AACR 2025: T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab
AACR 2025: T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab
Patients with advanced melanoma were treated with a personalized neoantigen (NeoAg) vaccine, EVX-01, in combination with pembrolizumab in a phase 2 clinical study (NCT05309421). The peptide-based EVX-01 vaccine consists of multiple tumor-specific NeoAgs identified by Evaxion Biotech’s target discovery AIImmunology™ platform. As reported in September 2024 at the one-year follow-up, the treatment was well tolerated, and the objective response rate was 69% in the overall cohort with 11 out of 16 patients responding to study therapy. Longitudinal blood samples were collected before, during and after EVX-01 treatment to monitor circulating vaccine specific T-cell responses. Baseline serum samples were analyzed by the Olink Target96 Immuno-oncology panel to identify potential predictive biomarkers of clinical response to treatment. Finally, baseline tumor biopsies were subjected to genomic and transcriptomic analyses, immunohistochemistry, and AI-assisted digital pathology to understand characteristics of the tumor and the immunological landscape of the tumor microenvironment (TME).
