EVAX · Evaxion Biotech A/S

This 6-K discloses pivotal Phase 2 clinical results for Evaxion’s lead asset EVX-01, a personalized neoantigen vaccine developed using its proprietary AI-Immunology™ platform. The 86% vaccine target precision — defined as the proportion of AI-selected targets that triggered a tumor-specific immune response — represents a quantitatively differentiated outcome versus prior methods, directly validating the platform’s core value proposition. Coupled with the 75% Objective Response Rate in advanced melanoma patients receiving EVX-01 alongside pembrolizumab, these data provide strong clinical evidence supporting both biological mechanism and therapeutic impact. The durability of de novo T-cell responses over two years suggests potential for long-term disease control, while the correlation between AI-prediction scores and immune magnitude reinforces the platform’s reproducibility and scalability. Importantly, the trial design — fully personalized vaccines manufactured per patient — confirms feasibility of Evaxion’s end-to-end TechBio model. With three-year clinical data anticipated in the second half of 2026 and AACR presentation scheduled for April 22, 2026, these findings materially advance EVX-01’s development path toward potential registrational studies and underscore the platform’s applicability beyond melanoma to other solid tumors. No financial metrics, guidance, or operational updates are disclosed; the materiality stems entirely from the strength, specificity, and clinical relevance of the disclosed immunological and efficacy endpoints.