Category Archives: Molecular Medicine

Oct. 27, 2020 12:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aviceda Therapeutics, a late-stage, pre-clinical biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to manipulate the innate immune system and chronic, non-resolving inflammation, is announcing the members of its Scientific Advisory Board who will help shape ongoing development efforts.

The Aviceda Scientific Advisory Board includes Pamela Stanley, PhD; Ajit Varki, MD; Christopher Scott, PhD; Geert-Jan Boons, PhD; Salem Chouaib, PhD; and Peng Wu, PhD.

Aviceda has assembled an extraordinary multi-disciplinary team of world-class scientists and renowned researchers to join our efforts in developing the next generation of glyco-immune therapeutics for the treatment of immune-dysfunction conditions, said Mohamed A. Genead, MD, Founder, CEO & President of Aviceda Therapeutics. Each individual offers a fresh perspective and unique strategic acumen that complements and strengthens the insights of our in-house leadership development team.

Prof. Scott, Aviceda Scientific Co-Founder, is Director of the Patrick G Johnston Centre for Cancer Research and Cell Biology at Queens University Belfast. He is internationally renowned for his work in development of novel approaches in the field of antibody and nanomedicine-based therapies for the treatment of cancer and other conditions. Prof. Scott has a background in both the pharmaceutical industry and academia and was a founding scientist of Fusion Antibodies Plc. Research in his laboratory is funded by agencies such as Medical Research Council, UK charities and various industrial sources. He also held a Royal Society Industrial Fellowship with GSK from 2012 to 2015 and won the Vice Chancellors Prize for Innovation in 2015 with his groups work on developing a novel Siglec targeting nanomedicine for the treatment of sepsis and other inflammatory conditions.

The novelty of Avicedas platform technology is its potential to affect immune responses associated with a wide range of disease states, many of which are currently unmet or underserved needs. I look forward to the continued development of Avicedas core technology and moving forward to clinical trials that will pave the way for truly disruptive therapeutic strategies to enter the clinic that will significantly impact and improve patients lives in the not-too-distant future, said Prof. Scott.

Avicedas Scientific advisory chairwoman, Prof. Stanley, is the Horace W. Goldsmith Foundation Chair; Professor, Department of Cell Biology; and Associate Director for Laboratory Research of the Albert Einstein Cancer Center, Albert Einstein College of Medicine, New York. She obtained a doctorate degree from the University of Melbourne, Australia, for studies of influenza virus, and was subsequently a postdoctoral fellow of the Medical Research Council of Canada in the laboratory of Louis Siminovitch, University of Toronto, where she studied somatic cell genetics. Prof. Stanleys laboratory is focused on identifying roles for mammalian glycans in development, cancer and Notch signaling. Among her many varied contributions, Prof. Stanleys laboratory has isolated a large panel of Chinese hamster ovary (CHO) glycosylation mutants; characterized them at the biochemical, structural and genetic levels; and used them to identify new aspects of glycan synthesis and functions. She serves on the editorial boards of Scientific Reports, Glycobiology and FASEB Bio Advances; she is an editor of the textbook Essentials of Glycobiology; and her laboratory is the recipient of grants from the National Institutes of Health. Prof. Stanley has received numerous awards, including a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology (2003) and the International Glycoconjugate Organization (IGO) Award (2003).

Working with Aviceda represents a unique opportunity to contribute to science at the cutting edge. Its pipeline contains a broad range of candidates that represents numerous first-in-class opportunities, said Prof. Stanley.

Prof. Varki is currently a distinguished professor of medicine and cellular and molecular medicine, Co-director of the Glycobiology Research and Training Center and Executive Co-director for the UCSD/Salk Center for Academic Research and Training in Anthropogeny at the University of California, San Diego; and an Adjunct Professor at the Salk Institute for Biological Studies. Dr. Varki is also the executive editor of the textbook Essentials of Glycobiology. He received basic training in physiology, medicine, biology and biochemistry at the Christian Medical College, Vellore, The University of Nebraska, and Washington University in St. Louis, as well as formal training and certification in internal medicine, hematology and oncology. Dr. Varki is the recipient of numerous awards and recognitions, including election to the American Academy of Arts and Sciences and the US National Academy of Medicine, a MERIT award from the National Institutes of Health, an American Cancer Society Faculty Research Award, the Karl Meyer Award from the Society for Glycobiology and the International Glycoconjugate Organization (IGO) Award (2007).

The Aviceda team is already building on the foundational work in the emerging field of glycobiology to develop potential therapeutics and interventional strategies. Their work could be critically important for growing the understanding of how glycobiology and glycochemistry are applicable to immunology, and more broadly, to the field of drug and therapeutic development, said Prof. Varki.

Prof. Boons is a Distinguished Professor in Biochemical Sciences at the Department of Chemistry and the Complex Carbohydrate Research Center (CCRC) of the University of Georgia (USA) and Professor and Chair of the Department of Medicinal and Biological Chemistry of Utrecht University (The Netherlands). Prof. Boons directs a research program focused on the synthesis and biological functions of carbohydrates and glycoconjugates. The diversity of topics to which his group has significantly contributed includes the development of new and better methods for synthesizing exceptionally complex carbohydrates and glycoconjugates. Highlights of his research include contributions to the understanding of immunological properties of complex oligosaccharides and glycoconjugates at the molecular level, which is being used in the development of three-component vaccine candidates for many types of epithelial cancer; development of convergent strategies for complex oligosaccharide assembly, which make it possible to synthesize large collections of compounds with a minimal effort for structure activity relationship studies; and creation of a next generation glycan microarray that can probe the importance of glycan complexity for biological recognition, which in turn led to identification of glycan ligands for various glycan binding proteins that are being further developed as glycomimetics for drug development for various diseases. Among others, Prof. Boons has received the Creativity in Carbohydrate Science Award by the European Carbohydrate Association (2003), the Horace Isbell Award by the American Chemical Society (ACS) (2004), the Roy L. Whistler International Award in Carbohydrate

Chemistry by the International Carbohydrate Organization (2014), the Hudson Award (2015) and the Cope Mid-Career Scholar Award from ACS (2016).

