FDA Grants IND Approval for CHM 2101, a Novel CDH17 CAR T Cell Therapy Targeting Advanced Gastrointestinal Cancers, Developed by Chimeric Therapeutics
1 November 2023
Chimeric Therapeutics, an Australian leader in cell therapy, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CHM 2101, the company's first-in-class CDH17 CAR T cell therapy designed for gastrointestinal cancers.
The company's plan is to investigate CHM 2101 in a multi-center, open-label Phase 1A/B clinical trial for patients with advanced Colorectal Cancer, Gastric Cancer, and Neuroendocrine Tumors.
CHM 2101 is a 3rd generation, novel CDH17 CAR T cell therapy targeting CDH17, a cancer marker associated with poor prognosis and metastasis in common gastrointestinal tumors, including Colorectal Cancer, Gastric Cancer, and Neuroendocrine Tumors.
The clinical program for CHM 2101 builds upon preclinical studies published in the scientific journal Nature Cancer in March 2022 by Dr. Xianxin Hua and his team at the Abramson Family Cancer Research Institute at the University of Pennsylvania. These studies demonstrated that CHM 2101 could eradicate established tumors in seven cancer models without causing toxicity to normal tissues.
Dr. Xianxin Hua, a leading immunotherapy scientist, expressed his enthusiasm for the progress from the discovery of the CDH17 target and CAR T therapy in preclinical studies to the initiation of clinical trials in patients with GI cancers and neuroendocrine tumors. He highlighted the critical step forward in developing a new CAR T therapy for these types of cancer, offering new hope for patients who do not respond to existing therapies.
With the FDA's IND clearance, Chimeric will now begin a phase 1/2 multi-site clinical trial for patients with advanced Colorectal Cancer, Gastric Cancer, and Neuroendocrine Tumors. The study is scheduled to begin patient enrollment in 2024 (ClinicalTrials.gov ID: NCT06055439).
Cellular Therapy at the University of Chicago, expressed his excitement about the upcoming Phase 1 clinical trial of CHM 2101 and the opportunity to bring a potentially transformative new investigational agent to cancer patients who need it most.
Source: prnewswire.com