Chimeric Therapeutics (ASX: CHM) secures FDA approval for its IND application, CHM 2101. This ground-breaking CDH17 CAR T cell therapy is designed to target gastrointestinal cancers. The FDA clearance is a significant milestone, allowing Chimeric to proceed with a Phase 1A/B clinical trial across multiple centers.
CHM 2101 represents a third-generation CDH17 CAR T cell therapy, specifically tailored to address CDH17, a marker associated with poor prognosis and metastasis in prevalent gastrointestinal tumors. Its development follows promising preclinical studies featured in Nature Cancer (March 2022) by immunotherapy scientist Xianxin Hua, MD, PhD, and his team at the University of Pennsylvania's Abramson Family Cancer Research Institute. These studies demonstrated CHM 2101's ability to eliminate established tumors across seven cancer models without harming normal tissues, marking a significant stride in cancer treatment innovation.
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