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CUE-101 + pembrolizumab is an investigational combination therapy being evaluated for the treatment of human papillomavirus 16 (HPV16)-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). CUE-101 is a novel Immuno-STAT biologic designed to selectively activate and expand HPV16 E7-specific CD8+ T cells by delivering high concentrations of interleukin 2 (IL-2) directly to these tumor-specific T cells. Pembrolizumab, marketed as Keytruda, is a humanized monoclonal antibody that inhibits the programmed cell death protein 1 (PD‑1) immune checkpoint on lymphocytes, thereby enhancing anti-tumor immune responses. The combination aims to synergistically boost tumor-targeted immunity by both expanding antigen-specific cytotoxic T cells and blocking inhibitory PD‑1 signaling. Cue Biopharma develops CUE‑101; Merck & Co. develops pembrolizumab[1][3][4][5][6].
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