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BNT221 is a **personalized, neoantigen-specific autologous T cell therapy** developed for the treatment of advanced or metastatic melanoma, especially in patients whose disease has progressed after immune checkpoint blockade or BRAF-targeted therapy. The therapy involves isolating T cells from a patient's blood and expanding those specific to tumor neoantigens using a proprietary ex vivo process called NEO-STIM. The resulting product, containing polyclonal CD4+ and CD8+ T cells reactive to multiple patient-specific tumor neoantigens, is administered back to the patient following lymphodepletion. The therapy is designed to maximize tumor-specific cytotoxicity while minimizing off-target effects by leveraging the unique mutations found in each patient's tumor. Phase 1 trial results show the approach is feasible, safe, can generate cytotoxic and polyfunctional neoantigen-reactive T cell populations, and demonstrates clinical proof of concept—though with limited objective responses to date. This cell therapy is part of a broader class related to Tumor-Infiltrating Lymphocyte (TIL) therapies and is under investigation both as monotherapy and in combination with immune checkpoint inhibitors[1][3][4][7][9][10].
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