies. We study consumers in more than 100 countries to give you the most complete view of trends and habits worldwide. Marketsandresearch.biz is a leading provider of Full-Service Research, Global Project Management, Market Research Operations and Online Panel Services.

Contact UsMark StoneHead of Business DevelopmentPhone:+1-201-465-4211Email:[emailprotected]Web:www.marketsandresearch.biz

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Global Hormone Replacement Therapy Market 2020 Research by Business Analysis, Growth Strategy and Industry Development to 2025 - Cole of Duty

Recommendation and review posted by Bethany Smith

CARLSBAD, Calif., July 1, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (NASDAQ: QLGN) ("Qualigen" or the "Company") announces it has submitted an official notification to the U.S. Food and Drug Administration ("FDA") to commence sales in the U.S. of the Company's FastPack SARS-CoV-2 IgGtest for COVID-19 antibodies. This test has already been submitted to the FDA for Emergency Use Authorization ("EUA"), but the notification enables Qualigen to commence sales even before the FDA considers or formally grants the EUA for the test. Qualigen expects sales and shipments of the new test to begin in mid-July.

The FastPackCOVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of SARS-CoV-2 IgG antibodies in bloodto identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease (which, as a practical matter, is believed to be indicative of immunity against re-infection). Qualigen's FastPacktest uses a specific protein that is also used by major diagnostics companies including Abbott Laboratories, Roche Diagnostics and Bio-Rad Laboratories in their COVID-19 antibody tests. The important advantage of FastPackover testing in large commercial laboratories, however, is its ability to deliver accurate results far more rapidly, in this case under 10 minutes, in physician offices, clinics and hospitals.

"Of the different options available, we chose to develop a test specific to the IgG antibody because IgG represents the long-term immune response. We believe our test's combination of high speed and high accuracy provides the clinician with more useful and actionable information than other testing approaches," Michael Poirier, the Company's CEO, explained. "We believe that reliable, yet convenient testing at the point-of-care is critical to helping combat this virus and get Americans back to their normal routines."

The new test is designed for use with Qualigen's new FastPack PRO System point-of-care diagnostic instruments. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system.

Qualigen has been producing high-quality diagnostic testing products for almost 20 years, and has established a strong reputation for delivering highly accurate point-of-care tests that help save people's lives.

About the FastPack SystemThe FastPack System is a rapid and highly accurate immunoassay testing system consisting of the FastPack Analyzer and the FastPack test pouch (a single-use, disposable, foil packet that includes the FastPack reagent chemistry). This "Laboratory in a Pouch" is installed in physician offices, clinics and small hospitals around the world, and quickly detects diseases and medical conditions at the point-of-care. Since the conception of the system, the Company has expanded its assay menu to 10 tests including tests for prostate cancer, thyroid function, metabolic disorders, antibodies against SARS-CoV-2, and research applications. Over the past 20 years, FastPack has generated more than $100 million in commercial sales. Qualigen's worldwide distributor for FastPack is Sekisui Diagnostics, LLC, a subsidiary of a multibillion-dollar Japanese chemical and technology company; Sekisui, in turn, works with national distributors including McKesson Corporation and Henry Schein Inc.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The FastPack menu includes tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F3 and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases, including COVID-19. RAS-F3 is a small molecule RAS oncogene protein-protein inhibitor for blocking RAS mutations that lead to tumor formation, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Qualigen Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to potential future development, testing and launch of product candidates. Actual events or results may differ from our expectations. For example, there can be no assurance that the Company will be able to manufacture the FastPack Pro System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack Pro System instruments and SARS-CoV-2 IgGtest kits will be profitable; that adoption and placement of FastPack Pro System instruments (which are the only FastPack instruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company's request to the FDA for Emergency Use Authorization will ultimately be approved; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that we will be able to procure or earn sufficient working capital to complete the development, testing and launch of our prospective therapeutic products; or that we will be able to maintain or expand market demand and/or market share for our diagnostic products. Our stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available at http://www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen, Inc.

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Qualigen Therapeutics Submits Notification to FDA to Commence Distribution of its FastPack COVID-19 Antibody Test - PRNewswire

Recommendation and review posted by Bethany Smith

Like most of us, Im doing my damnedest to stay healthy right now. Im social distancing and washing my hands almost obsessively. Im trying to eat as many vegetables as possible to ensure I'm getting health-supporting nutrients that I'm not exactly taking in via all the stress baking.

Its also not surprising that Ive been bombarded with news over the past few months about how to bolster my immune system. I cant scroll through my Instagram feed without seeing some influencer bragging about an immune-boosting smoothie or a supplement company promoting pills with elderberry and citrus.

Time-out, though. Immunity has a PR problem right now. The whole idea that you can power up your immunity in some quick-and-dirty way overnight (and, you know, avoid a cold or flu...or COVID-19) isn't actually how it works.

Think of immunity like this: If youre the star quarterback of your life, your immune system is like that super-jacked lineman whose number-one job is to protect you from all directions. And, separately (but still in that sports realm!), just like how strategic leadership can whip a team into shape, you can train your system to more efficiently pick off any opponentbug, virus, germthat comes your way. But that conditioning takes time and dedication.

So, taking a last-minute, reactionary approach to immunity is the opposite of how you should think about it, says Nicole Avena, PhD, visiting professor of health psychology at Princeton University. Immunity is a marathon, not a sprint. Because of that, there isnt any fast and easy way to immediately amplify yours. Youve got to take an all-in, holistic approach if youre going keep your immune system in fighting form, says Avena.

Recalibrating your immunity for the long game comes down to the classic health habits you hear time and time again: sleep, stress reduction, and sweating it out. The key is doing all of these to at least some degree and not expecting one to be the ultimate cure-all. You wont make your immune system healthier in a week by pumping yourself with vitamins because someone close to you is sick, says E. John Wherry, PhD, director of the Institute for Immunology at the University of Pennsylvania. But you absolutely can help your immunity by making certain lifestyle changes.

Nail Your Sleep Routine

Sleepspecifically getting at least seven hours most nightsmight be the Most Important Thing. The best data we have about how to improve immunity is on getting the right amount of good sleep, says Wherry. People who got six hours of shut-eye a night or less for one week were about four times more likely to catch a cold when exposed to a virus compared to those who got more than seven hours, according to a study published in the journal Sleep. (The risk of getting sick was even higher for those who snoozed less than five hours a night.)

Everything you do when youre awakeeating, digesting, working, walking, exercisingprompts your body to release inflammatory cells, says Rita Kachru, MD, section chief of the clinical immunology and allergy division and assistant professor at the David Geffen School of Medicine at UCLA. Sleep gives your body a break from all of that. Dont get hung up on one crappy night of Zs (or give yourself too much praise for one amazing one, for that matter); focusing on long-term, consistent good sleep habits is the way to go. Your building blocks, right here.

Mara de la Paz Fernndez, PhD, a sleep researcher and assistant professor of neuroscience and behavior at Barnard College of Columbia University

Mariana Figueiro, PhD, director of the Lighting Research Center and a professor of architecture at Rensselaer Polytechnic Institute

Mikka Knapp, a registered dietitian-nutritionist

Rebecca Robbins, PhD, a sleep researcher and co-author of Sleep for Success!

Megan Roche, MD, epidemiology researcher and Strava running coach

Its well established that stress prompts the release of cortisol, that fight-or-flight hormone that enables you to run for your life. When cortisol is high, your immune system isnt as active, says Daniel M. Davis, PhD, professor of immunology at the University of Manchester in England; your body sends all of its resources to the thing it thinks is most likely to kill you, and away from other stuff, like your protective network.

Dont stress? Ill just give up now, youre thinking. Stay calm and try this: Instead of attempting to eliminate negativity, refine the way you cope (with the genius advice ahead!)which will make the blues more manageable and mitigate that cortisol response, Davis says.

Joy Lere, a psychologist

Kevin Gilliland, PsyD, a clinical psychologist and executive director of Innovation360

Patricia Celan, MD, a psychiatry resident at Dalhousie University in Canada

Beatrice Tauber Prior, PsyD, a clinical psychologist

Working out creates inflammation in the body, but its the good kind, says Wherry. Its a little counterintuitive, because exercise actually disrupts your bodys homeostasis, he says. But when your sweat sesh is finished, your bod goes back to its status quokeeping your immunity on its toes in that brilliant way, he says. Research backs this up: Folks who exercise regularly develop more T cells (those destroyer white blood cells) than their sedentary peers, a recent study found. It also helps modulate the stress hormone cortisol, which, when raised, leads to inflammatory activity.

Some experts agree that overtraining (you know, that feeling when youve been pushing yourself too hard and youre feeling it) can hinder immunity. So if youre an everyday athlete, moderate exercise on a consistent basis is the end zone to aim for.

