On November 6, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology platform, reported new biomarker data from its phase 2 trial with personalized cancer vaccine EVX-01 in patients with advanced melanoma (skin cancer).

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The data demonstrate potent EVX-01 induced immune responses and further underline the strong predictive performance of Evaxion’s AI-Immunology platform. It will be presented in both an oral and a poster session today and tomorrow respectively at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting, taking place in Phoenix, Arizona.

"It is exciting to announce yet another set of new and promising data providing insights into the magnitude, quality and systemic impact of EVX-01-induced immunity in advanced melanoma. The data provide a clear demonstration of the very strong immune responses induced by EVX-01 and also validates our AI-Immunology platform further. We are looking forward to sharing and discussing this data with both scientific stakeholders and potential business partners at the important SITC (Free SITC Whitepaper) meeting", says Birgitte Rønø, CSO and COO of Evaxion.

Comprehensive data package
The new data adds to EVX-01’s already comprehensive data package which includes three-year clinical response and immune data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 held in October. These data showed 89% vaccine target precision and sustained T-cell and clinical responses at three-year follow-up in the phase 2 trial.

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. Ex vivo responses were dominated by CD4+ T-cells, while CD8+ T-cell responses were observed in half of patients.

The data also documents a significant association (p<0.001) between predictions by AI-Immunology and actual T-cell responses, confirming the strong predictive performance of the platform. Essentially, the platform predicts, with very high precision, which neoantigens will illicit the strongest immune responses allowing for selection of these as optimal vaccine targets.

SITC oral and poster presentation details:

Abstract title: EVX-01 personalized AI-designed vaccine plus pembrolizumab induce neoantigen-specific T-cell responses and systemic immune modulation in advanced melanoma
Abstract#: 502
Oral presentation:

Session: 105b: Rapid Oral – Clinical 1
Location: Phoenix Convention Center, West Building-300 Level – 301BC
Date/Time: Friday, November 6, 2026, 12:30-1:30pm MT / 20.30-21.30 CET
Presenter: Mads Lausen, Senior Scientist at Evaxion
Poster presentation:

Session: Poster Session
Location: Phoenix Convention Center, North Building-Lower Level – Exhibition Halls 4-6
Date/Time: Saturday, November 7, 2026, 12:30-1:30pm & 6:40-8:10pm MT / 20:30-21:30 CET & 02:40-04:10 CET (Sunday, November 8)
Presenter: Mads Lausen, Senior Scientist at Evaxion
About the phase 2 trial
The phase 2 trial investigated EVX-01 in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial received a unique vaccine designed with Evaxion’s AI-Immunology prediction platform and manufactured based on their individual biology.

At two-year follow-up, the trial 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. Clinical and T-cell responses were sustained at three-year follow-up. 89% of the EVX-01 neoantigen targets triggered a tumor-specific immune response in the patients.

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.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancer tumors. It is currently being evaluated as a treatment of advanced melanoma and is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system by mounting a targeted response against tumor-specific neoantigens.

(Press release, Evaxion, NOV 6, 2026, View Source [SID1234674390])