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 - Seite 2
One Vaccine, Two Trials, Three Routes of Immune Protection
The first two cohorts of the Phase Ib, open label, dose-ranging study (NCT04591717) of the vaccine received two different dose levels (.5 and 1ml). Participants received two subcutaneous injections 21 days apart. No grade three or four AEs and no SAEs were observed at either dose level and, in the intermediate (1ml) dose group, immunogenicity was observed as early as 14 days after the prime. An additional group of 40 subjects will be enrolled to evaluate safety, reactogenicity, and immunogenicity of the combination of hAd5 in four different cohorts receiving sublingual and subcutaneous formulations to select an optimal combination dose for future studies.
The second Phase 1b trial (NCT04732468) is designed to assess the safety, reactogenicity, and immunogenicity of the combination of hAd5 in oral capsule and subcutaneous formulations; and to select an optimal combination dose for future studies. Up to 65 subjects will be enrolled in the four-cohort study, which is anticipated to begin in Q1.
About the T-Cell-Based Vaccine Candidate
Developed by ImmunityBio and manufactured by NantKwest, this second generation hAd5 vectored vaccine is unique in targeting both spike (S) and nucleocapsid (N) SARS-CoV-2 proteins to generate B and T cell memory to these antigens and long-term immunity to the virus. Most of the COVID-19 vaccines approved by the FDA or in late-stage clinical trials deliver only the spike protein, which has already mutated several times. Another unique characteristic of the hAd5 design is its use of a second-generation hAd5 platform that was developed to elicit anti-SARS-CoV-2 immune responses even in Ad-immune individuals, meaning subjects can receive the vaccine multiple times, if necessary. The stimulation of anti-hAd5 immune responses is attenuated with the second-generation platform in comparison with the first-generation platforms, due to additional genetic deletions. The hAd5 room temperature-stable oral capsules were developed in partnership with UK-based biotechnology company iosBio.
Phase I trials have been initiated in the U.S. and recruitment is set to begin in February in Cape Town, South Africa for a trial (NCT04710303) of subcutaneous administration to be followed by additional trials using sublingual delivery and room temperature-stable oral capsules.
As previously announced, on December 21, 2020, ImmunityBio entered into an agreement to combine in a stock-for-stock transaction with NantKwest (NASDAQ: NK). The combination, which is expected to close in the first half of 2021, will create a leading immunotherapy and cell therapy company focused on oncology and infectious disease.