Evaxion Completes One-Year Extension of Phase 2 Trial for Personalized Cancer Vaccine EVX-01

Evaxion (EVAX) has completed the one-year extension of its phase 2 trial with personalized cancer vaccine EVX-01 with the last patient having now had last physician visit. Patients in the trial will continue to be monitored and data prepared for expected presentation in the second half of 2026. Designed with AI-Immunology, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma. In the first two years of the phase 2 trial, patients were treated with EVX-01 in combination with Merck's (MRK) anti-PD-1 therapy, Keytruda. In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine's effect both as stand-alone and combination treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of induced immune response. Data from the first two years of the trial demonstrated an Objective Response Rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed. In total 54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction was observed in 15 out of the 16 patients enrolled in the trial. In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. Th e company said this high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology platform in accurately identifying neoantigens, which leads to detectable signals in patients. Data also confirmed EVX-01 to be a well-tolerated treatment.