Evaxion finishes dosing in phase 2 trial for personalized cancer vaccine EVX-01

On January 15, 2025, Evaxion Biotech A/S, a company at the forefront of TechBio innovation, announced the completion of patient dosing in its phase 2 clinical trial of EVX-01, a personalized cancer vaccine. The vaccine, designed using Evaxion's proprietary AI-Immunology™ platform, targets advanced melanoma by tailoring its approach to the unique tumor and immune profiles of individual patients.

This milestone ensures that the study remains on schedule, with the trial expected to conclude and provide data insights in the latter half of 2025. The trial has already seen the first patient complete their participation, adhering to the prescribed protocol, and ongoing monitoring will continue to gather further data.

Christian Kanstrup, CEO of Evaxion, expressed satisfaction with reaching this pivotal stage, highlighting the company's adeptness in trial management. He emphasized the promising potential of EVX-01 to offer a new, effective treatment option for those battling advanced melanoma. With melanoma affecting over 300,000 new patients annually, the commercial prospects for EVX-01 are substantial.

EVX-01, a personalized peptide-based vaccine, leverages Evaxion’s AI-Immunology™ technology to stimulate the immune system in recognizing and combating cancer cells. The phase 2 trial is evaluating the vaccine in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by MSD (Merck & Co., Inc.). Each participant received a bespoke vaccine, crafted to align with their unique biological markers.

Interim results, presented at the European Society for Medical Oncology (ESMO) Congress in September 2024, have been encouraging. The data revealed a 69% Overall Response Rate, with reductions in tumor size observed in 15 out of 16 patients. Furthermore, there was a significant correlation between the AI-Immunology™ predictions and the immune responses triggered by the neoantigens in the EVX-01 vaccine, with 79% of the vaccine’s targets successfully invoking a targeted immune response. These results are notably favorable compared to other methodologies.

Previously, in a Phase 1/2a trial, the combination of EVX-01 and a PD-1 inhibitor yielded objective clinical responses in 67% of metastatic melanoma patients, including complete and partial remissions. T cell responses induced by the vaccine were detected across all patients, demonstrating a significant relationship between clinical outcomes and AI-Immunology™ predictions, thus validating the platform's predictive capability.

Evaxion Biotech A/S is distinguished for its AI-driven approach to immunotherapy. The AI-Immunology™ platform enables the development of targeted cancer vaccines by interpreting complex immune responses. Alongside its oncology initiatives, Evaxion is advancing a preclinical pipeline for tackling infectious diseases with unmet medical needs, showcasing its commitment to transforming patient health through innovative treatments.