Posted: 10 June 2025
Chimeric Therapeutics (ASX:CHM) announced that the US Food and Drug Administration (FDA) had granted Fast Track Designation to CHM CDH17. This designation was based on the FDA’s assessment of CHM CDH17’s potential to improve outcomes for patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs) who had progressed beyond at least one prior line of therapy in the advanced or metastatic setting.
The Fast Track Designation was designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Jason B. Litten MD, Chief Medical Officer at Chimeric, stated, “We were thrilled to announce that the US FDA had granted this designation and acknowledged the important unmet need that CHM CDH17 might serve for patients with GEP-NETs.”
Elyse Gellerman, MHS, Chief Executive Officer of the Neuroendocrine Tumor Research Foundation (NETRF), added, “It was gratifying to see scientific research that NETRF had supported at The University of Pennsylvania since 2014 now in the clinic and being recognized for its potential to be an effective treatment for neuroendocrine tumour patients.”
he ongoing Phase 1/2 trial (NCT06055439) was a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours (NETs). CHM CDH17 was a 3rd generation, novel CAR-T cell therapy that targeted CDH17, a cancer biomarker associated with poor prognosis and metastases in the most common gastrointestinal tumours. The Phase 1 portion of this study was expected to enrol up to 15 patients and lead to dose selection and expansion with indication-specific Phase 2 cohorts.
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