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Global Direct-to-Consumer Genetic Testing (DTC-GT) Market: Competitive Players

Family Tree DNA, MyHeritage, EasyDNA, Ancestry.com LLC, 24Genetics, Dante Labs, Atlas Biomed, Genebase, Mapmygenome

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Global Direct-to-Consumer Genetic Testing (DTC-GT) Market Size | Incredible Possibilities and Growth Analysis and Forecast To 2026 The Courier - The...

Recommendation and review posted by Bethany Smith

Five-year-old Addy, left, and three-month-old Ollie, right, both have the same genetic condition (Facebook)

A family faces a desperate race to raise enough money for their son to have life-saving treatment for a rare disease that will kill his five year-old sister.

The Rasberrys, from the Woodlands, Texas, need help to raise $500,000 for three-month-old Ollie to have treatment on a fatal genetic condition that attacks the central nervous system.

Its what his sister, Addy, aged five, has been suffering with since the age two leaving her unable to move, talk or eat, reports KHOU.

Tragically Addy will tragically die of rare genetic disorder, Metachromatic Leukodystrophy (MLD), but there is still time to save her little brother, Addys family has said.

The childrens mother, Victoria, said: My soul is tired. You know? Im weary, but Im trying to fight the fight and do what I need to do to save his life.

I dont know whats worse I dont know if its watching your child decline and not knowing whats going on or having a child and knowing that they will decline.

Its (the money) overwhelming, is the biggest thing that comes to mind, because we just have so little time to raise so much money.

Victoria added that Addy developed normally until about 15 months of age and then all of a sudden she started having trouble walking.

They visited a doctor for help and it took a long nine months to get Addy a diagnosis of MLD. Thats when Victoria said she learned it may be too late for treatment to save Addy.

They basically told us to go home and spend as much time with her as possible, to go on our Make-A-Wish trip and just enjoy her, she said.

Within two months of her diagnosis, Addy lost the ability to speak, eat and hold her head up.

Theres a lot of grief for what wont be and what she cant do anymore, Victoria added.

Its may sadly be too late for Addy but its not too late for Ollie, who was diagnosed with MLD shortly after birth.

The condition effects around one in every 40,000 babies born each year and is a progressive disease that is passed onto children from their parents via a faulty gene.

Because Addy has the disease, Victoria and her husband Zack knew it was important to test Ollie.

Victoria said: I was devastated, and I knew that we had to act fast.

Now they have the diagnosis Victoria and Zack can focus on giving Ollie the chance of survival via treatment. There is no recognized cure for MLD but theres a gene therapy procedure that has been approved for commercial medical use in Europe that could help.

Victoria said with the recommendation from his doctors in the US, doctors in Italy have agreed to treat him, but treatment has to start before Ollie is six-months-old.

It also costs $500,000 and the family need to raise the cash within the next few weeks. So far they have managed to raise more than $44,000 but need help from members of the public if they are to reach their goal.

To help the Rasberry family pay for Ollies life-saving treatment,click here.

Get in touch with our news team by emailing us at webnews@metro.co.uk.

For more stories like this, check our news page.

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Baby can be saved from rare genetic disorder - but sister, 5, will die of it - Metro.co.uk

Recommendation and review posted by Bethany Smith

Lung cancer is one disease, but it comes in different forms.

Some lung cancers involve gene mutations that affect how quickly the cancer grows. The anaplastic lymphoma kinase (ALK) mutation is one of those gene changes.

Knowing whether your cancer is ALK positive can help your doctor figure out which treatments will work best against it and what outlook you may expect.

To learn your ALK status, your doctor will remove a sample of your cancer during a biopsy and test it. They will also look for other gene changes that are linked to lung cancer.

ALK is short for anaplastic lymphoma kinase. Its a mutation in the DNA of your lung cells that happens when two genes become fused, or stuck together.

When you have this mutation, your lung cells make too many copies of themselves. These cells are cancerous and can spread to other parts of your body.

About 5 percent of people with non-small cell lung cancer (NSCLC) have the ALK-positive kind. Its most commonly seen in people with the adenocarcinoma type of NSCLC.

About 72,000 people are diagnosed with ALK-positive lung cancer worldwide each year, according to the advocacy group ALK Positive.

ALK-positive lung cancer responds very well to a group of targeted drugs called ALK inhibitors. Chemotherapy and other drugs also work against this cancer.

However it often returns after treatment.

How long a person might live with ALK-positive lung cancer depends in part on its stage at diagnosis. In a 2018 study, people with stage 4 ALK-positive lung cancer lived for an average of nearly 7 years after their diagnosis.

Your type of treatment also matters. People in a 2019 study who took the targeted drug crizotinib (Xalkori) lived longer than those who received chemotherapy.

Your age might also affect your life expectancy, according to 2019 research. Younger people are often diagnosed at a later stage when their cancer is harder to treat. People ages 60 and over sometimes live longer because theyre diagnosed at an earlier stage.

Overall, people with early-stage non-small cell lung cancer are 61 percent as likely as those without cancer to still be alive 5 years later, according to the American Cancer Society. Once the cancer has spread to other organs, five-year survival drops to 6 percent.

Survival rates for ALK-positive lung cancer are slightly better than those for non-small cell lung cancer overall. The aforementioned 2018 study found that people with late-stage ALK-positive disease live for an average of nearly 7 years.

Symptoms might not appear until youve had the cancer for some time and it has spread from your lungs to other parts of your body.

The symptoms of ALK-positive lung cancer are the same as those of other types of lung cancer, including:

Having symptoms like these doesnt mean you have cancer. These types of symptoms are much more likely to be a less serious condition, such as an upper respiratory infection.

But sometimes lung cancer is missed in younger people and nonsmokers because it tends to be more common in older people who smoke. If your doctor cant find another reason for your symptoms, ask for more tests or get a second opinion.

The ALK mutation isnt inherited like the BRCA mutations that cause breast cancer. This gene change happens during your lifetime.

ALK-positive lung cancer is most common in women under age 50 who have never smoked, according to ALK Positive.

People with ALK-positive lung cancer have a gene change that affects the way their lung cells grow and divide.

This type of lung cancer used to be hard to treat, but today there are a group of targeted drugs that are very effective against it.

If youve tried a few different drugs and the treatment youre on is no longer keeping your cancer under control, ask your doctor if you can enroll in a clinical trial of a new therapy.

More here:
ALK Positive Lung Cancer: Life Expectancy, Survival, and More - Healthline

Recommendation and review posted by Bethany Smith

Dr. William N. Kelley, MACP, MACR, Professor of Medicine at the University of Pennsylvania, was recently inducted into the International Association of Top Professionals (IAOTP) Hall of Fame.

Being selected by the International Association of Top Professionals is an esteemed honor, as only 20 IAOTP members are inducted each year into the exclusive Hall of Fame. These special honorees are distinguished by their longevity in their fields, the contributions they have made to society, and the impact they have had on their industries.

With over five decades of professional experience as an Educator, Physician Scientist, and Medical Doctor, Dr. Kelley has undoubtedly proven himself an extraordinary professional and an expert in medical research and education. Dr. Kelley is a dynamic, results-driven leader who has demonstrated success as one of the most respected doctors in America. In the early 1990s at PENN, Dr. Kelley, in his role as Dean of the Medical School and CEO of the Health System (the combination now known as PENN Medicine), began to build a broad research program focused on the creation of gene-based medicine and vaccines as a new method for preventing and curing human disease. While the road was a rocky one over the last three decades, he is proud to note that PENN Medicine is now the global leader in this new field. This includes the two recently FDA approved mRNA vaccines (Moderna and Biontech/Pfizer) to prevent COVID-19 which came from the PENN Medicine research laboratories of Doctors Katalin Kariko and Drew Weissman. He is noted for developing the first fully integrated university-based academic health system in the country at the University of Pennsylvania and expanding the Medical Centers regional footprint by acquiring hospitals and private practices, including Pennsylvania Hospital and Penn Presbyterian Medical Center. Dr. Kelleys impressive repertoire of roles has included Dean of the Perelman School of Medicine, CEO of the University of Pennsylvania Medical Center, and Founding CEO of the Penn Health System (now known as Penn Medicine).

Prior appointments included Professor of Medicine, Associate Professor of Biochemistry, and Chief of Rheumatic and Genetic Diseases at Duke University, followed by Professor of Biological Chemistry and Internal Medicine, and Chair of Internal Medicine with the Medical School at the University of Michigan in Ann Arbor.

Dr. Kelley was known for his breakthrough research and leadership of academic medical programs at Duke and the University of Michigan when he arrived at Penn. During Dr. Kelleys Tenure, the Perelman School became a research powerhouse moving the school into the top 3 rankings for NIH funding. There is now a Professorship named in his honor at the Perelman School of Medicine.

Dr. Kelley earned his Doctor of Medicine at Emory University in Atlanta, GA, in 1963 and subsequently served an internship and residency in Medicine at the Parkland Memorial Hospital in Dallas, TX. He completed his senior residency in Medicine at Massachusetts General Hospital in Boston. Dr. Kelleys other titles have included Clinical Associate in Human Biochemical Genetics with the National Institutes of Health, Educator to Fellow of Medicine at Harvard University, and Macy Faculty scholar at the University of Oxford in England. Later in his career, he received an honorary Master of Arts from the University of Pennsylvania.

The President of IAOTP, Stephanie Cirami, stated, Inducting Dr. Kelley into our Hall of Fame was an effortless decision for our panel to make. In addition to his long list of accomplishments and accolades, he is well regarded and well recognized in academic medicine. We are thrilled to honor him in this way and look forward to celebrating his success with him.

Throughout his illustrious career, Dr. Kelley has received many awards, accolades and has been recognized worldwide for his outstanding leadership and commitment to the profession. He will be honored at IAOTPs 2021 Annual Awards Gala, being held at the Plaza Hotel in NYC for his selection as Top Professor of the Year in Medicine for 2020; he will be inducted on stage at the ceremony for his appointment into the Hall of Fame. In 2018 he received the Albert Nelson Marquis Lifetime Achievement Award. In 2005, Dr. Kelley was presented with the Kober Medal by the Association of American Physicians and the Emory Medal in 2000 from his alma mater, Emory University. He was the recipient of the David E. Rogers Award from the Association of American Medical Colleges, the John Phillips Award of the American College of Physicians, the Gold Medal Award from the American College of Rheumatology, the Robert H. Williams Award from the Alliance for Academic Internal Medicine, and the National Medical Research Award from the National Health Council. Dr. Kelley has been featured in many magazines and publications, including Whos Who in America, Whos Who in Medicine and Healthcare, and Whos Who in the World.

Aside from his successful career, Dr. Kelley is a sought-after lecturer, speaker, and contributor to numerous professional journals and chapters to books. He was the co-inventor of a Viral-Mediated Gene Transfer System, now the most commonly used method today for in vivo gene therapy. Dr. Kelley founded and edited numerous early editions of Kelley and Firesteins Textbook of Rheumatology and Kelleys Textbook of Internal Medicine. He was also editor-in-chief for Essentials of Internal Medicine and co-editor of Arthritis Surgery and Emerging Policies for Bio-Medical Research. Dr. Kelley has served on the Board of Directors for many public companies such as Beckman Coulter, Inc. and Merck & Co., Inc, and has been involved with many committees and subcommittees with the National Institutes of Health. He is a member of the National Academy of Medicine, The American Academy of Arts & Sciences, and the American Philosophical Society.

Looking back, Dr. Kelley attributes his success to his perseverance, his education, his mentors as well as outstanding students and trainees he has had along the way. When not working, he enjoys traveling and spending time with his family. For the future, he hopes that his contributions will continue to improve human health worldwide.

For more information on Dr. Kelley please visit: http://www.iaotp.com

Watch his video: https://www.youtube.com/watch?v=6uhxBnYVY54

About IAOTP

The International Association of Top Professionals (IAOTP) is an international boutique networking organization that handpicks the worlds finest, most prestigious top professionals from different industries. These top professionals are given an opportunity to collaborate, share their ideas, be keynote speakers, and to help influence others in their fields. This organization is not a membership that anyone can join. You have to be asked by the President or be nominated by a distinguished honorary member after a brief interview.

IAOTPs experts have given thousands of top prestigious professionals around the world, the recognition and credibility that they deserve andhave helped in building their branding empires.IAOTP prides itself to bea one of a kind boutique networking organization that hand picks only the best of the best and creates a networking platform that connects and brings these top professionals to one place.

For More information on IAOTP please visit: http://www.iaotp.com

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Dr. William Kelley inducted into IAOTPs Hall of Fame - PRUnderground

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publication date: Jan. 29, 2021

Craig Lockhart was named chief of the Division of Hematology and Oncology in the Department of Medicine at the Medical University of South Carolina and associate director for clinical science at MUSC Hollings Cancer Center, effective April 1.

Lockhart will be replacing interim chief Michael Lilly, and will be working both on campus and remotely until he transitions to campus full time in September.

Lockhart holds several roles at the University of Miami Sylvester Comprehensive Cancer Center, including chief of the Division of Oncology and associate director for regional and strategic research affiliations. His research specialty is gastrointestinal cancers, and he has been a principal investigator on more than 100 phase I/II and III trials.

Lockhart is chief of service for oncology as part of the University of Miami Medical Group.

Prior to joining the University of Miami, Lockhart served on faculty and in leadership roles at Washington University and Siteman Cancer Center in St. Louis and at Vanderbilt University and Vanderbilt-Ingram Cancer Center in Nashville.

Lockhart has been conducting early-phase clinical trials for more than 20 years. His specific research interests are developing and conducting Phase I/II clinical trials of novel therapeutics applied to gastrointestinal cancers.

Terence M. Williams named radiation oncology chair at City of Hope

Terence M. Williams was named professor and chair of City of Hopes Department of Radiation Oncology.

Williams is tasked with expanding clinical and basic science research in the department. He will also integrate and expand novel treatment therapies, provide professional development and advancement opportunities for radiation oncology physicians, expand the Radiation Oncology Residency Program and build on the departments financial performance.

Previously, Williams held several leadership roles at The James Cancer Hospital and Comprehensive Cancer Center at The Ohio State University. Most recently, he served as vice chair of translational research, associate professor of radiation oncology and division director of the Thoracic and Hepatopancreaticobiliary clinical programs.

Williams specializes in treating patients with thoracic and gastrointestinal cancers, with a particular emphasis on non-small cell lung cancer, pancreatic cancer and hepatobiliary malignancies.

His laboratory-based, NIH-funded research focuses on DNA damage response pathways, DNA repair and novel mechanisms of sensitization to radiation and other genotoxic therapies and nutrient scavenging through caveolae-mediated endocytosis.

Coalition of cancer organizations urges resumption of cancer screening and treatment during pandemic

The National Comprehensive Cancer Network and the American Cancer Society are teaming up with cancer organizations across the country to endorse the resumption of cancer screening and treatment during the ongoing COVID-19 pandemic.

The coalition of 76 organizations released an open letter reminding the public that cancer still poses a major threat to peoples health, but acting as soon as is safely possible can lead to much better outcomes in the future.

The letter strongly recommends that hospitals, medical systems and patients:

Ensure people in our communities are not delaying care for important medical issues.

Encourage people in our communities to resume recommended cancer screening.

Facilitate and encourage people with cancer to resume evidence-based treatment.

Contact your doctor right away if any concerning medical symptoms arise.

Resume all preventive and prescribed care, including regular cancer screening, as recommended by your doctor.

The letter examines distressing trends showing a significant drop-off in recommended cancer screening and treatment compared to prior years. This concerning side-effect of the pandemic could lead to an increase of preventable cancer deaths over the next ten years and beyond.

Experts agree that people should not delay any necessary prevention or care.

