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EVX-04 is an AI-designed, off-the-shelf therapeutic DNA cancer vaccine candidate being developed by Evaxion for the treatment of acute myeloid leukemia (AML).[7][9] Using the company’s AI-Immunology platform and AML patient tumor sequencing data, the vaccine targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the “dark genome” that are overexpressed in tumors but absent from normal tissue, aiming to generate potent, specific T-cell responses and broad tumor coverage across patients.[3][5][7] The construct incorporates 16 optimally selected ERV antigen fragments to induce strong, multi-epitope cytotoxic T-cell immunity that has shown robust T-cell activation, cancer cell killing, and prevention of tumor growth in preclinical AML models, supporting its development as a novel immunotherapy for patients with high unmet medical need.[2][4][6][7]
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