Effective cancer vaccination requires the selection of tumor antigens capable of eliciting robust and durable tumor-specific T-cell responses. To address this challenge, Evaxion developed the proprietary AI-Immunology™ platform, which integrates tumor genomic, transcriptomic and immunological features to identify highly immunogenic, patient-specific neoantigens (neoAgs). EVX-01 is a peptide-based personalized neoantigen vaccine incorporating up to ten AI-selected neoAgs per patient. EVX-01 was evaluated in a phase 2 clinical study (NCT05309421) in patients with unresectable stage III/IV melanoma, administered in combination with pembrolizumab following a 12-week pembrolizumab run-in. Patients received six EVX-01 priming vaccinations followed by four booster vaccinations.
Here, we present a longitudinal analyses providing the final immunogenicity readout together with two-year clinical efficacy and safety outcomes, offering a comprehensive assessment of EVX-01–induced de novo T-cell immunity and its durability in advanced melanoma