Fitbit plans to initiate a prospective study with Northwell Health to help validate its algorithm for early COVID-19 detection

Fitbit (NYSE: FIT) Fitbit announced today it has been selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $2.5 million from the U.S. Department of Defense through a Medical Technology Enterprise Consortium (MTEC ) award to advance development of a wearable diagnostic capability for the early detection of a COVID-19 infection. As part of the award, Fitbit is working to initiate a prospective study with Northwell Health’s Feinstein Institutes for Medical Research to validate a Fitbit COVID-19 early detection algorithm.

The award is part of MTEC’s efforts to help keep military personnel healthy and fully operational. Because carriers of COVID-19 can be contagious without symptoms, detecting the virus before symptoms emerge is key to slowing its spread. Fitbit was selected by USAMRDC based on the Company's track record of innovation and the initial success of its COVID-19 research, specifically the role of wearable technology in early illness detection, as well as the ease of use and long battery life of Fitbit’s devices.

We believe Fitbit is uniquely positioned to deliver on USAMRDC’s goals based on our deep wearables expertise and established user base of nearly 30 million users, our early research in machine learning algorithms for detection of presymptomatic COVID-19, and our production and manufacturing capabilities to scale solutions and make them available quickly,” said Amy McDonough, GM and SVP of Fitbit Health Solutions. Our research shows that our bodies start to fight the disease before more visible symptoms appear and we believe Fitbit can reliably detect these signals, giving us an incredible opportunity to get ahead of this virus and help alert people that they could be sick before they unknowingly spread it to others. This award will help advance this important research.”

In connection with the award, Fitbit is working to initiate a prospective study with Northwell Health’s Feinstein Institutes for Medical Research. Northwell Health is the largest healthcare provider and private employer in New York State. We believe this collaboration will help expedite the development and validation of the Fitbit algorithm to detect COVID-19. As part of the prospective study, the parties plan to distribute several thousand Fitbit devices to Northwell Health employees, who will receive notifications of potential illness, as well as COVID-19 testing to assess and verify the results.

The combination of Feinstein Institutes’ research expertise, Northwell’s COVID-19 testing capabilities and Fitbit’s promising algorithm in development, presents a unique opportunity to accelerate early detection of COVID-19, particularly for our frontline health care workers,” said Karina Davidson, PhD, senior vice president at the Feinstein Institutes. Based on our learnings, we aim to work together to advise other large-scale health systems on this approach to minimizing the spread of COVID-19.”

This prospective study builds upon Fitbit’s work in COVID-19 research, which includes its collaborative research consortium with The Scripps Research Institute and Stanford Medicine that launched earlier this year. As part of that effort, Fitbit is conducting a retrospective study to determine whether it can develop an algorithm to detect COVID-19 before symptoms start. To date, the study has over 187,500 enrolled participants in the U.S. and Canada, including more than 2,700 confirmed positive cases of COVID-19. Early findings from that study show the Fitbit algorithm can detect nearly 50% of COVID-19 cases one day before participants report the onset of symptoms with 70% specificity. This is important because people can transmit the virus before they realize they have symptoms or when they have no symptoms at all. This study reinforces that breathing rate, resting heart rate, and heart rate variability (HRV) are all useful metrics for indicating onset of illness and are best tracked at night, when the body is at rest.

The Department of Defense seeks rapid, accurate wearable solutions to identify and isolate pre-symptomatic COVID-19 cases and help track and prevent the spread of the virus. To address this need, our proposal selection process sought mature solutions that could be rapidly and widely deployed,” said Commander Christopher Steele, Director of the Military Operational Medicine Research Program at USAMRDC. Wearable technologies, valuable data metrics and potentially rapid scaling solutions for broad availability, create ideal conditions for military and industry partnerships in the consumer wearables space.”

Early detection is critical, and Fitbit hopes to bring wearable illness detection capabilities to its users as soon as possible. Fitbit will engage with the appropriate regulators to determine the best path forward to bring these features to market.

About Fitbit, Inc. (NYSE: FIT)

Fitbit helps people lead healthier, more active lives by empowering them with data, inspiration and guidance to reach their goals. Fitbit designs products and experiences that track and provide motivation for everyday health and fitness. Fitbit’s diverse line of innovative and popular products include Fitbit Sense , the Fitbit Versa family of smartwatches, Fitbit Charge 4 , Fitbit Inspire 2 , and Fitbit Ace 2 activity trackers, and Fitbit Aria Air smart scale. Fitbit products are carried in approximately 39,000 retail stores and in 100+ countries around the globe. The Fitbit platform delivers personalized experiences, insights and guidance through leading software and interactive tools, including the Fitbit and Fitbit Coach apps, and Fitbit OS for smartwatches. Fitbit’s paid subscription service, Fitbit Premium , provides advanced analytics and actionable guidance in the Fitbit app to help you reach your health and fitness goals. Fitbit Premium + Health Coaching provides one-on-one virtual coaching with expert health coaches and personalized plans based on your Fitbit data. Fitbit Health Solutions develops health and wellness solutions designed to help increase engagement, improve health outcomes, and drive a positive return for employers, health plans and health systems. Fitbit and the Fitbit logo are trademarks or registered trademarks of Fitbit, Inc. in the U.S. and other countries. Additional Fitbit trademarks can be found http://www.fitbit.com/legal/trademark-list . Third-party trademarks are the property of their respective owners.

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About US Army Medical Research and Development Command

The U.S. Army Medical Research and Development Command is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine.

About Medical Technology Enterprise Consortium

MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transactional Agreement with the U.S. Army Medical Research and Development Command. To find out more about MTEC, visit http://www.mtec-sc.org .

