Evaxion will present new target validation data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia at ASH 2026 Meeting

The new findings extend earlier preclinical work with target-expression data and immune responses in humanized mice.

Rhea-AI Summary

Evaxion (EVAX) will present new EVX-04 leukemia vaccine target-validation data at the ASH meeting on December 12–15, 2026.

The findings show broad patient coverage, conserved target expression across disease stages and immune T-cell responses against endogenous retrovirus (ERV) targets in humanized mice. ERVs are viral sequences within the human genome. Evaxion says these findings further support EVX-04’s potential as an off-the-shelf therapeutic vaccine for acute myeloid leukemia. The results build on findings presented at ASH 2025 showing vaccine-specific T-cell responses and inhibition of tumor growth in preclinical mouse models.

Positive

• Minor pointEVX-04 target-validation data show broad patient coverage.
• Minor pointEVX-04 target expression is conserved across disease stages.
• Minor pointEVX-04 induces ERV-specific T-cell responses in humanized mice.

Negative

• None.

Key Figures

ERV antigen fragments discovered: 5 million fragments Selected ERV fragment sets: 16 sets Fragments with preclinical effects: All 16 fragments

ERV antigen fragments discovered

5 million fragments

Identified using the AI-Immunology platform

Selected ERV fragment sets

16 sets

Selected for cross-patient relevance and immunogenic potential

Fragments with preclinical effects

All 16 fragments

Each elicited a specific immune response and prevented tumor growth in preclinical models

Key Terms

aml, t-cell, immunogenic

3 terms

aml medical

"an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML)"

AML stands for anti-money laundering — the laws, rules and internal checks that banks and businesses use to spot and stop illicit cash flows, such as proceeds from crime or funding of illegal activities. Think of it as a security checkpoint for money: investors care because poor AML controls can lead to heavy fines, frozen assets and reputational harm that hurt profits and share value, while strong controls reduce legal and operational risk.

t-cell medical

"induction of ERV-specific T-cell responses in humanized mice"

A T-cell is a type of immune cell that acts like a trained security guard, identifying and attacking infected or abnormal cells in the body. Investors care because many drugs and vaccines are designed to boost, redirect, or mimic T-cell activity; positive clinical results or regulatory approvals for T-cell–based therapies can drive significant changes in a company’s valuation, while safety or efficacy setbacks can hurt it.

immunogenic medical

"based on their cross-patient relevance and immunogenic potential"

Immunogenic describes a drug or biological product’s ability to trigger the body’s immune system to respond, such as producing antibodies or activating immune cells. For investors this matters because strong or unintended immune responses can determine a product’s effectiveness, safety, regulatory approval, manufacturing complexity and commercial success—think of it like a smoke detector: you want it sensitive enough to detect threats but not so sensitive that it causes frequent false alarms.

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• The data further validate the potential of EVX-04 as an off-the-shelf therapeutic vaccine for acute myeloid leukemia
• Data will be presented in a poster session at the American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, December 12-15, 2026

COPENHAGEN, Denmark, November 4, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, will present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML), in a poster session at the American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, December 12-15, 2026.

The data further validate the potential of EVX-04 as an off-the-shelf therapeutic vaccine for AML, demonstrating broad patient coverage, conserved target expression across disease stages and the induction of ERV-specific T-cell responses in humanized mice. The data build on preclinical findings presented at the ASH meeting 2025 demonstrating strong EVX-04 specific T-cell responses and inhibition of tumor growth in preclinical mouse models.

Poster presentation details:

• Title: Validation of conserved ERV targets encoded by the off-the-shelf EVX-04 DNA vaccine for AML
• Poster#: 4310
• Session: 801. Gene Therapies: Poster II
• Location: Ernest N. Morial Convention Center - Hall F
• Date/Time: Sunday, December 13, 2026, 6:00-8:00pm ET / 00:00-02:00 (December 14) CET
• Presenter: Daniela Kleine-Kohlbrecher, Director, Immuno-oncology, at Evaxion

About EVX-04
Developed with our AI-Immunology™ platform, EVX-04 targets non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. These antigens are selectively expressed in specific tumors but absent in normal tissue, making them highly attractive therapeutic cancer targets.

Using sequencing data from AML patients, our AI-Immunology™ platform first identified ERV tumor antigens and then mined these to determine smaller fragments with the potential for immune recognition. From the five million ERV antigen fragments discovered, AI-Immunology™ combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. All 16 ERV fragments included in EVX-04 elicit a specific immune response and prevent tumor growth in preclinical tumor models.

The data-driven, target selection ensures that EVX-04 provides broad tumor coverage regardless of immune and tumor ERV antigen differences across patients. Thus, EVX-04 is developed as an off-the-shelf vaccine, pre-produced and ready for immediate administration after diagnosis. The same concept is broadly applicable across cancers where existing immunotherapies remain inadequate and conserved immunogenic antigens can be identified.

About AML
AML is an aggressive hematologic malignancy characterized by clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. It has poor outcomes for patients ineligible for intensive chemotherapy or stem cell transplantation, highlighting the need for novel and less toxic treatment strategies.

AML is the most frequent leukemia, occurring across all age groups, however, predominantly observed in older adults (median age at diagnosis of 68 years).

Approximately 50% of patients, typically the elderly, are not fit for intensive treatment, so the standard of care is low-intensity chemotherapy. Remissions are, however, short lived with a three‐year overall survival rate at only 25% reported (Kantarjian et al. 2025).

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 clinical-stage TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer as well as infectious and autoimmune diseases.

With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development.

We have developed a pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options.

For more information about Evaxion, AI-Immunology™ and our 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What do Evaxion’s new EVX-04 data show?

The new EVX-04 data show broad patient coverage, conserved target expression across disease stages and ERV-specific T-cell responses in humanized mice. Evaxion views these findings as further support for the vaccine’s potential as an off-the-shelf treatment for acute myeloid leukemia.