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
ImmunityBio, Inc., a privately-held immunotherapy company, and NantKwest, Inc. (NASDAQ: 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.
The expectations of inducing protective immune responses in healthy volunteers – with this novel combination of an oral boost with a subcutaneous prime – are based on the positive findings reported in the NIH/BARDA-sponsored Non-Human Primate (NHP) study. This recent data showed that when administered with an oral boost, the bivalent vaccine resulted in potent stimulation of S- and 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. On the basis of these findings, ImmunityBio has expanded the current Phase 1 study of subcutaneous prime with oral or sublingual boost to explore the potential of this second-generation vaccine to reduce disease and transmission of the virus.
The oral trial is a new study (NCT04732468) and the sublingual trial is the cohort C expansion to the Phase 1 subcutaneous trial (NCT04591717), which was initiated last Fall. Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California. Based on the findings of these trials involving over 100 participants, the optimal combination of route of administration and dose will be determined and entered into the Phase 2 / 3 design.
“The NHP study findings reinforce our hypothesis that a T-cell-based vaccine could be protective, not only in preventing mild, moderate, and severe disease, but also in potentially limiting transmission of the virus,” said Patrick Soon-Shiong, MD, Chairman and CEO of ImmunityBio. “We believe that the key to creating long-term immunity to the SARS-CoV-2 virus and overcoming the variants that are rapidly developing around the world is to create a vaccine that activates not only antibodies but also memory B and T cells to multiple antigens. Furthermore, room-temperature stable formulations for oral delivery have the potential to 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.”
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