About Northwell Health

Northwell Health is New York State’s largest health care provider and private employer, with 23 hospitals, nearly 800 outpatient facilities and more than 14,200 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 74,000 employees 18,500 nurses and 4,500 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook , Twitter , Instagram and LinkedIn .

About the Feinstein Institutes

The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn .

Forward Looking Statements

This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties including, among other things, statements about the future availability of wearable early illness detection and/or diagnostic capabilities; production and manufacturing capabilities; expected results of any trials conducted; performance and/or benefits of products or services described in this release, including but not limited to ability to track and prevent spread of illness; and our ability to help users manage or improve their health and wellness.

These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors, including the effects of the highly competitive market in which we operate, including competition from much larger technology companies; any inability to successfully develop and introduce new products, features, and services or enhance existing products and services; product liability issues, security breaches or other defects; the impact of COVID-19; and other factors discussed under the heading Risk Factors” in our most recent report on Form 10-Q filed with the Securities and Exchange Commission. All forward-looking statements contained herein are based on information available to us as of the date hereof and we do not assume any obligation to update these statements as a result of new information or future events.

The views expressed in this news release/article are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

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Jen Ralls, (415) 722-6937 PR@fitbit.com

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Fitbit Receives Army Award to Help Accelerate its COVID-19 Wearable Detection Technology - Stockhouse

Last week, the Food and Drug Administration (FDA) approved the antiviral remdesivir as a treatment for COVID-19 in adults and children 12 years and older, paving the way for wider use of the drug.

Dr. Lanny Hsieh, clinical professor of infectious diseases at UCI Health, said the FDAs move is very exciting.

Putting together all of the scientific evidence we have on remdesivir to date, it remains the standard of care for hospitalized patients with COVID-19, she said. Ultimately, it is our patients who would benefit from this FDA approval.

However, research so far on remdesivir is mixed, and the drug is far from a cure for COVID-19.

In May, the FDA issued an emergency use authorization (EUA) for remdesivir, marketed in the United States under the brand name Veklury. This allowed the drug to be used to treat those with severe COVID-19.

The agency broadened the EUA in August to allow for its use on all hospitalized patients with COVID-19, regardless of how severe their illness.

President Trump took remdesivir along with several other treatments when he was hospitalized for COVID-19 in early October.

The FDA based its decision on three randomized controlled trials.

One study of 1,062 participants with mild, moderate, or severe COVID-19 was published earlier in October in the New England Journal of Medicine.

Results from this trial show that remdesivir reduced the length of hospital stay by about 5 days from 15 down to 10.

Patients taking remdesivir also had a lower chance of dying after 28 days 11.4 percent compared with 15.2 percent in patients receiving an inactive placebo.

This [study], along with other trials reviewed by the FDA, has led to remdesivirs approval, Hsieh said, who is the principal investigator on the remdesivir clinical trial at UCI Medical Center.

The two other trials reviewed by the FDA had similar results. One of these also showed that a 5-day course of remdesivir worked just as well as taking the drug for 10 days.

However, preliminary results from the World Health Organization (WHO) Solidarity trial of more than 11,000 participants found that remdesivir had little effect on how long they stayed in the hospital and no effect on death.

This study was published as a preprint on medRxiv and hasnt yet been peer-reviewed, so the results should be viewed with some caution. The WHO plans to publish it in the New England Journal of Medicine.

Given the results of the WHO study, Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Translational Institute, questioned whether the FDA should have granted remdesivir a full approval.

How can Remdesivir get a full [FDA] approval when there are such mixed data? Not supportive of this decision at all, he wrote on Twitter. Does it work early? Does it work late? Does it work anytime? So much unresolved.

However, Hsieh said the WHOs study had several limitations, including not comparing remdesivirs effects to a placebo, and looking at several potential treatments in the same study.

Although interesting, Solidaritys findings do not take away from the results of [the NEJM trial], she said, which is a study that is conducted with the most scientific rigor to date.

Without a COVID-19 vaccine approved in the United States, doctors are anxious for an effective treatment for COVID-19. Remdesivirs approval finally gives them something to work with.

Given the limited arsenal of effective or even marginally effective treatments for COVID-19, and the fact that we dont have a fully curative therapy or a vaccine, it is good to have more options, said Dr. Matthew G. Heinz, a hospital physician and internist in Tucson, Arizona.

But he said remdesivir is still difficult to get in some parts of the country, especially in rural areas.

And its expensive. A 5-day course of treatment can cost $3,120 for people with private insurance, reports Vox.

Remdesivir is also not without risks. In some people, it can cause elevated liver enzymes, which could be a sign of liver damage. The most common side effect, though, is nausea.

In specific situations for certain patients, I do think [remdesivir] is reasonable to use, Heinz said, because it can inhibit viral replication if given at the right time point.

Remdesivir blocks the coronavirus from replicating, so it works best if given early.

Remdesivir is likely going to be more useful for stopping serious progression of the disease, Heinz said. But to give it to someone whos already critical getting intubated or who has already been intubated may not work.

The drug is less effective in later stages of severe COVID-19, when the damage is caused more by an overactive immune response than by the virus itself.

At this point, doctors turn to other treatments that target the immune system. One of these is the corticosteroid dexamethasone, which dampens the immune response and has been shown to reduce deaths from COVID-19.

Although remdesivir isnt completely effective against COVID-19, many doctors on the front line are glad to have it as an option.

Given that its not shown to have significant safety concerns, and at least one good study does show some benefit, it is reasonable to have remdesivir as an available treatment while we wait for better ones, Heinz said.

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Should the FDA Have Approved Remdesivir to Treat COVID-19 Patients? - Healthline

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

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

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...