Debio 1562M

Debio 1562M is a next-generation antibody-drug conjugate (ADC) developed by Debiopharm International SA for the treatment of hematological malignancies, specifically acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The drug consists of naratuximab (also known as K7153B or huCD37-3), a humanized monoclonal antibody targeting the CD37 transmembrane protein, which is highly expressed on hematological cancer cells. The antibody is conjugated to the maytansinoid cytotoxic payload DM1, a tubulin-binding agent, using Debiopharm's proprietary Multilink™ technology. This peptidic cleavable linker allows for a high and homogeneous drug-to-antibody ratio (DAR) of approximately 8, enhancing potency while maintaining systemic stability. Upon binding to CD37 and subsequent internalization, the linker is cleaved by intracellular Cathepsin B, releasing the DM1 payload to disrupt microtubule assembly and induce cell death. Debio 1562M is currently in Phase 1/2 clinical development for relapsed or refractory AML.