Evaxion presents new EVX-01 immune data at SITC, showing ex vivo T-cell detection

Evaxion A/S announced on November 6, 2026 new biomarker data from its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma, presented in oral and poster sessions at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting in Phoenix. The company said new findings include detection of EVX-01 induced neoantigen-specific T-cells directly ex vivo, which is a clear testament to the magnitude of the vaccine-induced immune responses, with ex vivo responses dominated by CD4+ T-cells, while CD8+ T-cell responses were observed in half of patients.¹

The data also documented a significant association (p<0.001) between predictions by AI-Immunology and actual T-cell responses, confirming the predictive performance of the platform, which the company said predicts with high precision which neoantigens will elicit the strongest immune responses.¹

The presentations, titled "EVX-01 personalized AI-designed vaccine plus pembrolizumab induce neoantigen-specific T-cell responses and systemic immune modulation in advanced melanoma," were given by Mads Lausen, Senior Scientist at Evaxion, in a rapid oral session on November 6 and a poster session on November 7.

This builds on three-year follow-up data presented at ESMO in October, which showed three-year clinical response and immune data including 89% vaccine target precision and sustained T-cell and clinical responses at three-year follow-up in the phase 2 trial.¹ At two-year follow-up, the trial had shown an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response.¹ In the first two years, patients received EVX-01 with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)¹, and in the third year, a subset of patients received EVX-01 as stand-alone therapy.¹