Biopharma Update on the Novel Coronavirus: August 10

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

FDA Actions

Revoked EUA: The FDA revoked a EUA for Autobio Diagnostics Co., Ltd.’s Anti-SARS-CoV-2 Rapid Test due to performance concerns.

Warning Letter: The FDA and the FTC issued a warning letter to Canadian Chaga for selling fraudulent COVID-19 related products.

Updated Coronavirus Treatment Acceleration Program (CTAP) Webpage: The FDA updated its CTAP webpage with new FAQs and new metrics (570+ drug development programs and 270+ trials reviewed).

Diagnostics Update: To-date the FDA has authorized 207 individual EUAs, which include 168 molecular tests, 37 antibody tests and 2 antigen tests.

Testing Therapies, Antivirals and Vaccines

Convalescent therapy has been touted as a fast, effective response to COVID-19, but a new therapy by GigaGen Inc. could be even more promising. GIGA-2050, a new class of drug called a recombinant hyperimmune, offers 100-fold higher potency than convalescent serum therapy.

Omeros Corporation reported positive results from a compassionate-use study evaluating narsoplimab, the company’s investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), in the treatment of COVID-19 patients with Acute Respiratory Distress Syndrome. All six patients, requiring mechanical ventilation prior to treatment, recovered, survived and were discharged from the hospital. Treatment with narsoplimab was associated with rapid and sustained improvement across all assessed markers of endothelial/cellular damage and/or inflammation.

As reported by CNN, looking at Moderna’s clinical trial numbers, there will not be a COVID-19 vaccine in November. Moderna intends to enroll 30,000 for its study, but currently, only have 4,536 enrolled. Most participants won’t get their second shot until October.

A laser therapy developed by Cutting Edge Laser Technologies was successfully used to treat a COVID-19 patient in a Massachusetts hospital. Results of the treatment were published in American Journal of Case Reports. The patient in this report is part of a randomized clinical pilot trial involving 10 patients with confirmed COVID-19.

Pluristem Therapeutics announced that Germany’s health regulatory agency cleared the company’s Phase II clinical protocol to study PXL PAD for the treatment of severe COVID-19.

Novocellbio Co., Ltd. announced that experiments conducted using NOVO-NK, an autologous natural killer cell treatment has shown its kills the human-derived COVID-19.

Company Actions/Announcements

Appili Therapeutics’ Investigational New Drug Application for broad-spectrum antiviral favipiravir was cleared by the FDA as a potential treatment to control outbreaks of COVID-19 in long-term care facilities. Appili intends to enroll up to 760 participants in a Phase II clinical trial across both the U.S. and in Canada for this indication.