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Rising to the COVID-19 Challenge; NIH Director Francis Collins Describes NIH Launch of “Rapid Acceleration of Diagnostics (RADx) Initiative,” Fueled By $1.5 Billion Investment of Federal Stimulus Funding

On April 29, 2020, in his Director’s Blog, NIH Director Francis Collins (photo), MD, PhD, described the NIH launch of the Rapid Acceleration of Diagnostics (RADx) Initiative. The text of Dr. Collins’ remarks in his blog are provided here. “Step into any major medical center, and you will see the amazing power of technology at work. From X-rays to functional MRIs, blood typing to DNA sequencing, heart-lung machines to robotic surgery, the progress that biomedical technology has made over the past century or so stands as a testament to human ingenuity—and its ability to rise to the all-important challenge of saving lives and improving health. Today, our nation is in the midst of trying to contain a most formidable health threat: the global coronavirus disease 2019 (COVID-19) pandemic. I’m convinced that biomedical technology has a vital role to play in this urgent effort, which is why the NIH today launched the Rapid Acceleration of Diagnostics (RADx) Initiative. Fueled by a bold $1.5 billion investment made possible by federal stimulus funding, RADx is an urgent call for science and engineering’s most inventive and visionary minds—from the basement to the board room—to develop rapid, easy-to-use testing technologies for SARS-CoV-2, the novel coronavirus that causes COVID-19. To achieve this, NIH will work closely with our colleagues at the Biomedical Advanced Research and Development Authority, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).” “If all goes well, RADx aims to support innovative technologies that will make millions more rapid SARS-CoV-2 tests available to Americans by late summer or fall.

NIH Mobilizes National Innovation Initiative for COVID-19 Diagnostics to Speed Delivery of Accurate, Easy-to-Use, Scalable Tests to All Americans; Initiative Has $1.5 Billion in Funding & Will Implement “Shark Tank”-Like Competition Amongst Innovators

On April 29, 2020, the National Institutes of Health (NIH) announced a new initiative aimed at speeding innovation, development, and commercialization of COVID-19 testing technologies, a pivotal component needed to return to normal during this unprecedented global pandemic. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative (see table at end) will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability. NIH will work closely with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals. The stimulus investment supercharges NIH’s strong research efforts already underway that are focused on prevention and treatment of COVID-19, including the recently announced planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (https://www.nih.gov/news-events/news-releases/nih-launch-public-private-...) public-private partnership to coordinate the international research response to the pandemic.“We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development,” said NIH Director Francis S. Collins, MD, PhD.

New HIV Vaccine Combination Strategy Provides Better and More Durable Protection; Injections of HIV-Env Protein Elicit Neutralizing Antibodies; Injections of HIV-Gag Protein Elicit Cellular Immunity; Combination Found Effective & Durable

Researchers from the Emory Consortium for Innovative AIDS Research in Nonhuman Primates and their colleagues across North America have shown that a new HIV vaccine is better at preventing infection and lasts longer than others, continuing to protect one year after vaccination. The findings, which were published online on May 11, 2020 in Nature Medicine, provide important insights for preventing HIV, and the timeliness of the results could also help shape the scientific community's approach to developing vaccines for COVID-19. The open-access article is titled “T Cell-Inducing Vaccine Durably Prevents Mucosal SHIV Infection Even with Lower Neutralizing Antibody Titers.” According to the researchers, the key to the new vaccine's markedly improved protection from viral infection is an alliance between neutralizing antibodies and cellular immunity. "Most efforts to develop an HIV vaccine focus on activating the immune system to make antibodies that can inactivate the virus, so called ‘neutralizing antibodies,’" says Eric Hunter, PhD, Professor of Pathology and Laboratory Medicine at Emory, a researcher at the Emory Vaccine Center (EVC) (http://www.vaccines.emory.edu/) and Yerkes National Primate Research Center (http://www.yerkes.emory.edu/), and a Georgia Research Alliance Eminent Scholar. "We designed our vaccine to also generate a strong cellular immune response that homed in on mucosal tissues so the two arms of the immune response could collaborate to give better protection," he continues. Dr. Hunter is one of five senior authors of this study. Two of his Emory colleagues are also senior authors: Rama Amara, PhD, Professor of Microbiology and Immunology at Emory and a researcher at Yerkes and the EVC; and Cynthia Derdeyn, PhD, Professor of Pathology and Laboratory Medicine at Emory and also an EVC and Yerkes researcher.