When the pandemic first hit the United States, a short delay in care was an appropriate choice for many cancer types. However, the balance of risk has shifted significantly, Robert W. Carlson, chief executive officer of NCCN, said in a statement. Cancer centers are taking multiple measures to protect patients and staff from COVID-19 and transmission within cancer centers is quite unusual. Meanwhile, far too many cancers are being left to grow unchecked. Postponing cancer care will add tragedy on top of tragedy.

Over the past decade we have seen overall cancer mortality rates drop dramatically. This decline is in large part due to screenings ability to catch cancers before they spreadwhen the chances of good outcomes are most likely, William G. Cance, chief medical and scientific officer of ACS, said in a statement. We have come too far in our fight against cancer to allow long breaks in vital screening to slow down our progress in saving lives.

Hospitals and medical systems have begun vaccinating health care providers among other measures to ensure a safe environment for people receiving cancer screening and treatment. The confirmed use of evidence-based precautions against COVID-19 should provide reassurance against fears of infection during necessary medical care.

Experts are now asking everyone, in coordination with their health care provider, to resume preventive and prescribed care and contact their doctor right away about any new symptoms or concerns.

Visit NCCN.org/resume-screening or acs4ccc.org/ReengageLetter to read the entire letter.

Coalition of cancer scientists create global initiative to evaluate genetic mutations

Cancer scientists from the Wellcome Sanger Institute, the Human Technopole in Milan, and the Broad Institute of MIT and Harvard are calling on cancer researchers to join a global initiative to systematically evaluate the effect of every genetic mutation and every drug on every cancer.

Researchers from the organizations published a perspective on the subject in Nature.

These collaborators plan to create the Cancer Dependency Map, an approach that has shown great promise in pilot studies to help develop new cancer treatments. The goal is to make precision cancer medicine a reality for every patient.

A dependency is a gene, protein, or other molecular feature that a tumor depends on for growth. These dependencies are also vulnerabilities, which can be targeted to kill a cancer. Such vulnerabilities can inspire new drugs or ways to repurpose existing drugs, even ones that have not been considered for cancer treatment before.

To build this map, the authors think it will be necessary to perturb 20,000 genes and assess 10,000 drugs in 20,000 laboratory cancer models. Doing that will take a coordinated global effort similar in scale to the Human Cell Atlas, drawing on the expertise of specialists in genome editing, machine learning, cancer biology, cancer modeling, and high-throughput drug screening.

Authors Mathew Garnett and Jesse Boehm will be giving a news briefing at the American Association for the Advancement of Science annual meeting on Feb. 8.

NYU Dentistry receives $3.28M NIH grant for oral cancer pain research

NYU College of Dentistry clinician-scientists Seiichi Yamano and Brian Schmidt have received a five-year, $3.28 million grant (R01DE029694) from the National Institute of Dental and Craniofacial Research.

With the grant, the researchers will test whether nonviral co-delivery of DNA and RNA will safely alleviate oral cancer pain. Yamano and Schmidt have set out to develop a new class of medicines using gene therapy to effectively and safely treat oral cancer pain.

Patients with oral cancer often suffer from severe pain. The opioid medications used to treat oral cancer pain become less effective as patients develop drug tolerance, and cause numerous debilitating side effects.

Gene therapy offers an alternative to opioids for the treatment of cancer pain by reversing cancer-induced epigenetic changes. This approach selectively disrupts pain signaling without the side effects of opioids.

Complete elimination of cancer pain in a patient is exceptionally challenging because there are multiple and redundant pain-signaling mechanisms and pathways, Schmidt, professor in the Department of Oral and Maxillofacial Surgery at NYU College of Dentistry and director of NYUs Bluestone Center for Clinical Research and the NYU Oral Cancer Center, said in a statement.

As a strategy to obstruct these multiple and varied pathways, Yamano and Schmidt created two nonviral vectors that can efficiently deliver DNA and RNA to cells (transfection) with no toxicity: a cell-permeable peptide combined with a cationic lipid for DNA, and a lipopolymer for RNA. They hypothesize that the combination of OPRM1 (mu opioid receptor gene) re-expression and F2RL1 (gene for protease-activated receptor-2, or PAR2) downregulation in the cancer could eliminate cancer pain.

In preliminary studies, Yamano and Schmidt demonstrated that nonviral transfection with OPRM1 DNA led to re-expression of the mu opioid receptor and partial reduction of pain in preclinical cancer models. PAR2 was found to be elevated in certain neurons that supply the cancer with nerves and drive pain. Knockdown of the F2RL1 gene partially attenuated pain.

In their newly funded NIH grant, the researchers will test whether the combination of OPRM1 re-expression and F2RL1 downregulation in the cancer can go beyond reducing cancer pain to eliminate it.

Our approach is innovative because delivering DNA and RNA into a cancer with nonviral vectors for the management of pain has not been done before, Yamano, associate professor of prosthodontics at NYU College of Dentistry, said in a statement. If we are successful, the knowledge generated through this research could set the stage for a clinical trial and ultimately lead to the development of novel non-opioid medicines for cancer pain.

Yamano and Schmidt have collaborated on this work over the last decade; their efforts have been supported by three previous NIH-funded grants.

UAMS Winthrop P. Rockefeller Cancer Institute receives $1M to pursue NCI designation

The University of Arkansas for Medical Sciences has received a $1 million pledge from Larry Crain Sr. to support the Winthrop P. Rockefeller Cancer Institutes pursuit of NCI designation.

In appreciation of the gift, UAMS will rename the Seed of Hope Garden on the Cancer Institutes ground floor as the Janett Crain Seed of Hope Garden, after Crains late wife, who died of cancer in 2018.

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Craig Lockhart named chief of hematology and oncology at MUSC - The Cancer Letter

Recommendation and review posted by Bethany Smith

The long national awakening to a renewed threat presented by Russia has prompted Swedens political leadership to dip into its past to prepare for potential future conflict.

The new preparations encapsulated in the governments Total Defense (Totalfrsvaret) 2021-2025 bill introduced in December seek to safeguard the countrys independence and territorial integrity by enhancing the military deterrent and drawing upon a whole-of-society approach traditionally referred to as Civil Defense.

Resiliency against myriad threats forms the basis of Swedens Total Defense concept, which originated in the 1940s but has now been dusted off and brought up to date to deal with modern gray-zone warfare tactical challenges.

Foremost in the countrys Total Defense preparation will be enhancing the force structure of the Swedish armed forces (Frsvarsmakten, or Defense Force).

The first step involves expanding the number of personnel across the military organization from the current 60,000 to 90,000, a 50 percent increase. In addition, the annual number of conscripts absorbed into the military ranks will grow from about 4,000 currently to 8,000 by 2025.

The government plans to retain the Swedish Armys two existing brigades while beginning to organize and stand up a third mechanized brigade and a reduced motorized brigade in the area of the capital, Stockholm.

An additional marine amphibious battalion will be created and based in Gothenburg, on Swedens western coast along the Kattegat Sea area, with both of these battalions receiving new vessels and unmanned systems.

The strategic island of Gotland will have its defenses further strengthened with air defense systems.

Back in late 2017, the Swedish government opted to reinstate a permanent military presence on the Baltic Sea island under the re-raised Gotland Regiment (roughly 350 troops), which had been disbanded in 2005. The disbanding of the regiment left the island situated strategically in the middle of the Baltic Sea, and thus crucial to controlling naval traffic through the Baltic waterways with no military presence. This step marked the nadir of Swedens reform measures begun in 1999 that significantly pruned the overall size and capabilities of the armed forces in order to generate cost savings for the government.

Also on tap is an expansion of the peacetime organization of the armed forces. This will entail the re-establishment of former regiments and building up a military presence across the country, the latter with the twin goals of increasing the security footprint and deterrent and bolstering popular national support for the military.

Along with more soldiers and units, the stand-by territorial defense force, the Home Guard, will receive additional materiel including vehicles, sensors, and nighttime combat equipment.

In terms of additional hardware capabilities, the Swedish Army will see a gradual replacement of its Leopard 2 (Stridsvagn 122 in Swedish service) main battle tanks and CV90 infantry fighting vehicles. These projects will begin in the timeframe of the Total Defense bill, resulting in the replacement of platforms introduced into service by the early 1930s. Additional firepower in the form of artillery pieces supplemental to the existing Archer wheeled self-propelled howitzers (SPHs) is also on tap.

On the naval side, the Royal Swedish Navy fleet of submarines will grow from four to five, as the third of three Gotland class submarines, HSwMS Uppland, will receive a service-life extension and upgrade to keep her in service into the latter half of the decade. This upgrade was earlier recommended by Swedens Defense Commission in its white paper presented to Parliament on May 14, 2019. With the two new-generation Blekinge class submarines (Type A26) expected to be delivered by 2025, this will provide the service with five active submarines just as a program to replace the Gotland class fleet kicks off.

The Navys surface fleet will receive some attention as well, with the five Visby class corvettes undergoing midlife upgrades that will equip them with new air defense, torpedo and unmanned systems, allowing them to remain in service out to 2040. Replacement projects for the other two types of corvettes the pairs of Gavle and Stockholm class ships will get underway on one-for-one bases, with the Gavle class successors arriving between 2026 and 2030 and the Stockholm class replacement to be ordered by 2030.

The minesweeping fleet consisting of two classes of ships (Sparo and Koster) will be put through a life-extension program.

For the Swedish Air Force, the combat aircraft fleet will remain at 100 fighters in six squadrons more than originally envisioned. The earlier goal was for the new JAS 39E Gripen models to replace the older JAS 39C/D variants outright, but instead up to 40 C/D models will be retained through 2035 to bolster combat aircraft capacity. This will result in 60 Gripen Es based in four squadrons, with the C/D variants filling the remaining two squadrons. The Gripen Es are to achieve Final Operational Capability (FOC) by 2027.

Additional missiles, electronic warfare capabilities, new unmanned systems, and new airborne early warning and control (AEW&C) platforms to replace the existing two Saab 340 Erieye units will also be acquired.

To cover the cost of these ambitions, the government plans to significantly increase annual defense expenditures with the goal of hitting a topline allocation of SEK89 billion ($10.7 billion) by 2025, a 27 percent rise in nominal value from the 2020 earmark. The annual upticks to the budget between 2021 and 2025 will average nearly SEK5 billion ($600 million) per year, with the 2021 budget already nominally 10 percent higher than the previous years budget and 8.3 percent higher in real terms.

The funding will no doubt be received gratefully by the armed forces, which have pressed for significantly higher allocations than previously provided. Now they will do better than what the cross-party Defense Committee called for in its white paper on development of Swedens defense released in May 2019, which was a defense spending increase to SEK84 billion by 2025. In an indication of the heightened concerns about Russia, the actual funding will instead come out 6 percent higher than the Defense Committee request.

The slow re-focus on defense has taken years and multiple indications of Russian aggression along the European periphery (most crucially in Ukraines Crimean Peninsula in 2014) and into Swedish waters and airspace to gather real momentum.

The following all contributed to the buildup of concern in Stockholm: a simulated air attack on Sweden during a Russian military exercise in March 2013; submarine intrusions in the Stockholm archipelago in October 2014 that stoked remembrances of the infamous October 1981 Whiskey on the Rocks incident near the Swedish naval base in Karlskrona in which a Soviet Whiskey class submarine ran aground in national waters; and a Russian amphibious operation rehearsal in Kaliningrad in August 2019, followed by the appearance of Russian vessels in Swedish waters near Gothenburg one month later.

Still, the slowness in responding to Russias provocations alarmed many in Swedens military.

Now Stockholm is trying to make up for lost time.

It has responded by re-equipping its coastal defense anti-ship batteries, reinforcing the defense of Gotland, restarting military conscription, and issuing civil defense brochures to all citizens in preparation of national emergencies. Parliament has even flirted with the idea of joining NATO more as a statement aimed at Russia rather than a practical political measure.

Meanwhile, Sweden has stepped up security cooperation with the U.S. and military exercises with American forces. It has even allowed the permanent stationing of a U.S. Army Green Beret team on its soil to help train the Home Guard in resistance operations.

The proactive steps being taken by Stockholm represent a past is prologue template, one that allowed Sweden to maintain its independence and neutrality during the Cold War.

Back then, of course, Sweden retained a significant combat component in terms of both capacity and capability. With exorbitant costs for cutting-edge military technologies and post-Cold War-era societal changes factored into the equation, Sweden is highly unlikely to embark on an effort to reconstitute a combat aircraft fleet of 300 fighters or a naval component featuring 12 submarines, for instance.

But it will once again devote enough attention and funding to its high-end military capabilities, while identifying and combatting cyber- and information-warfare tactics practiced by Russia, to lend the Kremlin pause before seeking to test Swedens mettle.

International Military Markets Europe

This service, authored by Daniel Darling, provides a country-by-country examination of the regions military capabilities, equipment requirements, and inventories. The individual country reports are structured to condense a vast range of information into concise segments. Governmental and political structures, political and economic trends, national and defense budgets, force structures, military planning requirements, recent and future procurements, the security environment, threat assessments, and military postures all are detailed in this volume. Prices begin at $2,295, click here for more information.

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Sweden Looks to the Past to Prepare for Its Defense Future - Defense & Security Monitor

Recommendation and review posted by Bethany Smith

TORONTO, Jan. 25, 2021 (GLOBE NEWSWIRE) -- YAMANA GOLD INC. (TSX:YRI; NYSE:AUY; LSE:AUY) (Yamana or the Company) herein provides 2021, 2022, and 2023 production guidance, 2021 cost guidance, and its 10-year production overview.

The following table presents the Company's total gold, silver and gold equivalent ounces ("GEO") production expectations in 2021, 2022 and 2023. The Company notes that it guides on GEO production and costs based on a particular assumption of gold and silver prices. Although underlying gold and silver production does not change with the fluctuation in gold and silver prices, the change in the GEO ratio from such fluctuations may result in a different GEO production than that guided.

The Company looks at production within a normal range of +/- 3%, and the guidance values noted below reflect the mid-point of this production range for the 2021-2023 period.

The production profile for 2021 to 2023 shows sequential growth in gold production. Several growth opportunities are available, and in the near and medium-term the Company remains focused on optimizing the existing portfolio of five operating mines while also advancing studies for various expansion projects and longer term development assets.

The Company expects to continue its established trend of delivering stronger production in the second half of the year, with approximately 53% of production slated for the second half, along with quarterly sequential increases in production.

(i) GEO assumes gold ounces plus the equivalent of silver ounces using a ratio of 72:1 for 2021, 2022 and 2023. Included in full year 2020 production figures are 18,929 gold ounces of pre-commercial production, related to the Company's 50% interest in the Canadian Malartic mine's Barnat deposit. Pre-commercial production ounces are excluded from sales figures, although pre-commercial production ounces that were sold during their respective period of production had the corresponding revenues and cost of sales capitalized to mineral properties.

The following table presents mine-by-mine production results for Yamana Mines for 2020 and expectations for 2021.

(ii) Included in full year 2020 production figures are 18,929 gold ounces of pre-commercial production, related to the Company's 50% interest in the Canadian Malartic mine's Barnat deposit. Pre-commercial production ounces are excluded from sales figures, although pre-commercial production ounces that were sold during their respective period of production had the corresponding revenues and cost of sales capitalized to mineral properties.

Cost Outlook

The Company anticipates that it will continue to incur some costs in relation to COVID-19 in the near future.Current expectation of pandemic related costs is that those costs will continue to be incurred during the first half of the year and begin to decrease in the second half of the year with a rollout of vaccinations expected in most countries in which the Company operates. With increasing numbers of the population receiving the vaccine, the Company would expect to see increasing immunity and decreasing caseloads, allowing for gradual easing of our COVID-related controls and associated costs toward the second half of 2021 as noted. Total costs are not expected to exceed approximately $20 million for the year. Similarly to 2020, COVID-19 costs are disclosed as part of mine operating earnings as temporary suspension, standby and other incremental COVID-19 costs and are excluded from cash costs and all-in sustaining costs (AISC).

