On December 6, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported new data demonstrating that its AML vaccine candidate, EVX-04, triggers strong specific T-cell responses and effectively prevents tumor growth in preclinical models.

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The data was presented today in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) 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 50% of AML patients are considered fit for intensive chemotherapy and stem cell transplantation. This combination is associated with a long-term overall survival rate of only 40% in younger patients and less than 10% in fit older patients.

For the approximately 50% not fit for intensive treatment, typically the elderly, the standard of care is low-intensity chemotherapy. Remissions are, however, short lived with a 3‐year overall survival rate at only 25% reported (Kantarjian et al. 2025).

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.

(Press release, Evaxion, DEC 6, 2025, View Source [SID1234661254])