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Pregnant Women Are Not at Greater Risk of Severe COVID-19 Than Other Women, According to Results Reported in Pre-Print from University of Oxford & Collaborating Institutions

Researchers from the University of Oxford, in collaboration with the Royal College of Obstetricians and Gynecologists, the Universities of Leeds and Birmingham, and Kings and Imperial Colleges London, have published new research that suggests that pregnant women are no more likely to become ill with severe COVID-19 than non-pregnant woman. However, the majority of women who did become severely ill were in their third trimester of pregnancy, emphasizing the importance of social distancing for this group. The study, published on May 12, 2020 as a pre-print, looked at 427 pregnant women admitted to hospitals in the UK between March 1, 2020 and April 14, 2020 with confirmed COVID-19 (4.9 women out of every 1,000 pregnant women, suggesting pregnant women are not at a higher risk of experiencing severe illness). Information for the study was collected from all 194 hospitals in the UK with a consultant-led maternity unit. Pregnant women from black and ethnic minority backgrounds were more likely to be admitted to hospital for COVID-19. This inequality persisted even when women from London, the West Midlands, and the North West were excluded from the analysis, meaning the difference cannot be explained by higher rates of COVID-19 infection in those areas. The analysis also showed that older pregnant women, those who were overweight or obese, and pregnant women who had pre-existing medical problems, such as high blood pressure and diabetes, were more likely to be admitted to hospital with the infection. Women who were admitted to hospital with COVID-19 in pregnancy were less likely to smoke than a group of comparison pregnant women. Other important findings from the study includethe following.

CytoDyn Completes Submission of All Remaining Parts of Biologics License Application (BLA) for Lernlimab As Part of Combination Therapy for HIV on May 11, 2020

On May 13, 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, confirmed that it had submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients to the U.S. Food and Drug Administration (FDA) on May 11, 2020. Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review. As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision. After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review).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. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact.

Tiny RNAs That Should Attack Coronavirus Diminish with Age & Co-Morbidities; Age- and Disease-Associated Decline in Virus-Fighting MicroRNAs May Play Key Role in Increased Disease Presentation and Mortality Rate in Elderly COVID-19 Patients

A group of tiny RNAs that should attack the virus causing COVID-19 when it tries to infect the body are diminished with age and chronic health problems, a decrease that likely helps explain why older individuals and those with preexisting medical conditions are vulnerable populations, investigators report. MicroRNAs (miRNAs) play a big role in our body in controlling gene expression, and also are a front line when viruses invade, latching onto and cutting the RNA, the genetic material of the virus, says Sadanand Fulzele, PhD, Aging Researcher in the Department of Medicine and Center for Healthy Aging at the Medical College of Georgia (MCG) at Augusta University. But with age and some chronic medical conditions, the attacking microRNA numbers dwindle, reducing our ability to respond to viruses, says Dr. Carlos M. Isales, MD, Co-Director of the MCG Center for Healthy Aging and Chief of the MCG Division of Endocrinology, Diabetes, and Metabolism. Much like not having enough troops on the ground in an actual war, the coronavirus is then better able to do what it does naturally, which is hijack our cell machinery so it can replicate, say the researchers who report, with collaborators, in an article published online for the June 2020 issue of Aging and Disease what appear to be key microRNAs involved in responding to this virus. They have a longer-term goal of identifying the biggest hitters and replenishing those troops.

Moderna Receives FDA "Fast Track" Designation for mRNA Vaccine (mRNA-1273) Against COVID-19; Company Finalizing Protocol for Phase 3 Study of mRNA-1273, Expected to Begin in Early Summer of 2020

On May 12, 2020, Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, MD, PhD, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.” Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. Moderna previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs. On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Moderna’s Investigational New Drug (IND) application for mRNA-1273, allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S.

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.

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