Chimeric Therapeutics Reports FDA Clearance of IND Application for CHM 2101 | A Novel CDH17 CART T Cell Therapy for Advanced Gastrointestinal Cancers

Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), 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 of CHM 2101, Chimeric’s first in class CDH17 CAR T cell therapy for gastrointestinal cancers.

The company plans 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 Tumours.

CHM 2101 is a 3rd generation, novel CDH17 CAR T cell therapy that targets CDH17, a cancer target associated with poor prognosis and metastasis in the most common gastrointestinal tumors including Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours.

The clinical program for CHM 2101 builds upon the preclinical studies published in the preeminent scientific journal, Nature Cancer in March 2022 by leading immunotherapy scientist Xianxin Hua, MD, PhD, and his team at the Abramson Family Cancer Research Institute at the University of Pennsylvania. These experiments demonstrated that CHM 2101 was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues.

“It is exciting to see the advancement from 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,” said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator. “This is a critical step forward in developing an entirely new CAR T therapy for GI-cancers and neuroendocrine tumors, providing new hopes for the cancer patients who are refractory to the existing therapies.”

With the FDA IND clearance Chimeric will now begin the initiation of a phase 1 /2 multi-site clinical trial in patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. The study is planned to begin patient enrollment in 2024. ( ID: NCT06055439)

“I am really excited about the planned Phase 1 clinical trial of CHM 2101 and the opportunity to bring a potentially transformative new investigational agent to cancer patients who need them most,” said Michael R. Bishop, MD, Professor of Medicine and Director, The David and Etta Jonas Center for Cellular Therapy, University of Chicago.

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