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hu2E2-GAALIE is a humanized, T-cell receptor (TCR)-like monoclonal antibody designed for the treatment of NPM1-mutated acute myeloid leukemia (AML). It specifically targets the neoantigen complex formed by the NPM1mutA283-291 peptide and the HLA-A*02:01 molecule, allowing it to recognize intracellular mutations that are typically inaccessible to standard antibodies. The antibody is engineered with the GAALIE Fc-modification (G236A/A330L/I332E), which significantly increases its affinity for the FcγRIIIa (CD16a) receptor, thereby enhancing its ability to mediate antibody-dependent cellular cytotoxicity (ADCC). Developed by researchers at Fujian Medical University and Xiamen University, hu2E2-GAALIE has demonstrated potent anti-tumor activity in both in vitro assays and in vivo humanized mouse models of AML.
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