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TG4001 + avelumab is a **combination investigational therapy** for HPV16-positive recurrent or metastatic cancers. TG4001 is a therapeutic vaccine based on a highly attenuated vaccinia virus vector engineered to express HPV16 E6/E7 antigens and interleukin-2 (IL-2), designed to stimulate an immune response against HPV16-infected cancer cells. Avelumab is a human anti-PD-L1 monoclonal antibody checkpoint inhibitor that boosts immune system detection and destruction of tumor cells. The combination aims to enhance cancer-specific immune activation and checkpoint inhibition to increase antitumor effects. In clinical studies (phase Ib/II), the regimen has demonstrated safety and promising clinical activity in heavily pre-treated HPV16-positive cancer patients, achieving notable response rates and is being further evaluated in randomized phase II trials in HPV-positive anogenital tumors without liver metastases[1][2][3][4][5][6].
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