- The FDA has signed off the expansion of Phase 1 testing of a COVID-19 vaccine candidate, developed by NantKwest Inc's NK merger partner, ImmunityBio Inc, to include sublingual boosts (cohort C expansion) to the currently active multi-cohort trial of the subcutaneous version of the vaccine.
- The agency also authorized a second Phase 1 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.
- The combination of an oral boost with a subcutaneous prime is based on the findings reported in the NIH/BARDA-sponsored Non-Human Primate study, which showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of spike (S) and nucleocapsid (N)-specific T cells with potent antibody release from memory B cells following viral challenge.
- Additionally, activation of the full immune system by S and N proteins resulted in complete viral clearance of SARS-CoV-2 in lung and nasal passages following the challenge.
- Both oral and sublingual trials are anticipated to begin this month. The optimal combination of the route of administration and dose will be determined.
- The company says that room-temperature stable formulations for oral delivery can potentially solve the cold-chain challenges of distribution and the ability to generate mucosal IgA antibody barriers to the virus in the upper respiratory tract where it first enters the body.
- In December last year, ImmunityBio announced an all-stock transaction with NantKwest, which would close in the first half of 2021. The combined entity will operate under ImmunityBio moniker focused on oncology and infectious disease.
- Price Action: NK stock gained 22.9% at $32 during premarket trading on the last check Friday.
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