Oral and Sublingual COVID-19 Vaccine Candidate Formulations Present Positive Safety Data
California-based ImmunityBio, Inc. 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. 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.
The two U.S. Phase Ib trials are studying a combination of subcutaneous/ sublingual (under the tongue) and subcutaneous/oral formulations of ImmunityBio’s hAd5 T-cell COVID-19 vaccine candidate.
Philip Robinson, M.D., the trial Principal Investigator and Medical Director of Infection Protection at Hoag Memorial Hospital Presbyterian in Newport Beach, where the vaccine trials are being conducted, stated in a press release, “Unlike most of the COVID-19 vaccines currently available, ImmunityBio’s hAd5 generates T-cell immunity, which is important for long-duration immunity."
"Based on the results of subcutaneous/oral regimen in the nonhuman primate study where the vaccine provided complete protection against the virus challenge, we are excited to explore with ImmunityBio the potential for the vaccine to provide a T-cell boost to currently available vaccines."
"I am particularly encouraged by the immune response to the nucleocapsid protein, which may mean this vaccine will remain effective against the many emerging spike protein variants.”
ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases.