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IFx-Hu2.0 is an investigational, intralesional cancer vaccine designed for the treatment of advanced skin cancers, including melanoma, Merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (cSCC). The drug consists of plasmid DNA encoding the streptococcal membrane protein Emm55, delivered within a cationic polymer formulation to facilitate transfection into tumor cells[2][6][8]. Upon injection directly into tumors, the encoded bacterial antigen is expressed on the surface of cancer cells, priming both innate and adaptive immune responses and enhancing tumor immunogenicity[1][6]. This immune activation aims to overcome primary resistance to checkpoint inhibitors by making tumors more recognizable to the immune system[5]. Clinical trials have demonstrated that IFx-Hu2.0 is safe and well tolerated at weekly dosing up to three weeks in patients with advanced or refractory melanoma, MCC, and cSCC; it has shown potential as an immune priming agent that can restore responsiveness to subsequent checkpoint inhibitor therapy in previously resistant patients[3][4][5].
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