COPENHAGEN, Denmark, October 17, 2025 – Evaxion A/S announced that its personalized cancer vaccine EVX‑01 achieved a 75% objective response rate in a two‑year phase 2 trial of patients with advanced melanoma, with 12 of 16 patients showing objective clinical responses, including four complete responses. The data also show that 92% of patients were still responding at 24‑month follow‑up, with no relapses observed, and 54% of patients experienced a deepened response during treatment, improving from stable disease or partial response to partial or complete response.
The trial demonstrated that 15 of the 16 patients had tumor reduction in target lesions, and 81% of the targeted neoantigens generated potent specific T‑cell responses, underscoring the high immunogenicity of the vaccine. The study was conducted in combination with Merck’s anti‑PD‑1 therapy KEYTRUDA® and is now being extended with a monotherapy arm, although data from that extension will be presented in 2026.
The results were presented today at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, marking the first time the company has reported two‑year efficacy data for EVX‑01. The data validate Evaxion’s AI‑Immunology platform’s ability to identify and target neoantigens with unprecedented precision, reinforcing the company’s competitive positioning in the precision oncology space.
These findings strengthen the case for EVX‑01’s continued development and support Evaxion’s strategy of partnering with larger pharmaceutical companies to advance its vaccine candidates. The high response rates and durable benefit observed in this patient population are expected to enhance the company’s attractiveness to potential collaborators and investors, providing a solid foundation for future clinical and commercial milestones.
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