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**NECVAX-NEO1** is a personalized, orally administered cancer vaccine developed by NEC Bio Therapeutics using a bacteria-based DNA platform (attenuated *Salmonella* Ty21a strain) that delivers patient-specific tumor neoantigens selected via proprietary AI/machine learning technology (NEC Immune Profiler or NEC OncoImmunity). It stimulates a neoantigen-specific T-cell immune response to target and destroy tumor cells, intended as an add-on to checkpoint inhibitors (anti-PD-1/PD-L1) or standard-of-care therapies in solid tumors. Phase 1 trials demonstrated safety (no treatment-related toxicities at 10^7-10^8 CFU doses), immunogenicity (ELISPOT responses in 68% of neoepitopes, significant signals in 40% of patients), and clinical activity (83% stable disease at 24 weeks in melanoma, renal cell cancer, head/neck cancer patients).[1][3][16]
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