The expected decline in COVID-19 costs throughout the upcoming year also corresponds to the Companys customary lower second half of the year costs, associated with higher production levels.

The following table presents guidance ranges for 2021.

(iii) A cautionary note regarding non-GAAP financial measures and additional subtotals in financial statements are included in Section 12: Non-GAAP Performance Measures of this MD&A. Total cost of sales per GEO sold will be provided in conjunction with the Companys annual results.(iv) Mine site AISC includes cash costs, mine site general and administrative expense, sustaining capital, capitalized exploration and expensed exploration. Consolidated AISC incorporates additional non-mine site costs including corporate general and administrative expense.

The following table presents expansionary capital, sustaining capital and exploration spend expectations by mine for 2021:

(i) Related to Yamanas ownership in MARA of 56.25%

Approximately 70% of the Companys expected exploration spend is capital in nature.

Capital expenditure values for 2021 do not include the cost to add to long-term ore stockpile balances at Canadian Malartic. These costs are estimated at $15.0 million for 2021 compared to $5.9 million for 2020, both on a 50% basis.

The following table presents other expenditure expectations for 2021:

(i) 2021 guidance for cash taxes paid is based on metal prices per the guidance assumption table. Further, cash taxes paid consider payments made in relation to prior years, as in certain jurisdictions, payments and true-ups related to a fiscal years taxes are settled in the next fiscal year.

Guidance Assumptions

Key assumptions, in relation to the above guidance, are presented in the table below.

2021 Sensitivity Impact

Change

AISC/GEO

(i) Actual metal prices and exchange rates shown in the table above are the average metal prices and exchange rates for the year ended December 31, 2020.

The Company may enter into forward contracts or other risk management strategies, from time to time, to hedge against the risk of an increase in the value of foreign currencies in the jurisdictions in which the Company operates. Please refer to the Foreign Exchange Hedging Section of this release for further details.

MINE BY MINE NEAR-TERM OUTLOOK

Canadian Malartic (50%)

Canadian Malartic exceeded its revised 2020 guidance, producing 284,000 ounces of gold. Production last year was impacted by COVID-19 related restrictions on mining in Quebec and is forecast to increase in 2021 to 350,000 ounces, with AISC projected to decline to $850-$885 per ounce from $945 per ounce in 2020. Mining is transitioning from the Canadian Malartic pit to the Barnat pit, which is now in commercial production, and 70% of the total tonnes mined in 2021 are expected to come from Barnat. The Canadian Malartic pit will be depleted in the first half of 2023, and waste rock and tailings will be deposited into the pit beginning in 2023.

The operation continues to advance the underground project, which consists of the East Gouldie, Odyssey, and East Malartic zones, (collectively known as the Odyssey project). Key development milestones over the next three years include the development of a ramp into the Odyssey, East Malartic, and East Gouldie zones, which will allow for tighter definition drilling to further expand the mineral resource base, along with headframe construction and shaft sinking. First production from Odyssey is expected in 2023. These milestones are included in the production and cost outlooks provided above. A preliminary economic assessment for the project is expected to be completed in February 2021.

Jacobina

The Jacobina mine continues to be a standout performer, consistently exceeding expectations. Production in 2021 is forecast to be in a similar range to the all-time high recorded in 2020 at low AISC of $735-$765 per ounce. The operation exceeded the targeted throughput rate of 6,500 tonnes per day (tpd) for the Phase 1 expansion, and it continues to identify and implement additional processing plant optimizations to further increase throughput, improve recoveries, and reduce costs. Beyond further optimizations, the Feasibility Study for Jacobinas Phase 2 expansion plans to increase throughput to 8,500 tpd and raise annual production to 230,000 ounces remains on track for mid-2021.

In a separate initiative, Jacobina is evaluating the installation of a backfill plant that would allow up to 2,000 tpd of tailings to be deposited in underground voids. In addition to reducing the mines environmental footprint, a backfill plant would extend the life of the mines existing tailings storage facility and improve mining recovery, resulting in increased conversion of mineral resources to mineral reserves.

El Pen

Overall GEO production in 2021 is forecast to be in line with production in 2020, but improvements to cost structure are expected to be realized in 2021, with cash costs expected to range between $620-$660 per GEO and AISC(1) forecast at between $835-$870 per GEO. The mines current production ratethe result of the right-sizing of the operation initiated in late 2016increased cash flow while ensuring the long-term sustainability of the mine. Exploration successes over the last two years has resulted in an increase in mineral reserves, unlocking opportunities to incrementally increase production by leveraging excess processing capacity at El Pen. The operation can process approximately 4,200 tpd, which represents upside of 20-30% above currently budgeted levels, with no additional capital expenditures required.

1. Refers to a non-GAAP financial measure.

Minera Florida

Minera Florida exceeded its full year production guidance, posting its highest production level since 2010 and the second highest since entering production in 1986.(1) Gold production is forecast to be at a similar level in 2021. The strategy at Minera Florida is to extend mine life and unlock opportunities for increased annual gold production following an approach similar to the approach taken at Jacobina. This includes focusing on mineral reserve development and generating an inventory of prepared mining areas to increase operational flexibility. The short-term focus is to achieve consistent throughput of 74,500 tonnes per month (tpm) from the underground mine while continuing improvements in the mine that will increase feed grade to align with mineral reserve grade and set the stage for further expansions.

1. Excluding gold production from the reclamation of historic tailings.

Cerro Moro

Production and costs in 2020 at Cerro Moro were significantly impacted by COVID-19 related restrictions on travel and work rosters. The mine and processing plant are currently running at full capacity, though COVID-19 continues to present a risk of further disruptions, particularly during the first half of the year. Exploration drilling and underground capital development were also delayed by COVID-19 in 2020. Hence, Cerro Moro is planning higher production in 2021, but will ramp-up gradually throughout the year as it mines new underground levels. Exploration drilling continues in the core mine area at Cerro Moro with positive results and opportunities to convert mineral resources into mineral reserves and generate new high-grade discoveries. The operation is evaluating construction of a heap leach operation, a lower-cost processing alternative that would allow for the processing of lower-grade mineral reserves, potentially extending mine life. The evaluation is in the early stages with a preliminary study completed and metallurgical lab testing currently underway.

TEN-YEAR PRODUCTION OVERVIEW

A graphic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4e5ea3bd-e322-4966-b94e-7c8baf50adfa

1. Production guidance for the period 2021 2023 reflects the mid-point of the production range of +/- 3%.2. Production from 2024 2030 is illustrative production profile.3. GEO assumes gold plus silver at a ratio of 72:1.

Base Case

Yamana has a strong 10-year base case outlook with a sustainable production platform of 1 million GEO per year through 2030. Production will be underpinned by continued operational success at the Companys existing operations, which have consistently replaced mineral reserves above depletion.

Robust exploration results are expected to drive incremental production growth at Minera Florida, which has a low-cost opportunity to increase capacity at its existing processing plant. The long-term strategy at Minera Florida is to increase monthly throughput from 74,500 tpm to 100,000 tpm with a corresponding production increase of up to 120,000 ounces of gold per year at AISC below $1,000 per ounce.

At El Pen, which recently completed its twenty-first year of production, the Company has a high degree of confidence that it will continue to replace mineral reserves through new discoveries and infill drilling on several major veins, thereby maintaining mine life visibility for at least another 10 years. The operation is targeting annual production of 260,000 GEO at AISC below $900 per GEO, with the production increase to be supported by the mines existing processing capacity of up to 4,200 tpd and no additional capital spending required.

The base case assumes continuing exploration success at Cerro Moro, which will support a mine life extension. The Company is investing in exploration drilling on its large mine property and surrounding area, which together exceed 300,000 hectares, with efforts currently focusing on both the core mine area and new mineralized zones close to existing mineral reserves. Further upside is available from significant mineralization that has been identified at below current mineral reserve cut-off grades that could potentially be mined economically using lower-cost heap leach processing that would occur in parallel with the existing processing plant.

The base case also includes the Canadian Malartic underground project, which represents the next evolution for Canadas largest gold mine. First production is expected in 2023 from the Odyssey South zone with the Upper East Gouldie zone expected to come online in 2027. The most recent underground mineral resource for the project, which was published in February 2020, showed more than 10 million ounces of gold (100% basis), including 9,596,000 ounces of inferred mineral resources (100% basis) and 830,000 ounces of indicated mineral resources (100% basis). In the interim, exploration results have been exceptional, improving economics and increasing confidence that the underground project will be a multi-hundred thousand ounce annual producer for decades. The Company will provide an updated mineral resource and further details on the development for the underground project when it reports its fourth quarter and full year results on February 11, 2021.

The base case scenario also includes the Jacobina Phase 2 expansion, which will increase throughput to 8,500 tpd and raise annual production to 230,000 ounces, a 28% increase from current levels. In addition, the Company plans to implement a Phase 3 expansion at Jacobina which, for a modest cost, would increase throughput to 10,000 tpd without the need for additional grinding capacity and raise annual production to 270,000 ounces by approximately 2027.

The Company is well-positioned to fund all exploration, expansions, projects and opportunities identified in its guidance and decade-long outlook using available cash and cash flow from operations. Based on current forecasts, annual expansionary capital expenditures are expected to be in the range of $100 million and $125 million, on average, over the next four years, the result of which is that the Company will be well-positioned to manage all its capital allocation priorities, objectives and plans, including payment and increases in dividends. The Company forecasts that it should be able to sustain its dividend at the current rate even if the price of gold were to decline to significantly lower levels, and should be able to support and increase its dividend at the current price of gold as its cash balances increase. The Company notes that in addition to its cash balances and cash flows, it also has interests in securities, instruments and assets that can and, over time, will likely be monetized, which will further increase cash balances for redeployment to the Companys capital allocation priorities, objectives and plans.

Upside Case

The Companys upside case is for annual production to trend above 1 million GEO by mid-decade, reaching 1.2 million GEO by approximately 2028. The upside case is underpinned primarily by the newly acquired Wasamac projecta future underground mine located in Quebecs Abitibi region just 100 kilometres away from Canadian Malartic. The project, which is expected to enter production in 2025, currently has a mineral reserve base of 1.8 million ounces of gold. Based on the 2018 Feasibility Study conducted by Wasamacs previous owner, Monarch Gold, production is projected at 160,000 ounces of gold per year at a low AISC of $635 per ounce. Yamana believes there is considerable upside for future exploration success and mineral resource conversion, with the deposit remaining open at depth and along strike. The Company will target increasing the mineral inventory and perform optimizations to enhance the projects value, advance engineering, and de-risk execution, leveraging the Companys technical expertise and adhering to its disciplined capital approach.

Additional Long-Term Upside

The Company has a number of compelling development and exploration stage projects in its pipeline with the potential to drive significant long-term production upside towards the end of the current decade and beyond. These include the MARA project, one of the largest copper-gold projects in the world; the Suyai Project, a large gold project in Chubut Province, Argentina, that is projected to reach production of up to 250,000 ounces annually in its first eight years; and a number of advanced exploration projects in the Companys generative exploration program, including Lavra Velha, Monument Bay, Jacobina Norte, and Borborema. Assuming just two of these projects, MARA and Suyai, are constructed within the next 10 years, annual production would almost double.

FOREIGN EXCHANGE HEDGING

As at December 31, 2020, the Company had zero-cost collar contracts, which allow the Company to participate in exchange rate movements between two strikes, as follows:

(i) R$ = Brazilian Reais(ii) Evenly split by month.

In addition, as at December 31, 2020, the Company had forward contracts as follows:

(i) R$ = Brazilian Reais(ii) Evenly split by month.

Subsequent to December 31, 2020, the Company entered into new zero-cost collar contracts, which allow the Company to participate in exchange rate movements between two strikes, as follows:

(i) R$ = Brazilian Reais(ii) Evenly split by month.

Additionally, the Company entered into new forward contracts as follows:

(i)R$ = Brazilian Reais, CLP = Chilean Pesos, C$ = Canadian Dollars(ii)Evenly split by month.

CORPORATE UPDATE CALL AND WEBCAST

The Company will provide a corporate update webcast on Tuesday, January 26, 2021, from 10:00 am-12:00 pm ET (3:00-5:00 pm GMT) during which it will expand on its guidance and decade-long outlook, share its strategic priorities, and provide an operational update.The event will be accessible via conference call or webcast with further details below. Analysts and investors who intend to attend or who may not be able to attend the webcast are advised that a detailed presentation which will be relied upon for the webcast is available and can be accessed on the Companys website at http://www.yamana.com.

The conference call replay will be available from January 26, 2021, until 11:59 p.m. ET (5:00 am GMT) on February 26, 2021.

About YamanaYamana Gold Inc. is a Canadian-based precious metals producer with significant gold and silver production, development stage properties, exploration properties, and land positions throughout the Americas, including Canada, Brazil, Chile and Argentina. Yamana plans to continue to build on this base through expansion and optimization initiatives at existing operating mines, development of new mines, the advancement of its exploration properties and, at times, by targeting other consolidation opportunities with a primary focus in the Americas.

FOR FURTHER INFORMATION PLEASE CONTACT:Investor Relations416-815-02201-888-809-0925Email: investor@yamana.com

FTI Consulting (UK Public Relations)Sara Powell / Ben Brewerton +44 203 727 1000Email: Yamana.gold@fticonsulting.com

Credit Suisse (Joint UK Corporate Broker)Ben Lawrence / David Nangle Telephone: +44 (0) 20 7888 8888

Joh.BerenbergGossler& Co. KG (Joint UK Corporate Broker)Matthew Armitt / Jennifer Wyllie / Detlir EleziTelephone: +44 (0) 20 3207 7800

Peel Hunt LLP (Joint UK Corporate Broker)Ross Allister / David McKeown / Alexander AllenTelephone: +44 (0) 20 7418 8900

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This news release contains or incorporates by reference forward-looking statements and forward-looking information under applicable Canadian securities legislation and within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking information includes, but is not limited to information with respect to the Companys strategy, plans or future financial or operating performance, changes to its dividend policy and dividend reporting, the implementation of a cash reserve fund in order to sustain dividend level independent of gold prices, the Companys expectation that it will continue to generate cash flow and execute on monetization initiatives, some of which will support the cash reserve fund, or updates regarding mineral reserves and mineral resources. Forward-looking statements are characterized by words such as plan", expect, budget, target, project, intend, believe, anticipate, estimate and other similar words, or statements that certain events or conditions may or will occur. Forward-looking statements are based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made, and are inherently subject to a variety of risks and uncertainties and other known and unknown factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. These factors include unforeseen impacts on cash flow, monetization initiatives, and available residual cash, an inability to maintain a cash reserve fund balance that can support current or future dividend increases, the outcome of various planned technical studies, production and exploration, development, optimizations and expansion plans at the Company's projects, changes in national and local government legislation, taxation, controls or regulations and/or change in the administration of laws, policies and practices, and the impact of general business and economic conditions, global liquidity and credit availability on the timing of cash flows and the values of assets and liabilities based on projected future conditions, fluctuating metal prices (such as gold, silver and zinc), currency exchange rates (such as the Brazilian Real, the Chilean Peso and the Argentine Peso versus the United States Dollar), the impact of inflation, possible variations in ore grade or recovery rates, changes in the Companys hedging program, changes in accounting policies, changes in mineral resources and mineral reserves, risks related to asset dispositions, risks related to metal purchase agreements, risks related to acquisitions, changes in project parameters as plans continue to be refined, changes in project development, unanticipated costs and expenses, higher prices for fuel, steel, power, labour and other consumables contributing to higher costs and general risks of the mining industry, failure of plant, equipment or processes to operate as anticipated, unexpected changes in mine life, final pricing for concentrate sales, unanticipated results of future studies, seasonality and unanticipated weather changes, costs and timing of the development of new deposits, success of exploration activities, permitting timelines, government regulation and the risk of government expropriation or nationalization of mining operations, risks related to relying on local advisors and consultants in foreign jurisdictions, environmental risks, unanticipated reclamation expenses, risks relating to joint venture or jointly owned operations, title disputes or claims, limitations on insurance coverage, timing and possible outcome of pending and outstanding litigation and labour disputes, risks related to enforcing legal rights in foreign jurisdictions, as well as those risk factors discussed or referred to herein and in the Company's Annual Information Form filed with the securities regulatory authorities in all provinces of Canada and available at http://www.sedar.com, and the Companys Annual Report on Form40-F filed with the United States Securities and Exchange Commission. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results not to be anticipated, estimated or intended.There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or managements estimates, assumptions or opinions should change, except as required by applicable law. The reader is cautioned not to place undue reliance on forward-looking statements. The forward-looking information contained herein is presented for the purpose of assisting investors in understanding the Companys expected financial and operational performance and results as at and for the periods ended on the dates presented in the Companys plans and objectives and may not be appropriate for other purposes.