Aviceda is leading the field of glycoimmunology in exciting new directions. I look forward to working with the company as it pursues multiple lines of development efforts that will someday transform the way immune-inflammatory conditions are treated in the clinic, said Prof. Boons.

Prof. Chouaib is the Director of Research, Institute Gustave Roussy, Paris, where he is active in research in tumor biology. Previously, Prof. Chouaib worked at the French National Institute of Health and Biomedical Research (INSERM) where he led a research unit focused on the investigation of the functional cross talk between cytotoxic cells and tumor targets in the context of tumor microenvironment complexity and plasticity. His research was directed at the transfer of fundamental concepts in clinical application in the field of cancer vaccines and cancer immunotherapy. Prof. Chouaib is a member of the American Association of Immunologists, New York Academy of Sciences, French Society of Immunologists, International Cytokine Society, American Association for Cancer Research, International Society for Biological Therapy of Cancer and American Association of Biological Chemistry. He was awarded the cancer research prize of the French ligue against cancer in 1992 and in 2004 the presidential prize in biotechnology. He was awarded for translational research and scientific excellency by INSERM. His research has resulted in more than 310 scientific articles and several reviews in the field of human immunology, tumor biology and cancer immunotherapy; he has also been an editor for several textbooks.

Dr. Wu is an Associate Professor in the Department of Molecular Medicine at Scripps Research. The current research in the Wu laboratory integrates synthetic chemistry with glycobiology to explore the relevance of protein glycosylation in human disease and cancer immunotherapy. In 2018, Dr. Wu developed a platform to construct antibody-cell conjugates for cancer immunotherapy, which does not require genetic engineering. Previously, while working as a postdoctoral fellow in the group of Professor Carolyn R. Bertozzi at the University of California, Berkeley, Dr. Wu developed an aldehyde-tag (SMARTag) based technology for site-specific labeling of monoclonal antibodies, which served as the foundation for Redwood Biosciences Inc., a biotech company co-founded by Bertozzi. In 2014, Redwood Bioscience Inc. and the SMARTag Antibody-Drug Conjugate technology platform was acquired by Catalent Pharma Solutions.

About Aviceda Therapeutics

Founded in 2018 and based in Cambridge, Massachusetts, Aviceda Therapeutics is a late-stage, pre-clinical biotechnology company with a mission to develop the next generation of glyco-immune therapeutics (GITs) utilizing a proprietary technology platform to modulate the innate immune system and chronic, non-resolving inflammation. Aviceda has assembled a world-class, cross-disciplinary team of recognized scientists, clinicians and drug developers to tackle devastating ocular and systemic degenerative, fibrotic, oncologic and immuno-inflammatory diseases. At Aviceda, we exploit a unique family of receptors found expressed on all innate immune cells and their associated glycobiological interactions to develop transformative medicines. Combining the power of our biology with our innovative cell-based high-throughput screening platform and proprietary nanoparticle technology, we can modulate the innate immune response specifically and profoundly. Aviceda is developing a pipeline of GITs that are delivered via biodegradable nanoparticles and which safely and effectively target numerous immune-inflammatory conditions. Avicedas lead ophthalmic optimized nanoparticle, as an intravitreal formulation, AVD-104, is being developed to target various immune system responses that contribute to pathology associated with age-related macular degeneration (AMD).

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Aviceda Therapeutics Announces Formation of Scientific Advisory Board - BioSpace

TUCSON A promising new biomarker that appears in patients before stomach cancer develops may help with early detection of the disease and improve patient response to therapy, according to findings in a study led by University of Arizona Health Sciences researchers.

The biomarker can be detected through a simple blood test, saving time and lowering costs. Currently, stomach cancer diagnosis requires endoscopic collection of stomach tissue through a biopsy procedure, and then analysis by pathology.

Published in Gut, the journal of the British Society of Gastroenterology, the study was led by Juanita L. Merchant, MD, PhD, chief of the Division of Gastroenterology and Hepatology at the UArizona College of Medicine Tucson, a cancer biology program researcher at the UArizona Cancer Center and an elected member of the National Academy of Medicine.

See a video of how Drs. Juanita Merchant and Yana Zavros found a new biomarker to help diagnose stomach cancer.

The biomarker, MiR130b, is a microRNA or small non-coding RNA molecule that can play an important role in regulating gene expression, affecting disease development and progression. MiR130b can be produced by a group of immune cells called myeloid-derived suppressor cells (MDSCs), commonly associated with infections caused by Helicobacter pylori (H. pylori), a bacteria associated with ulcers. These particular cell types in the stomach correlate with early, preneoplastic changes (before a tumor develops) that can lead to gastric cancer long after an H. pylori infection has passed.

The study included collaboration with Yana Zavros, PhD, associate head for research in the College of Medicine Tucsons Department of Cellular and Molecular Medicine and the Cancer Centers shared resource director for Tissue Acquisition Cellular and Molecular Analysis.

Even though you get can get rid of the bacteria, oftentimes the infection itself already has initiated a cascade of events that inevitably may lead to cancer, Dr. Zavros said. That is why early detection is so important.

A Blood Test Instead of a Procedure

The study arose out of basic science mouse models that simulated changes in the stomach similar to that caused by H. pylori. This led the researchers to identify MiR130b in the mouse models, and they also detected the same microRNA in the plasma of human patients that either had precancerous changes or those that already had progressed to cancer.

This was a retrospective study, said Dr. Merchant, who is a member of the universitys BIO5 Institute. It is very exciting because now we can begin looking at this biomarker more prospectively in different patient populations.

Although less common in the United States, the National Cancer Institute reports gastric (stomach) cancer is the third most common cause of cancer-related deaths in the world. The findings, however, could have major implications for Arizonas rural areas and Hispanic and Native American populations, which are at greater risk for developing gastric and other gastrointestinal (GI) cancers, because these diseases often are caused by dietary and environmental factors and may go undetected for long periods.

Dr. Merchants lab has a sub-project in the Cancer Centers U54 grant (Partnership for Native American Cancer Prevention) to study detection of the microRNA described in the Gut paper in members of Native American populations with H. pylori.

This molecular signature (the microRNA MiR130b) that we discovered may help us see if patients have changes in their mucosa (the membrane that lines the stomach) related to having H. pylori, Dr. Merchant said. And a blood sample would be less invasive and then could be a way to make the decision whether we need to bring a patient in for an endoscopy.

Broader Implications for Treatment

Once diagnosed, gastric cancer can be difficult to treat. Immunotherapies with proven effectiveness in treating other types of cancer are not as successful against most GI cancers, including stomach cancer. The researchers believe these new findings in gastric cancer may help to address why other GI cancers also are resistant to therapy.

The underlying mechanism by which a patient may not respond well in gastric cancer may be applicable in other organs as well Dr. Zavros said. The way the cells interact with each other to render that patient resistant to therapy may be quite similar between gastric, pancreatic and colon cancers.

Dr. Merchant added: There may be dual-purposes. We can look at it as a biomarker to help us from a diagnostic perspective, but we also can look at therapies that can be developed based on what this microRNA itself is targeting.

Another project funded by the Cancer Centers Sparking Bench-to-Bedside Team Science Project award is building from results of this study to explore therapies for pancreatic and gastric cancer. The investigators are exploring the tumor microenvironment, in particular the immune cell MDSCs, referred to previously, that appears to dampen the chemotherapeutic response to immunotherapies.

The project relies heavily on Dr. Zavros BioDroid program, which develops miniature organs in the lab with a realistic microanatomy, also known as organoids. These are used in collaboration with the Tissue Acquisition Repository for Gastrointestinal and HEpaTic Systems (TARGHETS), created by Dr. Merchant. TARGHETS is a GI/Hepatology biorepository that collects samples from patients who undergo endoscopy.

Both Drs. Zavros and Merchant are looking to the BioDroid and TARGHETS efforts to reveal additional information that will allow them to develop new approaches to address resistance of gastric cancer to immunotherapies.

We want to find a way to reprogram the cancer cells or the immune cells within that patients tumor environment to make the patient more responsive to the therapy, Dr. Zavros said. A biomarker gives us a place to start.

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UArizona researchers have breakthrough related to stomach cancer - Eastern Arizona Courier

FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved in August to provide tumor mutation profiling in accordance with professional guidelines for patients with any solid tumor. Concurrently, it was approved as a companion diagnostic for a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for the treatment of metastatic castration-resistant prostate cancer patients with qualifying BRCA1/2 alterations, and for three first-line EGFR tyrosine kinase inhibitors (TKIs) for the treatment of non-small cell lung cancer patients.

FoundationOne Liquid CDx offers oncologists an important and minimally invasive tool to consider when making treatment decisions for their patients, regardless of the type of cancer they have, said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. These three additional companion diagnostic claims expand the tests clinical utility into breast and ovarian cancer, demonstrating our commitment to bringing precision medicine to more patients, and we plan to continue working with our biopharma partners to increase that reach.

Todays approval expands FoundationOne Liquid CDxs companion diagnostic indications to include the following targeted therapies:

PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation.1

An estimated one in four women with epithelial ovarian cancer have a mutation of the BRCA1 or BRCA2 gene.2

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for genomic alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. It also enables accelerated companion diagnostic development for biopharma companies developing precision therapeutics.

As a laboratory professional service which has not been reviewed or approved by the FDA, the FoundationOne Liquid CDx report delivers information about the genomic signatures microsatellite instability (MSI) and blood tumor mutational burden (bTMB), as well as single gene alterations, including NTRK fusions, to help inform the use of other therapies including immunotherapies. Also, as a laboratory professional service, the report provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

About FoundationOne Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit http://www.F1LCDxLabel.com.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

PIQRAY is a registered trademark of Novartis AG.

RUBRACA is a registered trademark of Clovis Oncology, Inc.

ALECENSA is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.

Source: Foundation Medicine

1 The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.2 Pennington et al, Clin Cancer Res. 2014; 20(3):764-7753 Dearden et al. Ann Oncol. 2013 Sep; 24(9): 23712376.

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FDA Approves New FoundationOneLiquid CDx Companion Diagnostic Indications for Three Targeted Therapies That Treat Advanced Ovarian, Breast and...

The Food and Drug Administration on Thursday gave its first full approval for a drug to treat Covid-19 to the antiviral remdesivir. But some researchers say the FDA is once again promoting a Covid-19 therapy based on shaky evidence.

Developed by Gilead Sciences and marketed under the brand name Veklury, remdesivir previously received emergency use authorization (EUA) from the FDA in May, which allowed it to be used to treat patients with severe Covid-19. In August, the FDA relaxed its guidelines to allow the drug to be used in less serious cases. President Donald Trump also took the drug as part of his treatment when he was diagnosed with Covid-19 earlier in October.

Full FDA approval promotes remdesivir to the standard of care for hospitalized patients, and other potential treatments for Covid-19 will now have to be compared to it during clinical research.

