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Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01

Key Takeaway: Evaxion A/S presented new immune response data for its personalized cancer vaccine, EVX-01, at the SITC 2025 Annual Meeting. The phase 2 trial data indicates that EVX-01, in combination with KEYTRUDA, induces a clinically relevant immune response in patients with advanced melanoma. The findings highlight the potential of AI-designed vaccines in cancer treatment.
Price reaction · baseline $6.38 (2025-11-07 close) · hit after-hours · 1 other EVAX headline(s) in the window, move may be shared
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Market Sentiment Analysis

POSITIVE FACTORS

  • Presentation of promising immune response data from EVX-01.
  • Encouraging interest from the medical community in EVX-01.
  • Combination therapy with KEYTRUDA shows potential benefits.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+17%
120-day peak, hindsight
Typical move
14.2%
average across 4 past catalysts
Lead asset
EVX-01
Phase 2 · Melanoma Stage IV

Full Press Release Details

COPENHAGEN, Denmark, November 7, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data exploring immune responses following treatment with AI-designed personalized cancer vaccine EVX-01. The data was presented today in a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor, Maryland.
Developed with Evaxion’s AI-Immunology™ platform, EVX-01 is designed to target multiple neoantigens - cancer unique proteins arising from mutations - and to induce a clinically relevant immune response. The new biomarker and immune data stems from the phase 2 trial evaluating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer).
Longitudinal patient blood samples were collected before, during and after treatment to unravel treatment-induced changes in specific immune cell populations. More specifically, circulating T-cell subsets were characterized aiming at increasing the understanding of the immune responses induced by EVX-01. In subsets of analyzed patients, clinical responses were accompanied by a rapid and sustained induction of EVX-01-specific T-cells.
“We are pleased with the opportunity to present these exploratory translational data at a conference as important as SITC as we continue to add to EVX-01’s strong data package. Having presented the two-year clinical efficacy data from the phase 2 trial just last month at the European Society for Medical Oncology 2025 congress, we are encouraged by the interest in EVX-01 from the medical community”, says Birgitte Rønø, CSO and interim CEO of Evaxion.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Contact informationEvaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96mak@evaxion.ai
About EvaxionEvaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, pleasevisit our website.
Forward-looking statementThis announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available atwww.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Frequently Asked Questions

What is EVX-01?

EVX-01 is a personalized cancer vaccine developed by Evaxion, targeting neoantigens.

What was presented at the SITC 2025 Annual Meeting?

Evaxion presented new immune response data from the phase 2 trial of EVX-01.

How does EVX-01 work?

EVX-01 is designed to induce immune responses against cancer-specific proteins using AI.

What combination therapy was used in the trial?

The trial evaluated EVX-01 in combination with KEYTRUDA, an anti-PD-1 therapy.

What type of cancer was targeted in the trial?

The trial focused on patients with advanced melanoma.

Last updated: Nov 7, 2025