Jennifer Haythe, MD, a critical care cardiologist at Columbia University Medical Center

Lisa Ballehr, DO, an osteopathic physician and Institute for Functional Medicine certified practitioner

Ian Braithwaite, MD, an emergency physician at The Royal London Hospital

Kym Niles, certified personal trainer

Kristen Gasnick, board-certified physical therapist

Jenn Randazzo, registered dietitian

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How To Boost Your Immune System - 15 Tips From Experts - Women's Health

Recommendation and review posted by Bethany Smith

Rihaan* came out to his parents in the summer of 2008 three days after they created a profile for him on a matrimonial site. His conservative upper-class family in Pune reacted badly. There was confusion, rage, tears. My father begged me to meet a psychiatrist, who instantly diagnosed my condition as mother-fixation. Rihaans treatment started the same week. First it was coercion and counselling; then he was given medicines and dragged to brothels.

Then came the final sitting to reverse my orientation and cure the disorder. I was locked into a room wallpapered with pictures of nude men and they gave me some injections that made me throw up. I retched the entire day, collapsing in between, then waking up covered in vomit. Two days later the session was repeated and I was shown gay porn. Within a couple of weeks Rihaan was a defeated man. Panic rose in my chest even at the mention of same-sex attraction. My parents were summoned and officially informed that my conversion was complete. I lived like a zombie those days. I was heavily dependent on medicines and each time I tried to stop, I was ravaged by withdrawal symptoms. I contemplated suicide. Then, before I knew it, I was married to a cis woman.

Rihaans marriage lasted five months, but more than 10 years later, he still gets panic attacks. He has no career or confidence. I am unable to have a meaningful relationship and at times the shame and pain are unbearable, he says. Now, Rihaan is finally on the road to recovery.

Curing queerness

Not everyone is so lucky. Anjana Harish, the 21-year-old queer student from Kerala who was found dead in Goa last month, was also subjected to conversion therapy. Her friends say that Harish live-streamed a video revealing the torture she had to endure from pseudo-therapists.

Disturbingly, it looks like the discredited concept of conversion therapy is still being practised. Claiming to cure queerness, it can involve everything from shock treatment to exorcism and hormones to psychotropic drugs and kindling a sense of shame. According to medical experts, it causes irreparable damage to the mental health of victims.

Members of the LGBTQIA+ community say conversion therapy is practised in stealth. The patients are taken to psychiatric wards in hospitals or de-addiction centres with falsified files. When Jay*, a trans man from Ahmedabad, consulted a psychiatrist at a government facility for sex reassignment surgery, the doctor insisted that he go through conversion therapy first. I am a 43-year-old gazetted officer and I went there with some community members. If they could try to coerce me, think about what they must do to younger people with no support, says Jay.

Quacks and clerics

This so-called therapy is dished out not just by unscrupulous health professionals but also by preachers, naturopaths, shamans, and religious establishments. When Marie* told her parents in Coimbatore that she was a trans woman, they asked her to attend a course at an ashram the family used to frequent. On the second day of the course, I woke up in another place where I was held prisoner for two months, she says. I was slapped, body-shamed and sexually abused for being a sinner and acting against the divine plan.

Realising there was no point in fighting, Marie stopped reacting and convinced them that she had changed. I was sent home where I continued the charade for two more months. At the very first opportunity, I fled and never went back. Marie has since undergone sex reassignment surgery and works as a doctor in a hill station where nobody knows her past. I survived because I stayed vigilant from the beginning. Once they break your spirit, there is no going back.

Salmas* relationship with another girl became a scandal that rocked her hometown, Lucknow. It was a cleric who advised the family to keep her in isolation; she was raped multiple times by a close relative, a man she called kaka (uncle). In India, religious institutions and representatives play a big part in promoting conversion therapy. In the West, groups like Exodus International openly promoted conversion therapy across nearly 20 countries, but it has been more hush-hush here, with saints, pastors and babas doing it on the sly. Organised groups operate as de-addiction centres, prayer groups or ashrams.

Against the law

We condemn conversion therapy. Its unlawful, says P.K. Dalal, President, Indian Psychiatric Society (IPS). IPS has taken a strong stand against it. We have a protocol when it comes to such cases and we will soon be coming out with a statement, he adds.

Although there is no specific law prohibiting conversion therapy, legal experts emphasise that the practice violates the Right to Privacy enshrined under Article 21. If sexual abuse is involved, its an IPC offence anyway and now we have the Mental Healthcare Act, 2017, that gives a lot of agency to individuals, says Sandhya Raju, an advocate at the Kerala High Court and a member of the Human Rights Law Network. Once mental health review boards are constituted as part of enforcing the law, the community can use it to protect their rights.

If the practice is used against children below 18, the law is even more stringent. Parents can be booked under Section 75 of the Juvenile Justice Act, 2015. Prijith P.K., president of the Thiruvananthapuram-based Queerythm, which operates a 24x7 helpline for LGBTQIA+ people, says, Very often parents are involved, and doctors claim the treatment is for depression or schizophrenia. He thinks new legislation is needed to address the issue. While transpersons are protected under the NALSA judgment, other segments including gays, lesbians and bisexuals have no legal support. Same-sex marriages are still not legal in India. We talk about inclusivity and awareness, but legal backing is very important to achieve that goal. When the discrimination ends, the rest will follow, he says.

While most such practitioners are quacks, there are some who strongly believe they are offering a service. A Kerala-based psychiatrist who practises conversion therapy said, on condition of anonymity, that his patients undergo the treatment willingly as its easier to live as a heterosexual individual.

According to him, many of his patients now have a family and children. But he admits that many of them return due to marital discord and are on endless medication for depression.

A Hyderabad-based sexologist is equally confident. He offers different programmes tailored to the severity of queerness and says, You can fix most homosexuals with hormone therapy. Psychiatric interventions have been successful in most cases Ive treated. For example, testosterone injections can reverse same-sex desire to a great extent while some people respond to behavioural therapy.

He refuses to share his methods and says sexual deviance often springs from childhood sexual abuse and conditioning. He believes he is helping queer people by reaffirming their real orientation or gender identity, making them acceptable, and protecting the honour of their families.

Hypnotised, lobotomised

The origins of this clandestine practice date back to the 19th century, when deviant sexual orientations were considered sinful or criminal. One of the first documented cases comes from the accounts of Albert von Schrenck-Notzing, a German physician who reportedly used hypnosis to cure homosexuality in the 1890s.

By the early 1900s, practitioners worldwide began to use hypnosis as well as electroconvulsive therapy and sometimes surgical procedures like lobotomy. People were tortured, castrated and subjected to sordid corrective measures. Aversion therapy, of the kind Rihaan underwent, was portrayed in Stanley Kubricks 1971 film A Clockwork Orange.

In India, the Department of Psychiatry at AIIMS, New Delhi, conducted a study to reverse sexual orientation between 1977and 1982. The subjects were six homosexual people, who were administered electric shocks using an aversion therapy apparatus set at 50 volts to control their homoerotic fantasies. The report claimed that four persons were successfully reoriented. By the 2000s, several doctors and healers had popped up across the country.

In May this year, the U.N. published a report cataloguing the severe and everlasting impacts of conversion therapy. The report says, Attempts to pathologize and erase the identity of individuals, negate their existence as lesbian, gay, bisexual, trans or gender diverse and provoke self-loathing have profound consequences on their physical and psychological integrity and well-being. It urges governments to ban conversion therapy. So far only five countries Germany (for under-18s), Malta, Ecuador, Brazil, Taiwan have drawn up bills making it illegal, but efforts are on in other countries too.

At the most basic level, conversion therapy is unethical and a human rights violation. Even after the Supreme Court decriminalised consensual same-sex relationships by striking down Section 377 and came out with the historic NALSA judgment to protect transgender rights, Indian society is far from queer-friendly: LGBTQIA+ individuals still face violence, hostility and stigma. And a very real threat to their mental and physical health.

The Turing Effect

In January 1952, English mathematician Alan Turing, who played an important role in breaking German war codes during WW II,

was charged under the Criminal Law Amendment Act, 1885 for being in a sexual relationship with a man. Turing, who would later become famous as the father of modern computer science and artificial intelligence, was convicted. He was made to undergo hormonal therapy or chemical castration for one year, which reportedly made him impotent and led to the formation of breast tissue. Turing was also barred from continuing his government work.

In June 1954, two weeks before he turned 42, Turing was found dead at home, by apparent suicide, although subsequent reports claimed his death may have been due to accidental poisoning. Turings path-breaking research and his persecution were the subject of the 2014 Oscar-winning film, The Imitation Game, starring Benedict Cumberbatch. In December 2013, Queen Elizabeth II overturned Turings conviction. And in September 2016, the U.K. government said it would extend the retroactive exoneration to other men convicted similarly, under a new Alan Turing law.

*Names changed to protect identity.

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Shock treatment, exorcism, psychotropic drugs: behind conversion therapy for queers - The Hindu

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With more than two million new cases diagnosed in 2018, breast cancer is the most common cancer in women worldwide.[1] The disease represents about 25% of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. Breast cancer is also the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths annually

An estimated 90% of all breast cancer is diagnosed at an early stage. [2] And approximately 70% of all breast cancers are HR+, HER2-, the most common subtype of the disease. [3] Even within this subtype, HR+, HER2- breast cancer is a complex disease, and many factors, including cancer which spread to the lymph nodes and the biology of the tumor, can impact the risk of recurrence. Recent data shows that about 30% of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning, potentially leading to incurable metastatic disease.[4]

Metastasized diseaseBreast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor is getting worse when the cells invade surrounding tissues or metastasize to distant areas of the body. In that case and in ths stage of breast cancer also referred to as stage IV breast cancer, spreads or metastasizes beyond the breast and nearby lymph nodes to other parts of the body. In the majority of cases, this includes the bones, lungs, liver, or brain.

Although an advanced disease, most women with metastatic or stage IV breast cancer are treated with systemic therapy. This treatment may include hormone therapy, chemotherapy, targeted therapy, or a combination of these options.

No an end-stage cancerWhile some people may refer to metastatic breast cancer as end-stage cancer, the disease is NOT hopeless and many people continue to live long, productive lives with breast cancer in this stage.

In an interview with The OncoZine Brief in December 2019, Susan Rafte describes her experience as a 25-year metastatic breast cancer survivor. While challenging, she became a peer-to-peer support volunteer through MD Anderson Cancer Center and has helped many patients with her peer support program. Rafte has also contributed to many research projects and committees as a patient advocate.

Listen to The OncoZine Brief: Susan Rafte: A 25+ Year Survivor of Metastatic Breast Cancer and Patient Advocate

A growing number of treatment optionsAnd while metastatic breast cancer may be treated in a different way than breast cancer diagnosed at an earlier stage, there is a wide variety of treatment options for metastatic disease. And investigators are studying new drugs in clinical trials.

Although metastatic breast cancer can be unpredictable, with hopeful times when patients are responding well to treatment and the disease is stable to scary time of progression, the result of ongoing research and development is that more and more patients are given the opportunity of living life to the fullest while, at the same time, being treated for metastatic disease.

Metastatic breast cancer can not be cured. But ongoing treatment may control the disease for a number of years. New treatment options may not only help patients live longer, but they can also help in relieving cancer-related symptoms, and improve the patients overall Quality of Life (QoL), something doctors describe keeping [the patient] feeling as good as they can for as long as they can. And Quality of Life, including issues related to sexual intimacy, is important for the overall health of patients as was demonstrated during a round table discussion with patients and physicians during the 2019 San Antonio Breast Cancer Symposium (SABCS).

With a growing number of treatment options, if one option fails, there is usually another option patients can try. For patients diagnosed with a metastatic disease today, there is, as a result, more hope for many years of good Quality of Life compared to patients diagnosed two decades ago. palliative

Listen to The OncoZine Brief: Candid Conversations on Mets, Sex, and Side Effects: a Panel Discussion With Breast Cancer Oncologists, Womens Health Experts, and Patients.

Clinical developmentClinical trials are an important step in establishing the safety and efficacy of potential new treatments. Clinical trials also help investigators decide if established side effects or adverse events as a result of a particular new treatment option are acceptable when weighed against the benefits of that particular treatment option.

But ongoing research is also instrumental in understanding breast cancer leading to a better understanding of the biology of the disease and help physicians to better (or earlier) detect and diagnose the disease.

According to the American Cancer Society, more than 1,000 investigational drugs are studies before just one makes it to clinical trials. And, on average, a new drug for the treatment of breast cancer may take 6 years and in some cases even longer before scientists begin are able to test a particular new drug in a clinical trial. And, the clinical trial process itself (from phase I to phase III and market approval) may add another 6 10 years to the development process.

ProgressEarlier this week, investigators at Oncolytics Biotech confirmed that they have dosed a first patient in the so-called phase II BRACELET-1 study (BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel; NCT04215146), a clinical trial designed to evaluating Pelareorep-based combination therapies in patients with endocrine-refractory, HR+/HER2- metastatic breast cancer.

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus, a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The investigational compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

In the study, being conducted under a co-development agreement with Merck KGaA and Pfizer, participating patients receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio).

The randomized, open-label, BRACELET-1 study is designed to support the results of a prior successful phase II trial (IND-213) that showed a near doubling of overall survival (OS) with pelareorep treatment, by demonstrating pelareoreps ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- metastatic breast cancer).

The ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort. Importantly, the trial also aims to validate peripheral T-cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancerm, which may aid in future registrational trial study design and patient selection.

MonarchEAnother clinical trial, the randomized, open-label, phase III monarchE study, is designed to investigate abemaciclib (Verzenio; Eli Lilly and Company) in combination with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone in patients with high-risk, node-positive, early-stage, hormone-receptor-positive, human epidermal receptor 2 negative, breast cancer. The study includes research on acquired genomic alterations in circulating tumor DNA (ctDNA)an area of particular interest as scientists try to understand how to individualize treatment for people living with HR+, HER2- advanced breast cancer.

Abemaciclib is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to abemaciclib inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in a reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of abemaciclib and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Investigators at Eli Lilly and Company recently presented data of a study of abemaciclib in combination with standard adjuvant endocrine therapy (ET) and confirmed that study has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone.

These results are from a pre-planned interim analysis of the phase III monarchE study making abemaciclib the only CDK4 & 6 inhibitors to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high-risk hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer. The established safety profile was consistent with that observed in other abemaciclib studies in the MONARCH clinical program.

When a [patient] is diagnosed with high-risk early-stage breast cancer, they strive to do everything in their power to prevent a recurrence. And as clinicians, we have the same goal, noted Maura Dickler, M.D., vice president of oncology, late-phase development, Lilly Oncology.

The monarchE [trial] was intentionally designed for people whose breast cancer is at a high risk of returning. We are incredibly excited by the results of monarchE and that we can potentially offer a new treatment option for patients with high-risk HR+, HER2- early breast cancer. This would not have been possible without the tremendous commitment from the people who participated in this trial.

ManufacturingAbemaciclib is Lillys first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing, a new and advanced type of manufacturing adopted by the pharmaceutical industry.

Continuous production, which is contrasted with batch production, is a flow production method used to manufacture, produce, or process materials without interruption. The production method is called continuous production because the raw materials, either dry bulk or fluids that are being processed, are continuously in motion, undergoing chemical reactions or subject to mechanical or heat treatment. One of the benefits of this approach is that it eliminates, or significantly reduces, the hold times in-between steps that are typical in batch manufacturing. Lilly was one of the first companies to use this technology on a large scale basis.

Antibody-drug ConjugatesHuman epidermal growth factor receptor 2 (HER2) is a gene that can promote cancer progression when mutated or expressed at high levels. High expression levels of HER2 have been observed in different cancer types, including breast cancer. Several HER2-targeted therapies are approved for the treatment of HER2-overexpressing breast cancer.

One of these agents is the HER2-targeted antibody-drug conjugate (ADC), fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo/AstraZeneca). The FDA-approval of the drug in late 2019, was based on the results of the registrational Phase II trial DESTINY-Breast01 of trastuzumab deruxtecan-nxki (5.4mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer. All patients received prior trastuzumab, trastuzumab emtansine with the majority of patients (66%) receiving prior treatment with pertuzumab (Perjeta; Genentech/Roche).

The Phase II trial results showed a confirmed objective response rate of 60.3% (n=111, 95% CI 52.9-67.4) including a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103). Median duration of response of 14.8 months (95% CI 13.8-16.9) was demonstrated as of 1 August 2019. [5] In addition, a median progression-free survival of 16.4 months (95% CI 12.7-not estimable), based upon a median duration of follow up of 11.1 months, was presented at the 2019 San Antonio Breast Cancer Symposium and published online in The New England Journal of Medicine.[6]

The approval oftrastuzumab deruxtecan underscores that this specifically engineered HER2-directed antibody-drug conjugate is delivering on its intent to establish an important new treatment for patients with HER2-positive metastatic breast cancer, noted Antoine Yver, Executive Vice President and Global Head, Oncology R&D, Daiichi Sankyo

Since the beginning of our clinical trial program four years ago, we have focused on the opportunity to transform the treatment landscape for patients with HER2-positive metastatic breast cancer, and we are extremely proud of how quickly we delivered Enhertuto patients in the US, as trastuzumab deruxtecan represents one of the fastest-developed biologics in oncology, Yver added.

In late May 2020, the drug was also approved in Japan.

Triple-negative breast cancerOne of the most difficult to treat forms of breast cancer is (metastatic) triple-negative breast cancer. Traditional breast cancer treatment options dont work because cancer cells in (m)TNBC cancer test negative for estrogen or progesterone receptors and dont make too much of the protein called HER2.

This disease, which accounts for about 10-15% of all breast cancers, is more common in women younger than age 40, African-American women, or women who have a BRCA1 mutation and differs from other types of invasive breast cancer in that they grow and spread much faster, have limited treatment options, and overall worse prognosis.[7]

In April 2020 a new treatment option for adult patients diagnosed with (metastatic) triple-negative breast cancer who have received at least two prior therapies for metastatic disease, received accelerated approval in the United States. The drug, sacituzumab govitecan (sacituzumab govitecan-hziy; Trodelvy) developed by Immunomedics, is a Trop2-directed antibody conjugated to SN-38, the active metabolite of the topoisomerase I inhibitor, irinotecan. Trop2 is a cell-surface receptor that is over-expressed in epithelial cancers, including TNBC. In addition to breast cancer, the uniquely targeting agent is being studied in phase III trials for urothelial cancer, glioblastoma, endometrial cancer, and prostate cancer.

Listen to The OncoZine Brief: Sacituzumab Govitecan, a Novel Treatment for Patients with mTNBC

The confirmatory multicentre, randomized, phase III ASCENT trial, which compared sacituzumab govitecan versus the physicians choice of chemotherapy in patients with mTNBC who have failed2 prior lines of therapy, was stopped earlier than planned after an independent Data Safety Monitoring Committee confirmed compelling evidence of efficacy in the treatment of patients with mTNBC.

An ongoing phase III study is comparing sacituzumab govitecan with the physicians choice of chemotherapy in patients with HR-positive/HER2-negative metastatic breast cancer (NCT03901339; TROPiCS-02). In addition, a phase I/II trial (NCT04039230) is investigating the novel antibody-drug conjugates in combination with talazoparib (Talzenna; Pfizer), a oncedaily oral PARP inhibitor approved for the treatment of gBRCAmutated HER2negative locally advanced or metastatic breast cancer. In addition, a phase I/II, open-label, multicentre, randomized umbrella study (NCT03424005; Morpheus-TNBC) is evaluating the efficacy and safety of multiple immunotherapy-based treatment combinations, including sacituzumab govitecan, in patients with mTNBC.

Precision oncologyPrecision oncology ensures that treatment is specifically designed and targeted to a specific form of cancer using a patients individual genetics the genes that are mutated and cause cancer to grow to create a personalized treatment protocol based on the genetic mutations. Such an approach may offer far better results with fewer side effects than standard chemotherapy.

Recently, two companies, Invitae Corporation and ArcherDX, confirmed that they entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader with unrivaled breadth and scale in cancer genetics and precision oncology.

The combined company is expected to help transform care for cancer patients, accelerating the adoption of genetics through the most comprehensive suite of products and services available. Integrating germline testing, tumor profiling, and liquid biopsy technologies and services in a single platform may enable precision approaches from diagnostic testing to therapy optimization and monitoring, expanding access to best-in-class personalized oncology.

Rucaparib and lucitanibClovis Oncology, presented four abstracts showcasing non-clinical data from rucaparib and lucitanib development programs during the virtual meeting II of the American Association for Cancer Research (AACR), held June 22 24, 2020.

The presented data summarize findings from preclinical studies evaluating the pharmacokinetics (PK)/pharmacodynamics (PD) and anti-tumor activity of rucaparib, an oral, small-molecule PARP inhibitor in orthotopic and intracranial mouse models, and its synergy with CHK1 inhibition in tumor cell lines.

Additional presentations included findings from a study of the PK of lucitanib, an oral, potent inhibitor of tyrosine kinase activity, in a simulated patient population to inform dosing-regimen selection, and from a pre-clinical study evaluating the anti-tumor efficacy and mechanism of action of lucitanib in combination with a mouse ortholog of ALKS 4230, a selective agonist of the intermediate affinity IL-2 receptor, in a mouse colon cancer model. Lucitanib and ALKS 4230 are both development-stage compounds.

Data from our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients, noted Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology.

In particular, we are pleased to present new, non-clinical data exploring the PK/PD of our PARP inhibitor Rubraca, evaluating the synergies of PARP and CHK1 inhibition in combination, as well as important data for lucitanib to understand optimal dosing and use in combination with other anticancer agents to treat solid tumors, Mahaffy added.

Modulating the effects of cortisolCorcept Therapeutics, a commercial-stage company developing novel drugs to treat severe metabolic, oncologic, and psychiatric disorders by modulating the effects of cortisol, presented updated genomic data from patients with adrenocortical carcinoma at the 2020 American Association of Cancer Research (AACR) Annual Meeting.

Excessive cortisol in patients with adrenal cancer causes Cushings syndrome and may also blunt the efficacy of immunotherapeutic agents such as checkpoint inhibitors, said Andreas Grauer, M.D., Corcepts Chief Medical Officer.

The data we are presenting informed our Phase Ib trial of our proprietary, selective cortisol modulator relacorilant in combination with the PD-1 checkpoint inhibitor pembrolizumab (Keytruda; Merck & Co) in patients with metastatic or unresectable adrenocortical cancer. Our trial examines whether relacorilant can, in addition to treating Cushings syndrome in these patients, also help immunotherapy achieve its maximum effect, by reducing the immunosuppressive effects of excess cortisol activity, Graucer concluded.

Clinical TrialsA Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel BRACELET-1 Study NCT04215146Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production NCT04373265.ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT)

References[1] World Health Organization. Breast cancer: prevention and control. Online. Last accessed on June 20, 2020.[2] Howlader N, et al. SEER Cancer Statistics Review, 1975-2013. Online. Last accessed on June 20, 2020.[3] Howlader N, Altekruse S, Li C. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5).[4] Reinert T and Barrios CH. Optimal Management of Hormone receptor-positive Metastatic Breast Cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.[5] ENHERTU [fam-trastuzumab deruxtecan-nxki] US prescribing information; 2019.[6] Modi, S., et. al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. NEJM. December 11, 2019. DOI:10.1056/NEJMoa1914510.[7] Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019;380(8):741-751. doi:10.1056/NEJMoa1814213

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New Therapies may Offer Hope for Patients with Metastatic Breast Cancer - OncoZine

Recommendation and review posted by Bethany Smith

Precisely 32 pages into The Unwelcome Visitor, Loose Women panellist Denise Welchs chatty, conversational account of living with clinical depression, my stomach abruptly swooped upwards before plunging into liftshaft freefall.

This was not the plan. Having suffered from debilitating depressive episodes on and off since my early teens, I have deliberately body swerved what I term Low Mood Literature on the Tolstoyan grounds that each unhappy person is unhappy in their own way and its actually quite tedious (sorry) to plough through other peoples usually quite niche travails.

But these days theres a celebrity out there for every mental health cohort; the drinkers, the thinkers, the wild swimmers, free runners, gardeners and agoraphobics all have their various champions.

Thats not a bad thing but it is A Thing. Former Labour spin doctor Alistair Campbell is due to publish his Living Better: How I Learned to Survive Depression and I can safely predict there wont be much crossover between the readership of his book and Welchs. But by God, there will be a readership for both in the wake of the Covid-19 pandemic.

Theres a mental health tsunami on its way, says Welch, speaking to me on the phone from her home in Cheshire. As lockdown eases off so many people will need treatment, but the NHS just hasnt got the resources. So what are they to do?

Self-help memoirs are a start. Welch has written two best-selling autobiographies but The Unwelcome Visitor: Depression and How I Survive Itis different. It concentrates on her tormented inner life rather than the relentlessly upbeat pocket-rocket persona she projected in public.

Welch thinks as she speaks as she writes; calling her depression the unwelcome visitor is her one and only foray into metaphor.

The likes of Stephen Fry and Ruby Wax have written very eloquently about their mental health battles, she says. My tribe wouldnt be drawn towards someone who was Oxbridge-educated. My book is aimed at Becky from Bolton.

She needs help too. So does her husband and her friends. They need to understand that she cant just pull herself together, that she cant control the pain. Im relatable. I dont have the answers. I am just telling my story, my truth and if I can help people then that will be my proudest legacy.

Welch was 31, a hugely popular soap star and self-confessed party girl when severe post-natal depression hit after the birth of her first baby, Matthew. It never quite left.

The next thirty-one years have been spent learning how to manage her Unwelcome Visitor, the grim reaper who appears unbidden, draining the colour, leeching the joy from her world.

I tell her that despite my best efforts, her plain prose reduced me to rubble. I felt, as a young person might say, triggered when I abruptly welled up with tears of recognition at her shameful, secret post-natal trauma.

I wanted my feelings back: just to be able to experience emotions again, especially for my baby; just to be normal, Welch writes in The Unwelcome Visitor.

Even though Im not religious in the least, I used to pray, Dear God, please, please, help me to love my baby.'

I had no inkling that I would be spirited back to the aftermath of a wretched labour in 2008 when I too felt desolate, empty, mad and as terrified as she was of being unmasked as a wicked, unnatural woman devoid of maternal feeling.

I literally couldnt bear to look at my desperately-wanted second daughter, with her unnervingly intense brown gaze. Instead, I would fix my own eyes on the middle distance while baring my teeth in a caricature of a smile so she wouldnt guess I was broken.

For her part, Welch recounts that years later, long after baby Matthew had grown up to become Matt Healy, singer in the achingly cool band the 1975, he wrote a song She Lays Down, that painfully captured the slow-motion horror of post-natal depression.

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Denise Welch on her struggle with depression: 'I feel grateful that I'm still standing' - Telegraph.co.uk

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SCIENTISTS claims that the G-spot does not exist has made many ladies raise an eyebrow.

Researchers could not find it but lots of women say they can.

3

The US study, which we revealed yesterday, found an even distribution of nerves rather than just one small area triggered female orgasms.

That will be a relief to the 22 per cent of men who say searching for the G-spot is their main aim during sex but you can still have fun trying to find it.

Here, a sex expert offers her A-to-G guide on looking for the zone, while another writer encourages women to seek it out.

A is for AROUSAL: Before you launch your G-spot search party, be sure to spend time warming up first.

When you kiss, touch and hug, you increase the flow of blood down below.

That helps all the nerves to be as sensitive as possible, and makes further investigations easier.

Foreplay also increases your natural levels of oxytocin (the bonding hormone) which boosts feelings of affection, meaning you will be less likely to get annoyed if your partner gets lost.

B is for BELIEVE. Id recommend you start with the attitude that the G-spot does exist, until exhaustive research proves you wrong.

It might not be a precise anatomical organ, but there are certainly many thousands of sensitive nerve endings that will respond well to a thorough investigation.

B is also for bursting. Some women describe a sensation like they need a pee when their G-spot is stimulated.

Dont worry you wont. But if you get that feeling, its a sign youre getting a wee bit closer.

C is for COORDINATES: The G-spot is said to be located at around 3 centimetres inside the vagina, on the front anterior wall the side directly beneath your tummy.

But it is not a precise measurement, so think of it as a zone rather than a spot.

Focusing on the journey rather than the destination will maximise your fun.

D is for DIFFERENT TEXTURE: Early studies suggested the G-spot was a walnut-sized area that was raised, bumpy or had a different texture to surrounding tissue.

But medical examinations have never proven the theory. Other research suggested the G-spot might be tissue that expands under stimulation. As you explore, watch for places that feel different, and apply firm, steady pressure there.

D is also for doggy style, which is a good position to target this area.

E is for EROGENOUS ZONES: While youre down there, take time to explore another area of outstanding natural interest.

About four inches higher than the G-spot is the less well-known A-spot (known as the Anterior Fornix Erogenous Zone). This was discovered in 1997 and is sometimes called the female prostate.

3

F is for FINGERTIPS: The easiest way to manually hit the G-spot is to use the soft, flat part of your fingertip.

When youve found the right zone, use your fingertip to make a beckoning, come here motion against the spot, as if youre trying to coax it out of hiding (because you are.)

When you find a place that feels good, keep going at exactly the same pace.

The G-spot responds best to steady, prolonged touches.

G is for GIRL ON TOP: This is a great position to stimulate the G-spot as it stimulates that front wall.

The woman straddles her partner, and sits up straight.

Then she leans back slightly, holding on to his legs for balance.

In this position, the area where the G-spot is believed to be gets maximum attention.

Adjust your posture until you feel a pleasurable sensation, then keep moving in the same steady way until you feel a climax start to build.

So glad my partner found it

By Georgette Culley

WHO knows whether the G-spot is a spot, a zone or even exists at all?

But my partner has definitely hit the jackpot in that area before.

My orgasm was as big as the smile on his face and lasted longer than any other climax Id experienced.

Like most women, I find the route one orgasms easier to achieve, perhaps because the crucial equipment is easier to find.

But dont let that stop you from digging for gold.

Of course, it requires a bit more creativity in the bedroom and a LOT of patience on his part. But with the right position and the right partner I think it can be done.

Most men will be more than happy to oblige but if they are anything like my ex-lovers they will definitely need a helping hand.

If youre still struggling there are a vast array of erotic toys on the market to help you locate it. Just dont make it too methodical you dont want to zap the joy out of sex.

One guy I was dating was so determined to find mine, he ended up injuring me in the process.

Put it this way, Ive had more pleasurable gynaecological examinations.

DOCTOR Ernst Grafenberg was a German gynaecologist who served as a medical officer in World War One.

In 1929, he developed the first contraceptive coil known as the Grafenberg ring.

3

But in 1950 he was ridiculed for stating there was a part of a womans body that could bring untold sexual pleasure.

His findings were built upon the research carried out by 17th Century Dutch physician Regnier de Graaf, who had described a female erogenous zone that was similar to the male prostate.

Dr Grafenberg, who was a Jew, was jailed by the Nazis in 1937 for smuggling a valuable stamp.

In 1940 he was allowed to leave Germany and went to New York where he opened a new practice. He died in 1957.

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Dr Grafenberg was too modest to name the G-spot after himself.

The term was only coined in 1981 by Dr Frank Addiego, in a report in the Journal Of Sexual Medicine.

In 2008, Italian researchers concluded that the area exists, but only some women have it.

GOT a story? RING The Sun on 0207 782 4104 or WHATSAPP on 07423720250 or EMAILexclusive@the-sun.co.uk

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G-spot does exist and you can still have fun while looking for it - The Sun

Recommendation and review posted by Bethany Smith

Something doesnt feel quite right. Theres a tightness, a fogginess, a malaise, a pain. Thirty minutes later we might use other words: splitting, pounding, banging. Now its a headache.

This happened to me recently. I was late for a meeting and couldnt find my glasses, and I was very tired. I had watched a dystopian drama the previous night with a glass of wine, and I couldnt get to sleep. Everybody was very understanding when I got there in my hot and bothered state. But after that I seemed to chase my tail all day. By the time I got home at 6pm all I wanted for dinner was a paracetamol sandwich.

Women are known to suffer more headaches than men. In the case of migraines, there are three times as many female sufferers as male ones. To understand why, its useful to know whats happening in our brains when we get a headache.

With all headaches, the pain comes from an increase of blood flow to your brain and the widening of the blood vessels (the cerebrovascular system) that feed it. Blood is toxic to the brain, so that system keeps it neatly separate from the neurons that make your brain produce all of your behaviours. The alarm system for the brain is the stretching of the pain receptors in the blood vessels as they dilate.

The pain makes us stop what we are doing and in some instances, such as in migraine, will incapacitate us until everything is back to normal. Tension can cause headaches, but the headache is caused as much by the stresses of our daily lives as it is by the choices we make under stress. We might sit in the same place for longer and not move around as we are under time pressures, leading to stiff muscles, inflammation and nitric oxide release. We might not drink as much water as we should to replenish that which we are losing to make the coffee, sugary snacks and alcohol we are consuming safe to excrete.

Heat increases stress on the body due to the sheer effort of maintaining a safe body temperature. Your heart rate increases and blood vessels move towards the surface of the skin to help heat escape. This results in sweating, which draws water away from joints, muscles and the brain.

Decreasing water levels in the body cause dehydration and affect the brain. Heat may trigger migraines more frequently in some sufferers.

It is more likely that lifestyle changes relating to hot weather trigger migraines more than heat itself. We sleep less, need to drink more water and lose our appetites.

You should avoid direct sunlight from noon to about 3pm. If you are heading outside, wear a hat which protects your head and neck fully, and wear dark sunglasses. Ensure you drink plenty of water throughout the day. If you find that you are feeling tired and can feel a migraine coming on, lie down in a cool, dark room and place a cold compress on your head such as a flannel.

A few ways to soothe migraines are to place a cold pack or cold flannel on your forehead to try to reduce the pain. Lavender oil has been known to ease migraine or headache pain; drop a bit of oil on tissue and inhale gently. Ginger has also been known to ease symptoms; try adding some to hot water for a home-made ginger tea.

Parvinder Sagoo, simplymedsonline.co.uk/migraine

When this happens, we lose water from the brain, which is an oasis in the body. If the kidneys need more water to dilute our urine, this is one of the places they get it from. If you are dehydrated, your brain shrinks in volume, pulling on the membrane covering it and causing more pain signals. Whats worse, those few glasses of wine you had to destress play with your neurochemistry, which ultimately leads to feelings of anxiety later.

Worst of all, long-term stress makes us unhappy and this can be linked to a dip in serotonin, the happy hormone which controls our mood. Fortunately, chocolate contains tryptophan, which is converted into serotonin in our bodies. Our craving for chocolate in stressful times is often our bodys way to self-medicate. A good laugh helps boost serotonin, too.

A painkiller such as ibuprofen can ease the pain, and paracetamol, particularly in combination with caffeine, is effective against tension headaches.

Although almost everyone has had a tension-type headache, not everyone has experienced a migraine. Migraine has a specific symptom set that means it is recognised as something separate from other classes of headache. In migraine, much has happened in the brain before the pain even starts.

In this prodrome phase, there are warning signs such as drowsiness, food cravings, aversion to light, thirst or blurred vision. All can be linked to altered concentrations of chemicals in the brain, which creates the conditions necessary for the next stage: the sensory disturbance known as an aura.