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Yamana Gold Provides 2021-2023 Guidance and Ten-Year Overview - GlobeNewswire

Recommendation and review posted by Bethany Smith

The International Society for Stem Cell Research (ISSCR) will present this years ISSCR Momentum Award to Valentina Greco, PhD, Carolyn Walch Slayman Professor of Genetics and member of the Yale Stem Cell Center. The prize recognizes the exceptional achievements of an investigator whose innovative research has established a major area of stem cell-related research with a strong trajectory for future success. Greco will present her science during a special lecture on June 25 during ISSCR 2021 Virtual, the worlds leading meeting of global innovators in stem cell science and regenerative medicine.

Studies from Grecos lab are redefining scientific understanding of the complex mechanisms that organize and regulate the skin stem cell niche and the behavior of normal and mutant cells in the epidermis under physiologic challenge and with aging. Her groups body of work exploring cell biology in vivo determined that the niche, rather than the stem cells, are required for tissue growth, that location in the niche dictates stem cell fate, that the niche exploits stem cell plasticity to maintain homeostasis, and that homeostatic correction battles disease emergence. These breakthroughs pave the way for new concepts in mammalian regenerative biology.

Valentina is a wonderful ambassador for the stem cell community and in particular for young, female scientists in our field, said Christine Mummery, PhD, ISSCRs president. She has a confidence and skill to pursue bold new ideas. Not only is she a pioneer in live cell imaging, but she also has made multiple important discoveries regarding the mechanisms that regulate epithelial stem cell function. We are honored to recognize Valentina for her momentous achievements.

Beyond her creativity and scientific talent, Greco has shown great leadership. She is deliberate in her commitment to career development and the training of young faculty and her lab members, and brings tremendous enthusiasm to her work. Throughout her career, Greco has sought out new ways to enhance her effectiveness as a mentor by pursuing education from others, thereby establishing a strong foundation for making fundamental scientific discoveries in partnership with her lab members. She shared her perspectives and experiences as a woman and an immigrant working in science in Stem Cell Reports, Women in Stem Cell Science, Part 1.

My lab and I are honored to be recognized with this award, Greco said. Our science is inspired by the previous insights of incredible scientists that have paved the way for our contributions including the inspiring work of Cristina Lo Celso, David Scadden, Charles Lin, and Shosei Yoshida and their pioneering live imaging of mammalian stem cells in blood regeneration and spermatogenesis.

Greco was also awarded the ISSCR Dr. Susan Lim Outstanding Young Investigator Award in 2014.

Submitted by Robert Forman on January 25, 2021

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Valentina Greco Receives the 2021 ISSCR Momentum Award < Yale School of Medicine - Yale School of Medicine

Recommendation and review posted by Bethany Smith

GlobeNewswire

Fast-Growing U.S. Region Now Served by EPCORPHOENIX, Jan. 29, 2021 (GLOBE NEWSWIRE) -- EPCOR Water Arizona Inc., a subsidiary of EPCOR USA Inc. (EPCOR USA), has acquired the assets and operations of Johnson Utilities LLC. (Johnson Utilities), making EPCOR USA the water and wastewater service provider for one of the fastest-growing regions in the United States. Regulatory approval for the transfer of ownership was received from the Arizona Corporation Commission (ACC) on December 22, 2020. The financial transaction and transfer of ownership from Johnson Utilities to EPCOR was completed January 29, 2021. Recognizing the potential of the San Tan Valley, George Johnson founded Johnson Utilities in 1997. Under George Johnsons ownership of Johnson Utilities, the area experienced significant growth. Now known as the San Tan water and wastewater districts, EPCORs newest service areas are located just southeast of the greater metropolitan Phoenix area and anchor the Arizona Sun Corridor connecting the Phoenix and Tucson metropolitan areas, one of the most desirable growth corridors in the country. The 160-square-mile service area serves approximately 29,450 water and 40,160 wastewater customers in the communities of Florence, Queen Creek and unincorporated San Tan Valley in Pinal County. Were honored to be part of these vibrant communities where values that are important to EPCOR family and community are both the foundation and the future. We look forward to being an active community partner and bringing the kind of investment that is essential for job opportunities and the regions strong long-term economic outlook, said Joe Gysel, President of EPCOR USA. The ACC appointed EPCOR Interim Manager of Johnson Utilities in August 2018 and the company has worked to enhance service and reliability, address public health issues, and significantly improve customer satisfaction. More than $138 million in infrastructure improvements are still necessary over the next three years, including the construction of a new treatment facility and the expansion of another. This is the beginning of a new chapter. We are fully committed to bringing these customers safe, reliable service that is consistent with customer expectations, our brand and company values and were eager to get started, Gysel said. For further information, please contact: Rebecca StenholmDirector, Public & Government AffairsEPCOR USAO 623.445.2424 | C 602.390.5662 | rstenholm@epcor.com About EPCOR USAHeadquartered in Phoenix, Arizona, EPCOR USAs wholly owned subsidiaries build, own and operate water and wastewater and natural gas facilities and infrastructure in the southwestern United States. EPCOR USA is among the largest private water utilities in the Southwest and the largest in Arizona, providing water, wastewater, wholesale water and natural gas services to approximately 780,000 people across 42 communities and 18 counties in Arizona, New Mexico and Texas. About EPCOR Utilities Inc.EPCOR, through its wholly owned subsidiaries, builds, owns and operates electrical, natural gas and water transmission and distribution networks, water and wastewater treatment facilities, sanitary and stormwater systems, and infrastructure in Canada and the United States. The Company also provides electricity, natural gas and water products and services to residential and commercial customers. EPCOR, headquartered in Edmonton, is an Alberta Top 75 employer.

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Love Your Skin: What Is SPF And Why Is It Important? - Yahoo Movies Canada

Recommendation and review posted by Bethany Smith

[Courtesy of ToolGen]

SEOUL --ToolGen, a South Korean developer of genome editing technology, tied up with T&R Biofab, a 3D bioprinting company, to cooperate in applying induced pluripotent stem cells to gene correction. ToolGen has original technology related to third-generation gene scissors to cut out genetic information in cells.

Induced pluripotent stem cells (iPSCs) are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes. iPSCs can be derived directly from adult tissues and bypass the need for embryos.

ToolGen signed a memorandum of understanding T&R Biofab, which prints human organs and tissues for clinical transplantation, to develop and utilize cells that combine iPSCs and gene calibration technologies. "Inductive pluripotent stem cells are an ideal platform for developing gene correction therapy because they can be segmented into various cells," said ToolGen co-CEO Kim Young-ho.

ToolGen has partnered with VivaZome Therapeutics, an Australian biotech company, to develop therapies based on exosomes which are recognized for their critical role in cell-to-cell communication and transportation. The market for exosome therapeutics has been growing rapidly, and many life science companies have launched tools and systems to support exosome research.

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ToolGen ties up with 3D bioprinting company to apply induced pluripotent stem cells to gene correction - Aju Business Daily

Recommendation and review posted by Bethany Smith

If you have cancer and your doctor recommends Opdivo to treat it, you may be wondering what side effects this drug might cause.

Opdivo (nivolumab) is a brand-name prescription medication used in adults to treat certain types of cancer. These include specific forms of bladder, colorectal, and esophageal cancer, as well as several other cancer types. Its also used in some children to treat colorectal cancer.

Opdivo is a biologic drug (a type of drug made from living cells). Specifically, its an immunotherapy treatment, which means it can cause side effects involving your immune system. Its given as an intravenous infusion (an injection into a vein thats given over a period of time). For more information about Opdivo, see this in-depth article.

Opdivo may be a long-term cancer treatment. Your doctor will decide the length of your treatment based on various factors, including what side effects you experience.

Read on to learn more about the possible mild and serious side effects of Opdivo.

Like all drugs, Opdivo may cause side effects in some people.

The more common side effects of Opdivo include:

For more information about rash as well as muscle, bone, and joint pain, see the Side effects explained section below.

Certain side effects may be more common if other cancer drugs, such as ipilimumab (Yervoy), are part of your treatment plan. You may have a higher risk for certain side effects depending on the type of cancer you have.

Talk with your doctor about your risk for side effects, given your specific treatment plan. Also tell them about any side effect symptoms you may have.

Learn more about Opdivos side effects in the next sections.

You may experience mild side effects with Opdivo, such as:

For more information about muscle, bone, and joint pain, see the Side effects explained section below.

Opdivo may cause mild side effects other than the ones listed above. See the Opdivo Medication Guide for details.

Opdivos mild side effects should be manageable, and theyll likely go away during your treatment. But some could also be signs of more serious side effects.

If any side effects bother you, get worse, or dont go away, talk with your doctor or pharmacist. Try to keep all of your appointments to get Opdivo unless your doctor stops your treatment.

Opdivo may cause serious side effects. While these are generally rare, some people may be at higher risk for certain serious side effects. For example, your risk for some side effects may increase if youre receiving both Opdivo and other drugs for your cancer.

Call your doctor right away if youre having any new or worsening symptoms. If your symptoms feel life threatening, call 911 or get emergency medical care right away.

Serious side effects can include:

For more information on hepatitis, type 1 diabetes, and allergic reaction, see the Side effects explained section below.

Talk with your doctor about your risk for serious side effects. Also let them know about any concerns you may have.

Get answers to some frequently asked questions about Opdivos side effects.

No, Opdivo shouldnt cause confusion. In clinical studies of Opdivo, confusion wasnt a reported side effect.

However, confusion may be a symptom of rare, serious side effects of Opdivo, such as:

Also, Opdivo can cause hyponatremia (low blood sodium levels). Confusion is a symptom of this condition, which was a common side effect in certain clinical studies of Opdivo.

If youre feeling disoriented or having trouble thinking clearly during Opdivo treatment, contact your doctor right away.

In clinical studies of Opdivo as a melanoma treatment, reported side effects were similar to those researchers found when looking at the drug to treat other cancers.

However, Opdivo isnt always used alone to treat melanoma. The risk of side effects may differ depending on your treatment plan. For more information, see the Opdivo Medication Guide.

If youre receiving Opdivo infusions to treat melanoma, ask your doctor about your side effect risks.

Side effects with Opdivo can happen at any time, including after stopping treatment.

For example, severe reactions have happened during Opdivo infusions. However, these are rare compared with mild or moderate infusion-related reactions. Some people have had reactions within 2 days after their infusion, although these are rare as well.

Opdivo may cause your immune system to attack healthy tissues or organs. This can happen anytime during or after stopping Opdivo treatment.

Symptoms of a severe reaction that may happen during an Opdivo infusion can include:

If you have these or other symptoms during an Opdivo infusion, immediately tell the healthcare provider who is giving you the infusion.

Though rare, people have had reactions up to 2 days after their infusion. You should watch for any new or bothersome symptoms on the days between your infusions, too.

If you have a severe reaction, your healthcare provider may stop your Opdivo infusion. If you have a mild or moderate reaction during your infusion, they may slow the rate of infusion or pause it to help manage your symptoms.

Yes, it can. For example, Opdivo treatment could increase your risk for pneumonia. Pneumonia is a serious infection of the air sacs in one or both of your lungs.

In clinical studies for certain cancers, pneumonia was one of the more common serious reactions when Opdivo was used alone or with the cancer drug ipilimumab (Yervoy).

In clinical studies for certain cancers, rare but fatal infections have also occurred when Opdivo was used alone or with other cancer drugs.

Upper respiratory tract infection, such as a cold, is a common side effect of Opdivo. Though upper respiratory tract infections arent usually serious, they can lead to secondary infections such as pneumonia.

See your doctor if you have any infection symptoms such as a cough, shortness of breath, or fever.

Learn more about some of the side effects Opdivo may cause.

You may have painful joints from treatment with Opdivo. Joint pain is a common side effect of the drug.

Muscle, back, and bone pain are also common side effects of Opdivo.

Opdivo can cause your immune system to attack healthy tissues, even after youve stopped the drug. This can happen to any part of your body, including your joints. Rarely, arthritis (swelling in your joints) has occurred with Opdivo treatment.

If youre experiencing pain in your joints or other areas of your body during or after Opdivo treatment, talk with your doctor. They can check your symptoms and suggest ways you can manage them.

For mild joint pain, they may recommend you take an over-the-counter pain reliever, such as ibuprofen (Advil or Motrin). They may also suggest applying ice packs or warm compresses to your joints.

Rash is a common side effect of Opdivo.

In rare cases, Opdivo may cause a severe skin reaction, such as Stevens-Johnson syndrome. It may also result in allergic reactions, which may be mild or serious. Rash can be a symptom of both of these reactions.

During and after Opdivo treatment, contact your doctor if you have a rash that bothers you, gets worse, or doesnt go away. Get emergency medical care right away if you have blisters, peeling skin, or rash accompanied by fever, swelling, or trouble breathing. These could be signs of a severe, life threatening reaction.

If your symptoms are mild to moderate, your doctor may suggest that you manage them with a topical cream or ointment, such as hydrocortisone cream.

If youre having a severe skin reaction, your healthcare provider will pause or permanently stop your Opdivo infusions. Theyll manage the reaction with corticosteroids, such as prednisone, or other immune-suppressing drugs.

Though rare, Opdivo treatment may cause your immune system to attack healthy tissues, including your liver. When this happens, it can cause inflammation (swelling and damage) of your liver known as hepatitis.

This side effect may be more likely to happen if your treatment plan includes both Opdivo and the cancer drug ipilimumab (Yervoy).

If you have hepatitis from Opdivo treatment, your healthcare provider will pause or permanently stop your infusions. Theyll manage the condition with a corticosteroid drug, such as prednisone. In some cases, you may need to take another immune-suppressing drug.

During and after stopping Opdivo treatment, tell your doctor if you have any symptoms of hepatitis, such as:

Rarely, Opdivo may cause type 1 diabetes. With type 1 diabetes, your blood glucose (sugar) level becomes too high because your pancreas isnt releasing insulin. If untreated, this can lead to serious complications. An example is diabetic ketoacidosis (high levels of blood acids called ketones), which can be fatal.

Your doctor may check your blood glucose level while youre getting Opdivo. During and after your treatment, watch for any diabetes or ketoacidosis symptoms, such as:

Remember, high blood glucose can cause severe complications. If you have any of the symptoms listed above, see your doctor or get medical care right away.

Like most drugs, Opdivo can cause an allergic reaction in some people. Symptoms can be mild or serious and can include:

For mild symptoms of an allergic reaction, such as a mild skin rash or itching, call your doctor right away. They may suggest an over-the-counter oral antihistamine, such as diphenhydramine (Benadryl), or a topical product, like hydrocortisone cream, to manage your allergic reaction.

If your doctor confirms you had a mild allergic reaction to Opdivo, theyll decide if you should continue receiving this drug.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Opdivo, theyll stop your Opdivo treatment and decide if another cancer treatment is right for you.

