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

SHANGHAI, May 18, 2020 /PRNewswire/ -- CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that one of its first-in-class drug candidates, CT041 humanized anti-claudin18.2 autologous Chimeric Antigen Receptor (CAR) T Cells (CT041) for the treatment of patients with claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction, or pancreas, has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration (FDA). CT041 is the first claudin18.2-targeted CAR-T cell therapy IND cleared for clinical trials in the world. The proof-of-concept preclinical data was published in 2019 ([1]). The IND clearance was supported by an ongoing investigator-initiated Phase I trial conducted by Professor Lin Shen at Beijing Cancer Hospital, Peking University in China (NCT03874897). An open label, multicenter, Phase 1b clinical trial to evaluate the safety and efficacy of autologous CT041 cell therapy in patients with advanced gastric or pancreatic adenocarcinoma will be initiated by CARsgen in Q3 2020 in the United States.

"The IND clearance of CT041 by the FDA is of great significance to patients with advanced gastric and pancreatic cancer," 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([2]). Despite the development of novel therapies, gastric and pancreatic adenocarcinomas remain incurable and new treatment options are needed. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."


[1] Jiang H, Shi Z, Wang P, et al. Claudin18.2 - specific chimeric antigen receptor engineered T cells for the treatment of gastric cancer. J Natl Cancer Inst. 2019;111(4):409-18. doi: 10.1093/jnci/djy134.

[2] 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 immuno-oncology company committed to the development and commercialization of CAR T-cell therapeutics for unmet medical needs. The company has collaborated with top hospitals in China to launch several first-in-human studies such as anti-GPC3 CAR T cells for hepatocellular carcinoma and squamous lung cancer, anti-EGFR/EGFRvIII CAR T cells for glioblastoma multiforme and anti-claudin18.2 CAR T cells for gastric and pancreatic cancer.

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