Evaxion reports 75% Objective Response Rate in phase 2 trial with AI-designed personalized cancer vaccine EVX-01

Core Insights - Evaxion A/S announced unprecedented two-year clinical efficacy data for its personalized cancer vaccine EVX-01 in patients with advanced melanoma, showcasing a significant potential as a new treatment option [1][6] Clinical Efficacy Data - The two-year phase 2 data revealed an Objective Response Rate (ORR) of 75%, with 12 out of 16 patients showing objective clinical responses, including four achieving complete response [2][11] - A durable clinical benefit was noted, with 92% of patients still responding at the 24-month follow-up and no relapses observed [2][11] - 54% of patients experienced a deepened response during treatment, transitioning from stable disease or partial response to partial or complete response [3][9] Immune Response and Safety - EVX-01 induced an immune response in all patients, with 81% of targeted neoantigens generating potent specific T-cell responses, indicating high immunogenicity [4][11] - The treatment was confirmed to be well-tolerated, aligning with the favorable safety profile observed in the phase 1 study [5][11] Future Developments - The trial has been extended for an additional year, during which participants will receive EVX-01 as monotherapy, with data from this extension expected to be presented in 2026 [14] - Evaxion plans to discuss the data with stakeholders and potential partners, emphasizing the need for partnerships in further clinical development [6][12] Presentation and Engagement - Data was presented at the European Society for Medical Oncology (ESMO) Congress 2025, with opportunities for discussions at the conference [8][11] - An online webinar featuring key opinion leader Professor Muhammad Adnan Khattak is scheduled for October 22, 2025, to discuss the two-year phase 2 data and challenges in treating advanced melanoma [12]