Drug intelligence / Profile preview

hu2E2-GAALIE

Development stage
Preclinical
Lead developer
Fujian Medical University
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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.

Other names
humanized 2E2-GAALIEhumanized2E2-GAALIEhumanized-2E2-GAALIE
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)NPM1mut-A283-291/HLA-A*02:01 (Nucleophosmin 1 mutant A283-291 peptide presented by Human Leukocyte Antigen A*02:01)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)FCGRT (Neonatal crystallizable fragment receptor)

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