Medicinal Plants Thrive in Biodiversity Hotspots

With their rich repertoire of anti-infective substances, medicinal plants have always been key in the human fight to survive pathogens and parasites. This is why the search for herbal drugs with novel structures and effects is still one of the great challenges of natural product research today. Scientists from Leipzig University (UL), the Leibniz Institute of Plant Biochemistry (IPB), and the German Centre for Integrative Biodiversity Research (iDiv) have now shown a way to considerably simplify this search for bioactive natural compounds using data analyses on the phylogenetic relationships, spatial distribution, and secondary metabolites of plants. Their new approach makes it possible to predict which groups of plants and which geographical areas are likely to have a particularly high density of species with medicinal effects. This could pave the way for a more targeted search for new medicinal plants in the future. Over 70 per cent of all antibiotics currently in use originate from natural substances obtained from plants, fungi, bacteria, and marine organisms. In the battle against infectious diseases, humans are particularly dependent on new drugs from natural sources, as pathogens are constantly changing and producing new dangerous strains. At the same time, we have not exhausted our natural resources. In the plant kingdom alone, only about ten per cent of all vascular plants have so far been screened for suitable active compounds. There are currently about 250,000 structures of natural products stored in scientific databases, with an estimated total of ~500,000 in plants alone.

British Companies Mologic & BioSure Partner on COVID-19 Antibody Self-Test--Innovative Design Suitable for At-Home Self-Test Giving Result in 10 Minutes; Final Validations Underway Ahead of Mass Production

On May 11, 2020, Mologic Ltd, a leading developer of diagnostic technologies, announced today that it has joined forces with BioSure, leading experts in self-testing, to produce a COVID-19 antibody self-test. By combining Mologic’s independently verified COVID-19 lateral flow test with BioSure’s market-leading design, the companies have created a self-test for COVID-19 that can be used without any training being required. The innovative design has been proven to be extremely easy to use, requires only a fraction of a drop of blood, and gives the user his or her own result in just 10 minutes. Since launching the first CE-marked HIV self-test in 2015, BioSure has become a world leader in self-testing. The BioSURE COVID-19 Antibody Self-Test will be ready for mass production at the beginning of June. It will be available to the UK and global markets and will also be available to be directly purchased by end-consumers. Building on a longstanding partnership, materials for all of Mologic’s COVID-19 diagnostics are being supplied to the Institut Pasteur de Dakar in Senegal who will manufacture tests for the African continent at their flagship facility diaTROPiX in Dakar. Since March, alongside the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London; leading laboratories across the world have partnered with Mologic to rapidly iterate, improve, and validate the company’s COVID-19 diagnostic prototypes and independently assess performance. Mark Davis, Co-Founder & CEO, Mologic said, “Mologic is thrilled to be partnering with BioSure on this COVID-19 self-test, which will enable people to quickly and safely test for antibodies to the virus in their own home.

Regeneron & Colorado Center for Personalized Medicine Announce Major Human Genetics Research Collaboration; Regeneron to Sequence 450,000 Informed & Consented Patients; Effort Should Aid Genomic Medicine, Drug Discovery, and Personalized Medicine

On May 11, 2020, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus announced a large-scale research collaboration designed to advance the field of human genetics and precision medicine through the sharing of 450,000 DNA samples and corresponding health records from de-identified, consented patient participants in the expansive UCHealth system (https://www.uchealth.org/). The Regeneron Genetics Center (RGC), a wholly owned subsidiary of Regeneron, has entered into the collaboration with CCPM and will sequence these samples, producing genomic data that can be used to facilitate translational medical research and ultimately enable physicians to make better decisions for their patients. The CCPM is one of the largest health data warehouses in the United States and a pioneer in the use of a secure cloud platform with more than 8.7 million de-identified patient records. The five-year-old research enterprise is also one of the first and largest programs in the country to integrate personalized genomic information with clinical data via a research biobank. CCPM physicians will validate any genetic findings from the RGC data in their CLIA-certified lab, enabling the return of clinically-actionable results to patients. "This collaboration will take an already notable program at the CCPM and expand the depth and breadth of its capabilities, allowing us to give more back to our patient participants than ever before," said Kathleen Barnes, PhD, Professor and Director of CCPM at the University of Colorado Anschutz Medical Campus. "We have made tremendous strides with our work in pharmacogenomics, but having access to such a large genomic dataset that enables the return of clinically actionable results will be transformative.

