ImmunityBio and NantKwest Announce FDA Authorization to Study hAd5 T-Cell COVID-19 Vaccine for Combination of Subcutaneous, Oral and Sublingual Boost to Induce T-Cell, Mucosal, and Antibody Immunity

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Feb 12, 2021
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ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ%3A+NK), a clinical-stage, natural killer cell-based therapeutics company, today announced they have received FDA authorization to expand Phase I testing of a bivalent hAd5 T-cell COVID-19 vaccine. The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine in order to study the addition of sublingual boosts. The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration. As a result, the companies will enroll another 105 participants in the U.S. trials of their vaccine candidate, which is unique in targeting both the spike (S) and nucleocapsid (N) proteins of the SARS-CoV-2 virus.