One of the few therapies currently available to treat patients with COVID-19 is REGEN-COV, a monoclonal antibody cocktail that combines two antibodies that can bind to and neutralize the SARS-CoV-2 virus. The Southwest National Primate Research Center (SNPRC) at Texas Biomedical Research Institute (Texas Biomed) worked with Regeneron Pharmaceuticals Inc., maker of REGEN-COV, to test the effectiveness of the medication before it moved to human clinical trials. The result: the Food and Drug Administration granted emergency use authorization for REGEN-COV as a treatment for mild to moderate COVID-19 patients as well as for patients at high-risk for severe COVID-19 after an exposure to the virus.
SNPRC’s work began quite early during the pandemic. Texas Biomed has been a longtime collaborator with Regeneron, and the two organizations had just wrapped up work on a successful Ebola virus treatment as COVID-19 began to spread.
That established relationship made it easy to team up on SARS-CoV-2, the virus that causes COVID-19, explained Professor Ricardo Carrion, Jr., Ph.D., who co-leads the Disease Intervention & Prevention Program and directs high containment contract research at Texas Biomed. “We had the experience and processes in place for evaluating therapeutics in animal models of emerging diseases and understood what we needed to do to be successful in a short timeframe,” Carrion, Jr. said.
Within three months, SNPRC and Texas Biomed researchers had evaluated or established several different animal models for SARS-CoV-2, including rhesus macaques, transgenic mice and golden Syrian hamsters. The researchers tested the antibody cocktail for Regeneron in rhesus macaques. The data from these advanced, pre-clinical studies helped the candidate COVID-19 therapy move forward to clinical trials in people.
Carrion, Jr. was not surprised the initial results, published in the peer-reviewed scientific journal Science, showed the antibody cocktail was safe and effective. “They are a very professional company and very good at what they do,” he said. “Regeneron ensured that all the tests that could be done prior to moving to animals were done, so there was a high likelihood of this antibody cocktail succeeding.”
As variants of SARS-CoV-2 emerged, SNPRC and Texas Biomed scientists continued to work with Regeneron to evaluate the lasting effectiveness of the cocktail, which was determined a resounding success. The study, published in the journal Cell, featured information from both human trials and hamster animal models of COVID-19. The animal models enabled researchers to gather precise insights in a highly controlled environment, which help explain what is observed in the human population.
Such teamwork drives scientific advancements and, in this case, has been critical to helping people who have COVID-19 overcome the virus.