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Key points:
FDA orphan drug designation granted for CDH17 in gastric cancerPromising results in phase one trials, with tumour shrinkage and stable disease observedCDH17 cell therapy could address multiple gastrointestinal cancers, including rising colon cancer rates in younger patientsChimeric Therapeutics (ASX:CHM) cites strong funding support and anticipates further milestones in 2024
Chimeric Therapeutics (ASX:CHM) has achieved a significant regulatory milestone with its cell therapy asset, CDH17, receiving FDA Orphan Drug Designation for gastric cancer. Dr. Rebecca McQualter states this recognition underscores the urgent need for new treatment options in this patient population. The company currently operates four active clinical trial sites in the United States and is progressing towards the conclusion of its phase one trial, having treated ten patients and observed promising signs of tumour shrinkage and stable disease at the second dose level.
McQualter outlines that CDH17 is a cutting-edge cell therapy, differing fundamentally from existing treatments such as surgery, chemotherapy, and immunotherapy. The process involves engineering a patient’s immune cells to target and destroy cancer cells from within. She notes that the therapy’s potential reach extends beyond gastric cancer, addressing several cancers along the digestive tract, including the colon, where incidence among younger patients is rising.
With a clear regulatory path ahead and backing from a supportive US family office, McQualter points to substantial market opportunity, estimating the annual global addressable market at $27 billion for the targeted cancers. She sees recent share price levels for Chimeric Therapeutics as a potentially attractive entry point for investors.