Biopharma Update on the Novel Coronavirus: September 14
News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays.
Temporary Guidance: The FDA issued temporary guidance to help drug and biological product manufacturers transition from operations impacted by the COVID-19 pandemic by providing recommendations to prioritize products and activities.
The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health: In a new FDA Voices, agency leaders describe how they are committed to making COVID-19 vaccine decisions made by science and data.
Diagnostics Update: To-date the FDA has authorized 247 individual EUAs, which include 197 molecular tests, 46 antibody tests and 4 antigen tests.
Imanis Life Sciences will present information about the development and validation of IMMUNO-COV, the scalable, quantitative neutralizing antibody test for COVID-19 at the American Society of Gene and Cell Therapy (ASGCT) COVID-19 Symposium. The IMMUNO-COV assay specifically measures antibodies in the blood that can block infection by SARS-Co-V-2, the virus that causes COVID19.
Testing Therapies, Antivirals and Vaccines
Regeneron and the University of Oxford announced that one of the world’s largest clinical trials of potential COVID-19 treatments, RECOVERY, will evaluate Regeneron’s investigational anti-viral antibody cocktail, REGN-COV2.
Eli Lilly and Incyte announced positive preliminary data from the Adaptive COVID-19 Treatment Trial (ACTT-2). The trial, evaluating the combination of baricitinib and remdesivir met the primary endpoint of reducing the time to recover of COVID-19 patients when compared to remdesivir.
In a weekend interview on CBS’ “Face the Nation,” Albert Bourla, chief executive officer of Pfizer indicated they may have key data from its Phase III trial of Pfizer and BioNTech’s COVID-19 vaccine to the U.S. Food and Drug Administration (FDA) by the end of October. If it is then approved, he said they would be prepared to distribute “hundreds of thousands of doses.”
Pfizer and BioNTech announced they are proposing expanding their COVID-19 vaccine Phase III clinical trials to include more diversity. The trials will include 44,000 participants up from 30,000 and will include people as young as 16.
AstraZeneca announced that it has resumed the U.K. portion of its Phase III COVID-19 vaccine study following a safety review by the Medicines Health Regulatory Authority (MHRA).
Vaxart, Inc. will move its COVID-19 vaccine tablet into clinical trials, marking the first oral vaccine program for the novel coronavirus. The company believes an oral treatment that is stable at room temperature could be distributed to a wider number of areas that do not have the refrigeration capabilities that most traditional vaccines require. The Phase I study is expected to begin within several weeks and data could be available in early 2021.
France-based Valneva SE, a specialty vaccine company, partnered with the U.K. government for its inactivated COVID-19 vaccine, VLA2001. If vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. Valneva’s inactivated SARS-CoV-2 vaccine is expected to have a two-dose regimen. The U.K. government is also investing up-front in the scale-up and development of the vaccine, with the investment being recouped against the vaccine supply under the partnership.
Mateon Therapeutics will begin a Phase I study in India for ARTI-19 for Artemisinin Intervention against COVID-19.
Other Industry News
A survey out of Ben-Gurion University of the Negev evaluated 115 people in the UK and 41 in Israel to find out what three “vices” have grown the most among people quarantining during the COVID-19 pandemic. Perhaps not surprisingly, the top three were alcohol, chocolate and pornography.