Evaxion presents new data for EVX-04, a cancer vaccine candidate for acute myeloid leukemia at ASH Annual Meeting
Rhea-AI Summary
Evaxion (NASDAQ: EVAX) presented new preclinical data for its AML vaccine candidate EVX-04 at the ASH Annual Meeting on December 6, 2025. Using the company's AI-Immunology™ platform and AML patient sequencing data, EVX-04 comprises 16 ERV antigen fragments selected from ~5 million fragments for cross-patient relevance and immunogenic potential.
In preclinical tumor models, EVX-04 induced strong, specific T-cell responses and prevented tumor growth. The program is positioned as an off-the-shelf therapeutic vaccine intended for immediate administration after diagnosis and described as broadly applicable to other cancers where conserved immunogenic ERV antigens are found.
Positive
- EVX-04 induced strong specific T-cell responses in preclinical models
- EVX-04 prevented tumor growth in preclinical tumor models
- AI-Immunology™ selected 16 ERV fragments from ~5 million candidates
- Off-the-shelf design enables immediate administration after diagnosis
Negative
- Results reported are limited to preclinical models with no clinical efficacy data reported
- Claims of broad applicability across cancers are preclinical and not yet validated clinically
Key Figures
Market Reality Check
Peers on Argus 3 Up
Momentum scanner shows 3 biotech peers (e.g., LSTA, SYBX, MTVA) moving up (median change about 4.9%), indicating broader positive sector dynamics around the time of this news.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 20 | Preclinical vaccine data | Positive | +9.4% | New preclinical CMV vaccine data showing immune responses and viral inhibition. |
| Nov 12 | Financial calendar | Neutral | +0.7% | Publication of 2026 financial calendar with key reporting and AGM dates. |
| Nov 07 | Phase 2 immune data | Positive | +1.9% | New biomarker and immune data from phase 2 trial of EVX‑01 at SITC. |
| Nov 06 | Earnings and pipeline | Positive | +10.6% | Q3 2025 results plus 75% ORR EVX‑01 data and EVX‑B3 out‑licensing. |
| Nov 03 | Pipeline expansion | Positive | +0.3% | Announcement of new AI‑designed AML cancer vaccine candidate EVX‑04. |
Recent positive R&D and earnings news has consistently aligned with positive 24h price reactions.
Over the last few months, Evaxion released multiple positive updates, including strong phase 2 data for EVX‑01 with a 75% ORR, out‑licensing EVX‑B3 with up to $592M potential payments, and preclinical progress for EVX‑V1 and EVX‑04. Each of these announcements on Nov 3, Nov 6, Nov 7, and Nov 20, 2025 was followed by a positive price move, suggesting that historically, the stock has reacted favorably to pipeline and business milestones.
Market Pulse Summary
This announcement highlights new preclinical data for EVX‑04, an off‑the‑shelf AI‑designed cancer vaccine for acute myeloid leukemia that targets 16 ERV fragments selected from about 5,000,000 candidates. The data show strong T‑cell responses and tumor growth prevention in models. In recent months, Evaxion has repeatedly reported positive vaccine data across its pipeline and executed capital-structure changes via warrants, so future updates on clinical transition and financing will be important to watch.
Key Terms
AI-Immunology™ technical
AI-generated analysis. Not financial advice.
- Designed with our proprietary AI-Immunology™ platform based on patient sequencing data, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens
- EVX-04 induces targeted immune responses and prevents tumor growth in preclinical models
- EVX-04 is an off-the-shelf therapeutic cancer vaccine developed for acute myeloid leukemia (AML), a disease characterized by high mortality rates and massive unmet medical need
- The off-the-shelf vaccine concept behind EVX-04 is broadly applicable with potential across other hard-to-treat cancers
COPENHAGEN, Denmark, December 6, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data demonstrating that its AML vaccine candidate, EVX-04, triggers strong specific T-cell responses and effectively prevents tumor growth in preclinical models.
The data was presented today in an oral session at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida. Evaxion will discuss the new findings with scientists, doctors and potential business partners throughout the meeting.
“AML is characterized by high mortality rates and massive unmet medical need as current treatment options are limited and often insufficient. The new data confirms our belief that EVX-04 could significantly improve treatment options for AML patients. It is another example of the unique capabilities of AI-Immunology™ in finding novel targets enabling the design of therapies with transformative potential,” says Birgitte Rønø, CSO of Evaxion.
Broad tumor coverage
Developed with our AI-Immunology™ platform, EVX-04 targets non-conventional ERV tumor antigens from the dark genome. These antigens are selectively expressed in specific tumors but absent in normal tissue, making them highly attractive cancer vaccine targets.
Using sequencing data from AML patients, the 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 antigens fragments discovered, AI-Immunology™ combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. The new data confirms that all 16 ERV fragments included in EVX-04 elicit a specific immune response and that EVX-04 prevents 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 preproduced and ready for immediate administration after diagnosis. The same concept is broadly applicable across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified.
About AML
AML is an aggressive hematologic malignancy characterized by the clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. The malignant proliferation leads to suppression of normal hematopoiesis, resulting in cytopenia, increased susceptibility to infections, bleeding, and fatigue (Döhner et al. 2022).
AML is the most frequent leukemia. It occurs across all age groups, however, it is predominantly a disease observed in older adults with a median age at diagnosis of 68 years.
Approximately
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About ERVs
ERVs are remnants of ancient viruses lying dormant in our genome. ERVs are often overexpressed in cancer but not in healthy tissue, making them visible to the immune system and hence promising targets for cancer vaccines. AI-Immunology™ is crucial in allowing the identification of therapeutically relevant ERV tumor antigens from genomic patient tumor data.
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
What preclinical results did Evaxion (EVAX) announce for EVX-04 on December 6, 2025?
How many ERV antigen fragments are included in EVX-04 (EVAX)?
What technology did Evaxion use to design EVX-04 (EVAX)?
When and where were the EVX-04 data presented by Evaxion (EVAX)?
Is EVX-04 available for patients now (EVAX)?
Does Evaxion claim EVX-04 can be used in cancers beyond AML (EVAX)?