Not everybody has a conscious perception of an aura but it is thought that the same thing is happening in the brains of those who experience an aura and those who dont. The difference lies in how eloquent your cerebral cortex is.

What is happening in this stage is that a wave of excitation is passing over your brain followed by a wave of inactivity. You might therefore see things that arent there, such as flashing lights and scintillating lines as the wave passes over your visual areas, or experience other disturbances in your touch or smell.

Alterations in chemical balance that these waves cause, however, are the triggers for the pain phase because the waves set up vasoconstriction that the brain knows is dangerous: a lack of blood flow to the brain is as damaging as a bleed. This is corrected by vasodilation that stretches the vessels, which we feel as a throbbing, usually towards the front of the head. The relay system for pain signals in the brainstem and thalamus beneath the cortex is connected to all the other parts of the brain and so makes you feel wobbly, clumsy, sick and, of course, very averse to light.

All of this can knock you flat until the chemical balances can be brought back in line. The whole sorry episode leaves the migraineur exhausted in the postdrome phase, while their neurotransmitters and hormones are rebalancing.

Why are women more likely to suffer from this syndrome than men? In 1939, American physician Herman Selinsky argued that this was because a migraine episode could be seen as an escape for the patient from a bad situation and that harassed housewives were particularly prone.

But we now know it comes down to hormones. It turns out that 70 per cent of female migraineurs experience menstrual migraine. Indeed, oestrogen can play with neuronal excitability in lots of ways and it also interacts with the blood vessels of the brain.

Given that we know how important chemical and hormonal balance is in staving off headache, it is not surprising that those of us who experience monthly fluctuations are particularly at risk for migraine.

The use of external hormones such as oral contraceptives might ease symptoms as they stop the fluctuation of hormones necessary for ovulation, which can affect our mood and cognitive function. In essence, functions that would normally be served by one side of the brain now include both. A lack of normal inhibition between the brains hemispheres can lead to the wave of excitation in migraine and so women are vulnerable to migraine at times in their menstrual cycles.

Serotonin, which controls how much pain signal gets to our brain in addition to controlling our mood, may drop during the second half of the menstrual cycle. This explains why sumatriptan, which acts just like serotonin in the brain, is an effective migraine treatment.

But it also explains chocolate craving during the cycle: the chocolate doesnt cause your migraine, as is often thought. It really is your brain telling your body to self-medicate as the migraine begins, through the tryptophan it contains. Although males and females profess to love chocolate to the same degree, it seems women have more licence to eat it.

Splitting: The Inside Story on Headachesby Amanda Ellison (Green Tree, 16.99) is out now

Read more from the original source:
Three times as many women suffer migraines and why they're worse in a heatwave - iNews

Recommendation and review posted by Bethany Smith

ZUG, Switzerland and CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, today announced the pricing of an underwritten public offering of 6,428,572 common shares at a public offering price of $70.00 per share. In addition, the underwriters have a 30-day option to purchase up to an additional 964,285 common shares at the public offering price less the underwriting discount. CRISPR Therapeutics anticipates its gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, to be approximately $450.0 million, excluding any exercise of the underwriters option to purchase additional shares. The offering is expected to close on or about July 6, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the offering. Canaccord Genuity, William Blair, SunTrust Robinson Humphrey and Roth Capital Partners are acting as co-managers for the offering.

The common shares will be offered and sold pursuant to the Companys previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the SEC) on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on June 29, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SECs website at http://www.sec.gov. A copy of the final prospectus supplement may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at prospectus_department@jefferies.com.

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding CRISPR Therapeutics anticipated public offering. The words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, such as the expected closing date, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the offering. These and other risks and uncertainties are described in greater detail in the section entitled Risk Factors in CRISPR Therapeutics Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the SEC on February 12, 2020, the prospectus supplement related to the public offering and other filings that CRISPR Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent CRISPR Therapeutics views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CRISPR Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

Investor Contact:Susan Kim+1-617-307-7503susan.kim@crisprtx.com

Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167reides@wcgworld.com

Follow this link:
CRISPR Therapeutics Announces Pricing of Public Offering of Common Shares - July 01, 2020 - BioSpace

Recommendation and review posted by Bethany Smith

Transparency Market Research (TMR) has published a new report titled, CRISPR and Cas GenesMarket Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026. According to the report, the globalCRISPR and Cas genes marketwas valued at US$ 7,234.5 Mn by 2026, expanding at a CAGR of around 20.1% from 2018 to 2026. Increase in applications of CRISPR and Cas gene editing technology in bacteria and usage of gene editing technology for prevention of various diseases are the major factors anticipated to drive the market from 2018 to 2026. Rise in need of alternative medicine for chronic diseases and increase in investments by key players in Asia Pacific are projected to propel the market during the forecast period.

Planning To Lay Down Future Strategy? Request Brochure Of CRISPR and Cas Genes Market

https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=26417

Increase in Usage of DNA-free Cas

DNA-free Cas9 is most commonly used with synthetic crRNA tracrRNA and chosen by researchers who strive to avoid unwanted vector DNA integration into their genomic DNA. CRISPR-Cas9 utilizing mRNA or protein is ideal for applications such as knocking of a fluorescent reporter using HDR or knockout cell line generation. Advantages such as gene editing with DNA-free CRISPR-Cas9 components to reduce potential off-targets and potential usage of CRISPR-Cas9 gene editing to find correlations with human diseases in model systems drive the segment.

Rise in Incidence of Genetic Disorders and Increase in Applications of CRISPR and Cas Genesto Propel Market

Genetic diseases are generally termed as rare diseases. According to NCBI, prevalence of these rare diseases is approximately 5 in 10,000. There are 6,000 to 8,000 rare diseases, with 250 to 280 new diseases diagnosed every year. Hence, 6% to 8% of the global population is projected to be affected by rare diseases i.e., genetic diseases in the near future. Researchers are developing treatments for these diseases with applications of new technologies such as CRISPR. The applications of CRISPR technology are expanding in other industrial sectors. This is expected to drive the market during the forecast period. Usage of CRISPR/Cas9 technology in plant research has enabled the investigation of plant biology in detail which has helped to create innovative applications in crop breeding. Site-directed mutagenesis and site-specific integration of a gene, which is also called knock-in, are important in precision crop breeding. Cas9/gRNA-mediated site-directed mutagenesis and knock-in is widely used in rice and Arabidopsis protoplasts. CRISPR/Cas9 provides a simple method to generate a DSB at a target site to trigger HDR repair.

To Obtain All-Inclusive Information On Forecast Analysis Of CRISPR and Cas Genes Market , Request A Discount

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Ethical Issues Concerning Gene Editing Technology to Restrain Market

Any changes in the human genome are made in the germline, and hence are expected to be passed on to the future generations. The safety and efficacy concerns with genome editing have gained momentum with the discovery of CRISPR, as it has the potential to make accurate use of genome editing technologies. Major ethical issues concerning the human genome editing technology are disturbance of the ecological equilibrium, patent regulations concerning CRISPR/Cas9 gene technology, non-therapeutic interventions using human genome, and formation of chimera which has the risk of violation of the order of nature and giving rise to moral confusion for treating organisms.

Asia Pacific Market to Witness Exponential Growth

In terms of revenue, the CRISPR and Cas genes market in Asia Pacific is expected to expand at a CAGR of 22.0% during the forecast period. Growth of the market in the region can be attributed to increase in incidence of chronic diseases such as cancer and the need of development of genetic engineered treatment options. According to the report, Call for Action: Expanding Cancer Care for Women in India, 2017, an estimated 0.7 million women in India are suffering from cancer. China dominated the CRISPR and Cas genes market in Asia Pacific. In 2016, scientists based in China launched the first known human trials of CRISPR, the genomic tech that involves slicing and dicing the bodys very source code to fight cancer. Japan was the second largest market for CRISPR and Cas genes in Asia Pacific.

Request For Covid19 Impact Analysis

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Addgene, Thermo Fisher Scientific, Inc., and Integrated DNA Technologies, Inc. to Lead Market

The report also provides profiles of leading players operating in the global CRISPR and Cas market such as Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

More:
CRISPR and Cas Genes Market Trends, Business Strategies and Opportunities With Key Players Analysis 2026 - 3rd Watch News

Recommendation and review posted by Bethany Smith

With genetic engineering, we will be able to increase the complexity of our DNA, and improve the human race. But it will be a slow process, because one will have to wait about 18 years to see the effect of changes to the genetic code. - Stephen Hawking

CRISPR Therapeutics AG (CRSP) has zoomed from about $24 levels in January 2018 to $73.09 as of June 25, 2020, and thats a massive appreciation of about 300% in a space of 30 months. It is an efficiently managed and profitable gene-editing company that looks all set to go places once the COVID-19 disruption is contained.

Im bullish on biotech and innovative technologies within the healthcare sector and have been tweeting and reporting about relevant stocks and ETFs in The Lead-Lag Report from as early as February 2020.

Image Source: Twitter

Though I am bullish on CRSP as a long-term pick, now is not the right time or price to invest in it. COVID-19 cases have started spinning out of control, and while we may not experience another lockdown, the surge in cases can disrupt the companys operations. Before spelling out the strategy to be followed, here are a few facts:

In its Q1 2020 filing with the SEC, the company has listed the following COVID-19-specific risks to its operations:

1. The companys clinical trials for products developed for the treatment of hemoglobinopathies and immuno-oncology-based treatment have been impacted. According to the company, COVID-19 disruption will continue to impact these trials adversely in future too, due to a variety of reasons, including: (A) ICU beds that are required for trials have been diverted for treating the virus-infected; (B) Investigators did/may not want to expose candidates to COVID-19, and (C) Shortage of staff at the trial location.

2. Some of the suppliers of the company (e.g., materials, drugs, quality testing, and samples) have paused their operations.

3. Most of the companys staff was in WFH mode as of late April 2020.

These factors have impacted the companys operations as of late April 2020, and even though many facilities had reopened in May 2020, some or many may now again be impacted by the virus resurgence. The point is that as long as the COVID-19 disruption continues, CRSPs trials and operations will continue to be impacted, upsetting its pipeline. No medical research organization is sure how and by when the virus will be contained.

The global gene therapy market is estimated to grow at an annualized rate of 40% in the next 10 years. In money terms, it is expected to be worth $10 billion by 2030.

Image Source: Roots Analysis

As per Roots Analysis, a research firm, the gene-editing market is likely to witness a small decline during the COVID-19 disruption. Once the virus is contained, or when there is clarity on virus containment, the gene-editing market will get back on its growth path.

As of Q1 2020, CRSP has $889.7 million cash and equivalents in its books. This accumulated cash is not because of past operational profits, but because the company has issued stock in the last 3 years.

Image Source: Seeking Alpha

Between 2018 and 2020, the company has issued $1.15 billion worth of stock and now looks very richly valued. Here are a few numbers:

1. CRSPs TTM P/E (GAAP) is a whopping 95.41 as compared to the sector median of 33.93.

2. Its TTM EV/EBITDA is a massive 131.30 as compared to the sector median of 17.70.

3. The Forward Price/Sales is way too high at 247.50 versus the sector median of 7.71.

Slice or dice it any which way, CRSP is a very expensive stock.

CRSP is an exciting stock with a bright future. Analysts such as Oppenheimer, Jefferies, Chardan Capital, and Canaccord Genuity have assigned it a buy rating, and many independent analysts are bullish on the stock.

I too am bullish about its growth prospects but am not putting out a buy call at this price because the stock is extremely expensive.

Q2 2020, as discussed above, is likely to be adversely impacted, and there is no clarity on when the COVID-19 disruption will end. The companys product pipeline is likely to slow down as well.

Considering all positives and negatives, I would rely more on price action than news. The stock hit a low of about $33 in March 2020 and is priced at $73.09 as of June 25, 2020. I would start accumulating the stock in small quantities after it retraces 50% of its rise from its March lows, or approximately $53. I would buy small parcels at this price and keep adding on dips.

If suddenly there is clarity on when the virus disruption is going to end, or if its severity (in terms of morbidity) has greatly reduced, I would buy this stock at whatever rate it is available on that day.

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Read more:
Crispr Therapeutics AG: Risks, Rewards, And Valuation - Seeking Alpha

Recommendation and review posted by Bethany Smith

Transparency Market Research (TMR) has published a new report titled, CRISPR and Cas GenesMarket Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026. According to the report, theglobal CRISPR and Cas genes marketwas valued at US$ 7,234.5 Mn by 2026, expanding at a CAGR of around 20.1% from 2018 to 2026. Increase in applications of CRISPR and Cas gene editing technology in bacteria and usage of gene editing technology for prevention of various diseases are the major factors anticipated to drive the market from 2018 to 2026. Rise in need of alternative medicine for chronic diseases and increase in investments by key players in Asia Pacific are projected to propel the market during the forecast period.

Get Brochure of the Report @https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=26417

Increase in Usage of DNA-free Cas

DNA-free Cas9 is most commonly used with synthetic crRNA tracrRNA and chosen by researchers who strive to avoid unwanted vector DNA integration into their genomic DNA. CRISPR-Cas9 utilizing mRNA or protein is ideal for applications such as knocking of a fluorescent reporter using HDR or knockout cell line generation. Advantages such as gene editing with DNA-free CRISPR-Cas9 components to reduce potential off-targets and potential usage of CRISPR-Cas9 gene editing to find correlations with human diseases in model systems drive the segment.

Rise in Incidence of Genetic Disorders and Increase in Applications of CRISPR and Cas Genesto Propel Market

Genetic diseases are generally termed as rare diseases. According to NCBI, prevalence of these rare diseases is approximately 5 in 10,000. There are 6,000 to 8,000 rare diseases, with 250 to 280 new diseases diagnosed every year. Hence, 6% to 8% of the global population is projected to be affected by rare diseases i.e., genetic diseases in the near future. Researchers are developing treatments for these diseases with applications of new technologies such as CRISPR. The applications of CRISPR technology are expanding in other industrial sectors. This is expected to drive the market during the forecast period. Usage of CRISPR/Cas9 technology in plant research has enabled the investigation of plant biology in detail which has helped to create innovative applications in crop breeding. Site-directed mutagenesis and site-specific integration of a gene, which is also called knock-in, are important in precision crop breeding. Cas9/gRNA-mediated site-directed mutagenesis and knock-in is widely used in rice and Arabidopsis protoplasts. CRISPR/Cas9 provides a simple method to generate a DSB at a target site to trigger HDR repair.

Request For Covid19 Impact Analysis https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=26417

Ethical Issues Concerning Gene Editing Technology to Restrain Market

Any changes in the human genome are made in the germline, and hence are expected to be passed on to the future generations. The safety and efficacy concerns with genome editing have gained momentum with the discovery of CRISPR, as it has the potential to make accurate use of genome editing technologies. Major ethical issues concerning the human genome editing technology are disturbance of the ecological equilibrium, patent regulations concerning CRISPR/Cas9 gene technology, non-therapeutic interventions using human genome, and formation of chimera which has the risk of violation of the order of nature and giving rise to moral confusion for treating organisms.

Asia Pacific Market to Witness Exponential Growth

In terms of revenue, the CRISPR and Cas genes market in Asia Pacific is expected to expand at a CAGR of 22.0% during the forecast period. Growth of the market in the region can be attributed to increase in incidence of chronic diseases such as cancer and the need of development of genetic engineered treatment options. According to the report, Call for Action: Expanding Cancer Care for Women in India, 2017, an estimated 0.7 million women in India are suffering from cancer. China dominated the CRISPR and Cas genes market in Asia Pacific. In 2016, scientists based in China launched the first known human trials of CRISPR, the genomic tech that involves slicing and dicing the bodys very source code to fight cancer. Japan was the second largest market for CRISPR and Cas genes in Asia Pacific.

Read our Case study at :https://www.transparencymarketresearch.com/casestudies/innovative-medical-device-manufacturing-start-up

Addgene, Thermo Fisher Scientific, Inc., and Integrated DNA Technologies, Inc. to Lead Market

The report also provides profiles of leading players operating in the global CRISPR and Cas market such as Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

More Trending Reports by Transparency Market Research 1.https://www.prnewswire.com/news-releases/global-radiation-therapy-market-to-reach-us-8-6-bn-by-2026product-approvals-to-drive-growth-transparency-market-research-300998453.html

2.https://www.biospace.com/article/cholesterol-lowering-drugs-market-increase-in-prevalence-of-coronary-artery-disease-to-drive-market/

Here is the original post:
CRISPR and Cas Genes Market Share is Thriving Worldwide By Size, Revenue, Emerging Trends and Top Growing Companies 2026 - Science Examiner

Recommendation and review posted by Bethany Smith

On 27 June, Verve therapeutics, a US-based biotechnology firm, in a press release,announced that they have demonstrated, in primate models, the successful use of base-editing to switch off two genes in the liver to reduce blood LDL (low-density lipoproteins) and triglyceride levels. These two factors increase the risk of coronary atherosclerosis.

Coronary atherosclerosis or coronary artery disease refers to the development of plaque inside the coronary arteries (arteries that supply blood to the heart). This plaque narrows down the arteries, reducing blood flow. This leads to chest pain, lightheadedness and shortness of breath and increase in the risk of a heart attack.

Base-editors are CRISPR-based tools that can specifically make point mutations in the DNA of an organism. Mutations refer to changes in the DNA sequence. A mutation can switch on or off a gene or it can increase or decrease its functioning.

Representational image. Reuters

CRISPR-Cas9 system consists of two things - CRISPR, which are short palindromic sequences of DNA/RNA that help identify the target sequences and Cas 9, which is an enzyme that cuts the sequences that CRISPR identifies.

