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

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 th...

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