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Vesigenurtacel-L (HS-410) in combination with BCG is an investigational immunotherapy regimen developed for the treatment of non-muscle invasive bladder cancer (NMIBC). Vesigenurtacel-L is an allogeneic cell-based therapeutic vaccine derived from a genetically modified bladder cancer cell line. It is engineered to secrete multiple bladder tumor-associated antigens—including survivin, LAGE-1, MAGE-A3, MAGE-A11, and PRAME—chaperoned by a secretable version of the heat shock protein gp96 (gp96-Ig). This gp96-Ig fusion protein acts as a potent immune adjuvant and delivery vehicle, facilitating the uptake of antigens by dendritic cells to activate a robust CD8+ cytotoxic T-cell response. The combination therapy pairs the systemic immune activation of intradermal vesigenurtacel-L with the localized immune stimulation of standard intravesical BCG (Bacillus Calmette-Guérin) therapy. Developed by Heat Biologics using their proprietary ImPACT (Immune Pan Antigen Cytotoxic Therapy) platform, the program was discontinued following Phase II clinical evaluations.
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