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New phase 2 data highlight the strength of the immune response induced by personalized cancer vaccine EVX-01

EVAX
  • Evaxion A/S announced new biomarker data from its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma patients at the SITC 2026 Annual Meeting in Phoenix, Arizona.
  • Detection of neoantigen-specific T cells directly ex vivo demonstrates potent EVX-01-induced immune responses & validates the predictive performance of Evaxion's AI-Immunology™ platform.
  • Ex vivo responses were dominated by CD4+ T cells, while CD8+ T cell responses were observed in half of the patients.
  • Data shows a significant association (p<0.001) between AI-Immunology™ predictions & actual T-cell responses, confirming high precision in selecting optimal vaccine targets.
  • The new findings supplement three-year clinical data previously presented at ESMO 2026, which showed 89% vaccine target precision & sustained T-cell & clinical responses.
  • The phase 2 trial demonstrated a 75% Objective Response Rate (ORR) at two-year follow-up, with 12 of 16 patients showing objective clinical responses & four achieving complete response.
  • Patients received EVX-01 combined with pembrolizumab (KEYTRUDA®) in the first two years, with a subset receiving EVX-01 as stand-alone therapy in the third year.
  • An oral presentation on the data will occur on Friday, November 6, 2026, followed by a poster session on Saturday, November 7, 2026, both presented by Senior Scientist Mads Lausen.
  • EVX-01 is a personalized peptide-based vaccine designed to target unique tumor profiles & neoantigens, currently evaluated for first-line treatment of advanced solid tumors.
Company
Evaxion
Keywords
Nasdaq:EVAX, Evaxion, EVX-01, Pers, SITC