During your Opdivo treatment, consider keeping notes on any side effects youre having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things like:

Sharing such notes with your doctor will help your doctor learn more about how Opdivo affects you. Your doctor can also use this information to adjust your treatment plan if needed.

Opdivo may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before starting Opdivo. Factors to consider include those mentioned below.

Stem cell or organ transplant. Opdivo treatment before or after an allogenic hematopoietic stem cell transplant (transplant of blood-forming cells from a genetic match) could cause serious or fatal problems.

If youre planning a stem cell transplant or have had one, talk with your doctor about the safety of Opdivo treatment. Also tell your doctor if youve received an organ transplant.

Allergic reaction. If youve had an allergic reaction to Opdivo or any of its ingredients, Opdivo shouldnt be part of your cancer treatment. Ask your doctor what other medications are better options for you.

Immune system problems. With Opdivo treatment, your immune system may attack healthy tissues.

Before starting Opdivo, tell your doctor if you have an autoimmune or inflammatory condition, such as Crohns disease, ulcerative colitis, or lupus. Tell them even if your condition is in remission (times when youre symptom-free).

History of chest radiation. Opdivo may cause a serious side effect of the lungs called pneumonitis. Your risk for pneumonitis may be higher if youve had radiation treatment to your chest.

Before starting Opdivo, tell your doctor about any past chest radiation treatments youve had and if youve received other drugs similar to Opdivo.

Nervous system problems. In rare cases, Opdivo treatment may cause your immune system to attack your nervous system, including your brain, spinal cord, or nerves.

Before starting Opdivo, tell your doctor if youve had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barr syndrome.

Opdivo doesnt interact with alcohol.

However, alcohol can harm your liver. In rare cases, Opdivo can cause inflammation (swelling and damage) of your liver known as hepatitis. Opdivo can be used to treat some liver cancers.

Ask your doctor if its safe to consume alcohol while being treated with Opdivo.

Its unsafe to be treated with Opdivo during pregnancy. If youre able to become pregnant, youll need to get a pregnancy test before starting Opdivo to make sure youre not pregnant.

Youll also need to use effective birth control during treatment and for at least 5 months after your last infusion.

Opdivos manufacturer hasnt given recommendations about contraception for people taking Opdivo who have a partner who can become pregnant. If you have questions or concerns about this, talk with your doctor.

Its unknown if Opdivo is safe to use while breastfeeding. You shouldnt breastfeed during Opdivo treatment or for at least 5 months after your last infusion.

Before starting Opdivo, talk with your doctor about safe ways to feed your child.

Opdivo may help treat your type of cancer. At the same time, it can put you at risk for rare but serious side effects. However, most common symptoms of Opdivo are mild or manageable.

If youre wondering about Opdivos side effects, talk with your doctor or pharmacist. Ask questions to get the answers you need to feel confident about your cancer treatment. Here are a few to get you started:

My doctor said thyroid problems are possible serious side effects of Opdivo. What symptoms should I watch for?

Opdivo may cause your immune system to attack your thyroid gland, resulting in thyroiditis (inflammation of the thyroid gland). Though thyroiditis isnt usually serious, it can lead to hypothyroidism (low thyroid levels) or hyperthyroidism (high thyroid levels).

Hypothyroidism may happen more often, especially when Opdivo is used with ipilimumab (Yervoy).

Symptoms of hypothyroidism include increased weight, fatigue (lack of energy), and feeling cold. They also include a slow heart rate, depression, and a puffy face.

Symptoms of hyperthyroidism include a fast heart rate, high blood pressure, shaking hands, and trouble sleeping.

Call your doctor if you have any of the above symptoms. They may pause or stop your Opdivo treatment depending on how severe the side effect is. Your doctor may also recommend that you take other medication to treat your hypothyroidism or hyperthyroidism.

Read more here:
Opdivo Side Effects: What They Are and How to Manage Them - Healthline

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Lets get into the science behind it: As hair is being formed, melanocytes inject pigment into keratinocytesthe cells containing keratinwhich is the protein making up hair, skin and nails, says Wayne, NJ plastic surgeon and hair specialist Jeffrey B. Wise, MD. Over time, melanocytes continue to inject pigment into the hairs keratin, which is where hair gets its color. In the aging process, melanocytes slow down and eventually stop secreting melanin, which causes a lack of pigment, and the hair turns gray.

According to Chicago dermatologist Dr. Quenby Erickson, going gray is programmed in our genetic code, which means we can get clues as to how extensively and when it will happen by looking at our parents. However, a 2020 study published in Science Daily shows there may also be a link between stress and gray hair. When testing on mice, researchers found that the type of nerve involved in the fight-or-flight response causes permanent damage to the pigment-regenerating stem cells in the hair follicle. The study makes perfect sense, says Dr. Wise. Stress is a huge factor in premature aging, as well as hair thinning. Naturally, it should also affect hair graying as well. There is also a lot of evidence that shows smoking cigarettes plays a role in making hair go gray earlier.

Color isnt always the only factor either; textural changes can ensue as well. Some people are blessed with gorgeous gray hair, but for most of us, the gray is accompanied with thinning and rougher texture that leave our hair finer and harder to style, Dr. Erickson says. There are no proven ways to prevent hair from turning gray, but both Drs. Erickson and Wise have seen some promising results from platelet-rich plasma (PRP) injections. Because these treatments are aimed at waking up your own stem cells, they could potentially reinvigorate melanocyte production as well, explains Dr. Wise. We have seen growth of darker, thicker hairs on some of our stem cell therapy patients, even though the original goal was to combat thinning. Treatment results are dependent on the patients individual conditions, so realistic expectations should be set by your doctor.

Celebrity colorists Chad Kenyon and Rita Hazan say none of their clients embraced their grays during quarantine, or they tried, but caved eventually. For those in camp cover them up, topical dyes and root concealers can help camouflage. The process to cover gray hair is the same on both blonds and darker shades, but my clients with lighter hair can go longer in between touch-ups because gray hairs blend with blond hairs more easily, says Kenyon. Celebrity colorist Aura Friedman often suggests adding a darker pepper tone to silver hair for people who feel more comfortable being darker, but dont want the two-, three- or four-week regrowth touch-up thats needed.

For those who want to permanently cover their grays at home, Nikki Lee, celebrity colorist and cofounder of Nine Zero One Salon, recommends Garnier Nutrisse Nourishing Color Creme ($8). There are more than 75 shades and you can easily find your match using a virtual shade selector, she says. If DIY color makes you nervous, temporary root sprays are great to use in between salon appointments.

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Why Hair Goes Gray, and How to Cover It If You Want To - NewBeauty Magazine

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PALM BEACH, Fla., Jan. 28, 2021 /PRNewswire/ -- According to the National Institutes of Health (NIH), the tide in the global fight against COVID-19, the disease caused by the SARS-CoV-2 virus, may soon begin to turn. Last month, three pharmaceutical companies announced promising results from vaccine trials. Countries around the world are now poised to begin the largest mass vaccination campaigns since the 1950s. Researchers led by Dr. Dan Barouch of Beth Israel Deaconess Medical Center used monkeys to look at levels of antibodies and immune cells required to prevent reinfection with the virus. NIH said some questions remainabout what types and amounts of immune system components are needed to produce long-term immunity against SARS-CoV-2. This information would be valuable both for tracking the effectiveness of vaccines and designing new ones in the future. It said that This finding suggests that T cells are needed for long-term protection from the virus. "Antibodies alone can protect, including at relatively low levels, but T cells are also helpful if antibody levels are insufficient," Barouch says. "Such knowledge will be important in the development of next generation vaccines, antibody-based therapeutics, and public health strategies for COVID-19."Active biotech companies in the Covid-19 developments this week include Sorrento Therapeutics, Inc. (NASDAQ: SRNE), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), INOVIO (NASDAQ: INO), CytoDyn Inc. (OTCQB: CYDY), Novavax, Inc. (NASDAQ: NVAX).

BMJ. Com reportedon a similar test but humans were the patients here, to find out how long the T Cells last after an infection. The results were that Robust cellular immunity persists for at least for six months after even mild or asymptomatic SARS-CoV-2 infection, research has shown. The study of 100 people showed that all had a cellular immune response against SARS-CoV-2 six months after infection although the size of response was 50% higher in those who had experienced symptomatic disease. There has been concern that the cellular immune response following covid-19 infection may not be sustained. "This data is reassuring," lead study author Paul Moss, from the University of Birmingham, told a Science Media Centre briefing on 2 November. "However, it does not mean that people cannot be re-infected. We need to have much larger population studies to show that." Moss also added that the findings "can't be taken as confirmation that an 'immunity passport' would be feasible."

BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS: COVID-T CLINICAL DEVELOPMENT PROGRAM INITIATED REGULATORY ADVISORY GROUP ENGAGED - BioVaxys Technology Corp. ("BioVaxys") is pleased to announce that it has initiated the clinical development program for Covid-T, the Company's novel diagnostic platform for detecting T-cell activity. The US Food and Drug Administration ("FDA") has tentatively agreed to permit that BioVaxys can file for a pre-Emergency Use Authorization ("EUA") for Covid-T. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Covid-T addresses an unmet need for a low-cost, easy-to-administer, and accurate tool to test for the presence of T-cells which may offer lasting protection against SARS-CoV-2.

It is believed that detection of T-cells can potentially identify safe and/or at-risk populations. Covid-T also provides an ability to evaluate the effectiveness of any SARS-CoV-2 vaccine candidate in stimulating T-cell immunity. Mass availability of Covid-T would complement antibody testing and various public health risk mitigation strategies.

James Passin, CEO of BioVaxys, stated, "We believe that our low cost, scalable, easy-to-administer test for T cell immunity to SARS-CoV-2 may help solve the urgent global public health crisis of prioritizing the distribution of Covid-19 vaccines; we look forward to rapidly advancing Covid-T towards commercialization."Current methods of measuring T-cell immunity require drawing blood from the test subject, followed by a time-consuming and expensive analysis of the blood sample at laboratories possessing specialized equipment.

Covid-T is based on the well-established concept of Delayed Type Hypersensitivity ("DTH"), the oldest and most reliable test of human T lymphocyte function. The process involves an intradermal "skin prick" of an immunogenic composition of the SARS-CoV-2 S-protein, where an inflammatory response develops 24-72 hours after skin exposure to the s-spike antigen.

BioVaxys anticipates that once clinical testing is complete, Covid-T would have the potential for detecting differences in T-cell responses between the original SARS-CoVC-2 virus and the two new strains of SARS-Cov-2 the had originally been identified in the UK and South Africa---B.1.1.7 and 501Y.V2, respectively--- but which are spreading worldwide.

"Although our vaccine programs are of major importance to us, Covid-T is a priority for BioVaxys, especially given the unmet need for such a simple, disposable, and accurate tool to test for the presence of T-cells against SARS-CoV-2," says BioVaxys President and Chief Operating Officer Ken Kovan.BioVaxys has prepared the clinical development plan for Covid-T, and engaged global regulatory advisory group Rio Pharmaceutical Services ("RPS") of Bridgewater, NJ, to provide strategic regulatory guidance, prepare an FDA pre-submission guidance package, recommend regulatory pathway, and support BioVaxys on the registration filing.

RPS has provided pharmaceutical and medical-device advisory services across the entire drug, biologic and device development and approval spectrum of the pharmaceutical industry since 2000.Collectively, the RPS team of pharmaceutical industry executives offers nearly 150 years of experience in providing advice and support services for medical, scientific, clinical-trial and regulatory issues to clients including a majority of Fortune 500 pharmaceutical companies. Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/

Other recent developments in the biotech industry include:

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced positive preliminary results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS). This ongoing study (PSC-CP-004) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106cells/kg. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. The secondary objective is to evaluate efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

The first three patients enrolled tolerated treatment well and improved rapidly. Each of the three patients was discharged from the hospital within a week of starting the patient's COVI-MSC infusions and two patients were discharged on the day of their last infusion. One of the patients had been in the hospital for three weeks, unable to be weaned from significant oxygen support, and another patient with uncontrolled diabetes had been discharged previously but had to be readmitted due to recurrent ARD. Each of the infusions were well-tolerated and no patient reported any infusion-related adverse events. A fourth patient is currently at the beginning of a course of treatment, with no safety issues following the patient's first infusion. Additional enrollment continues.

INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, and Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine"), an emerging biotech company with next-generation technology in vaccines, both preventive and therapeutic, recently announced that they have entered into a collaboration and license agreement for COVID-19 DNA vaccine candidate INO-4800.

Under the collaboration and license agreement, Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 withinGreater China, inclusive of Mainland China,Hong Kong,Macao, andTaiwan. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO's manufacturing partners. Additionally, Advaccine will provide its clinical data to INOVIO in support of INOVIO's global INO-4800 regulatory filings and INOVIO will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications inGreater China. Advaccine will make to INOVIO an upfront payment of$3.0 millionas well as pay an aggregate of$108.0 millionupon the achievement of specified development and sales-based milestones for INO-4800 inGreater China. INOVIO will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region withinGreater China.

CytoDyn Inc. (OTCQB: CYDY), a late-stage biotechnology company developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced this month a research manuscript submitted by Nicholas J. Agresti, M.D. has been accepted for publication in the Journal of Translational Autoimmunity. Dr. Agresti's research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND.

The manuscript Ms. No. JTAUTO-D-20-00043R1 is entitled "Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab."

Nicholas J. Agresti, M.D., stated, "We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19."

Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

"We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19 vaccine for the citizens of Canada," said John J. Trizzino, Chief Commercial Officer and Chief Business Officer, Novavax. "Novavax is proud to play our part in working tirelessly together with governments, scientists, regulators and others in the global effort to put an end to the pandemic."

The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada's regulatory agency.

DISCLAIMER:FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities.The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material.All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks.All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release.FNM is not liable for any investment decisions by its readers or subscribers.Investors are cautioned that they may lose all or a portion of their investment when investing in stocks.For current services performed FNM has been compensated forty nine hundred dollars for news coverage of the current press releases issued by BioVaxys Technology Corp. by a non-affiliated third party.FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

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Studies Indicating T-Cells May Be Needed For Long-Term Protection From The SARS-Cov-2 Virus - PRNewswire

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Unfortunately, there arent too many manatees that dont have a wound, says Jon (JP) Peterson, vice president of zoological operations at SeaWorld in Orlando, Fla. Peterson oversees the rescue team, a group of wildlife veterinarians and animal specialists who travel the coastal waterways of the Southeast providing emergency medicine to wild animals, including injured, cold and orphaned manatees. Boats are the most common cause of wounds: Sharp skegs and propellers scrape along the animals backs and flanks, leaving behind everything from minor scratches to much more severe lacerations like those Peterson calls sucking chest wounds.

Assess the cut and nearby tissue. Gray is bad, Peterson says. You want pink. If you see dark gray or brown, blood, pus or smell a pungent odor, there is usually infection. A manatees outer skin is tough, like an elephants hide, and prone to close up quickly. Clean, flush and scrub the wound with a sterile solution like chlorhexidine until youve removed the necrotic tissue (you may need to cut it out). To accelerate healing, Petersons team uses antibiotics, cold-laser therapy and stem cells, as well as raw, unpasteurized honey. Use a tongue depressor and pack the honey into the wound, Peterson says. With its sticky, antibacterial properties, honey stays put, even underwater.

Dont underestimate the strength of these animals. Theyre one ball of muscle, Peterson says. Dolphins and whales make less challenging patients. Release healed manatees back into the wild. Of course, unless youre trained and permitted by the U.S. Fish and Wildlife Service, you should not handle manatees at all. Mistreating them is illegal and can result in a fine and prison time. In 1967, only a few hundred manatees remained in Florida when they were listed among the first class of endangered species under the Endangered Species Act. Researchers now estimate the population at 6,300, most with crisscrossing bright white scars across their bodies. In fact, scarring is so prevalent that scientists use scar patterns to identify individual manatees during aerial surveys. You can look down from an airplane and see, Oh, look, theres so-and-so, Peterson says.

