UC Davis Health investigators, thanks to a recent federal grant, are preparing to test a promising new antibody cocktail, known as REGN-COV2, as a prevention and treatment for SARS-CoV-2, the virus behind COVID-19. Led by Dr. Timothy Albertson, chairman of internal medicine and specialist in pulmonary and critical care, the team gears up for the randomized, controlled trial sponsored by Regeneron, the developer of REGN-COV2.
The study will be conducted at UC Davis Medical Center in Sacramento and is supported by a federal grant for approximately $291,000 in addition to investments made by Regeneron. UC Davis’ Dr. Albertson was awarded the grant from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The Phase 1/2 study #NCT04426695 estimated primary completion date is January 29, 2021.
The Investigational Product
This product is known as REGN-COV2, which is actually a combination of two monoclonal investigational products called REGN10933 and REGN10987. Combined as a Phase 1, 2 randomized, double-blinded, placebo-controlled study, UC Davis will participate in the evaluation of this novel product.
In making the product, Regeneron leveraged their proprietary VelocImmune® mice which have been genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19 after Regeneron scientists evaluated thousands of fully-human antibodies.
This process allowed the New York State-based company to screen, qualify and ultimately select the two most potent, non-competing and virus-neutralizing antibodies while scaling them up for clinical use with their in-house VelociMab® (high-throughput screening) and manufacturing infrastructure. This investigational product was developed under the Regeneron ‘rapid response’ capabilities and antibody mixing model as the company did for its Ebola investigational product under review by the U.S. Food and Drug Administration (FDA).
Dr. Alberton commented, “We are very excited to test this antibody combination as a possible treatment to Covid-19.” He continued, “We are all up and running on this clinical trial and will start patient recruitment soon.”
Timothy Albertson, MD, MPH, PhD, Professor and Chair, Internal Medicine