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FK-PC101 is a personalized autologous cancer vaccine under development for the treatment of prostate cancer, specifically targeting patients at high risk of recurrence after prostatectomy. The therapy is created from the patient's own tumor cells collected during surgery, which are then modified ex vivo to express Major Histocompatibility Complex (MHC) Class II molecules on their surface and irradiated to prevent replication. When administered intradermally, these modified cells present unique tumor neoantigens to the immune system, activating both CD8-positive cytotoxic T cells via MHC I and CD4-positive helper T cells via MHC II pathways. This dual activation primes a coordinated immune response against residual or recurring cancer cells. The drug is currently in Phase II clinical trials for adjuvant therapy in prostate cancer and is being developed by CellVax Therapeutics with manufacturing support from Theragent[1][2][3][4][5][6][7][8].
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