Date: 24-Aug-2020

China NMPA Clears CARsgens CAR T-cell Therapy IND, CT041 To Treat Claudin18.2-positive Solid Tumors

CARsgen Therapeutics, a clinical-stage biopharmaceutical company, announced that the National Medical Products Administration (NMPA) has cleared its Investigational New Drug (IND) application for the first-in-class drug candidate CT041, autologous chimeric antigen receptor (CAR) T cells for the treatment of claudin18.2-positive solid tumors.

CT041, a humanized CAR-claudin18.2 T-cell therapy developed by CARsgen Therapeutics for patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, previously received IND clearance from the United States Food and Drug Administration (FDA) in May 2020. CT041 is the first claudin18.2-targeted CAR T-cell therapy IND cleared for clinical trials in China.

“Annual incidence of gastric cancer in China has already exceeded 600,000 cases. Pancreatic cancer is also one of the malignancies with highest unmet medical needs. Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable, and new treatment options are urgently needed,” said Professor Lin Shen, principal investigator from Beijing Cancer Hospital, Peking University in China. “Claudin18.2 is abundant in a variety of human malignancies including gastric, pancreatic, esophageal cancer, and biliary tract tumor, which indicates that claudin18.2, is a highly attractive target for cancer immunotherapies. We will continue to advance the clinical trial and facilitate its translation into robust clinical benefits.”

“The IND clearance by the NMPA is an important regulatory milestone in the clinical development and commercialization of CT041 anti-claudin18.2 CAR T cells,” said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. “According to the World Health Organization, about 1,030,000 new cases of gastric adenocarcinoma and over 450,000 new cases of pancreatic adenocarcinoma are expected each year. Gastric and pancreatic cancer is among the malignancies with the highest unmet medical needs. Our goal is to develop novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide.”