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How to Treat a Wounded Manatee - The New York Times

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Over the next 10 years, gene therapies are expected come into their own as a treatment option for a variety of diseases. So far, two such therapies have snagged regulatory approval, Novartis Zolgensma for spinal muscular atrophy, and Sparks Luxturna for a rare form of genetic blindness. More are waiting their turn.

Multiple companies are delving into gene therapy research with hopes of developing a one-time treatment for devastating genetic diseases. Gene therapies offer great reward in the form of treating various devastating diseases, but there are also significant risks. Over the past year, several clinical studies have been halted or scrapped due to safety concerns.

Bay Area-based Audentes Therapeutics had a temporary hold placed on the gene therapy under development for X-linked myotubular myopathy following reports of several patient deaths. That hold has since been lifted by the U.S. Food and Drug Administration. Uniqure also saw a hold placed on its hemophilia B trial after a patient in the study developed liver cancer. The hold was placed weeks after the company announced promising Phase III results at a conference in December.

Despite those risks, hundreds of millions of dollars in research dollars are being invested in gene therapies because of the potential near-curative capabilities the technology could offer. In December, life sciences giant Bayer launched a cell and gene therapy platform within its pharmaceutical division in order to become a leading company within a rapidly emerging and evolving field that offers the potential of life-saving therapies. Eli Lilly also dove into the field in December with the acquisition of Prevail Therapeutics. That deal was expected to extend Eli Lillys research efforts through the creation of a gene therapy program that will be anchored by Prevail's portfolio of clinical-stage and preclinical neuroscience assets.

This week, German scientists reported they were able to use gene therapy to help paralyzed mice run again. The researchers were able to genetically engineer a unique protein dubbed hyper-interleukin-6, which was then able to stimulate the regeneration of nerve cells in the visual system. A few weeks after the treatment, the injured animals were able to walk again.

Scientists in China announced the development of a gene therapy that could potentially reverse the effects of ageing. Initial research was conducted with mice, but if it is proven to be safe, human testing could begin. As Reuters reported, the method involved inactivating a gene called kat7 which the scientists found to be a key contributor to cellular ageing. Researchers used CRISPR/Cas9 to screen thousands of genes for those which were particularly strong drivers of cellular senescence, the term used to describe cellular ageing, Reuters said.

Earlier this month, a public-private partnership in Boston formed to open a new facility to boost advances in cell and gene therapies. This creation of this new facility is being helmed by Harvard University and the Massachusetts Institute of Technology. Those prestigious universities are partnering with industry members such as Fujifilm Diosynth Biotechnologies, Cytivia and Alexandria Real Estate Equities, as well as multiple research hospitals. Part of the goal of this new institute, which is still unnamed at this point, is to boost the supply of materials for research and early clinical studies, provide space for some research and also offer training in equipment used for gene therapies, The Harvard Gazette reported this week.

On Monday, Curadigm, a subsidiary of France-based Nanobiotix, forged a collaboration with Sanofi to assess if that companys Nanoprimer technology is a promising option to significantly improve gene therapy development. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.

Many promising nucleic acid-based therapeutics administered intravenously are limited in their efficacy due to rapid clearance in the liver, which prevents these therapies from reaching the necessary accumulation in target tissues to generate their intended outcomes. Additionally, accumulation in the liver, rather than in the target tissues, can lead to dose-limiting hepatic toxicity, Nanobiotix said in its announcement. The Nanoprimer is designed to precisely and temporarily occupy therapeutic clearance pathways in the liver. Delivered intravenously, immediately prior to the recommended therapy, the technology acts to prevent rapid clearancethereby increasing bioavailability and subsequent accumulation of therapeutics in the targeted tissues.

The Nanoprimer is a combination product candidate that does not alter or modify the therapies it is paired with, which means if the research with Sanofi is successful, Curadigm could seek out other opportunities for its technology.

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Are Gene Therapies the Medicine of the Future? - BioSpace

Recommendation and review posted by Bethany Smith

News Release

Thursday, January 28, 2021

Approach could provide new path for difficult-to-treat forms of Leber congenital amaurosis.

Scientists at the National Eye Institute (NEI) have developed a promising gene therapy strategy for a rare disease that causes severe vision loss in childhood. A form of Leber congenital amaurosis, the disease is caused by autosomal-dominant mutations in the CRX gene, which are challenging to treat with gene therapy. The scientists tested their approach using lab-made retinal tissues built from patient cells, called retinal organoids. This approach, which involved adding copies of the normal gene under its native control mechanism, partially restored CRX function. The study report appears today in Stem Cell Reports. NEI is part of the National Institutes of Health.

Our treatment approach, which adds more copies of the normal gene, could potentially treat autosomal-dominant LCA caused by a variety of mutations, said Anand Swaroop, Ph.D., chief of the NEI Neurobiology, Neurodegeneration and Repair Laboratory and senior author of the report.

The U.S. Food and Drug Administration approved Luxturna in 2017 for the treatment of LCA patients with mutations in a gene called RPE65. Although hailed as a major advance in gene therapy, Luxturna is ineffective against other forms of LCA, including those caused by autosomal-dominant mutations in CRX.

The CRX gene encodes a protein (also called CRX) that binds to DNA and instructs the retinas photoreceptors to make light-sensitive pigments called opsins. Without functional CRX protein, photoreceptors lose their ability to detect light and eventually die.

Disorders like autosomal-dominant LCA are tricky to treat with gene therapy, because adding more of the normal gene does not always restore function. People with autosomal-dominant mutations still have one normal copy of the gene, but the mutant version of the protein interferes with the normal protein. Sometimes, instead of restoring normal function, simply adding more of the normal protein can enhance the disease in unpredictable ways.

To explore how gene augmentation adding copies of the normal gene would affect autosomal-dominant LCA, Swaroops team, developed retinal organoids from two volunteers with LCA and from their unaffected family members. Led by Kamil Kruczek, Ph.D., a postdoctoral fellow in Swaroops lab, they built the complex retina-like tissues in several stages, starting with skin cells, inducing the production of mature photoreceptors and other retinal cells with the genetic profile of each volunteer. As expected, patient organoids made far less light-sensing opsin than the organoids made from unaffected family members.

To carefully control how much CRX gene would be expressed by the recipient photoreceptors, the team re-engineered the CRX promoter so it could be delivered with the CRX gene as part of the gene therapy. A promoter is a neighboring sequence of DNA that controls when and how genes are expressed. The researchers packed the gene and their engineered promoter inside a virus that shuttled them into the organoid photoreceptors.

The teams gene augmentation strategy restored some CRX protein function for organoids from both patients, driving expression of opsins in both types of photoreceptors: rods and cones.

The fact that this strategy worked for both CRX mutations was pretty exciting, said Swaroop. Gene augmentation may be a viable therapy for LCA caused by other autosomal-dominant mutations.

This proof-of-concept gene therapy study is the first step toward a potential treatment for a rare form of LCA, said Brian Brooks, M.D., NEI clinical director and co-author on the study. Its a great example of bench-to-bedside science, when researchers in basic and clinical science collaborate.

The current study was funded through the intramural programs of the NEI and the National Institute of Allergy and Infectious Diseases, both part of NIH. Patient samples were collected at the NIH Clinical Center, clinical trial number NCT01432847.

NEI has protected intellectual property around this technology which is available for licensing and or co-development. Details can be found on the NIH OTT Licensing website: Gene Therapy for Treatment of CRX-Autosomal Dominant Retinopathies | Office of Technology Transfer, NIH or by contacting NEI Office of Translational Research mala.dutta@nih.gov

Additional authors include: Zepeng Qu, James Gentry, Benjamin Fadl, Linn Gieser, Suja Hiriyanna, Zacahry Batz, Mugdha Samant, Ananya Samanta, Colin Chu, Laura Campello, and Zhijian Wu.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Kruczek K. Qu Z, Gentry J, Fadl BR, Gieser L, Hiriyanna S, Batz Z, Samant M, Samanta A, Chu CJ, Campello L, Brooks BP, Wu Z, and Swaroop A. Gene therapy of dominantCRX-Leber congenital amaurosis using patient stem cell-derived retinal organoids.Stem Cell Reports, January 28, 2020.https://doi.org/10.1016/j.stemcr.2020.12.018

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Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health

Recommendation and review posted by Bethany Smith

NOIDA, India, Jan. 29, 2021 /PRNewswire/ -- A comprehensive overview of the gene therapy market is recently added by UnivDatos Market Insights to its humongous database. The gene therapy market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities. This innovative report makes use of several analyses to get a closer outlook on the gene therapy market. The gene therapy market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth. Furthermore, this statistical market research repository examines and estimates the gene therapy market at the global and regional levels. The Global Gene therapy Market is expected to grow at a CAGR of 29.7% from 2021-2027 to reach US 20.9 billion by 2027.

Market Overview

Gene therapy is the next trend of curative transformation in the life sciences industry. Globally, around 2,600 clinical trials in gene therapy have been performed, are underway, or have been approved to date. More than ever, the field of gene therapy seeks to identify a route to the clinic and the market. Approximately 20 gene therapies have now been licensed and over two thousand clinical trials of human gene therapy have been published globally. Aging populations worldwide and socio-economic risk factors are among the primary influences driving this surge.

As per Alliance for Regenerative Medicine (ARM) Quarterly Regenerative Medicine Global Data Report Q12019, 372 gene therapy clinical trials were in progress as of the end of Q1. Remarkably, a margin (217 or 58%) were studies in Phase II, followed by Phase I (123 or 33%), and Phase III (32 or 9%). The number of gene therapy clinical trials edged up by 10 from the 362 recorded as of the end of 2018.

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Covid-19 Impact:

The COVID-19 pandemic has dislocated global management attempts across gene therapies. The manufacture and delivery of treatments, research and clinical development, and commercial operations are the three areas within the gene therapy sector that have been most interrupted amid the COVID-19 crisis. The development of gene therapies has been less affected. For instance, Peter Marks, Director of FDA's Center for Biologics Evaluation and Research (CBER) stated that with the arrival of therapies for cell and gene therapies over the last five years, it should have doubled in size while it is only modestly larger, 15-20% larger in size.

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Global Gene therapy Market report is studied thoroughly with several aspects that would help stakeholders in making their decisions more curated.

By Vector, the market is primarily bifurcated into

The viral vector segment dominated the gene therapy vector market in 2019 and will grow at 29.2% CAGR to reach US$ 17.9 billion by the year 2027.

By Viral Vector, the market is primarily sub-segmented into

Amongst viral vector types, adeno-associated virus accounted for the largest share and is expected to grow at 29.3% CAGR during the forecast period 2021-2027. In 2019, the adeno-associated virus segment accounted for a revenue share of almost 34%.

By Gene Type, the market is primarily studied into

In 2019, the antigen segment dominated the global gene therapy market with nearly 19.2% of the market share and it is anticipated by 2027, the segment will garner US$ 3.9 billion of the market.

By Indication, the market is primarily studied into

In 2019, the oncology segment dominated the global gene therapy market by indication with nearly 48.6% of the market share and it is anticipated to grow at 27.6% CAGR during the forecast period 2021-2027.

By Delivery Method, the market is primarily segmented into

Amongst delivery method, In vivo accounted for the largest share and is expected to grow at 28.6% CAGR during the forecast period 2021-2027. In 2019, the ex vivo segment accounted for a revenue share of 12.5%.

Gene therapy Market Geographical Segmentation Includes:

Based on the estimation, the North America region dominated the gene therapy market with almost US$ 1.7 billion revenue in 2019. At the same time, the Asia-Pacific region is expected to grow remarkably with a CAGR of 28.7% over the forecast period on account of owing increasing government initiative to improve healthcare infrastructure and rise in healthcare expenditure and surging cancer incidence rate in the region.

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The major players targeting the market includes

Competitive Landscape

The degree of competition among prominent global companies has been elaborated by analyzing several leading key players operating worldwide. The specialist team of research analysts sheds light on various traits such as global market competition, market share, most recent industry advancements, innovative product launches, partnerships, mergers, or acquisitions by leading companies in the gene therapy market. The leading players have been analyzed by using research methodologies for getting insight views on global competition.

Key questions resolved through this analytical market research report include:

We understand the requirement of different businesses, regions, and countries, we offer customized reports as per your requirements of business nature and geography. Please let us know If you have any custom needs.

For more informative information, please visit us @ https://univdatos.com/report/global-gene-therapy-market-current-analysis-and-forecast-2020-2027

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Gene Therapy Market to Reach US$ 20.9 Billion by 2027, Globally |CAGR: 29.7%|UnivDatos Market Insights - PR Newswire India

Recommendation and review posted by Bethany Smith

Newswise ROCHESTER, Minn. In a new study published in Circulation, Mayo Clinic researchers provide the first preclinical, proof-of-concept study for hybrid gene therapy in long QT syndrome, a potentially lethal heart rhythm condition.

Researchers demonstrated its potential therapeutic efficacy in two in vitro model systems using beating heart cells reengineered from the blood samples of patients with 1 long QT syndrome. They targeted the whole KCNQ1 gene rather than specific LQT1-causative mutations, making this study applicable to all patients with long QT syndrome 1, regardless of their specific disease-causing variant.

The team consisted of Mayo Clinic researchers from Mayo Clinic's:

The prevalence of long QT syndrome is about 1 in 2,000. When untreated, high-risk patients have an estimated 10-year mortality of 50%.

Long QT syndrome is a genetic heart rhythm condition that can potentially cause fast, chaotic heartbeats. These rapid heartbeats might trigger people to suddenly faint. Some people with the condition have seizures. In some severe cases, long QT syndrome can cause sudden cardiac death. The most common subtype, type 1 long QT syndrome, or LQT1, is caused by pathogenic variants in the KCNQ1 gene.

"Gene therapy is an emerging area of interest for treating a variety of genetic heart diseases in general and long QT syndrome in particular," says Michael Ackerman, M.D. Ph.D., a Mayo Clinic genetic cardiologist and director of Mayo Clinic's Windland Smith Rice Comprehensive Sudden Cardiac Death Program. "We designed and developed the first suppression and replacement KCNQ1gene therapy approach for the potential treatment of patients with type 1 long QT syndrome." Dr. Ackerman is senior author of this study.

According to Dr. Ackerman, over the past two decades, substantial improvements have been made to manage long QT syndrome, but current therapies, such as beta blockers and defibrillators, a more invasive therapy, still have limitations, risks and an array of unwanted side effects.

Gene therapy is a technique that treats diseases caused by defective genes by altering genes in a patient's cells rather than using drugs or surgery. Genes contain DNA the code that controls the body's form and function. Gene therapy replaces faulty genes or adds a new gene to try to treat a disease.

According to Dr. Ackerman in this case, this is the first time that hybrid gene therapy (simultaneous out with the old, in with the new) has been created for any form of genetic heart disease.

"If the therapeutic efficacy of this 'disease-in-the-dish' gene therapy trial with KCNQ1 can be replicated in a nonhuman, animal model of long QT syndrome, then suppression-replacement (hybrid) gene therapy may be a promising strategy for long QT syndrome in general and in theory almost any sudden death-predisposing autosomal dominant genetic heart disease," says Dr. Ackerman. "Of course, we still have a long way to go from nearly curing a patient's heart cells in the dish to effectively treating the whole person. Nevertheless, we are excited by this first critical milestone and look forward to the next step."

In addition to heart disease, researchers at Mayo Clinic's Center for Individualized Medicine are investigating an approach to replace and fix mutated genes in a wide range of genetic disorders.

Funding This work was supported by Mayo Clinic's Windland Smith Rice Comprehensive Sudden Cardiac Death Program (MJA), the Dr. Scholl Foundation (MJA), Mayo Clinic's Center for Individualized Medicine High-Definition Therapeutics grant (MJA), and Mayo Clinic's Department of Molecular Pharmacology and Experimental Therapeutics training grant under National Institutes of Health award T32GM072474 (SMD and MJA).

Disclosures Dr. Ackerman is a consultant for Abbott, Armgo Pharma Inc., Audentes Therapeutics, Boston Scientific Corporation, Daiichi Sankyo Co. Ltd., Invitae Corporation, LQT Therapeutics Inc., Medtronic, MyoKardia, and UpToDate Inc. Dr. Ackerman and Mayo Clinic are involved in an equity/royalty relationship with AliveCor Inc.

About Mayo Clinic Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news and Mayo Clinic Facts for more information about Mayo.

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First hybrid gene therapy shows early promise in treating long QT syndrome - Newswise

Recommendation and review posted by Bethany Smith

With the rising demand for cell and gene therapies, the need for manufacturing innovation has never been higher. A surge of deals and expansions in the last year is fuelling the push to truly make these therapies widely available and affordable.

Cell and gene therapies offer huge potential to treat a wide range of diseases including cancer, neurological, and genetic diseases. They have even shown promise to treat the symptoms of Covid-19.

The amount of academic and early-stage biotech research in this area has skyrocketed over the last few years. According to the Alliance for Regenerative Medicine, there are currently 1,220 ongoing clinical trials in this space, 152 of which are at phase III. Despite the global pandemic, investment in this area is also at a record high around the world, with the equivalent of 15.7B invested in 2020, a figure double that of 2019.

But research alone cannot get these complex treatments to patients. The sharp discrepancy between the high number of products in early-stage development and the still very small number that have made it onto the market, as well as their cost, speaks to the impact and importance of cost-effective and scalable manufacturing, Ryan Cawood, CEO of Oxgene (previously Oxford Genetics), told me. Oxgene is a UK biotech aiming to improve manufacturing for cell and gene therapies.

To meet this challenge, cell and gene therapy producers are exploding into motion. With 2021 only just getting started, weve seen manufacturing deals between Vigeneron and Daiichi Sankyo, Sirion Biotech and Cellectis, and Cevec and Biogen. The giant Thermo Fisher Scientific absorbed the Belgian viral vector producer Henogen for 724M. And CDMO heavyweights like Cognate BioServices and Polyplus Transfection have announced expansions to their manufacturing capacity.

Thedifficulties with manufacturing the recently approved Covid-19 mRNA vaccines in high enough quantities has really highlighted the importance of having a solid manufacturing strategy in place. This lesson applies equally to companies trying to take cell and gene therapies to market.

Stuck in the first generation

Despite the huge increase in development of cell and gene therapies over the past couple of years, manufacturing technology for these therapies is largely still at the first-generation stage. This can make scaling up a challenge.

Often cell and gene therapy manufacturing processes are highly manual stemming from the early academic or process development stage and, without adequate technology solutions available currently, these processes often remain this way through clinical trials and then into commercial manufacturing, said Jason Foster, CEO of Ori Biotech, a London- and New Jersey-based company focusing on cell and gene therapy manufacturing.

These first-generation processes cause manufacturing to be expensive, highly variable and low-throughput, which reduces the ability of patients to access these potentially life-saving therapies.

Another problem common to all bio-based therapeutics is that any product sourced from a live cell or a component of one is subject to a lot more variation than a simpler pharmaceutical product.

Most gene therapies are built on viruses found in nature. They have not evolved for very high productivity in a large-scale, animal component-free bioreactor, said Cawood.

The more complicated the biologic becomes, the more parts of it require optimization, and the more analytics you require.

According to Kevin Alessandri, the cofounder and CEO/CTO of the French company TreeFrog Therapeutics, there is also a lot of waste in cell therapy manufacturing.

Yields are impaired by high cell death at every passage, and genetic alterations inevitably arise, said Alessandri. When it comes to producing commercial batches to treat thousands of patients, scaling out 2D cell culture processes is far too expensive and poses batch-to-batch reproducibility issues.

While many in the industry are now turning to bioreactors to produce cells on a bigger scale, this is also not without problems. Impeller-induced shear stress is damaging the cells, thus negatively impacting cell viability and triggering undesired genetic mutations, explained Alessandri.

Taking manufacturing up a gear

What are companies in this space doing to make scaling up cell and gene therapies easier, quicker, and cheaper?

Ori Biotech raised24.8M in Series A funding in October last year to develop an automated and robotic manufacturing system to minimize the number of manual steps needed to produce a given cell or gene therapy. This speeds up the process as well as making it more accurate. Another advantage of the technology is that it can tailor the production capacity according to demand.

This is impossible to do in most current processes, which involve manual tube welding and transfers from flask to bag to bigger bag to bioreactor, said Foster, adding that this increases cost and variability while constraining throughput. Oris technology, in contrast, could take years off the production timeline and cut costs by as much as 80%.

London-based Synthace is one of several companies trying to improve advanced therapeutic manufacturing by developing software and computer systems to optimize the process, rather than industrial machinery.

Peter Crane, Corporate Strategy Manager for the company, said that in-depth data analysis and planning before starting the manufacturing process can make a big difference to outcomes, and that connected software can help make this task easier.

The best way to remove some of the risk associated with biomanufacturing of these products is to solve as many problems as possible before manufacturing.

In addition to making the process quicker, cheaper, and more accurate, computing tools can also help with quality control and tracking. In cell therapy manufacturing, especially autologous products, line of sight around electronic batch records, as well as the vein-to-vein supply chain, is incredibly important, emphasized Crane.

Another company specifically focusing on logistics and quality control is the Cardiff- and San Francisco-based TrakCel, which nailed deals with Ori Biotech in February and the UKs National Health Service in November.

The company TreeFrog Therapeutics works with cell encapsulation technology to improve quality and reduce waste, albeit from a more mechanical viewpoint. The company launched an industrial demonstration plant in June last year, followed by two co-development deals with undisclosed big pharma partners.

Encapsulated stem cells spontaneously self-organize in an in vivo-like 3D conformation promoting fast and homogeneous growth, as well as genomic stability, said Alessandri. The resulting 3D stem cell colony can then be differentiated in the capsule into functional microtissues ready for transplantation.

With our technology, which is based on high-throughput microfluidics capable of generating over 1,000 capsules per second, it becomes possible to expand and differentiate stem cells at a large scale, in industrial bioreactors, with best-in-class cell quality and reduced operating costs.

Oxgene has a focus on scaling up production for manufacturers. In September, the company launched a technology to scale up manufacturing of viral vector production with less contamination and a 40-fold improvement in yield compared to current methods. Oxgenes expertise with viral vectors also prompted a collaboration deal in April with the CDMO Fujifilm Diosynth Biotechnologies.

Innovation in new manufacturing technologies just hasnt kept pace with the level of discovery around genetic disease and potential avenues open to treat them, or even development of the viral vectors themselves, said Cawood. This is definitely changing though.

Enter the second generation of manufacturing

Cell and gene therapy manufacturing is definitely hot right now, boosted by increased needs from biotech and pharma companies developing Covid-19 vaccines and therapies, and by notable increases in investment.

Huge advances in gene and cell therapies over the last few years, such as the approval of the eye gene therapy Luxturna and the first CAR T-cell therapies, mean the demand for new manufacturing technologies has also increased exponentially.

A lot of very promising programs are now in the pipeline, and patients are waiting for their approval, said Alessandri. Industry urgently needs robust manufacturing technology, capable of serving millions of patients.

European biotechs are busy developing second-generation technologies to allow easier and cheaper scale up, producing higher quality products with less waste. They could start to phase out first-generation methods very soon.

The realm of cell manufacturing in industrial and food biotech is also likely to see big breakthroughs in the coming years. Earlier this month, for instance, the nutrition and health giant Royal DSM set up a lab in the Netherlands dedicated to applying artificial intelligence (AI) to the challenge of growing microbial strains at a commercial scale.

Rapid improvements in advanced computing options such as AI and machine learning technology, as well as robotics, are already having an effect on the industry, but this will only get bigger as time goes on.

Cover image from Elena Resko. Body text image from Shutterstock

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Cell and Gene Therapy Firms Gear up to Revolutionize Manufacturing - Labiotech.eu

Recommendation and review posted by Bethany Smith

Vancouver, British Columbia, Jan. 26, 2021 (GLOBE NEWSWIRE) -- The global cell and gene therapy market is projected to reach a market size of USD 7,250.0 Million by 2028 at a rapid and steady CAGR of 16.3% over the forecast period, according to most recent analysis by Emergen Research. The growing demand for cell and gene therapy can be attributed to increasing investments in production capacity expansion for cell and gene therapy. Several contract development & manufacturing organizations and contract manufacturing organizations are making huge investments in the expansion of cell and gene therapy production capacity, anticipating a rise in demand for their services from biopharmaceutical companies that emphasize the development and production of emerging therapeutic technologies.

For instance, in May 2019, CDMO Catalent invested USD 1.20 billion in Paragon Bioservices, a contract development & manufacturing organization involved in developing and producing viral vector development for gene therapy. In April 2019, Paragon Biosciences had commenced its second good manufacturing practices (GMP) gene therapy production facility in Harmans, Maryland, the US, to provide customized manufacturing set-ups to manage the specific requirements for gene therapy products.

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Cell and Gene Therapy Market Size to Reach USD 7,250.0 Million by 2028 | Increasing Investments in Production Capacity Expansion for Cell and Gene...

Recommendation and review posted by Bethany Smith

RED BANK, N.J., Jan. 28, 2021 /PRNewswire/ --Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today reported results from a pre-clinical proof-of-concept study for PRV-3279, a DART(bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B, conducted in a murine model of gene therapy for Pompe disease. A PRV-3279 mouse surrogate was tested in mice transgenic for human CD32B, which received gene therapy with an adeno-associated virus (AAV) vector AAV9 encoding for the enzyme acid-alpha-glucosidase (GAA) gene. Errors in the GAA gene cause the serious human glycogen storage disease type II (Pompe disease).

In the study, the PRV-3279 surrogate reduced anti-AAV9 vector antibody levels in a dose-dependent fashion. Anti-AAV9 antibodies have been linked to reduced efficacy, safety concerns and the inability to re-dose patients, and thus, based on these and other study data, we believe PRV-3279 co-administration with gene therapy products has the potential to improve the safety and efficacy of this therapeutic modality. The PRV-3279 surrogate in combination with sirolimus increased skeletal muscle levels of GAA enzyme expression. Consistent with prior results from clinical trials in healthy human subjects, the PRV-3279 surrogate decreased IgM production and was well tolerated.

"As the field of gene therapy advances, patients' immune responses to the viral vectors and the transgene products remain a key challenge negatively impacting the safety, efficacy and ability to deliver additional courses systemically," stated Francisco Leon, M.D., Ph.D., chief scientific officer, Provention Bio. "One of the current mitigation strategies to overcome these immune responses is pharmacological modulation of the patients' antibody immune responses with the B cell depleting agent rituximab in combination with the immune-suppressive agent sirolimus. Prolonged use of rituximab has been associated with certain adverse events. The use of PRV-3279, a non-depleting B cell inhibitor, is a potential strategy to address this unmet need in serious genetic diseases."

"A critical challenge for the success of gene therapy is the host immune responses to both the vector capsid and transgene product, which pose ongoing concerns regarding the safety, longevity, extent of gene expression and ability to re-dose," stated Professor Barry Byrne, director of the Powell Gene Therapy Center at the University of Florida. "PRV-3279's mechanism of action, inhibiting B cell activation without depleting these important cells, has the potential to provide a unique opportunity to be used as an adjunctive therapy with gene therapy products. We look forward to collaborating with Provention Bio and other potential partners in forthcoming clinical studies."

"We believe PRV-3279 has the potential to intercept and prevent the immunogenicity of life-saving gene therapy products and other biotherapeutics," stated Ashleigh Palmer, CEO and co-founder, Provention Bio. "Administration of PRV-3279 has been well-tolerated and pharmacodynamically effective in Phase 1 studies, with linear PK and dose-dependent reduction in B cell activation in the absence of depletion. PRV-3279 has also been shown to reduce B cell responses to viral antigens using experimental vaccine challenge in Phase 1. Given these promising clinical data and the novel pre-clinical data in gene therapy, we look forward to opportunities to work with academic and industry experts to combine PRV-3279 with gene therapy products to further our mission of preventing and intercepting devastating immune-mediated conditions."

The company plans to submit the data from this study for presentation at an upcoming medical conference later in 2021.

About PRV-3279:

PRV-3279 is a humanized diabody (a bispecific DART molecule) targeting the B cell surface proteins, CD32B and CD79B.Simultaneous engagement of the CD32B and CD79B receptors triggers inhibition of B cell function and suppression of autoantibody production, thereby regulating B cells without causing depletion. Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder characterized by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies.PRV-3279 also has the potential to prevent or reduce the immunogenicity of biotherapeutics, including but not limited to gene therapy vectors and transgenes.

About Provention Bio, Inc.:

Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Biologics License Application (BLA) for teplizumab, its lead investigational drug candidate, for the delay or prevention of clinical type 1 diabetes in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit http://www.ProventionBio.comfor more information and follow us on Twitter: @ProventionBio.

Internet Posting of Information:

Provention Bio, Inc. uses its website,www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation F.D. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases,SECfilings and public conference calls and webcasts.

Forward Looking Statements:

Certain statements in this press release are forward-looking, including but not limited to, statements relating to the Company's studies, the potential safety, health benefits of and planned research and development efforts for PRV-3279. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to delays in, or failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; uncertainties of patent protection and litigation; dependence upon third parties; substantial competition; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year endedDecember 31, 2019, our quarterly reports on form 10-Q,and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.

Partnering:Alex Rabiee, SVP, Business Development & Program Management[emailprotected]908-698-4612 (EXT-118)

Investor Contacts:Robert Doody, VP of Investor Relations[emailprotected] 484-639-7235

Sam Martin, Argot Partners[emailprotected]212-600-1902

Media:Lori Rosen, LDR Communications[emailprotected]917-553-6808

SOURCE Provention Bio, Inc.

Link:
Provention Bio Announces Key Findings from Pre-clinical Proof-of-concept Study for PRV-3279 for the Prevention of Immunogenicity of Gene Therapy -...

Recommendation and review posted by Bethany Smith

Among the logistical challenges facing public health agencies that are struggling to vaccinate the masses against COVID-19 is that the two mRNA shots on the market, from Moderna and Pfizer, need to be stored at ultra-cold temperatures. Now, an alternative technology for shielding patients from the novel coronavirusone that doesnt pose that storage challengeis showing early promise.

Two vaccine candidates built from gene-therapy technology and developed by Mass General Brigham scientists elicited strong immune responses in mouse and nonhuman primate models, the researchersreported on the journal preprint site bioRxiv. The team received a grant of up to $2.1 million from the Bill & Melinda Gates Foundation to further develop the vaccine technology, called AAVCOVID.

The vaccines, which remain stable when stored at room temperature, use an adeno-associated virus (AAV) vector to deliver genetic sequences of SARS-CoV-2, the virus that causes COVID-19. That generates antigens of the viruss signature spike protein, in turn prompting an immune response.

Blazing a Trail to Clinical Trial Diversity: Four-Part Webinar Series from Syneos Health, Featuring Pharma, Clinical Research and Community Health Leaders

This series will identify obstacles that stifle appropriate patient diversity in trials; unpack the organizational overhaul needed; share how sponsors, patients & investigators have come together to overcome hurdles; and explore how policy innovations can move the industry forward.

A single injection of either of the AAVCOVID vaccine candidates induced neutralizing antibodies in one mouse model of obesity and another of agingtwo conditions that have been linked with poor COVID-19 outcomes. The response lasted for at least three months, according to the study. In the monkey models, the immune response lasted for five months.

All animals also showed memory T-cell responses, which are believed to be critical for maintaining long-term immunity to COVID-19.

