- Three-year data from phase 2 trial will provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response
- Data will also offer insight into the vaccine’s effect also as stand-alone treatment of patients with advanced melanoma
- Unprecedented two-year data from the trial presented last year showed high response rates and an impressive durability of responses
COPENHAGEN, Denmark, July 17, 2026 - Evaxion A/S (NASDAQ:EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will present three-year clinical efficacy data from its phase 2 trial with personalized cancer vaccine candidate EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2026 to be held in Madrid, Spain, from October 23-27, 2026.
The data stems from a one-year extension of the phase 2 trial evaluating EVX-01 in patients with advanced melanoma (skin cancer). In the third year, patients received EVX-01 as stand-alone therapy, meaning the data will offer insight into the vaccine’s effect also when not administered in combination with anti-PD-1 therapy. Further, the data may also provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response.
Convincing results
The three-year data will add to already convincing results from the phase 2 trial. The two-year data demonstrated an Objective Response Rate (ORR) 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.
54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) 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 86% of the targeted neoantigens generating potent specific T-cell responses.
The phase 2 trial investigated EVX-01 in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed and manufactured based on their individual biology. In the first two-years, patients received EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). In the third year, a subset of patients received EVX-01 as stand-alone therapy. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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