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TBio-4101 + pembrolizumab is a combination therapy for advanced solid cancers, specifically being studied in anti-PD-1–resistant, advanced head and neck squamous cell carcinoma (aHNSCC). TBio-4101 consists of autologous, neoepitope-selected, tumor-reactive tumor-infiltrating lymphocytes (TILs), manufactured by selecting and expanding patient-specific T cells that target multiple tumor neoantigens. The process involves enriching for tumor-reactive CD8+ and CD4+ T cells, reducing bystander non-reactive T cells, and activating/selecting for neoantigen reactivity via dendritic cell co-culture. After lymphodepletion, TBio-4101 is infused, followed by IL-2 and pembrolizumab (an anti-PD-1 monoclonal antibody and immune checkpoint inhibitor). Pembrolizumab blocks the PD-1 receptor on lymphocytes, restoring T-cell mediated anti-tumor immunity by preventing PD-1/PD-L1-mediated checkpoint inhibition[1][2][3][4][5][6].
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