Todays approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic, FDA commissioner Stephen Hahn in a statement Thursday. The FDA based its decision on three randomized controlled trials. (The largest of those looked at 1,062 hospitalized patients.) The trials results showed that remdesivir reduced the length of hospital stays in some Covid-19 patients.

However, shortly before the approval was granted, a study from the World Health Organization announced preliminary results that found the drug had no effect on mortality and unlike the FDAs findings negligible effects on how long patients were in hospitals. The study, known as the Solidarity Trial, recruited almost 12,000 patients, making it the largest Covid-19 treatment study in the world thus far. Researchers say the findings should have given the FDA pause.

I think its really inappropriate to give this a full approval because the data dont support it, said Eric Topol, a professor of molecular medicine at the Scripps Research Translational Institute. What [the FDA] should have done instead of issuing the approval was put on the brakes.

Absent a vaccine, doctors are desperate for an effective treatment for Covid-19, and the FDAs approval of remdesivir finally gives them an option. In the United States, Covid-19 case counts are rising again, with states like Wisconsin opening field hospitals to deal with a looming surge.

But the approval of remdesivir has raised concerns, not only because of the results of the WHOs trial but also because it follows a number of questionable FDA authorizations for other Covid-19 therapies that appear to have been influenced by political pressure from the White House.

Now some researchers and doctors are concerned that remdesivir could not only be less effective than promised, but that its approval could also undermine other efforts to develop better Covid-19 therapies.

Remdesivir seems to be most effective relatively early on for hospitalized patients with severe Covid-19. To help beat back the illness, it interferes with how SARS-CoV-2, the virus that causes Covid-19, makes copies of itself. The virus uses genetic instructions in the form of RNA, written in a code made of molecules represented by the letters A, U, G, and C. The drug mimics the molecule represented by A, adenosine. The fake adenosine blocks the virus from copying itself but doesnt fool human cells. The result is the virus cant reproduce as much within a patients body.

The antiviral drug was originally developed to treat the Ebola virus, and it has received a hefty investment from the US government over almost two decades, as Ekaterina Cleary, lead data analyst and research associate at the Center for Integration of Science and Industry, wrote in a piece for Stat News:

Research from the Center for Integration of Science and Industry, with which I am affiliated, determined that between gathering knowledge behind remdesivirs chemical structure and molecular target, the NIH invested as much as $6.5 billion between 2000 and 2019.

Remdesivir treatment is not without risks. It has been shown to cause some side effects in some people, such as elevated liver enzymes, which could indicate liver damage. The drug can also trigger allergic reactions, resulting in fever, shortness of breath, wheezing, swelling, low blood oxygen, and changes in blood pressure.

For a patient with private insurance, the intravenous drug can cost $3,120 for a five-day course of treatment.

Antivirals like remdesivir are most effective early on during the progression of Covid-19, when most of the damage is being done by the virus itself. Its less effective in later stages, when the problem isnt just the virus. The severe manifestations of the disease are caused by an out-of-control immune response to the infection, said Angela Rasmussen, a virologist at the Columbia University Mailman School of Public Health.

If the immune system gets riled up, it can cause a lot more destruction than SARS-CoV-2 and require more-drastic interventions like intubation, at which point another approach is needed. Thats a big reason why corticosteroids like dexamethasone, which tamp down on the immune system, are the only drugs so far reliably demonstrated to actually reduce Covid-19 mortality.

But giving a patient steroids too early in an infection could prevent the immune system from mounting an effective response against SARS-CoV-2.

Coming up with an effective treatment regimen requires delicately balancing where a patient is in the course of their coronavirus infection and how severe their illness has become. But given how murky it is to identify an infection to begin with let alone confirming the diagnosis and starting the correct treatment during the appropriate window researchers have a hard time teasing out what interventions work best.

Thats why carefully controlled, large-scale clinical trials are so important. And with mixed results coming from the studies conducted to date, some scientists dont think the evidence for remdesivirs effectiveness is enough for the FDA to grant approval.

I was really surprised when I saw that news, Rasmussen said.

The FDA has already made some controversial decisions around Covid-19 drug treatments. The agency granted an EUA for the anti-malaria drug hydroxychloroquine in March, after Trump called it a game changer. The FDA revoked the EUA in June, saying hydroxychloroquine was unlikely to be effective and could cause lead to heart problems.

Then in August, the agency granted an EUA for convalescent plasma to treat Covid-19. But the National Institutes of Health said the evidence used by the FDA was insufficient.

There is more evidence that remdesivir works compared with that of convalescent plasma, but thats not saying much. Its not as weak as the case for plasma, but thats no standard. The case for plasma is nonexistent, said Jeremy Faust, attending physician in emergency medicine at Brigham and Womens Hospital in Boston and an instructor at Harvard Medical School. There is actually randomized controlled trial data that suggests [that] for a subset of patients, remdesivir can decrease hospital length of stay.

The strongest results in favor of remdesivir show that patients who received it had a median recovery time of 10 days, compared to 15 days for those who took the placebo. Its a significant effect, but its not huge, and its certainly not a cure for Covid-19, nor a way to guarantee fewer deaths.

Faust said one of his concerns with the FDAs remdesivir approval is a phenomenon known as indication creep, in which a treatment shown to work in only a limited set of circumstances gets prescribed to more and more people. The worry here is that remdesivir, which is approved only for Covid-19 patients over 12 years old who required hospitalization, could start being used in patients with milder Covid-19 illness, or in more severe cases past the point where it could be effective.

What will happen, I guarantee, is people will start to use the medication more than they need it, Faust said. Since the course of treatment is five days, it could also extend the length of hospital stays in patients who would otherwise be discharged earlier, saddling them with unnecessary costs.

Another concern is that the approval of remdesivir, especially with such mixed evidence for its effectiveness, could undermine further research.

