Biopharma Update on the Novel Coronavirus: September 30
News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays.
FDA Actions
The U.S. Food and Drug Administration (FDA) accepted Windtree Therapeutics' Investigational New Drug (IND) application for a Phase II trial for its KL4 surfactant drug. The drug will be tested in COVID-19-associated lung injury and ARDS patients.
Diagnostics
President Donald Trump announced that 150 million units of Abbott's BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic test will be distributed across the country. Abbott’s test was designed to deliver results within 15 minutes without the necessity of a laboratory.
Becton, Dickinson and Company received a CE mark for its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System. The test delivers results in 15 minutes. The company expects commercial availability of this new assay at the end of October for countries in Europe that recognize the CE mark.
Avacta Group announced its BAMs assay to detect COVID-19 is now in use as a research kit, courtesy of partner company Adeptrix. The bead-assisted mass spectrometry (BAMS) assay uses the Affimer reagents specific to the SARS-CoV-2 virus to capture the virus spike protein from the sample for rapid detection by mass spectrometry. Up to one thousand samples per day can be analyzed by a single technician using BAMS.
Testing Therapies, Antivirals and Vaccines
Russia announced it will share preliminary data from the first six weeks of the ongoing Phase III study for its already-approved COVID-19 vaccine. Russia’s vaccine is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute.
Regeneron Pharmaceuticals announced early data from its Phase I/II/III trial of its antibody cocktail, REGN-COV2, against COVID-19. The analysis showed that the antibody cocktail decreased viral load and alleviated symptoms faster in non-hospitalized COVID-19 patients.
Windtree Therapeutics, Inc. will initiate Phase II studies of lyo lucinactant, a KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients.
Algernon Pharmaceuticals has enrolled 100 patients, two-thirds of its target, in a Phase II/III study of NP-120 (Ifenprodil), an N-methyl-D-aspartate (NMDA) receptor antagonist, for the treatment of COVID-19. The study is expected to be completed in November with a planned data readout before the end of the fourth quarter.
Moderna published second interim analysis of its open-label Phase I trial of its COVID-19 vaccine, mRNA-1273. This particular data focused on two age cohorts, one ages 56-70 and the other 71+.
Company Actions/Announcements
Grand River Aseptic Manufacturing (GRAM) inked a deal with Janssen Pharmaceutical, a Johnson & Johnson company, to support the manufacturing of Janssen’s COVID-19 vaccine candidate. The agreement with GRAM includes technical transfer and fill-and-finish manufacture of the vaccine candidate.
The FDA granted expanded access to Organicell Regenerative Medicine for its proprietary therapeutic, Zofin as a treatment of COVID-19. This expanded access protocol will provide access to the investigational product Zofin for patients who have mild to moderate COVID-19, or who are judged by a healthcare provider to be at high risk of progression to moderate disease.
Other Industry News
According to new research published in the Journal of Fluid Mechanics, ventilation systems in many modern office buildings may increase the risk of coronavirus exposure, especially in the coming winter months. Researchers found that the ventilation systems disperse airborne contaminants, which could potentially include droplets and aerosols containing viruses.