Drug intelligence / Profile preview

BL-M11D1

Development stage
Phase 3
Lead developer
Biokin Pharmaceutical
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

BL-M11D1 is a novel antibody-drug conjugate (ADC) designed for the treatment of hematologic malignancies, primarily relapsed or refractory acute myeloid leukemia (AML). It consists of a monoclonal antibody targeting CD33, conjugated via a cleavable linker to a novel topoisomerase I inhibitor payload. The drug exerts its effect by binding to CD33 on cancer cells, triggering antibody-dependent cellular cytotoxicity (ADCC), and facilitating internalization and release of the cytotoxic payload within the cell. This dual mechanism leads to targeted tumor cell death. Developed by SystImmune and Sichuan Baili Pharmaceutical, BL-M11D1 is currently in phase 1 clinical trials for AML[1][3][4][5][7].

02

Targets

CD33 (Myeloid cell surface antigen CD33)TOP1 (DNA Topoisomerase I)

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