Self-Corrective Mechanism at Synapse Doubles Lifespan in Mouse Model of ALS (Lou Gehrig’s Disease), Suggests New Approach to Therapy for Human Brain Diseases

A common feature of neurodegenerative diseases such as Alzheimer’s disease and amyotrophic lateral sclerosis (ALS) (also called Lou Gehrig’s disease) is the progressive loss of synapses – the anatomical sites of communication between brain cells – throughout the brain and spinal cord. Typically, synapse loss becomes pervasive before the outward appearance of symptoms of disease, such as memory loss or paralysis. The fact that there must be extensive synapse loss before brain function begins to seriously decline suggests that the nervous system maintains a deep functional reserve that keeps everything working normally until the damage passes a tipping point and the brain’s resilience begins to break down. But how exactly does this functional reserve confer resilience in the face of ongoing brain degeneration? Could differences in this reserve explain why some individuals with ALS decline and die within months, while others – like astrophysicist Steven Hawking (photo)--live for decades? And could a treatment that boosts this functional reserve help more patients survive and prosper as long as Hawking? In a new study, published online on May 6, 2020 in Neuron (https://www.sciencedirect.com/science/article/abs/pii/S0896627320302786?...), University of California San Francisco (UCSF) neuroscientist Graeme Davis, PhD, and his team have identified a powerful self-corrective mechanism within synapses that is activated by neurodegeneration and acts to slow down disease progression in animal models of ALS. Selectively eliminating this self-corrective mechanism dramatically accelerated progression of ALS in mice, shortening their lifespan by 50 percent.

Coordinated Strategy to Accelerate Multiple COVID-19 Vaccine Candidates Is Key, NIH Director Francis Collins & NIAID Director Anthony Fauci Say

A harmonized and collaborative approach to the clinical testing, scale-up, and distribution of candidate vaccines to prevent COVID-19 is essential, scientific leaders write in a Policy Forum piece published online on May 11, 2020 in Science. The open-access article is titled “A Strategic Approach to COVID-19 Vaccine R&D.” As the COVID-19 pandemic continues, government, industry, and academia have introduced a variety of vaccine candidates. The authors note that more than one effective vaccine approach likely will be required to successfully protect the global community from SARS-CoV-2, the virus that causes COVID-19. They describe a strategic approach to research and development that would generate essential data for multiple vaccine candidates in parallel. NIH Director Francis S. Collins, MD,PhD; NIAID Director Anthony S. Fauci, MD; Lawrence Corey, MD, Professor in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center in Seattle; and John R. Mascola, MD, Director of NIAID’s Vaccine Research Center are the co-authors of the Policy Forum article in Science. The open-access article discusses diverse vaccine candidates and key considerations for development, including the characteristics of various vaccine platforms in terms of prior commercial experience, scalability, and the types of immune responses generated. It also emphasizes that no single vaccine or vaccine platform is likely to meet the global need, highlighting the need for a coordinated strategic approach to vaccine development. The authors stress that researchers need to learn more about what constitutes a durable protective immune response against COVID-19.

CytoDyn to Present at Wall Street Reporter’s NEXT SUPERSTOCK Livestream Event on Its Monoclonal Anti-CCR5 Antibody (Leronlimab) for COVID-19, and Also for HIV, Cancer, & Graft Versus Host Disease; Wednesday, May 13, 2020, at 12:30 pm EDT / 9:30 am PDT

On May 11, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that Jacob Lalezari, MD, CEO of Quest Clinical Research: Bruce Patterson, MD, Chief Executive Officer and Founder of IncellDx, a diagnostics company, and an advisor to CytoDyn; and Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, will provide a comprehensive business update. The Wall Street Reporter’s event is scheduled for Wednesday, May 13, 2020 at 12:30 pm ET / 9:30 am PT. The presentation will be approximately 15 minutes, followed by a Q&A session of approximately 45 minutes. You may register for the event at the following link (https://attendee.gotowebinar.com/register/8072137589911916560). Interested participants are encouraged to log in early prior to the start of the event, as the online event has a capacity of 3,000 participants. Please note that there will be no telephone access; this is a webcast-only event. The livestream presentation will be archived for 30 days. For anyone unable to attend, a video will be posted on CytoDyn’s website approximately 24 hours after the presentation. The conference sponsor provides corporate visibility services to CytoDyn for a fee. CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious.

NIH Clinical Trial Testing Antiviral Remdesivir Plus Anti-Inflammatory Drug Baricitinib for COVID-19 Begins

A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States. The trial is expected to open at approximately 100 U.S. and international sites. Investigators currently anticipate enrolling more than 1,000 participants.The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial. The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT) (https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-trea...), which began on February 21 to evaluate remdesivir, an investigational broad-spectrum antiviral treatment developed by Gilead Sciences, Inc. That trial closed to enrollment on April 19 after recruiting 1,063 participants at 47 U.S. and 21 international sites. An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 and shared their preliminary analysis with the study sponsor, NIAID. Their analysis showed that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo (https://www.niaid.nih.gov/news-events/nih-clinical-trial-shows-remdesivi...). More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report. In this next trial with baricitinib, called ACTT 2, all participants will receive remdesivir or remdesivir with baricitinib.

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