October 15, 2020 -- ImmunityBio has been authorized by the U.S. Food and Drug Administration (FDA) to begin a phase I clinical trial of its hAd5-COVID-19 vaccine candidate.
The candidate is the first human adenovirus (hAd5) vector vaccine candidate to deliver both the outer spike and inner nucleocapsid antigens from SARS-CoV-2. The dual constructs offer the potential for durable, long-term cell-mediated immunity with potent antibody stimulation against both antigens. The nucleocapsid protein is engineered with a novel signaling domain to enhance T-cell activation.
In preclinical studies, the vaccine with its enhanced T-cell signaling domain generated potent CD4+ and CD8+ COVID-19 specific T-cell activation that recognizes both the spike and the nucleocapsid proteins.
ImmunityBio anticipates launching the phase I trial at Hoag Hospital in Irvine, CA, by the end of the month in a patient population with adult subjects up to 55 years of age.
Doses of the vaccine candidate have been manufactured in the U.S. by NantKwest, which has the capacity to produce over 100 million doses annually under a joint development agreement with ImmunityBio.
Under the joint collaboration, ImmunityBio and its affiliate NantKwest will share the costs of development, manufacturing, and commercialization of all COVID-19-related products, including the hAd5 vaccine candidate. Upon successful commercialization, the companies have agreed to a 60%-40% split of net profits.