On Mar. 15, 2021, ImmunityBio announced it had met the safety requirements for the first 12 participants in its Phase Ib human adenovirus (hAd5)-based T-cell COVID-19 vaccine trials in sublingual and oral formulations. The independent Safety Review Committee recommended the study continue with no modifications to the trial design. The trials, which will involve 80 participants, were expected to be fully enrolled in Quarter 2.

The two U.S. Phase Ib trials are studying a combination of subcutaneous/ sublingual (under the tongue) (NCT04591717) and subcutaneous/oral (NCT04732468) formulations of ImmunityBio’s hAd5 T-cell COVID-19 vaccine candidate. Six participants have been dosed in each trial to date and the trial is anticipated to be fully enrolled in Q2 (prime plus boost). Based on the findings of these trials, the optimal combination of administration route and dose will be determined and entered into the Phase II/III design.

At the recent 2021 Conference on Retroviruses and Opportunistic Infections (CROI), ImmunityBio scientists presented pre-clinical data from SARS-CoV-2 challenge study involving subcutaneous and oral immunization that shows hAd5-COVID-19 T-cell vaccine candidate is completely protective in non-human primates against high SARS-CoV-2 titer exposures. This data is critically relevant to NCT0473468 mentioned above which is testing various combinations of subcutaneous and oral capsule administration in a Phase I clinical trial.

The vaccine-focused presentation, titled “Dual-Antigen Covid-19 Vaccination with Oral Boost Protects NHP from Viral Challenge”, detailed the results of a BARDA-funded COVID-19 challenge study in rhesus macaques assessing the antibody- and T cell-mediated immune responses to vaccination and protection against live SARS-CoV-2 challenge with ImmunityBio’s human adenovirus (hAd5)-based T-cell COVID-19 vaccine candidate in serial subcutaneous and oral administrations.

ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”