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Dorgenmeltucel-L is an investigational allogeneic whole-cell cancer vaccine comprised of genetically engineered melanoma cell lines that express alpha-1,3-galactosyltransferase to display alpha-Gal epitopes, designed to provoke a strong innate and adaptive immune response against melanoma antigens when the non-self alpha-Gal is recognized and targeted by pre-existing natural antibodies, thereby promoting tumor cell killing and antigen spreading. It was originated by NewLink Genetics and further developed by Lumos Pharma, primarily for malignant melanoma; clinical studies also explored combination immunotherapy settings. Phase I/II studies reported immune activation (universal seroconversion) and signals of clinical activity in advanced melanoma, and the program remained in Phase II for melanoma per public pipeline summaries. The approach belongs to NewLink’s HyperAcute platform of allogeneic, alpha-Gal–expressing tumor cell vaccines.
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