Topol noted that with remdesivir now as the only fully approved drug, it becomes much more difficult to conduct studies on other therapies because they now have to be compared against remdesivir, the new standard treatment, as well as a a placebo.

That raises the cost and complexity of trials, delaying results. Such comparisons are worthwhile if the standard of care is effective, but it adds unnecessary complications if its not.

It also makes it harder to recruit people for subsequent clinical trials of the drug to better validate its effectiveness. People may be more reluctant to sign up for a trial where they could get a placebo when they know they could get the actual drug.

The biggest, most serious problem is that we wont get to the truth, Topol said.

Its worth noting that remdesivir could still be a viable treatment for Covid-19, but the evidence presented so far is contradictory and more investigation is needed to clarify its effectiveness. So why did the FDA go ahead with its approval, then?

Its hard to say, but Herschel Nachlis, a research assistant professor of government at Dartmouth College, suggested the approval might be a strategic move by the agency to deflect political pressure away from the all-important Covid-19 vaccination campaign. Trump has linked a vaccine to his election prospects and blamed the FDA for holding it back. The appearance that a Covid-19 vaccine was rushed to meet political needs could make people reluctant to get vaccinated, so regulators are keen to distance themselves from the 2020 election campaign.

If, in the short term, approving remdesivir gives the President a win and alleviates some pressure on the agency from the President about vaccines, that helps buy the FDA important time, Nachlis told Vox in an email. It might be another case, like convalescent plasma, of giving up some ground in a battle to put yourself in the position to be able to win the broader war.

Whether Nachliss hypothesis is correct isnt yet known. But what is clear is that the evidence on remdesivirs effectiveness appears to be mixed, which is why it would have been helpful for the FDA to have held a public advisory committee meeting to discuss the evidence, a step it typically takes for full pharmaceutical approvals.

Since it may be months before a vaccine for Covid-19 is available, treatments are still urgently needed and other approaches are being studied. Trump, for example, also underwent a course of an experimental monoclonal antibody therapy from the company Regeneron when he was treated for Covid-19. There are multiple clinical trials of these drugs underway, but now they have competition.

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Remdesivir approved by FDA to treat Covid-19, but the evidence is mixed - Vox.com

CAMBRIDGE, Mass.--(BUSINESS WIRE)--QurAlis Corporation, a biotech company focused on developing precision medicines for amyotrophic lateral sclerosis (ALS) and other neurologic diseases, today announced the appointment of Angela Genge, MD, FRCP(C), eMBA to the position of Chief Medical Officer (CMO). Dr. Genge is the Executive Director of the Montreal Neurological Institutes Clinical Research Unit and the Director of Montreal Neurological Hospitals ALS Global Center of Excellence.

The company also announced the formation of its Clinical Advisory Board, which will work closely with Dr. Genge on QurAlis clinical research and development programs in ALS and frontotemporal dementia (FTD) as the company prepares to move its pipeline to the clinical stage.

As QurAlis grows and advances quickly toward the clinic, we are proud to welcome to the team Dr. Genge, a world-renowned expert in ALS clinical drug development, and announce the highly esteemed group of ALS experts who will be forming our Clinical Advisory Board, said Kasper Roet, PhD, Chief Executive Officer of QurAlis. Dr. Genge has been treating patients and studying and developing therapeutics and clinical trials for ALS and other rare neurologic diseases for more than 25 years, diligently serving these vulnerable patient populations. Along with our newly formed Clinical Advisory Board, having a CMO with this extensive expertise, understanding and experience is invaluable to our success. Dr. Genge and our Board members are tremendous assets for our team who will undoubtedly help us advance on the best path toward the clinic, and we look forward to working with them to conquer ALS.

Previously, Dr. Genge directed other clinics at the Montreal Neurological Hospital including the Neuromuscular Disease Clinic and the Neuropathic Pain Clinic. In 2014, she was a Distinguished Clinical Investigator in Novartis Global Neuroscience Clinical Development Unit, and she has served as an independent consultant for dozens of companies developing and launching neurological therapeutics. Dr. Genge has served in professorial positions at McGill University since 1994.

At this pivotal period in its journey, QurAlis is equipped with a strong, committed leadership team and promising precision medicine preclinical assets, and I look forward to joining the company as CMO, said Dr. Genge. This is an exciting opportunity to further strengthen my work in ALS and other neurological diseases, and I intend to continue innovating and expanding possibilities for the treatment of rare neurological diseases alongside the dedicated QurAlis team.

QurAlis new Clinical Advisory Board Members are:

Dr. Al-Chalabi is a Professor of Neurology and Complex Disease Genetics at the Maurice Wohl Clinical Neuroscience Institute, Head of the Department of Basic and Clinical Neuroscience, and Director of the Kings Motor Neuron Disease Care and Research Centre. Dr. Al-Chalabi trained in medicine in Leicester and London, and subsequently became a consultant neurologist at Kings College Hospital.

Dr. Andrews is an Associate Professor of Neurology in the Division of Neuromuscular Medicine at Columbia University, and serves as the Universitys Director of Neuromuscular Clinical Trials. She currently oversees neuromuscular clinical trials and cares for patients with neuromuscular disease, primarily with ALS. Dr. Andrews is the elected co-chair of the Northeastern ALS (NEALS) Consortium and is also elected to the National Board of Trustees of the ALS Association.

Dr. Cudkowicz is the Julianne Dorn Professor of Neurology at Harvard Medical School and Chief of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Mass General Hospital. As co-founder and former co-chair of the Northeast ALS Consortium, she accelerated the development of ALS treatments for people with ALS, leading pioneering trials using antisense oligonucleotides, new therapeutic treatments and adaptive trial designs. Through the Healey Center at Mass General, she is leading the first platform trial for people with ALS.

