Biopharma Update on the Novel Coronavirus: September 25

CV Update_September 25

News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays. 


FDA Actions

Testified: This week, Stephen M. Hahn, FDA Commissioner, testified before the Senate Committee on Health, Education, Labor and Pensions.

Supportive Evidence: The FDA posted a summarized document to present updated evidence to support the emergency use of COVID-19 convalescent plasma.

Re-Issued EUA: The FDA re-issued a EUA for the Assure COVID-19 IgG/IgM Rapid Test Device. This is the first authorized serology test that can be used at the point of care.

Diagnostics Update: To-date the FDA has authorized 254 individual EUAs, which include 203 molecular tests, 47 antibody tests and 4 antigen tests.


Testing Therapies, Antivirals and Vaccines

Maryland’s Novavax initiated a Phase III study of its COVID-19 vaccine candidate in the United Kingdom. The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.

Olatec is enrolling a COVID-19 trial assessing a selective small molecule NLRP3 inhibitor as a potential treatment for cytokine storms in patients. NLRP3 has been identified by some as the most direct target to prevent or treat cytokine release syndrome (CRS) a major cause of Acute Respiratory Distress Syndrome (ARDS) and multiple organ failure in COVID-19. The study will treat-at-home patients, positive to the SARS-CoV-2 virus with evidence of Cytokine Release Syndrome and seek to prevent hospitalization.

Immunoprecise Antibodies (IPA) and LiteVax BV initiated pre-clinical vaccine trials against SARS-CoV-2. The companies expect that the combination of IPA's vaccine with LiteVax's adjuvant technology will have a significant impact toward a successful single-low-dose vaccine against SARS-CoV-2.

First-generation therapeutics have been largely ineffective against the SARS-CoV-2 virus, resulting in significant challenges and opportunities for the second-generation therapeutics that are being designed now. “As first-generation therapeutics for COVID-19 struggle, we must learn why they struggle and how to address their limitations,” Daniel Chen, M.D., Ph.D., CMO for IGM Bioscience, said at the recent Bioinsider virtual meeting discussing the therapeutic pipeline for COVID-19. Please read more here

Scientists in the UK want to launch a COVID-19 challenge trial in which hundreds of participants will be deliberately infected. The trial would launch in January.


Company Actions/Announcements 

Grand River Aseptic Manufacturing, an injectable contract development and manufacturing organization entered into an agreement with Janssen Pharmaceuticals, to support the manufacture of its SARS-CoV-2 vaccine candidate.

Endo International subsidiary Par Sterile Products, LLC entered into a non-exclusive fill-finish manufacturing services agreement with Novavax for NVX-CoV2373, the company’s COVID-19 vaccine candidate.

Seattle-based Lumen Bioscience was awarded a $4 million grant by the U.S. Army Medical Research and Development Command (USAMRDC), operating via the Medical Technology Enterprise Consortium (MTEC), to develop a rapid, scalable and inexpensive biologic drug cocktail to treat gastrointestinal (GI) infection in COVID-19 patients. Please read more here


Other Industry News

Infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy does not appear to increase the risk of complications during delivery or negatively impact the health of newborns, according to a new JAMA study. This research also found that approximately two out of three women who tested positive for SARS-CoV-2 – the coronavirus responsible for coronavirus disease 2019 (COVID-19) – were asymptomatic. Please read more here

Politics is once again rearing its head concerning potential approval of a COVID-19 vaccine head of the Nov. 3 election. New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers. Please read more here

The head of the U.S. Food and Drug Administration (FDA)’s vaccine advisory committee recused herself from the review of vaccines for the novel coronavirus. The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate. Please read more here

President Donald Trump signaled the White House may attempt to override a more stringent guidance for Emergency Use Authorization of a vaccine for the novel coronavirus under consideration by the U.S. Food and Drug Administration (FDA). Please read more here

Reported by Bloomberg Law, HHS Secretary Alex Azar said in a Fox Business interview that he doesn’t see anything so far indicating COVID-19 mutations would affect vaccine development.

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