SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia
Tuesday, October 15, 2024
SystImmune, Inc, a clinical-stage biotechnology company, announced 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. 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.
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 ourPhase 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.
Source: systimmune.com