Dr. Shaw serves as Director of the Sheffield Institute for Translational Neuroscience, the NIHR Biomedical Research Centre Translational Neuroscience for Chronic Neurological Disorders, and the Sheffield Care and Research Centre for Motor Neuron Disorders. She also serves as Consultant Neurologist at the Sheffield Teaching Hospitals NHS Foundation Trust. Since 1991, she has led a major multidisciplinary program of research investigating genetic, molecular and neurochemical factors underlying neurodegenerative disorders of the human motor system.

Dr. Van Damme is a Professor of Neurology and director of the Neuromuscular Reference Center at the University Hospital Leuven in Belgium. He directs a multidisciplinary team for ALS care and clinical research that is actively involved in ALS clinical trials, but is also working on the genetics of ALS, biomarkers of ALS, and disease mechanisms using different disease models, including patient-derived induced pluripotent stem cells.

Dr. van den Berg is a professor of neurology who holds a chair in experimental neurology of motor neuron diseases at the University Medical Center Utrecht in the Netherlands. He also is director of the centers Laboratory for Neuromuscular Disease, director of the Netherlands ALS Center, chairman of the Neuromuscular Centre the Netherlands, and chairman of the European Network to Cure ALS (ENCALS), a network of the European ALS Centres.

About ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrigs disease, is a progressive neurodegenerative disease impacting nerve cells in the brain and spinal cord. ALS breaks down nerve cells, reducing muscle function and causing loss of muscle control. ALS can be traced to mutations in over 25 different genes and is often caused by a combination of multiple sub-forms of the condition. Its average life expectancy is three years, and there is currently no cure for the disease.

About QurAlis Corporation

QurAlis is bringing hope to the ALS community by developing breakthrough precision medicines for this devastating disease. Our stem cell technologies generate proprietary human neuronal models that enable us to more effectively discover and develop innovative therapies for genetically validated targets. We are advancing three antisense and small molecule programs addressing sub-forms of the disease that account for the majority of patients. Together with a world-class network of thought leaders, drug developers and patient advocates, our team is rising to the challenge of conquering ALS. http://www.quralis.com

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QurAlis Announces Appointment of New Chief Medical Officer and Formation of Clinical Advisory Board - Business Wire

A microscope photograph of a heart muscle cell. The regular green patterns show stained actin filaments.

By Tina Hilding, Voiland College of Engineering and Architecture

It might look like a little game at the molecular scale.

Filament-like proteins in heart muscle cells have to be exactly the same length so that they can coordinate perfectly to make the heart beat.

Another protein decides when the filament is the right size and puts a wee little cap on it. But, if that protein makes a mistake and puts the cap on too early, another protein, leiomodin, comes along and knocks the cap out of the way.

This little dance at the molecular scale might sound insignificant, but it plays a critical role in the development of healthy heart and other muscles. Reporting in the journal, Plos Biology,a WSU research team has proven for the first time how the mechanism works.

The finding could someday lead to improved diagnostics and medical treatments for serious and sometimes devastating hereditary heart conditions that come about from genetic mutations in the proteins. One of these conditions, cardiomyopathy, affects as many as one in 500 people around the world and can often be fatal or have lifetime health consequences. A similar condition called nemaline myopathy affects skeletal muscles throughout the body with often devastating consequences.

Mutations in these proteins are found in patients with myopathy, saidAlla Kostyukova, associate professor in the Gene and LindaVoiland School of Chemical Engineering and Bioengineeringand leader of the project. Our work is to prove that these mutations cause these problems and to propose strategies for treatment.

Heart muscle is made of tiny thick and thin filaments of proteins. With the help of electrical signals, the rope-like filaments bind and unbind in an intricate and precise architecture, allowing heart muscle to contract and beat.

The thin filaments are made of actin, the most abundant protein in the human body. Tropomysin, another protein, wraps itself around the actin filaments. Tropomyosin together with two other proteins, tropomodulin and leiomodin, at the end of the actin filaments act as a sort of cap and determine the filament length.

Its beautifully designed, said Kostyukova, whose research is focused on understanding protein structures.

And, tightly regulated.

To keep heart muscle healthy, the actin filaments, which are about a micron long, all have to be the exact same length. In families with cardiomyopathy, genetic mutations result in formation of filaments that are either too short or too long. Those affected can have significant heart problems that cause disability, illness and death.

In a project that spanned seven years, the researchers proved that leiomodin attaches to the end of the actin filament and kicks out the other protein, tropomodulin, to assure the actin filaments proper length.

This is the first time that this has been shown with the atomic-level precision, said Dmitri Tolkatchev, research assistant professor in the Voiland School and lead author on the paper. Previously, several laboratories attempted to solve this problem with very little success. With our data we finally have a direct proof.

The researchers used state-of-the-art approaches to make the key proteins and study them at the molecular and cellular level. The work entailed designing the molecules, constructing them at the gene level in a plasmid, and then producing them into bacterial or cardiac cells. The researchers used nuclear magnetic resonance, which works on the same physical principle as Magnetic Resonance Imaging (MRIs), to understand the proteins binding at the atomic level. They also used molecular dynamic simulation to model them.

The probability of being able to show this mechanism was not high, but the impact of the discovery is, said Tolkatchev, an expert in nuclear magnetic resonance. This was a very important problem to study and could have a significant impact in the field of muscle mechanics.

The researchers hope to continue the work, identifying additional components and molecular mechanisms that regulate thin filament architecture, whether diseased or healthy.

The multidisciplinary group included researchers from the University of Arizona led by Carol Gregorio, director of the Cellular and Molecular Medicine Department. WSUs group has expertise in protein structure, structural biochemistry, and properties of actin filaments and regulatory proteins, and UAs group has expertise in molecular, cellular and developmental biology of muscle assembly. The collaborative work was funded by the National Institutes of Health.

