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TIDAL-01 is an autologous cell therapy consisting of in vitro expanded tumor-infiltrating lymphocytes (TILs) selected for high potency against tumor-specific antigens. Developed as a next-generation TIL therapy, TIDAL-01 uses an unbiased identification and functional screening process to isolate and expand the most comprehensive set of tumor-reactive T cells from a patient’s own tumor. The product aims to deliver a higher proportion of functional, potent tumor-reactive T cells compared to standard bulk TIL therapies, with manufacturing designed to yield at least 10⁹ total cells per dose. The mechanism of action is immunologic cytotoxicity via replacement and expansion of autologous anti-tumor T lymphocytes. Clinical development focused on advanced solid tumors including metastatic colorectal cancer (CRC), head and neck squamous cell carcinoma, uveal melanoma, breast cancer, malignant melanoma, non-small cell lung cancer, and squamous cell cancer. Early clinical data showed promising response rates in microsatellite stable metastatic CRC; however, all clinical programs have since been discontinued[1][2][3][4][5][6][8].
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