The global biopharmaceutical company AstraZeneca said Oct. 5 it has requested emergency use authorization (EUA) from the U.S. Food and Drug Administration for a long-acting antibody combination originally developed at Vanderbilt University Medical Center to protect against COVID-19.
If the EUA is granted, the combination of long-acting monoclonal antibodies, called AZD7442, would be the first to be given to prevent symptoms of COVID-19 and serious illness in people who are infected by the COVID-19 virus, SARS-CoV-2
The EUA application is based on results of a phase 3 clinical trial, which showed that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. Importantly, the trial included immunocompromised and chronically ill adults in whom vaccination against SARS-CoV-2 may not provide sufficient protection against COVID-19.
“This single-shot prevention is likely to be a game changer for at-risk patients,” James Crowe Jr., MD, director of the Vanderbilt Vaccine Center who led the research effort, said when the clinical trial results were released in August.
“The near-term availability of AZD7442 comes at an opportune time,” added Robert Carnahan, PhD, associate director of the Vanderbilt Vaccine Center. “It is clear that we need additional solutions beyond vaccines to protect those most vulnerable members of our society, such as the immunocompromised.”
Delivered by intramuscular injection, the two-antibody treatment was well tolerated with only minor side effects and could afford up to 12 months of protection from COVID-19, company officials said. Preliminary laboratory findings also suggest that AZD7442 can neutralize recent emergent variants of the virus, including the delta variant, they said.
The original antibodies that were the basis for the engineered long-acting antibodies that make up AZD7442 were isolated last year at VUMC. Crowe and his colleagues have developed ultra-fast methods for discovering highly potent antiviral human monoclonal antibodies and validating their ability to protect small animals and non-human primates.
Six of the antibodies were licensed to AstraZeneca in June for advancement into clinical development. In October the company announced it was advancing into phase 3 clinical trials an investigational therapy consisting of two long-acting antibodies discovered at VUMC and optimized by AstraZeneca.
Crowe is the Ann Scott Carell Professor and professor of Pediatrics and Pathology, Microbiology & Immunology at VUMC. Carnahan is associate professor of Pediatrics and Radiology and Radiological Sciences.
The VUMC research was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the Defense Advanced Research Projects Agency of the U.S. Department of Defense, the Dolly Parton COVID-19 Research Fund at Vanderbilt, and Merck KGaA, Darmstadt, Germany.