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Study shows a molecular dance that keeps your heart beating - WSU News

Cancer immune plays a critical role in cancer progression. Tumour immunology and immunotherapy are one of the exciting areas in bladder cancer research. In this study, we aimed to develop an immune-related gene signature to improve the prognostic prediction of bladder cancer. Firstly, we identified 392 differentially expressed immune-related genes (IRGs) based on TCGA and ImmPort databases. Functional enrichment analysis revealed that these genes were enriched in inflammatory and immune-related pathways, including in 'regulation of signaling receptor activity', 'cytokine-cytokine receptor interaction' and 'GPCR ligand binding'. Then, we separated all samples in TCGA data set into the training cohort and the testing cohort in a ratio of 3:1 randomly. Data set GSE13507 was set as the validation cohort. We constructed a prognostic six-IRG signature with LASSO Cox regression in the training cohort, including AHNAK, OAS1, APOBEC3H, SCG2, CTSE and KIR2DS4. Six IRGs reflected the microenvironment of bladder cancer, especially immune cell infiltration. The prognostic value of six-IRG signature was further validated in the testing cohort and the validation cohort. The results of multivariable Cox regression and subgroup analysis revealed that six-IRG signature was a clinically independent prognostic factor for bladder cancer patients. Further, we constructed a nomogram based on six-IRG signature and other clinicopathological risk factors, and it performed well in predict patients' survival. Finally, we found six-IRG signature showed significant difference in different molecular subtypes of bladder cancer. In conclusions, our research provided a novel immune-related gene signature to estimate prognosis for patients' survival with bladder cancer.

Journal of cellular and molecular medicine. 2020 Oct 13 [Epub ahead of print]

Yongwen Luo, Liang Chen, Qiang Zhou, Yaoyi Xiong, Gang Wang, Xuefeng Liu, Yu Xiao, Lingao Ju, Xinghua Wang

Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China., Department of Biological Repositories, Zhongnan Hospital of Wuhan University, Wuhan, China., Department of Pathology, Lombardi Comprehensive Cancer Center, Georgetown University Medical School, Washington, DC, USA.

PubMed http://www.ncbi.nlm.nih.gov/pubmed/33048468

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Identification of a prognostic gene signature based on an immunogenomic landscape analysis of bladder cancer. - UroToday

Proposition 14 asks voters to spend nearly $8 billion to continue the stem cell research program at a time when the COVID-19 pandemic has decimated the state budget.

CALIFORNIA, USA For the second time in 16 years, California voters will decide the fate of the states multi-billion dollar stem cell research program that established the state as a worldwide leader.

How the times have changed.

In November, as the pandemic drags on, Proposition 14 asks voters to spend nearly $8 billion to continue the program during a period when the research environment has significantly evolved and coronavirus has battered the states budget.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

At least $1.5 billion would be earmarked for brain and central nervous system diseases like Alzheimers and Parkinsons. The overall cost of the bonds and their interest totals about $7.8 billion, according to the state legislative analyst. The state would pay about $260 million annually for 30 years, or about 1 percent of Californias annual budget.

Proposition 14 is essentially a repeat with a bigger price tag and a few tweaks of Proposition 71, which California voters approved in 2004 after then-President George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.

That groundbreaking measure authorized $3 billion in state bonds to create the states stem cell research agency, the California Institute for Regenerative Medicine, and fund grants for research into treatments for Alzheimers disease, cancer, spinal cord injuries and other diseases.

The institute has nearly used up its original funding, so Prop. 71s author, real estate investor and attorney Robert N. Klein II, led a new effort to get Prop. 14 on the November ballot.

This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

Voters will want to consider what Californias previous investment in stem cell research has accomplished. Its a nuanced track record.

While many scientific experts agree that Prop 71 was a bold social innovation that successfully bolstered emerging stem cell research, some critics argue that the institutes grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71s supporters made years ago. Although the agency is funded with state money, its overseen by its own board and not by the California governor or lawmakers.

The agency had done a very good job of setting priorities for stem cell research, including research using human embryos, and doling out $300 million annually to build up California as a regenerative medicine powerhouse, according to a 2013 evaluation by the National Academies of Science, Engineering and Medicine.

But the report also found that because the institutes board is made up of scientists from universities and biotech firms likely to apply for grants, board members had almost unavoidable conflicts of interest.

Because human stem cells can develop into many types of cells, including blood, brain, nerve and muscle cells, scientists have long looked to them for potential treatments for currently incurable diseases and injuries. Researchers use two types of stem cells: embryonic stem cells, derived from unused human embryos created through in vitro fertilization, and adult stem cells, which are harder to work with but in some cases can be coaxed in a lab into behaving more like embryonic stem cells.

From the start, stem cell research has been ethically charged and politically controversial because human embryos are destroyed in some types of studies. Federal restrictions on the research have waxed and waned, depending on which political party holds power. While former President Bush restricted federal money for embryonic stem cell research, former President Obama removed those restrictions.

The Trump administration has restricted government research involving fetal tissue but not embryonic stem cells. However, anti-abortion lawmakers have called on the President to once again end federal funding for embryonic stem cell research.

California-funded research has led to one stem cell treatment for a form of Severe Combined Immunodeficiency known as the bubble baby disease. Children with the rare disease dont make enough of a key enzyme needed for a normal immune system. Without treatment, they can die from the disease if not kept in a protective environment. The U.S. Food and Drug Administration is now reviewing the treatment but has not yet approved it for widespread use.

Although many of the agencys early grants were for basic science, the institute also has supported 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonly known as Lou Gehrigs disease.

A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the states economy.

