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BL-M02D1 is a novel antibody-drug conjugate (ADC) targeting TROP2 (trophoblast cell surface antigen 2), developed for the treatment of various solid tumors that overexpress TROP2. The drug consists of a humanized monoclonal antibody (hu4D3) specific to TROP2, linked via a cathepsin B-cleavable linker to a novel topoisomerase I inhibitor payload (Ed-04), which is a derivative of camptothecin. Upon binding to TROP2-expressing tumor cells, the ADC is rapidly internalized and trafficked to lysosomes where the cytotoxic payload is released, inducing genotoxic stress and apoptosis through S-phase cell cycle arrest. In addition to direct cytotoxicity, its wild-type Fc region can mediate innate immune effector functions against cancer cells. Preclinical studies have shown potent antitumor activity and bystander effects in heterogeneous tumor models. Clinical trials are ongoing in multiple solid tumor types including non-small cell lung cancer and triple negative breast cancer[1][3][5][6].
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