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BNT121 is a personalized, genome-tailored, poly-neo-epitopic mRNA cancer vaccine developed by BioNTech that encodes multiple patient-specific tumor neoantigens to induce potent CD4+ and CD8+ T cell responses against malignant melanoma. The vaccine is produced on demand for each patient based on the individual mutanome and delivered as naked mRNA by intranodal injection, leading to in vivo translation of neoantigen peptides that are presented by antigen-presenting cells to drive neoantigen-specific cytotoxic T lymphocyte infiltration, tumor cell killing, and recurrence-free activity in unresectable or advanced melanoma. Early-phase clinical studies (e.g., NCT02035956) have shown that BNT121 is immunogenic and has an acceptable safety profile in patients with malignant melanoma, validating BioNTech’s individualized neoantigen-specific immunotherapy (iNeST) platform as a therapeutic mRNA approach in oncology.[1][5][10][16]
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