Biopharma Update on the Novel Coronavirus: May 18
News information is not all-inclusive. Please check back for updates.
FDA Actions
First Standalone At-Home Sample Collection Kit: The FDA authorized an at-home sample collection kit that would then be sent to specified laboratories for COVID-19 testing. This EUA was issued to Everylwell, Inc.
Warning Letters: The FDA and FTC issued warning letters to Benjamin McEvoy and White Eagle Native Herbs for selling fraudulent COVID-19 products.
EUA: The FDA issued a EUA for the G Medical VSMS ECG Patch. This device is intended to be used in a hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) for patients, 18 years of age or older, who are undergoing COVID-19 treatment. The patch is not intended for use on critical care patients.
Clinical Trials of Medical Products: The FDA added more Q&A content in the appendix of guidance titled, “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”
Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 100 individual EUAs have been issued, which includes 87 molecular tests, 12 antibody tests and 1 antigen test.
Diagnostics
Todos Medical announced the first commercial sale of its COVID-19 antibody test. The same was made by way of a sub-distribution deal with a U.S.-based medical distribution company with clients in state and local governments throughout the Southeastern U.S. who are looking for comprehensive testing solutions for Return-to-Work programs. The sale was for rapid IgM/IgG fingerprick antibody test kits that will be deployed over Memorial Day weekend for the first of several Return to Church programs.
Testing Therapies, Antivirals and Vaccines
Moderna released positive interim Phase I data from its clinical trial of mRNA-1273, its mRNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The vaccine furthest along in human trials, showed positive results for both efficacy and safety, overall.
Vir Biotechnology announced its research findings have been published in the May 18, 2020 issue of the journal Nature. The research findings are those related to the development of therapies for COVID-19. The findings characterize the identification of S309, an antibody isolated from a 2003 recovered SARS patient which has been shown to prevent SARS-CoV-2 live virus infection of cells.
As reported by the San Francisco Business Times, last Thursday, Genentech dosed the first patient, targeting minorities, for a late-stage clinical trial of its RA drug Actemra as a potential treatment for COVID-19.
Oryzon Genomics enrolled the first patient in its Phase II trial of vafidemstat in seriously ill COVID-19 patients. The ESCAPE study will evaluate vafidemstat in combination with standard of care to prevent progression to Acute Respiratory Distress Syndrome (ARDS). Vafidemstat is an oral, CNS optimized LSD1 inhibitor, which decreases cognitive impairment, being developed for Alzheimer’s and multiple sclerosis, as well as other psychiatric disorders. The drug also appears to decrease inflammation.
CytoDyn plans to submit a protocol to the FDA for a trial comparing the effectiveness of its leronlimab compared to Gilead’s remdesivir and in combination with remdesivir for the treatment of COVID-19. Preliminary results from its leronlimab trial in 60 COVID-19 patients led to the company’s Phase IIb/III trial for 390 patients. It also has approval for a Phase II trial for mild-to-moderate COVID-19 patients in the U.S.
Company Actions
The University of Oxford’s partnership with AstraZeneca on the development and distribution of Oxford’s COVID-19 vaccine is one of the leaders in this project. AstraZeneca reported it plans to manufacture as much as 30 million doses of the vaccine for the UK market by September, with expectations of 100 million doses by the end of the year. The UK would be the first country to get access to that vaccine, assuming it proves to be safe and effective.
Thermo Fisher Scientific received a contract from the U.S. government to provide highly specialized viral transport media for COVID-19 sample collection.
Chembio Diagnostics announced it has signed a multi-year agreement with Thermo Fisher Scientific to distribute Chembio’s rapid serological test and analyzer, DPP COVID-19 System in the United States. This is a non-exclusive agreement.
Abivax SA announced Bpifrance, the investment bank of the French government, approved a €36 million non-dilutive funding for its Phase IIb/III trial of ABX464 in high-risk patients with COVID-19 as well as manufacturing scale-up and additional clinical and other development costs.
VistaGen Therapeutics, Inc. submitted its protocol for a Phase IIa study of an investigational anti-anxiety drug, PH94B, for treatment of adjustment disorder with anxiety related to the COVID-19 pandemic. The company submitted the protocol through the FDA's new Coronavirus Treatment Acceleration Program. Adjustment disorder is an emotional or behavioral reaction considered excessive or disproportionate to a stressful event or major life change, occurring within three months of the stressor.
Other Industry News
As reported by Reuters, the European Union may give the go in the next few days for sale of Gilead’s drug remdesivir as a COVID-19 treatment, fast-tracking the drug to market.
The Cancer Research Institute and IQVIA have published new findings on the current challenges, risks, and contingencies for global oncology trial management amid the COVID-19 pandemic. The results were published online today in Nature Reviews Drug Discovery. The study adds to the growing analysis of COVID-19’s impact on R&D activities, and the downstream effect on new or improved treatments. The results showed that patient enrollment in oncology clinical trials was significantly impacted, especially in the United States and Europe, where 60% and 86% of institutions, respectively, were enrolling new patients at a lower rate.
As reported by NPR, the U.S Navy says there are 13 sailors who recovered from COVID-19 and had negative results have now tested positive for a second time.