Biopharma Update on the Novel Coronavirus: April 21
News information is not all-inclusive. Please check back for updates.
FDA Actions
Serological (Antibody) Tests: The FDA posted information on the use of serological tests to help in the identification of those who may have been to or have recovered from COVID-19.
Face Mask EUA: Due to concerns about insufficient supply and availability of face masks for use by members of the public and health care personnel to help prevent the spread of COVID-19, the FDA issued a face mask emergency use authorization (EUA).
Temporary Policy for State-Licensed Pharmacies and Federal Facilities: The FDA issued guidance for facilities that are not outsourcing facilities, compounding certain human drugs for hospitalized patients during the COVID-19 pandemic. The FDA does not intend to take action for providing drugs to hospitals that is a copy of commercially available drugs or providing drugs to a hospital without obtaining a patient-specific prescription.
The Path Forward: Coronavirus Treatment Acceleration Program: The FDA issued information describing the program that aims to find new treatments for COVID-19 as soon as possible. To date, 72 clinical trials of potential COVID-19 treatments are in progress with FDA oversight.
Diagnostics Update: The FDA has worked with more than 340 test developers who plan to submit EUA requests to detect COVID-19. Also, 41 EUAs have been issued. The FDA has been notified that more than 210 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
Diagnostics
The Rockefeller Foundation laid out its COVID-19 Testing Action Plan as a fundamental step to reopen the country.
LabCorp, one of the two largest clinical diagnostic laboratory companies in the U.S., received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its at-home COVID-19 test kit.
Applied DNA Sciences Inc. entered into an agreement with Stony Brook University Hospital to validate the company’s patent-pending nucleic acid diagnostic (LineaCOVID-19) to detect and quantify in diagnostic samples the presence of SARS-CoV-2, the virus that causes the disease, COVID-19. Validation is expected to begin immediately with results to be used to support the company’s application to the U.S. Food and Drug Administration before the end of April 2020 for Emergency Use Authorization.
Todos Medical received EUA from the FDA for its real-time digital PCR diagnostic test for COVID-19. Gibraltar Brothers & Associates, a U.S.-based subsidiary of Shanghai Liangrun Biomedicine Technology had added Gnomegen as a supplier of PCR Test Kits to Todos under Gibraltar’s existing deals with Todos, which allows Todos to use the Gnomegen PCR Test Kits for its CLIA lab business.
Testing Therapies, Antivirals and Vaccines
Bay Area-based Vaxart, Inc. has obtained positive pre-clinical results for its COVID-19 vaccine candidates, with several of the vaccine candidates generating immune responses in all tested animals after a single dose. Now, the company plans to push one or more into the clinic.
Hope Biosciences received FDA approval for its third COVID-19 clinical trial. This study assesses Hope Biosciences’ adipose-derived mesenchymal stem cells as a potential treatment for hospitalized COVID-19 patients. MSCs are well-known for their immunomodulatory and regenerative potential. These characteristics make them a potential therapeutic option to fight the inflammation and lung degeneration that is known to occur in severe COVID-19 patients.
RedHill Biopharma Ltd. entered into an agreement with the National Institute of Allergy and Infectious Diseases to provide its investigational drug, RHB-107 (upamostat, WX-671), for testing in non-clinical studies for activity against COVID-19. RHB-107 is a serine protease inhibitor active against a number of human trypsins and several other related serine proteases. Inhibition of serine proteases, including trypsins, may inhibit viral attachment and replication and decrease lung damage from viral pneumonia.
According to the FDA, there are 72 clinical trials for vaccines against the novel coronavirus that causes COVID-19. Although occasionally someone gives an optimistic timeline suggesting a vaccine will be ready in the fall of 2020, most experts believe it will be sometime in mid-2021, if at all. Some of the companies leading the way include: Inovio Pharmaceuticals; Novavax; Johnson & Johnson; Moderna; Oxford University, CanSino Biologics and others.
aTyr Pharma’s IND for a Phase II trial of ATYR1923 in COVID-19 patients with severe respiratory complications was given the go-ahead. ATYR1923 in preclinical studies downregulated T-cell responses, dampening the inflammatory cytokine and chemokine signaling implicated in severe COVID-19. It will look at 30 confirmed COVIOD-19 patients at up to 10 U.S. sites.
Company Actions
As more companies aim resources at COVID-19, a consortium launched the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified and limited patient-level data sets made available to public health and policy researchers to extract insights to help combat the pandemic.
Merck is taking a number of new steps to support patients in the United States who may have lost their jobs and insurance coverage. Merck will continue to ensure access to Merck medicines at no cost for eligible patients through its Merck Patient Assistance Program. The Merck Patient Assistance Program is making a number of changes to help patients who have lost their job or cannot get into their doctor’s office during this crisis, including assessing patients’ real-time financial situations, providing assistance with expiring enrollments, and offering new options to collect signatures on enrollment forms. Merck will also make changes to other access and assistance programs, including a temporary $0 co-pay for certain products for eligible patients who are enrolled in the Merck Access Program. Additionally, the company has, where appropriate, relaxed certain refill restrictions related to coupon use, and all existing coupon programs remain available to privately insured eligible patients.
Researchers from the Vlaams Institute for Biotechnology in Ghent, Belgium have found antibodies in llama blood which they think could help to neutralize COVID-19. Similar antibodies from llama blood have been used against MERS and SARS, which are close relatives of COVID-19.
BriaCell Therapeutics filed a provisional patent application in the U.S. describing the development and use of certain antibodies for the treatment of cancer and infectious diseases, including COVID-19. The method for generating antibodies to neutralize SARS-CV-2 uses computer-based simulation technology.
Governments have had to lean on smaller biotech companies in the efforts to develop vaccines against COVID-19. This is largely because there are only four large pharma companies in the field of vaccine development and commercialization: GlaxoSmithKline, Merck & Co., Sanofi and Johnson & Johnson. The U.S. Biomedical Advanced Research and Development Authority (BARDA) has issued three grants for vaccine development for COVID-19, one to J&J, another to Sanofi Pasteur, but the third went to Moderna. Moderna is a smaller Cambridge, Massachusetts-based biotech that is leading the charge in a new approach to vaccine development. The grant was for $483 million.
NovelStem International announced two new collaborations to apply NewStem’s technology platform, one for a potential cancer immunotherapy drug and another to research genes responsible for COVID-19. NewStem is a spinoff of Yissum, The Hebrew University of Jerusalem’s technology-transfer company, 27.3% owned by NovelStem.
Other Industry News
Science 37, Inc. and Advarra have partnered to expedite approvals on COVID-19–related virtual trials. The partnership will help companies continue clinical research during the pandemic by allowing them to make quick adjustments to protocols for existing ongoing trials, including to virtualize these trials, and have the changes expeditiously reviewed by an approved IRB.