SystImmune, Inc (SystImmune), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) authorized the company to proceed with the planned clinical study of the HER2-specific HIRE platform ADC, BL-M07D1, in the Investigational New Drug (IND) application on November 28, 2023. This milestone paves the way for the multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2 expressing cancers in the United States.
Dr. Yi Zhu, Chief Executive Officer of SystImmune, remarked, “The FDA’s approval of our IND application for BL-M07D1 underscores our commitment to advancing innovative therapies in the field of oncology with our HIRE platform of ADCs. We look forward to collaborating with our clinical partners, trial treatment centers, and global regulatory agencies to contribute meaningfully to the ongoing evolution of cancer treatment.”
The clearance of this IND application marks a significant milestone for SystImmune as the company continues to advance its pipeline of therapeutic candidates into global clinical development.