(Boston, MA): The Neuroendocrine Tumor Research Foundation (NETRF) is proud to join Chimeric Therapeutics in announcing that CAR T-cell therapy using CHM CDH17 has been granted Fast Track Designation by the US Food and Drug Administration. This designation recognizes the potential of this new treatment to address the unmet need for additional therapies for GEP-NETs. NETRF funded the preclinical development of CDH17 by Dr. Xianxin Hua at the University of Pennsylvania. Chimeric Therapeutics, an Australian company, has developed the clinical trial.
CHM CDH17 was granted Fast Track Designation based on the FDA’s assessment of CHM-CDH17’s potential to improve outcomes for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed beyond at least one prior line of therapy in the advanced or metastatic setting.
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This designation by the US FDA is intended to get important new drugs to patients earlier. With this designation, Chimeric will have increased FDA interactions that include more frequent meetings with the FDA to discuss the drug’s development plan, more frequent written communication from the FDA, and potential eligibility for Accelerated Approval, Priority Review and Rolling BLA Review.
“We are thrilled to announce that the US FDA has granted this designation and acknowledged the important unmet need that CHM CDH17 may serve for patients with GEP-NETs,” said Jason B Litten MD, Chief Medical Officer at Chimeric.
Elyse Gellerman, MHS, Chief Executive Officer of the Neuroendocrine Tumor Research Foundation said, “It is deeply gratifying to see the scientific research that NETRF has supported at The University of Pennsylvania since 2014 is now in the clinic and being recognized for its potential as an effective treatment for neuroendocrine tumor patients.”
The Phase 1/2 clinical trial (NCT06055439) is 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 tumors (NETs). CHM CDH17 is a third generation, novel CAR-T cell therapy that targets CDH17, a cancer biomarker associated with poor prognosis and metastases in the most common gastrointestinal tumors.
The Phase 1 portion of this study is expected to enroll up to 15 patients and lead to dose selection and expansion with indication-specific Phase 2 cohorts. Five patients have been treated so far. In addition to the University of Pennsylvania, the trial is open at the University of Chicago, Sarah Cannon Research Institute, and Emory University Winship Cancer Center.
“We are gaining significant momentum on CHM CDH17 and look forward to our interactions with the FDA to get our advanced therapy to patients in need,” said Dr Rebecca McQualter CEO, Chimeric.
CHM CDH17 is a first-in-class, 3rd generation CDH17 CAR T-cell therapy invented at the University of Pennsylvania in the laboratory of Dr. Xianxin Hua, professor in the Department of Cancer Biology in the Abramson Family Cancer Research Institute. NETRF awarded Dr. Hua an initial grant in 2014 to explore whether CAR T-cell technology could be an approach to neuroendocrine cancer treatment. In 2018, Dr. Hua was awarded a Petersen Accelerator Award to continue this important work. Preclinical evidence for CDH17 CAR T was published by Dr. Hua and his colleagues in 2022 in Nature Cancer, demonstrating complete eradication of tumors in 7 types of cancer in mice.
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