Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting

Rhea-AI Summary

Evaxion (NASDAQ: EVAX) will present new biomarker and immune data for its AI-designed personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting.

The poster (Abstract #605, Poster #605) is titled "Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients" and will be presented on November 7, 2025, 5:10–6:35 p.m. ET by Michail Angelos Pavlidis. Two-year efficacy data from the same phase 2 trial will be presented orally at ESMO 2025 on October 17, 2025. The phase 2 study evaluates EVX-01 plus KEYTRUDA (pembrolizumab) in advanced melanoma with individualized vaccines per patient.

Insights

Clinical development expert

Evaxion will present new biomarker and immune data from its ongoing phase 2 EVX-01 trial at SITC 2025; two-year efficacy is scheduled for ESMO 2025 on October 17, 2025.

What it means: The company will disclose additional biological and immune-response data from the ongoing phase 2 study of the personalized vaccine EVX-01 combined with KEYTRUDA®. Presentations at major conferences formally place these datasets into the scientific record and allow independent scrutiny.

Why it matters: Conference disclosure can move a program from company-controlled messaging to peer review and investigator discussion, which affects clinical credibility and partner engagement. The press release confirms two distinct, date-specific disclosures: a poster at SITC on November 7, 2025 and an oral presentation of two-year efficacy at ESMO on October 17, 2025.

Translational immunology expert

New biomarker and immune correlates for EVX-01 will be publicly presented; specifics are not disclosed in this release.

What it means: The announcement signals that immune correlate analyses exist and that the company will share them at SITC 2025 as poster #605. The release names the poster title and presenter but does not report actual biomarker values, effect sizes, or statistical significance.

Why it matters: Biomarker and immune-correlate data inform on mechanism of action and which patients may benefit. However, the release contains no raw or summary results, so scientific interpretation must wait for the poster and the later two-year efficacy oral at ESMO 2025.

Monitorable item: Attend or review the SITC poster on November 7, 2025 and the ESMO oral presentation on October 17, 2025 for concrete data.

• New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting 
• The data will be the latest of many additions to EVX-01’s strong data package
• Two-year clinical efficacy data from the trial will be presented at the European Society for Medical Oncology (ESMO) 2025 congress on October 17, 2025
  

COPENHAGEN, Denmark, October 3, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01. The two-year clinical efficacy data from the trial will, as earlier announced, be presented in an oral presentation at the ESMO 2025 congress on October 17, 2025. Both datasets will add to an already strong data package for EVX-01, which includes convincing one-year interim data from the phase 2 trial.

The phase 2 trial investigates 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). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

SITC presentation details:

• Abstract title: Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients
  Abstract#: 605
• Poster#: 605
• Session (category): Clinical trials in progress (subcategory: Skin cancers)
• Location: Lower Level Atrium - Prince George's ABC
• Date/Time: Friday, November 7, 2025, 5:10–6:35 p.m. ET/23.10-00.35 CET        
  Presenter: Michail Angelos Pavlidis, Research Associate at Evaxion

About EVX-01

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.

In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™ predictions have been observed, underlining the predictive power of the platform.

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

About Evaxion

Evaxion 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, please visit our website.

Forward-looking statement 

This 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 at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law. 

FAQ

When will Evaxion (EVAX) present EVX-01 data at SITC 2025?

Evaxion will present a poster on November 7, 2025, 5:10–6:35 p.m. ET at SITC 2025.

What is the SITC 2025 poster title and number for EVAX's EVX-01 presentation?

Abstract title: "Immune correlates of clinical response..." with Abstract #605, Poster #605.

Which trial data for EVX-01 will Evaxion present at SITC and ESMO 2025?

SITC: new biomarker and immune data from the ongoing phase 2 trial; ESMO (Oct 17, 2025): two-year clinical efficacy data.

What indication and combination therapy is EVAX's EVX-01 being tested for in the phase 2 trial?

EVX-01 is evaluated in advanced melanoma in combination with Merck's KEYTRUDA (pembrolizumab).

Who will present Evaxion's EVX-01 poster at SITC 2025 and where is it located?

Presenter: Michail Angelos Pavlidis. Location: Lower Level Atrium - Prince George's ABC.

How personalized is the EVX-01 vaccine in Evaxion's phase 2 trial (EVAX)?

Each patient receives a unique vaccine designed and manufactured based on their individual biology.