Gov. Gavin Newsom has endorsed Proposition 14, and other supporters include the Regents of the University of California, the California Democratic Party, the Juvenile Diabetes Research Foundation, patient advocacy groups like the March of Dimes, and some local politicians and chambers of commerce.

Supporters have raised more than $8.5 million, including about $2 million from billionaire Dagmar Dolby, to pass the measure, according to California Secretary of State campaign finance reports.

The passage of Proposition 71 helped save my life, Sandra Dillon, a blood cancer patient, wrote in a San Diego Union-Tribune commentary supporting Proposition 14. She wrote that she had benefited from a drug developed with Institute-funded research that has been designated by the FDA as a breakthrough therapy.

It is unimaginable to think that Californians would vote to discontinue this amazing effort I dont know where I would be or what condition I would be in if it wasnt for the investment Californians made nearly two decades ago.

Lawrence Goldstein, a UC San Diego professor of cellular and molecular medicine and stem cell researcher, said the grants were instrumental in furthering his research on treatments for Alzheimers disease and that Prop. 14 will help create new jobs. The agency has funded a great deal of very important stem cell medical research thats already produced terrific results and has the prospect of saving many more lives in the decade to come, he said.

Opponents include one member of the institutes board and a nonprofit that advocates for privacy in genetic research. They contend that the proposition seeks too much money and does not sufficiently address the conflicts of interest that cropped up after Prop. 71 was passed. They also note that private funding, including venture capital, for stem cell research has grown in recent years. Opponents had raised only $250 by late September, from a single contribution by the California Pro Life Council.

The editorial boards of some of Californias biggest newspapers also have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop 14.

Jeff Sheehy, the only institute board member not to support Proposition 14, told CalMatters that the research environment has changed since voters initially approved state funding for stem cell research in 2004 and that California should prioritize other needs like education, health care, and housing.

I think the agencys done good work, but this was never planned to be funded forever with debt, Sheehy said. At this point the state cant afford it; were looking at a huge deficit.

Originally posted here:
Prop. 14: In the COVID age, can California still afford its stem cell research program? - CBS News 8

Global COVID-19 Sample Collection Kits Market: Introduction

The recent novel Coronavirus (COVID-19) outbreak in 2019 has led to the use of several types of swabs, media, and kits to test the collected samples for COVID-19. The CDC guidelines for the collection and handling of clinical specimens suspected of Coronavirus Disease 2019 (COVID-19) mentions that health workers should only use synthetic fiber swabs with plastic shafts. The CDC recommends collection of only the nasopharyngeal (NP) swab for Coronavirus Disease 2019 (COVID-19). OP- oropharyngeal swabs remain an acceptable specimen type. NP swabs can be utilized to test asymptomatic persons. Increase in COVID-19 testing, globally, requires a safe and easy sample collection and transport mechanism.

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Key Drivers of Global COVID-19 Sample Collection Kits Market

Rising geriatric population

The global geriatric population continues to increase at an unprecedented rate. Presently, 8.5% of people across the world (617 million) are aged 65 and over. According to a new report An Aging World: 2015, the percentage is projected to jump to nearly 17% of the worlds population by 2050 (1.6 billion). According to the National Institutes of Health, the population aged 65 and over in the U.S. is anticipated to nearly double in the next three decades, from 48 million to 88 million by 2050. The global population aged 80 and older is expected to more than triple between 2015 and 2050, from 126.5 million to 446.6 million. The population aged 80 and older in some countries in Asia and Latin America is likely to quadruple by 2050.

Increase in prevalence of COVID-19

According to Spandidos Publications 2020- Molecular Medicine Reports, the global spread of COVID?19 can be described as the worst pandemic in humanity in the last century. To date, COVID?19 has infected more than 3,000,000 people worldwide and killed more than 200,000 people. Obese patients are at a higher risk of hospital admission regardless of their viral status. Furthermore, obese patients are at a higher risk of hospitalization as compared to normo-ponderal ones, when affected by influenza. The World Health Organization (WHO) has characterized both the COVID-19 outbreak and obesity epidemic as international public health emergencies. Global clinical and epidemiological observations confirm that CoVs can cause more severe symptoms and complications in people with obesity-related conditions. According to WHO World Health Organization, on March 19, 2020, 209 839 (16 556) confirmed COVID-19 cases and 8778 deaths (828) were recorded.

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North America to Account for Major Share of Global COVID-19 Sample Collection Kits Market

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Key Players Operating in Global COVID-19 Sample Collection Kits Market

The global COVID-19 sample collection kits market is highly consolidated owing to the presence of a number of key players. Leading players operating in the global COVID-19 sample collection kits market include:

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COVID-19 Sample Collection Kits Market: Increase in prevalence of COVID-19 to drive the market - BioSpace

Zhibing Zhang, M.D., Ph.D., associate professor of the C.S. Mott Center for Human Growth and Development at the Wayne State University School of Medicine, has been selected to serve as guest editor for an upcoming special issue of the journal Cells.

The special issue, Molecular Mechanism of Ciliogenesis/Spermatogenesis, is scheduled to be published in 2021, and is now accepting manuscripts for consideration.

Dr. Zhang, also an associate professor of Obstetrics and Gynecology, researches the issues topic, the process in which male germ cells proliferate and differentiate to produce spermatozoa.

Cells is an international peer-reviewed journal publishing articles pertaining to cell biology, molecular biology and biophysics.

Serving with Dr. Zhang as guest editors on the special edition are Zine-Eddine Kherraf, M.D., Ph.D., of the French Institute of Health and Medical Research, and Shuiqiao Yuan, Ph.D., of the Institute of Reproductive Health, Tongji Medical College, Huazhong University of Science and Technology, in China.

Originally posted here:
Dr. Zhang selected to edit special issue of Cells journal - The South End