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This investigational gene therapy, developed by the University of Colorado, Denver, consists of a plasmid DNA encoding interleukin-2 (IL-2) complexed with liposomes and combined with the superantigen staphylococcal enterotoxin B (SEB). Designed for the treatment of metastatic melanoma, the therapy is administered via intratumoral injection. The mechanism involves the local expression of IL-2 to stimulate a potent T-cell mediated immune response within the tumor microenvironment, while SEB acts as a superantigen to further enhance immune activation by cross-linking MHC class II molecules and T-cell receptors. This approach aims to provide the therapeutic benefits of IL-2 while minimizing the systemic toxicities typically associated with high-dose recombinant IL-2 administration.
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