Biopharma Update on the Novel Coronavirus: June 1

CV Update_June 1

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FDA Actions

Investigation Boost: FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies in the Apple App store and in the Google Play store.

Warning Letters: The FDA issued warning letters to Quadrant Sales & Marketing, Inc. and StayWell Copper Products for selling fraudulent COVID-19 products.

At Home Testing: The FDA took steps to support the development of COVID-19 tests for at-home self-collection by adding a voluntary EUA template for at-home sample collection kits to its website. The template includes recommendations for use by laboratories and commercial manufacturers who may use it to facilitate the preparation and submission of an EUA request.


Siemens Healthineers received Emergency Use Authorization from the FDA for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data demonstrated 100% sensitivity and 99.8% specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure.

Longhorn Vaccines & Diagnostics LLC and Cenetron Diagnostics are collaborating with Coca-Cola bottlers to begin producing test tubes for use in COVID-19 kits. The goal is to manufacture 1-2 million preform test tubes per week to help meet the broader U.S. testing goal of performing 10 million COVID-19 tests per week.

Testing Therapies, Antivirals and Vaccines

Eli Lilly and AbCellera dosed the first patients in a Phase I study of a potential antibody treatment for COVID-19 three months after forming a partnership. Patients were dosed with LY-CoV555, a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, which should neutralize the virus, and potentially prevent and treat COVID-19. 

A new COVID-19 study conducted by Gilead Sciences showed remdesivir plus standard-of-care boosted clinical improvement of hospitalized patients with moderate COVID-19 pneumonia by 65% over the course of treatment. The study demonstrated that patients in the 5-day remdesivir treatment group were 65 percent more likely to have clinical improvement after 11 days compared with those in the standard of care group. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance, the company announced.

Codiak BioSciences entered into two strategic collaborations with the Ragon Institute of MGH, MIT and Harvard to investigate the potential of its exoVACC vaccine platform in COVID-19 and in HIV. Codiak will evaluate the ability of exoVACC to induce neutralizing antibody and antigen-specific T cell responses in the lung and other mucosal surfaces where SARS-CoV-2 may initiate infections. 

Anixa Biosciences and OntoChem GmbH have synthesized four potential COVID-19 compounds that will advance to biological assay testing. 

Celltrion Group announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, with data demonstrating a 100-fold reduction in the viral load of SARS-CoV-2, the virus causing COVID-19. The treatment was also able to show improvement in lung lesions to a normal activity level in animal models.

The FDA Greenlit Opko Health, Inc.’s Phase II study of Rayaldee in patients with mild-to-moderate COVID-19. The trial is estimated to enroll 166 subjects, including many with stage 3 or 4 chronic kidney disease.

Company Actions

Canada-based Resverlogix is moving forward to evaluate apabetalone’s impact on COVID-19. The first step will be to investigate whether apabetalone treatment of human cells susceptible to COVID-19 infection will impact the replication cycle of the virus.

Twist Bioscience joined the international alliance led by Proteona to develop neutralizing antibody therapy against COVID-19 for vulnerable immunocompromised patients. With its DNA synthesis platform, Twist has the ability to manufacture millions of oligos of different lengths with industry-leading accuracy.

Other Industry News

Leading birth defects scientists will present the latest research pertaining to the COVID-19 infection during pregnancy during a June 11 webinar hosted by the Society for Birth Defects Research and Prevention from 12:30 to 2 p.m. EDT.

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