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**NeoVaxMI** is an investigational, personalized therapeutic cancer vaccine developed at Dana-Farber Cancer Institute for melanoma. Each patient-specific product contains up to 20 synthetic long peptides encoding tumor neoantigens identified by tumor DNA and RNA sequencing, formulated with the immune adjuvants poly-ICLC and Montanide ISA-51 VG. The vaccine is designed to prime and expand neoantigen-specific CD4-positive and CD8-positive T-cell responses against the patient's tumor. In the Phase 1 NCT03929029 study in advanced or high-risk cutaneous melanoma, NeoVaxMI was administered with systemic nivolumab and locally administered subcutaneous ipilimumab; the regimen generated de novo neoantigen-specific T-cell responses in all fully vaccinated patients.
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