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C215Fab-SEA is a tumor-targeted superantigen (TTS) fusion protein consisting of a Fab fragment of an anti-EpCAM (C215 antigen) antibody fused to the bacterial superantigen staphylococcal enterotoxin A (SEA). The drug is engineered to selectively bind tumor cells expressing EpCAM and activates T cells via the superantigen, leading to potent T-cell dependent cytotoxicity directed at tumor tissue. Preclinical studies demonstrate that repeated administration of C215Fab-SEA induces robust T-cell infiltration, significant inhibition of tumor growth, prolonged survival, and the establishment of long-lasting antitumor memory responses. The immune activation is accompanied by upregulation of cytotoxic and T helper 1 signatures, increased CD8:Treg ratios, and a reduction of immunosuppressive regulatory T cells in the tumor microenvironment. C215Fab-SEA demonstrates enhanced efficacy when combined with checkpoint inhibitors (anti-PD-1 or anti-CTLA-4). Its primary indication is for the treatment of solid tumors expressing EpCAM, with research ongoing in various neoplasm models[1][2][3].
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