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**IFx-Hu2.0 + pembrolizumab** is an investigational combination therapy comprising IFx-Hu2.0, a personalized in situ cancer vaccine, with pembrolizumab (Keytruda), an anti-PD-1 monoclonal antibody checkpoint inhibitor. IFx-Hu2.0 consists of a plasmid DNA encoding an immunogenic bacterial protein (Emm55 segment) that is delivered intratumorally, causing tumor cells to express this foreign antigen and thereby activating the innate and adaptive immune responses against tumor cells. Pembrolizumab blocks the PD-1 immune checkpoint pathway, releasing T cell inhibition to promote anti-tumor activity. This combination is under study primarily for its ability to overcome primary resistance to checkpoint inhibitors, particularly in advanced or metastatic Merkel cell carcinoma (MCC), and potentially in cutaneous squamous cell carcinoma (cSCC) and melanoma. Early-phase clinical data indicate that IFx-Hu2.0 can stimulate both B and T cell antitumor responses, and the combination is being evaluated in a Phase 3 trial as first-line therapy in checkpoint inhibitor–naïve advanced MCC patients[2][4][6][8].
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