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Breaking News, Trials & Filings

FDA Clears SystImmune’s IND for BL-M17D1 ADC

The IND supports the initiation of a Phase 1 clinical trial.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

The U.S. Food and Drug Administration (FDA) has cleared SystImmune Inc.’s Investigational New Drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC) with a novel linker and payload technology.
 
The IND supports the initiation of a Phase 1 clinical trial, BL‑M17D1-ST-101, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M17D1 for the treatment of patients with advanced or metastatic solid tumors 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, said, “Our mission at SystImmune is to bring therapies that can provide transformative clinical benefit to patients. As BL-M17D1 is developed using our next generation linker and payload technology, the initiation of clinical development for BL-M17D1 demonstrates our ability to continue to innovate in the ADC space and bring potentially best-in-class products to patients.”

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