COPENHAGEN, Denmark, June 11, 2026
Evaxion A/S announced new preclinical data for EVX-04, its off-the-shelf therapeutic cancer vaccine being developed for acute myeloid leukemia (AML). The vaccine, designed using the company’s proprietary AI-Immunology™ platform, targets multiple endogenous retrovirus (ERV) tumor antigens derived from the dark genome. The latest findings demonstrated successful expression, secretion, immune recognition, and targeted cancer cell-killing activity, supporting the continued development of EVX-04 as a potential treatment option for AML patients. The data will be presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden.
EVX-04 Demonstrates Strong Immune Activation in Preclinical Studies
The newly presented preclinical data showed that EVX-04 was successfully expressed and secreted in human cells, enabling effective immune system recognition and activation. Researchers confirmed proper transcription and translation of the vaccine antigens, validating the vaccine’s ability to generate the intended biological response. Importantly, the study demonstrated that all ERV antigens included in EVX-04 generated specific immune responses across different human immune profiles, both in animal models and human cell-based experiments. These findings suggest that the vaccine may provide broad patient coverage regardless of individual immune system differences.
AI-Driven Vaccine Design Targets the Dark Genome
EVX-04 was developed using Evaxion’s AI-Immunology™ platform, which identifies novel therapeutic targets from large biological datasets. The platform analyzed sequencing data from AML patients and identified multiple ERV-derived tumor antigens that are selectively expressed in cancer cells while remaining absent from healthy tissues. From millions of potential antigen fragments, artificial intelligence selected 16 optimized ERV antigen fragments based on their immunogenicity and relevance across patient populations. The resulting vaccine induced targeted immune responses capable of recognizing and destroying AML-related cancer cells in preclinical testing, highlighting the potential of AI-powered drug development in oncology.
Advertisement
Off-the-Shelf Vaccine Approach Could Expand AML Treatment Options
Acute myeloid leukemia remains one of the most aggressive blood cancers, particularly affecting older adults and patients who are not eligible for intensive chemotherapy or stem cell transplantation. Current treatment options often provide limited long-term survival benefits, creating a significant unmet medical need. Evaxion believes EVX-04’s off-the-shelf design could offer important advantages by allowing immediate treatment without the delays associated with personalized therapies. Because the vaccine is pre-manufactured and designed to target shared cancer antigens across patients, it may provide a scalable and accessible immunotherapy solution for AML and potentially other cancers.
Regulatory Preparations Continue Ahead of Clinical Development
Following these encouraging preclinical results, Evaxion is continuing regulatory preparations for future clinical testing of EVX-04. The company stated that ongoing development activities remain on track while discussions with regulatory authorities continue. As EVX-04 advances toward human studies, the program represents another example of how artificial intelligence, immunology, and biotechnology are being combined to develop next-generation cancer therapies. The successful demonstration of immune activation and targeted tumor cell killing strengthens the rationale for advancing EVX-04 into clinical development and supports its potential role as a novel therapeutic vaccine for patients with AML.
Source: Evaxion, press release
