August 20, 2020

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Duke Institute Tapped to Test Monoclonal Antibody Preventative for COVID-19


DURHAM, N.C. — The Duke Human Vaccine Institute Pandemic Prevention Program (DHVI-P3) has received an additional $7.6 million in federal funding to manufacture and test in humans a neutralizing monoclonal antibody for the prevention of COVID-19.

The funding, from the U.S. Department of Defense, Defense Advanced Research Project Agency (DARPA), enables the Duke team to move forward with a Phase 1 study of highly potent antibodies isolated from COVID-19 patients who have recovered from the illness.

The DHVI-P3 program is led by Gregory D. Sempowski, Ph.D., in partnership with Duke clinical investigators Emmanuel “Chip” Walter, M.D., and Christopher Woods, M.D., and Duke antibody discovery experts Barton F. Haynes, M.D., and Kevin Saunders, Ph.D.

The Duke team will manufacture and test the potent SARS-CoV-2 neutralizing antibody using an RNA-based delivery. RNA is the genetic material that instructs the body to make antibody proteins.

Manufacturing will begin in late 2020 in the DHVI clinical Good Manufacturing Practice facility run by Matthew Johnson, Ph.D. The Phase 1 clinical trial with healthy volunteers is on target to start in early 2021 at the Duke Vaccine and Treatment Unit, directed by Emmanuel Walter, M.D.

“The global pharmaceutical industry can produce billions of vaccine doses, but it lacks the capacity to manufacture monoclonal antibody protein at such a large scale,” Sempowski said. “Our program was designed to innovate platform approaches for gene-delivered antibodies to overcome these challenges of production scale and speed to meet global pandemic needs.”

The DHVI-P3 started in September 2017 with an initial grant from DARPA. It combines expertise in virology, immunology, clinical manufacturing and first-in-human testing with the aim of rapidly responding to pandemic viral outbreaks, such as COVID-19, with gene-delivered monoclonal antibodies.

The Duke Human Vaccine Institute conducts basic and translational research to develop novel vaccines, therapeutics and diagnostics for emerging infectious diseases that threaten the health of our world.

DHVI is home to one of twelve Regional Biocontainment Laboratories in the United States established by the NIH with state-of-the-art Biosafety Level 2 and 3 facilities for priority pathogen research, such as SARS-CoV-2.

[Originally posted by Duke Health — Aug 19, 2020]