The U.S. government has reserved up to 700,000 doses of a monoclonal antibody cocktail against the COVID-19 virus discovered at Vanderbilt University Medical Center (VUMC) and developed by AstraZeneca, officials have announced.
The investigational therapy, AZD7442, is in late-stage clinical trials in the United States and Europe. Preliminary findings from the studies in healthy adults are expected in the upcoming weeks and months.
If the clinical trials demonstrate that the long-acting antibody combination is effective in preventing and treating COVID-19, the company could seek authorization from the U.S. Food and Drug Administration (FDA) to provide the drug on an emergency use basis.
The FDA previously has granted emergency use authorization to monoclonal antibody combinations made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. for the treatment of outpatients with mild to moderate COVID-19 who are at high risk for progression to severe disease.
While nearly 3 million Americans are being vaccinated every day against SARS-CoV-2, the virus that causes COVID-19, and hospitalizations and deaths from the disease continue to decline or remain stable, cases of the infection are on the rise again, especially in the Northeast and Upper Midwest.
AstraZeneca's long-acting antibody combination "has the potential to offer almost immediate protection to those who are not able to be vaccinated, to prevent infection or treat the disease in patients already infected with the virus," Pascal Soriot, Chief Executive Officer of AstraZeneca, said in a news release last month.
"The U.S. government's support is critical in helping accelerate development of AZD7442,which we believe will be an important tool in the fight against COVID-19," Soriot said.
"We are excited to see that the antibodies we discovered here on campus are poised to be used widely in the population with U.S. government support, if the current clinical trials are successful," said James Crowe, MD, director of the Vanderbilt Vaccine Center, which discovered the monoclonal antibodies developed by AstraZeneca.
So far this year the U.S. Departments of Defense (DoD) and Health and Human Services (HHS) have committed approximately $726 million for the development and supply of up to 700,000 doses of AZD7442 in 2021.
Specific agreements have been signed with the U.S. Army and with the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response.
Five DoD facilities, including the Naval Medical Center in Portsmouth, Virginia, are also participating in one of the clinical trials, called STORM CHASER.
"If you're in the barracks or on a ship, you want an option that you can give a product that would protect individuals after an exposure," Lieutenant Commander Tida Lee, MD, an infectious disease specialist and lead investigator for the Portsmouth STORM CHASER trial, told Norfolk's WTKR-TV last month.
"So, this is a great population to take a look at this, where we have active duty individuals working in tight spaces," Lee said.
The original antibodies that were the basis for the engineered long-acting antibodies that make up the AZD7442 two-antibody cocktail 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.
The research at VUMC was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the DoD's Defense Advanced Research Projects Agency, the Dolly Parton COVID-19 Research Fund at Vanderbilt, and Merck KGaA, Darmstadt, Germany.