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FK-GI101 is a patient-specific, autologous cell-based immunotherapy developed for the treatment of gastrointestinal cancers, including gastric, pancreatic, and colon cancer. The drug is created by harvesting a patient's own tumor cells during surgery, which are then genetically modified in a lab to express Major Histocompatibility Complex (MHC) Class II molecules to enhance immune system recognition. These cells are irradiated to prevent replication and then re-administered to the patient, with the objective of activating a robust, personalized immune response targeting residual or recurring tumor cells[1][4]. The underlying technology is based on a proprietary platform developed by CellVax Therapeutics, and the drug targets tumors via improved antigen presentation to both CD4+ and CD8+ T-cells[4].
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