The results of the study were presented at the 2020 Virtual Annual Meeting of the International Society for Stem Cell Research (ISSCR).

The study

For the study, the researchers at Verve targetted and turned off (by giving an intravenous drug) one of the two genes in a group of 14 monkeys - PCSK9 (proprotein convertase subtilisin/Kexin type 9) or ANGPTL3 (angiopoietin-like protein 3). The former produces a protein that increases LDL levels in the blood while the latter produces a protein that increases blood-triglyceride rich lipoprotein levels.

Results were noted two weeks after delivering the drug. Here is what was found:

The future prospects

According to the World Health Organisation, cardiovascular diseases, including coronary artery disease, are the number one cause of death in the world, claiming about 17.9 million lives each year.

The condition is currently treated through a combination of lifestyle modifications and medications to control the symptoms and keep the disease from worsening. Surgery is often needed to remove the plaque.

Praising their new tool, Dr Andrew Bellinger, Chief Scientific Officer at Verve Therapeutics said in the press release that the fact that PCSK9 and ANGPTL3 can be silenced safely and effectively in non-human primates and that blood LDL and triglyceride levels can be reduced is very exciting.

He added that one of the most important things is that no other non-target gene was affected in the study and that this just proves that Verves once-and-done gene editing treatments may actually be effective in treating coronary artery disease in adults.

Since the genes are silenced, the person will not need to be on treatment for long. Verve is set to start the clinical phase of their study by 2023.

For more information, read our article on Heart Disease.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

Original post:
Research on a gene-editing technique to treat heart disease shows promising results in animal trials - Firstpost

Recommendation and review posted by Bethany Smith

The Global Gene Therapies Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. Gene Therapies market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This Gene Therapies market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

To Learn More About This Report, Request a Sample Copy:https://www.worldwidemarketreports.com/sample/179400* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

Adaptimmune Therapeutics Plc., Celgene Corporation, Crispr Therapeutics Ag, Glaxosmithkline Plc, Intellia Therapeutics Inc., Merck & Co. Inc., Novartis Ag, Regenxbio Inc., Voyager Therapeutics Inc., Abeona Therapeutics Inc. are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

Key players in the Gene Therapies market were identified through a second survey, and their market share was determined through a primary and second survey. All measurement sharing, splitting, and analysis were solved using a secondary source and a validated primary source. The Gene Therapies market report starts with a basic overview of the Industry Life Cycle, Definitions, Classifications, Applications, and Industry Chain Structure, and when used together, how key players can meet market coverage, offered characteristics, and customer needs It helps to understand.

The report also makes some important suggestions for new Gene Therapies market projects before evaluating their feasibility. Overall, this report covers Gene Therapies market Sales, Price, Sales, Gross Profit, Historical Growth,and Future Prospects. It provides facts related to the widespread merger, acquisition, partnership, and joint venture activities on the market.

This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the Gene Therapies market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

What Gene Therapies Market report offers:

Remarkable Attributes of Gene Therapies Market Report:

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Read more:
Gene Therapies Market: Future Opportunities, Revenue Growth, Rating, and Profit (2020 2027): Adaptimmune Therapeutics Plc., Celgene Corporation,...

Recommendation and review posted by Bethany Smith

Japanese pharma and biotech friend Takeda is set to spend nearly $1 billion in backloaded payments for a deal with early-stage startup Carmine Therapeutics.

The pair will target rare diseases using gene therapies out of the biotechs red blood cell extracellular vesicles (RBCEVs) platform, which it calls Regent and was first published in Nature back in 2018 (with the startup officially launching a year later).

An initial focus is non-viral gene therapies rather than the traditional path of adeno-associated virus (AAV)-based gene therapies that can lead to unwanted side effects.

De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

There is a high attrition rate during the development of biotherapeutics impacting the high cost of development. Early identification of the preferred expression host for manufacturing, along with lead candidate screening and material supply can help to reduce both attrition rates and cost.

The biotech said its RBCEV-based gene therapy has the potential for repeat dosing, a significantly larger transgene payload capacity in excess of 11KB, and enhanced bio-distribution in selected tissues through RBCEV surface modification.

The deal could be worth as much as $900 million, with Takeda leading Carmine's convertible note seed plus funding round by extending a $5 million convertible loan to the biotech. Theres an upfront payment and extra research funding cash, though details of dollar amounts here were not given.

Takeda nabs an option to license the programs following the completion of preclinical proof of concept studies; from here, it would be responsible for clinical development and sales.

Carmine Therapeutics was founded last year by Esco Ventures X, a life science fund, professor Harvey Lodish of the Whitehead Institute at MIT and Singaporean professors Minh Le and Jiahai Shi.

Lodish was a founding member of several big biotechs, including Genzyme (which was snapped up by Sanofi).

XQ Lin, founding CEO of Carmine Therapeutics and managing partner of Esco Ventures, said: We are pleased to enter this collaboration with Takeda, a recognized global leader in rare disease therapies, slightly more than a year since Carmine was created and incubated by Esco Ventures X. This provides Carmine with significant funding to further develop our REGENT(TM) platform, and advance our wholly-owned programs.

This also marks another, albeit very early venture into gene therapies for Takeda. In April, German CRO-biotech hybrid Evotec allied with Takeda to expand into gene therapy research. The move saw Evotec establish a 20-person team in Austria, the focal point of Takedas gene therapy operation, and sign up to work on programs for its Japanese partner.

Takeda acquired a gene therapy center in Orth an der Donau, Austria, through its purchase of Shire, which picked up the site two years earlier in its takeover of Baxalta. Throughout the series of changes in ownership, which began when Baxter spun out Baxalta in 2014, a team at the site has worked on gene therapies.

At Takeda, we're expanding our foundation in gene therapy by establishing a network of innovative partners like Carmine Therapeutics who are pursuing non-viral vector approaches that could leapfrog today's technology, added Takeda's rare disease drug discovery unit head Madhu Natarajan.

Developing alternative gene therapy delivery vehicles like the REGENT platform that could address the challenges of AAV gene therapy is critical to one day delivering next-generation cures for rare diseases.

Excerpt from:
Takeda pens $900M biobucks pact with Carmine for non-viral gene therapy work - FierceBiotech

Recommendation and review posted by Bethany Smith

PARIS--(BUSINESS WIRE)-- Regulatory News:

Lysogene (Paris:LYS)(FR0013233475 LYS), a Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced that the company has entered into a collaborative research agreement with Yeda Research and Development Co Ltd, the commercial arm of the Weizmann Institute of Science.

The agreement involves collaboration between Lysogene and the lab of Prof. Anthony Futerman at the Weizmann Institute of Science, with the aim of developing a novel AAV gene therapy approach for neuronopathic Gaucher disease, Parkinson disease, and other diseases associated with mutations of the GBA1 gene. Under the terms of the agreement, Lysogene will provide expertise in AAV vector design and production, while the lab of Prof. Futerman will provide glucocerebrosidase variants with enhanced biological properties and conduct biological proof and concept studies. Lysogene has an exclusive option to license the program.

Ralph Laufer, Chief Scientific Officer at Lysogene said: We are thrilled to start this research collaboration with Prof. Futerman, a leading expert in the field of sphingolipid biology. The Weizmann Institute is one of the world's leading multidisciplinary research institutes, and the source of numerous groundbreaking medical discoveries and technological applications. Lysogene is developing gene therapy approaches for monogenic neurological disorders, including neuronopathic lysosomal storage diseases. This collaboration is a perfect fit with Lysogenes strategy, providing the opportunity to develop a novel therapy for a rare lysosomal disease, with the potential to expand into neurological diseases with much larger patient populations, such as Parkinson.

About Lysogene

Lysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system (CNS). The company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner on a gene therapy approach for the treatment of Fragile X syndrome, a genetic disease related to autism. http://www.lysogene.com.

Forward Looking Statement

This press release may contain certain forward-looking statements, forecasts and estimates with respect to Lysogenes clinical trials, clinical trial data releases, clinical development plans, anticipated future activities and cash runway of Lysogene. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Companys control, (iii) clinical trial results, (iv) increased manufacturing costs and (v) potential claims on its products. These statements may include, without limitation, any statements preceded by, followed by or including words such as target, believe, expect, aim, intend, may, anticipate, estimate, plan, objective, project, will, can have, likely, should, would, could and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Companys control that could cause the Companys actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A further list and description of these risks, uncertainties and other risks can be found in the Companys regulatory filings with the French Autorit des Marchs Financiers, including in the 2019 universal registration document, registered with the French Markets Authorities on April 30, 2020, under number D.20-0427, and future filings and reports by the Company. Furthermore, these forward-looking statements are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn that it will or will not make additional updates with respect to those or other forward-looking statements.

This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall supersede.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200630005931/en/

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Lysogene Announces a Research Collaboration With the Weizmann Institute of Science - BioSpace

Recommendation and review posted by Bethany Smith