Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completes Dosing with Personalized Cancer Vaccine EVX-01

Evaxion Biotech A/S, a clinical-stage TechBio company, has made significant progress in its Phase 2 clinical trial for the EVX-01 personalized cancer vaccine. The first patient in the trial, which focuses on metastatic melanoma, has completed the dosing regimen. This trial assesses the efficacy, safety, and ability of EVX-01 to induce a tumor-specific immune response when used in combination with KEYTRUDA® (pembrolizumab).

The EVX-01 vaccine is an individualized therapy designed using Evaxion’s proprietary AI-Immunology™ platform, tailored to match the unique tumor profile and characteristics of each patient's immune system. Patients receive ten doses of EVX-01 over 78 weeks alongside the anti-PD-1 therapy, KEYTRUDA®.

Initial data from the Phase 2 trial, reported at the end of 2023, confirmed the vaccine's favorable safety profile and promising immunological data, consistent with the successful Phase 1 clinical trial outcomes. The trial is on track for a one-year clinical efficacy readout in Q3 2024.

Birgitte Rønø, CSO of Evaxion, expressed optimism about the trial's progress, highlighting the company's mission to save and improve lives through AI-Immunology™. Professor Adnan Khattak from One Clinical Research also emphasized the importance of personalized cancer therapies, stating that this approach represents the future of cancer treatment.

The Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial conducted in collaboration with Merck Sharp & Dohme LLC and leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma.