On October 14, 2024 SystImmune, Inc (SystImmune), a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BL-M11D1, an antibody-drug conjugate (ADC) binding CD33, a protein on myeloid cells (Press release, SystImmune, OCT 14, 2024, View Source [SID1234647185]). The IND supports the initiation of a Phase 1 clinical trial, BLM11D1-HM-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M11D1 for the treatment of patients with relapsed/refractory Acute Myeloid Leukemia (AML) in the United States.
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The clearance of this IND application marks an important milestone for SystImmune as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Dr. Jie D’Elia, Chief Executive Officer of SystImmune, commented, "Our mission at SystImmune is to continue to bring therapies that can provide clinical benefit to patients. The initiation of clinical development for BL-M11D1 emphasizes that commitment."
"We are excited to receive the FDA Study-May-Proceed letter enabling the initiation of our Phase 1 study with BL-M11D1. We believe that this novel, potentially best-in-class ADC can offer an important therapeutic option for patients with relapsed/refractory AML and look forward to implementing this study," expressed Dr. Jonathan Cheng, Chief Medical Officer at SystImmune.
About BL-M11D1
The company is developing BL-M11D1, an ADC comprising a monoclonal antibody component binding CD33 and a linker-payload component that is composed of a topoisomerase I inhibitor payload and a stable enzyme-cleavable linker. BL-M11D1 works by triggering antibody-dependent cellular cytotoxicity (ADCC) when it binds to CD33 on cancer cells. In addition, the binding to CD33 causes its internalization followed by the release of the payload, which then kills the tumor cell.