RELATED: Biopharma tackles COVID-19, HIV and other viruses with gene and cell therapies

Although the demand for the mRNA vaccines from Pfizer and Moderna is strong, the shots present some hurdles. The need for cold storage will make distributing the vaccines in developing countries difficult. And both vaccines require two doses to confer full immunity, which only adds to the logistical challengesand the costthe Mass Gen researchers argued in their study.

Because AAVs are already widely used to deliver gene therapies like Novartis Zolgensma for spinal muscular atrophy, the Mass Gen team was able to ramp up its preclinical studies quickly. To accelerate the effort, the researchers formed early partnerships with gene therapy specialists at the University of Pennsylvania and with Novartis, which agreed to manufacture the AAVCOVID vaccines for clinical trials.

The fact that theres an established industry out there around AAV made it easy for us to step into the existing [manufacturing] capacity, rather than having to build it, said lead investigator Luk Vandenberghe, Ph.D., an associate professor at Harvard Medical School and director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear, in an interview with Fierce Biotech last year.

Vandenberghes team is now planning to start clinical trials of the vaccines overseas.

The researchers acknowledged in the study that several other vaccine candidates are nearing approval. But they believe the AAVCOVID shots will prove valuable because of other attributes that will likely be critical to achieving the desired long-lasting herd immunity at a global population scale, they wrote. Many of these considerations are logistical in nature and seek to reduce the cost, time, and complexity of vaccine distribution using available infrastructure around the world.

Excerpt from:
One-dose COVID-19 vaccine candidate that can be stored at room temperature prompts immunity in animals - FierceBiotech

Recommendation and review posted by Bethany Smith

Dr. Li has over 30 years of experience in basic and applied biomedical research. She joins Neurophth from the University of Louisville School of Medicine, where she was a professor in the department of Ophthalmology and Visual Sciences for over 14 years. Her research focuses on the role of Hippo/YAP1 signaling pathway on different stages of ocular development, NF-kB/IKK2 inhibition of neovascularization, and gene discovery screening for eye diseases using mouse models.

Throughout her career, Dr. Li has contributed to more than 45 publications in journals including Investigative Ophthalmology & Visual Science (IOVS), Proceedings of the National Academy of Sciences of the United States of America(PNAS), Nature Review Immunology, and Science. She is currently the editorial board member of Scientific Reportsand Source Journal of Ophthalmology. Dr. Li holds a Ph.D. in cell biology from the Washington University in St. Louis and obtained both her Bachelor's and Master of Science degrees in Genetics from Beijing University.

"We are thrilled to have Dr. Li on our team, bringing over 3 decades of her diverse experience in basic and applied biomedical research," said Bin Li, M.D., Ph.D., Founder and Chairman of the Board of Neurophth. "Given her prior experience at Baylor College of Medicine mentored by Dr. Savio Woo, an internationally recognized expert in molecular human genetics and gene therapy, and Dr. Mark Kay, a leading researcher in the fields of AAV gene therapy and the current Head of Division of Human Gene Therapy at the Stanford University School of Medicine, Dr. Li has extensive knowledge in gene therapy for hepatic deficiencies, ocular diseases, and viral vector reconstruction."

"We are excited to have Qiutang join and expand our exceptional research and development team. She brings a wealth of experience in gene therapies for ocular diseases to Neurophth," said Alvin Luk, Ph.D., M.B.A., C.C.R.A., Chief Executive Officer at Neurophth. "Her deep understanding of viral vector design and animal models in the inhibition of neovascularization for ocular diseases, such as age-related macular degeneration and diabetic retinopathy, further bolsters our ability to deliver on our growing pipeline of clinical programs and platform capabilities."

"It has been captivating to watch the scale, scope, and speed with which Neurophth has successfully transformed itself into an innovative and diversified gene therapy company," said Dr. Li. "I look forward to being a part of Neurophth team as the company executes the next stage of its growth strategy and expands its pipeline of gene therapy candidates focused on ocular and non-ocular diseases, building a brighter future for patients worldwide."

About Neurophth

Neurophth is China's first gene therapy company in ophthalmic diseases.Headquartered in Wuhan with subsidiaries in Shanghai, Suzhou, and the U.S., Neurophth, a fully integrated company, is striving to discover and develop gene therapies for patients suffering from blindness and other eye diseases globally. Our AAV validated platform which has been published in Nature - Scientific Reports, Ophthalmology, and EBioMedicine, successfully delivered proof-of-concept data with investigational gene therapies in the retina. Our most advanced investigational candidate, NR082 (rAAV2-ND4), in development for the treatment ofND4-mutated LHON, has received orphan drug designations in theU.S. The pipeline also includesND1-mutated LHON, autosomal dominant optic atrophy, glaucoma, wAMD/DME, and other preclinical candidates. Neurophth has initiated the scaling up in-house process in single-use manufacturing technologies to support future commercial demand at the Suzhou facility. To learn more about us and our growing pipeline, visitwww.neurophth.com.

SOURCE Neurophth Therapeutics, Inc.

http://www.neurophth.com

Visit link:
Neurophth Therapeutics Further Expands Ocular Gene Therapy Expertise with Appointment of Qiutang Li, Ph.D., as Chief Scientific Officer - PRNewswire

Recommendation and review posted by Bethany Smith

PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext: NANO NASDAQ: NBTX the Company), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment, today announced a new collaboration agreement secured by its wholly-owned subsidiary, Curadigm.

Pursuant to the selection of a project involving Curadigms Nanoprimer technology as a promising option to significantly improve gene therapy development, Curadigm will enter into a one-year agreement with the pharmaceutical company inclusive of direct funding and scientific exchanges. The goal of the project is to establish proof-of-concept for the Nanoprimer as a combination product that could improve treatment outcomes for gene therapy product candidates.

Many promising nucleic acid-based therapeutics administered intravenously are limited in their efficacy due to rapid clearance in the liver, which prevents these therapies from reaching the necessary accumulation in target tissues to generate their intended outcomes. Additionally, accumulation in the liver, rather than in the target tissues, can lead to dose-limiting hepatic toxicity.

The Nanoprimer is proprietary technology invented at Nanobiotix and licensed to Curadigm for development and commercialization. The Nanoprimer is designed to precisely and temporarily occupy therapeutic clearance pathways in the liver. Delivered intravenously, immediately prior to the recommended therapy, the technology acts to prevent rapid clearancethereby increasing bioavailability and subsequent accumulation of therapeutics in the targeted tissues.

Given that the Nanoprimer is a combination product candidate that does not alter or modify the therapies it is paired with, Nanobiotix expects that the team at Curadigm will continue to seek partnerships across drug classesparticularly with RNA-based therapies. The Company believes that the ongoing expansion of Curadigms development pipeline could create new pathways for the significant improvement of treatment outcomes for patients around the world.

***

About CURADIGM: http://www.curadigm.com

Curadigm, a Nanobiotix SA subsidiary, is an early-stage nanotechnology company dedicated to improving outcomes for patients by shifting the therapeutic delivery paradigm. Curadigms Nanoprimer platform is designed to increase drug bioavailability while decreasing unintended off-target effects, specifically liver toxicity. The platform can be used with most intravenous (IV) therapeutics across multiple drug classes. Curadigm is dedicated to advancing therapeutic development based on our deep understanding of how drugs interact with the body, to impact both known and novel drugs across multiple clinical indications.

About NANOBIOTIX: http://www.nanobiotix.com

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

Nanobiotixs novel, potentially first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotixs Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP) and on the Nasdaq Global Select Market (Nasdaq: NBTX). The Companys headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany.

About Sanofi: http://www.sanofi.com

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life.

Disclaimer

This press release contains certain forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as at this time, anticipate, believe, expect, intend, on track, plan, scheduled, and will, or the negative of these and similar expressions. These forward-looking statements, which are based on our managements current expectations and assumptions and on information currently available to management, include statements about the timing and progress of Curadigms development program, the prospects of Curadigms collaboration with Sanofi, the timing of proof-of-concept data, the potential of Curadigms platform to achieve clinical and commercial success, and Curadigms relationship with, and the performance of, its collaboration partners. Such forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our prospectus filed with the U.S. Securities and Exchange Commission on December 11, 2020 under the caption Risk Factors and those set forth in the universal registration document of Nanobiotix registered with the French Financial Markets Authority (Autorit des Marchs Financiers) under number R.20-010 on May 12, 2020 (a copy of which is available on http://www.nanobiotix.com), as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

See the original post:
Nanobiotix Subsidiary Curadigm Secures New Collaboration Agreement With Sanofi Focused on Gene Therapy Pipeline - Business Wire

Recommendation and review posted by Bethany Smith

LAS VEGAS, Jan. 25, 2021 /PRNewswire/ -- The AAV Vector-Based Gene Therapy market size is anticipated to shoot up exponentially attributing to an increase in the approval of a growing number of gene therapies and readily adoption on approval, ability to treat a broad array of conditions, increasing prevalence of diseases, convenient one-time dosing approach and curative treatment options.

DelveInsight's Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Marketreport offers a clear picture of the market position of the AAV vectors in the Gene therapy, emerging pipeline therapies, AAV vector-based Gene Therapy market share occupied by individual diseases, current and forecasted market share in the 7MM (the US, EU5 (the UK, Germany, France, Italy and Spain) and Japan) for the study period 2017-30.

The Report highlights the drivers and constraints shaping the present AAV Vector-Based Gene Therapy marketalong with the unmet medical needs that offer opportunities to the key players to explore the underlying potential of the market.

Key Highlights of AAV Vector-Based Gene Therapy Market:

Know more about the report highlights @ Adeno-associated virus (AAV) Vector-Based Gene Therapy Market Landscape

Adeno-Associated Virus (AAV)

Adeno-associated virus hails from the genus Dependoparvovirus, which in turn belongs to the family Parvoviridae. They are small viruses (25-nm) with a genome of single-stranded DNA (~4.7kb) that can either be the plus (sense) or minus (anti-sense) strand. AAV is replication-defective and depends on a helper virus for effective and productive replication in mammalian cells. However, for choosing AAV as a gene delivery vector depends on:

Adeno-associated virus (AAV) Vector-Based Gene Therapy

With advances in bioengineering and genetics, the horizon of the medical approaches giving rise to novel treatment options, such as Gene therapy has also widened. Gene therapyhas emerged out as a promising treatment approach for a number of inherited disorders, certain types of cancer, and certain viral infections. The delivery of gene therapy involves "vectors" which can be either viral or non-viral vectors. Out of the several viral vectors, Adeno-associated virus (AAV) vectors are currently among the most frequently used, safest and effective viral vectors for gene therapy delivery. AAV vectors are the leading viral vectors for gene delivery to treat a variety of human diseases.

Key Indications:

Haematology

Ophthalmology

Lysosomal Storage Disorders

Neurology

Neurological Disorders

Musculoskeletal

Request for sample @ Adeno-Associated Virus Vector-Based Gene Therapy Market

Epidemiology Segmentation

In the year 2020, the total prevalent cases of selected indications in which AAV Gene Therapies were administered were estimated to be 2,863,103 in the 7MM. DelveInsight's Adeno-Associated Virus Vector-Based Gene Therapy MarketReport provides historical as well as forecasted epidemiological analysis for the study period 2017-30 for the 7MM segmented into:

Adeno-Associated Virus Vector-Based Gene Therapy Market

At the moment, the AAV Vector-Based Gene Therapy Markethas only two FDA-approved AAV vector-based gene therapies approved.

Spark Therapeutics' Luxturna is approved for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. It is the first FDA-approved gene therapy for a genetic disease, the first and only pharmacologic treatment for an inherited retinal disease and the first AAV vector gene therapy approved in the United States.

Another therapy occupying the market share is Novartis/AveXis's Zolgensma, an AAV-delivered gene therapy indicated for the treatment of paediatric patients <2 years of age with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Currently, it is being investigated in the global Phase III STR1VE clinical program (consisting of STR1VE-US, STR1VE-EU, and STR1VE-AP) to evaluate the intravenous (IV) formulation of AVXS-101 in patients who have SMA Type 1, and the multinational Phase III SPR1NT trial in presymptomatic patients who have a genetic diagnosis of SMA with two or three copies of the SMN2 gene.

However, before Luxturna and Zolgensma managed to steal the spotlight in the AAV Vector-Based Gene Therapy Market,there was another candidate, Glybera, which got the nod from the EMA to treat an ultra-rare, hereditary lipoprotein lipase deficiency(LPLD); and became the first Gene therapy to get launched. However, the decision of the company to not renew its market authorization after it expired in October 2017 stresses on the cost of the maintenance and development of the gene therapies even if they prove to be outright cures.

DelveInsight estimates that the Adeno-Associated Virus Vector-Based Gene Therapy Market,is anticipated to pick up momentum as companies across the globe are thoroughly working toward the development of new AAV-gene therapies to treat a spectrum of diseases. Key pharmaceutical and biotech companies such as Biomarin Pharmaceutical, Roche (Spark Therapeutics), Sangamo, Pfizer among several others are involved in exploring the AAV vector-based gene therapy for a wide range of indications such as Hemophilia A and B, MPS, and others.

Visit, Adeno-Associated Virus Vector-Based Gene Therapy Market, for more information

Key Pipeline Therapies:

There is not a shred of doubt that clinical successes in AAV-mediated gene replacement have helped Adeno-Associated Viruses to get recognized as an ideal therapeutic vector for delivery of gene therapies. With two AAV vector-based gene therapies having won regulatory approval,their popularity as the predominant vectors that deliver genes of interest to target tissues with improved specificity, efficiency, and safety in the Gene therapy market further fuelled. However, the production and formulation of AAV products require specified conditions so as to ensure good stability and yield, and even after caution, some of its processing methods (filtration or lyophilization) may lead to aggregation or loss of AAV titer. Further, storing the AAV products can also prove to be quite challenging.

Conclusively, Gene therapy has proved to be an ingenious tool in the healthcare sector and with dramatic advancements being made in the domain, its potential is unfolding at a rapid pace. Thus, it is not wrong to say that Gene therapy is set to emerge as a novel therapeutic option.

Scope of the report:

Table of Content

1

Key Insights

2

Executive Summary of Adeno-Associated Virus Vectors in Gene Therapy

3

Competitive Intelligence Analysis for AAV Vector-Based Gene Therapy Market

4

AAV Vector-Based Gene Therapy Market SWOT Analysis

5

Adeno-Associated Virus Vector-Based Gene Therapy Market Overview at a Glance

6

Adeno-Associated Virus Vector-Based Gene Therapy: Disease Background and Overview

7

Patient Journey

8

Adeno-Associated Virus Vectors in Gene Therapy Epidemiology and Patient Population

9

AAV Vector-Based Gene Therapy Market: Treatment Algorithm, Current Treatment, and Medical Practices

10

AAV Vector-Based Gene Therapy Market Unmet Needs

11

Key Endpoints of Adeno-Associated Virus Vectors in Gene Therapy Treatment

12

Marketed Products in AAV Vector-Based Gene Therapy Market

13

Emerging Adeno-Associated Virus Vector-Based Gene Therapies

14

Adeno-Associated Virus Vectors in Gene Therapy: Seven Major Market Analysis

15

Attribute analysis

16

Adeno-Associated Virus Vector-Based Gene Therapy Market Outlook: 7MM

17

Access and Reimbursement Overview of Adeno-Associated Virus Vector-Based Gene Therapy Market

18

KOL Views

19

Adeno-Associated Virus Vector-Based Gene Therapy Market Drivers

20

Adeno-Associated Virus Vector-Based Gene Therapy Market Barriers

21

Appendix

22

DelveInsight Capabilities

23

Disclaimer

24

About DelveInsight

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See original here:
Adeno-Associated Virus (AAV) Vector-Based Gene Therapy Market Expected to Grow at a Significant CAGR of 43.4% During the Study Period 2019-30 -...

Recommendation and review posted by Bethany Smith