Biopharma Update on the Novel Coronavirus: April 3

CV Update_April 3

News information is not all-inclusive. Please check back for updates.


FDA Actions

Warning Letters: The FDA and FTC issued three warning letters for selling fraudulent COVID-19 products and providing misleading claims that its products can prevent, treat, diagnose or cure COVID-19. These companies include: Gaia’s Whole Health Essentials LLC., Homeomart Indibuy and Health Mastery Systems DBA Pure Plant Essentials.

Diagnostics Update: The FDA has worked with more than 240 test developers who plan to submit EUA requests to detect COVID-19. Also, 25 EUAs have been issued. The FDA has been notified that more than 125 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. On April 1st, the FDA issued an EUA to Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test.

Blood Donor Eligibility: The FDA announced it is revising recommendations in several guidances including HIV, malaria and CJD/vCJD for immediate implementation. Additionally, the FDA is published a fourth guidance providing notice of alternatives for the duration of the COVID-19 pandemic.



Aytu BioScience: Aytu BioScience announced it has begun shipping its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test to U.S. customers.

BD (Becton, Dickinson and Company) received Emergency Use Authorization from the U.S. Food and Drug Administration for a new diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in under three hours. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country. Each unit is capable of analyzing hundreds of samples per day.

Mayo Clinic is reportedly to begin antibody testing on Monday, using an internally developed test.

Beroni Group’s SARS-CoV-2 IgG/IgM Antibody Detection Kit gets approval in Europe. It has also notified the FDA of its validated serology tests for its COVID-19 diagnostic test.

Predictive Technology Group signed a deal between its subsidiary, Predictive Laboratories, and Wellgistics, for U.S. distribution of its Assurance AB COVID-19 IgM/IgG Rapid Antibody Test.


Testing Therapies, Antivirals and Vaccines

Novartis/Incyte: Novartis announced that, with Incyte, it is launching a Phase III clinical trial to determine if their cancer drug Jakavi (ruxolitinib) can be used to treat COVID-19.

An experimental vaccine developed by the University of Pittsburgh is showing promise in the fight against COVID-19. The vaccine produced a significant amount of antibodies in mice that could protect against the virus for up to one year. The researchers are seeking to move the vaccine into human trials.

I-Mab: I-Mab announced the FDA has cleared the company’s Investigational New Drug (IND) application to initiate a clinical trial for TJM2.  This trial will assess treatment for cytokine release syndrome (CRS) associated with severe illness caused by COVID-19.

Cellex: The U.S. Food and Drug Administration approved the first blood test that looks for antibodies against the novel coronavirus that causes COVID-19. Research Triangle Park, North Carolina-based Cellex was granted an emergency use authorization (EUA) on its test yesterday.

After screening for antibodies against COVID-19, South Korea’s Celltrion Group  is moving its antiviral treatment into the next phase of clinical research. The first phase saw the securing of 300 different types of antibodies that bind to the antigen. The library of antibodies was created using the blood of recovered patients in Korea. Celltrion anticipates the candidate screening for the therapeutic monoclonal antibody will be complete by mid-April, sooner than originally expected.

GlaxoSmithKline has teamed up with Innovax Corporation to evaluate that company’s recombinant protein-based coronavirus vaccine candidate COVID-19 XWG-03. The COVID-19 XWG-03 vaccine candidate technology is based on a series of truncated S (spike) proteins which will be screened during the pre-clinical testing and a lead candidate will be determined by immunogenicity data. GSK will provide Innovax with its pandemic adjuvant system for preclinical evaluation of the vaccine. Early indications of the adjuvant’s benefit have been reported in the first pre-clinical experiments by one of the collaborations. GSK expects data to be reported from the various collaborations over the next three months and these data will inform the next steps for clinical development of the candidate vaccines.

FluGen and Bharat Biotech partnered with the University of Wisconsin at Madison to develop a COVID-19 vaccine candidate, dubbed CoroFlu. The intranasal vaccine will be based on FluGen’s flu vaccine candidate M2SR. Researchers at the university will add SARS-CoV-2 gene sequences into M2SR to create a vaccine that could generate immunity against the novel coronavirus, according to reports.

Australian researchers at Flinders University and Vaxine are testing a vaccine candidate against SARS-COV-2 leverage Oracle for technical collaboration.


Company Actions

resTORbio: resTORbio announced it will postpone enrollment in the fifth cohort of its ongoing Parkinson’s Phase Ib/IIa clinical trial of RTB101 in New Zealand. The delay is due to a COVID-19 level 4 alert.

Novartis: Novartis and the Novartis US Foundation have established a US COVID-19 Community Response Fund totaling $5 million for immediate response and recovery efforts.

Capricor Therapeutics: Capricor Therapeutics announced it will provide CAP-1002, its novel cell therapy to patients with advanced COVID-19 under the compassionate use pathway.

Global Blood Therapeutics (GBT): GBT announced a newly created GBT Community Fund that will commit $250,000 to support the sickle cell disease community during the COVID-19 pandemic.


Other Industry News

Comparison: 2003 SARS Pandemic vs. 2020 COVID-19 PandemicWhen COVID-19 first appeared in the news, scientists took note and began to prepare for a widespread outbreak. The general population, however, wasn’t concerned. Many assumed it would be like the SARS pandemic, affecting relatively few people and, aside from a few cities or regions, not disrupting daily life.

As the world continues to adjust to the new paradigm of self-quarantine due to COVID-19, Sanofi Chief Executive Officer Paul Hudson predicts the ways of working that many companies have adapted will become more permanent features. In an interview with the Wall Street Journal, Hudson predicted one-meeting trips will begin to disappear in favor of digital options like Zoom. Larger, multi-day meetings will remain a staple for networking purposes. Regarding the company’s efforts to develop a vaccine and therapeutic for COVID-19, Hudson predicted the company could have a vaccine ready to go by the second quarter of 2021.


The BIO International Convention, like numerous other conferences and conventions, is moving to a virtual format for its June 8-12 convention, which they are dubbing BIO Digital 2020. They are offering a variety of offerings—it is, after all, one of the largest industry gatherings in the world—including Virtual BIO One-on-One Partnering, Online Education, and On-Demand Company Presentations.

The Organization notes: “Nothing Stops Innovation. We’ll get beyond this health crisis together. Developing treatments and solutions to the world’s most urgent challenges and complicated problems is what we do.”

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