Biopharma Update on the Novel Coronavirus: September 23

CV Update_September 23

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


FDA Actions

Updated Guidance: The FDA added content to the Q&A appendix in the guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.”

Diagnostics Update: To-date the FDA has authorized 249 individual EUAs, which include 199 molecular tests, 46 antibody tests and 4 antigen tests.



Ortho Clinical Diagnostics was awarded another BARDA contract to accelerate antigen test development and additional SARS-CoV-2 antibody test milestones. The award is $12,850,000 to support the SARS-CoV-2 antigen test and continued regulatory pathway support for the company’s total and IgG antibody tests.

Decision Diagnostics Corp. completed two professional use instructional videos to go with its Genviro! COVID-19 Saliva Swift Kit to market both in the U.S. and internationally. The videos offer step-by-step instructions for health care professionals to follow for the most accurate results. The company hopes to eventually market the product for at-home use, but otherwise, it is point-of-care. The company is a leading manufacturer of diabetic test strips.

DetectaChem announced their MD-Bio (MobileDetect Bio (BCP19 Test Pouch for COVID-19 detection successfully passed the initial Deep Dive phase in July 2020 and is moving into Phase I of the NIH RADxSM (Rapid Acceleration of Diagnostics) Tech initiative. The RADxSM initiative was developed to quickly accelerate innovation in the development, commercialization, implementation and mass deployment of technologies for COVID-19 testing.

Abacus Diagnostica manufactures assays and devices for rapid molecular diagnostics. The company is currently working on a four-in-one test kit for detecting influenza A, influenza B, RSV and SARS-CoV-2.


Testing Therapies, Antivirals and Vaccines

In the U.S., most of the attention to the COVID-19 vaccine race has been on Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, which are leading the way. There are a number of other major biopharma companies also working to advance their vaccine candidates, and today, Johnson & Johnson announced a major milestone. It is launching its large-scale, international Phase III trial for its vaccine candidate, JNJ-78436735. The J&J vaccine appears to require only a single dose. Several of the other candidate vaccines require two doses about 28 days apart. Please read more here

Arcturus CEO Joseph Payne told BioSpace in an interview that his company’s vaccine candidate is a low-dose, single-shot treatment that generated not only neutralizing antibody titers, but also CD8+ T-cell induction in preclinical studies. Please read more here

Announced Tuesday, the National Institutes of Health expanded trials of convalescent plasma to treat COVID-19.

A team of researchers led by Andy Goren, MS from Applied Biology, has discovered a possible treatment for COVID-19. Their research looks at the possible role of androgens in controlling the infectivity of SARS-CoV-2 in human lung cells. The study on the effects of proxalutamide on COVID-19 has received national IRB approval and will be conducted in Brazil.

RedHill Biopharma announced the Brazilian Health Regulatory Agency has approved its ongoing global Phase II/III clinical trial evaluating opaganib, an orally-administered, sphingosine kinase-2 (SK2) selective inhibitor,  in patients hospitalized with severe COVID-19 pneumonia.

MediciNova, Inc. announced its intranasal SARS-CoV-2 vaccine prototype for COVID-19, using BC-PIV technology, successfully induced systemic serum IgG and mucosal IgA neutralizing antibodies against the S1 antigen (Ag) of SARS-CoV-2 in mice. 

Durect Corporation dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase II study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S.


Company Actions/Announcements 

Concerns continue to rise over the White House strong-arming the U.S. Food and Drug Administration to grant Emergency Use Authorization to a coronavirus vaccine candidate that has not yet passed rigorous Phase III testing ahead of the November election. Those worries are high enough that the FDA is expected to issue a new and more stringent guidance regarding a potential EUA for a COVID-19 vaccine. Please read more here

Sanofi and GSK announced they have signed agreements with the Government of Canada for the supply of up to 72 million doses of an experimental COVID-19 vaccine, starting in 2021.

Humanigen, Inc. partnered with Thermo Fisher Scientific to expand the manufacturing capacity for lenzilumab, currently in a Phase III registration study in patients with COVID-19, to support a potential Emergency Use Authorization. Lenzilumab is being developed to treat cytokine storms in COVID patients.

Lamar Alexander (R-Tenn.), chairman of the U.S. Senate health committee, said the COVIDI-19 vaccine program under Operation Warp Speed is on track. He made the statements during a Senate health committee hearing, “COVID-19: An Update on the Federal Response.”

Global Response Aid (GRA) and Dr. Reddy’s Laboratories announced the antiviral Avigan demonstrated promising results in a Phase III trial in Japan in COVID-19. Patients who received the drug recovered from symptoms 2.8 days earlier, on average, compared to the control group. The trial was sponsored by FujiFilm Toyama Chemical. Avigan contains the active ingredient Favipiravir and was originally developed as an anti-influenza drug.

Other Industry News

More than 150 countries have signed on to a World Health Organization (WHO) program to ensure global access to a COVID-19 vaccine, however, the United States, Russia and China refrained from signing the agreement. Please read more here

With so much focus on developing COVID-19 vaccines, developers also need to think ahead to how, exactly, they will transport clinical study materials and samples throughout the world. Competition for resources is growing, and the usual supply chain partners may not have available capacity in the preferred timeframe. Please read more here

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