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SystImmune Secures FDA Clearance for IND Application of Novel ADC Therapy BL-M17D1 for Advanced Solid Tumors

NextEdge Admin

11 Nov 2024

1 min 24 sec

SystImmune, Inc., a clinical-stage biotechnology company, has received FDA clearance for its Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) that incorporates advanced linker and payload technology. This IND approval enables SystImmune to initiate a Phase 1 clinical trial, BL-M17D1-ST-101, in the United States, aimed at evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 in patients with advanced or metastatic solid tumors.

Dr. Jie D'Elia, SystImmune's CEO, noted the significance of this milestone, emphasizing the company’s mission to develop innovative therapies that deliver meaningful clinical benefits. Dr. D'Elia highlighted that BL-M17D1 exemplifies SystImmune's commitment to pushing the boundaries of ADC technology through next-generation linkers and payloads. By advancing BL-M17D1 into clinical trials, SystImmune aims to potentially provide a best-in-class treatment option for patients facing complex cancer diagnoses, representing a promising step forward in their therapeutic pipeline.