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**EVX-01** is an AI-designed, personalized peptide-based neoantigen cancer vaccine developed by Evaxion for unresectable or metastatic melanoma. Each patient-specific vaccine contains up to 10 synthetic long peptides encoding tumor mutation-derived neoantigens selected from tumor and normal sequencing data, tumor RNA expression, and HLA information using Evaxion's AI-Immunology platform. The peptides have been formulated with the cationic liposomal adjuvant CAF09b in clinical studies to promote neoantigen-specific CD4-positive and CD8-positive T-cell responses. EVX-01 is being evaluated with pembrolizumab, with the intended therapeutic effect of expanding tumor-directed T-cell immunity while PD-1 blockade supports antitumor T-cell activity. A Phase 2 study in advanced melanoma is registered as NCT05309421.
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