CARsgen Therapeutics Receives IND Clearance from the NMPA for CT041 CLDN18.2-CAR-T Cells

SHANGHAI,Aug. 20,2020 --CARsgen Therapeutics Co.,Ltd.,a clinical-stage biopharmaceutical company,today 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[1]. Gastric and pancreatic cancer are 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."

[1] Bray F,Ferlay J,Soerjomataram I,Siegel RL,Torre LA,Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development of First-in-Class and Best-in-Class CAR-T and antibody therapeutics.

Founded in 2014,CARsgen is based in Shanghai,with operations in both China and the United States. CARsgen has established a broad pipeline of CAR-T product candidates covering several solid and blood tumors in areas of significant unmet medical need. The company has launched several First-in-Class CAR-T clinical trials for the treatment of relapsed/refractory tumors,including CAR-Claudin18.2-T for gastric and pancreatic cancer,CAR-GPC3-T for hepatocellular carcinoma (HCC) and squamous lung cancer and CAR-EGFR/EGFRvIII-T for glioblastoma. CARsgen also has ongoing clinical programs with a fully human CAR-BCMA-T for multiple myeloma and a humanized CAR-CD19-T for leukemia.

CARsgen's proprietary antibody platform enables the development of therapeutic antibodies. Its leading humanized monoclonal antibody targeting Claudin18.2 has obtained IND approval from the NMPA.

For more information,please visit: www.carsgen.com

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