FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

ImmunityBio, Inc., a privately-held immunotherapy company, announced it has received authorization from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). These dual constructs (bivalent sequences) of SARS-CoV-2 offer the potential for the hAd5 vaccine to provide recipients with durable, long-term cell-mediated immunity with potent antibody stimulation against both the S and N proteins.

“While there are a number of vaccine candidates in development, we believe most are limited by their sole focus on antibody responses to the monovalent spike protein, which may be insufficient to activate the full potential of the immune system to fight the coronavirus,” said Dr. Patrick Soon-Shiong, Chairman and CEO of ImmunityBio. “By targeting the nucleocapsid protein on the interior of the virus particle as well as the spike protein on the virus’s surface, we believe this vaccine can stimulate both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2.”