Evaxion A/S (“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, 6:00-8:00 pm 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).