Healthcare Industry News:  CARsgen Therapeutics 

Biopharmaceuticals Oncology FDA

 News Release - October 5, 2020

CARsgen Therapeutics Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers

SHANGHAI, Oct. 5, 2020 -- (Healthcare Sales & Marketing Network) -- CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that the United States (US) Food and Drug Administration (FDA) has granted orphan drug designation to one of CARsgen's first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma. CT041 is a humanized anti-claudin18.2 autologous chimeric antigen receptor (CAR) T-cell product and is targeted to treat patients with claudin18.2-positive tumors.

CT041 is the first claudin18.2-targeted CAR T-cell therapy that has received Investigational New Drug (IND) clearance by the US FDA and the first to receive IND clearance by the National Medical Products Administration (NMPA) in China. The initiation of an open label, multicenter, Phase 1b clinical trial (NCT04404595) to evaluate the safety and efficacy of autologous CT041 cell therapy in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma is currently underway.

"The orphan drug designation of CT041 by the FDA is of great significance to patients with advanced gastric 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 are expected each year [1]. Despite the development of novel therapies, gastric cancer is still a disease with one of the highest unmet medical needs. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

Orphan drug designation is granted by the FDA Office of Orphan Products Development to investigational treatments that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the US. Under the Orphan Drug Act, the CT041 anti-claudin18.2 product would be eligible for certain benefits including FDA support for clinical studies, special fee exemptions and reductions, and seven years of market exclusivity in the United States following marketing approval by the FDA.


[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 immuno-oncology company committed to the development of first-in-class and best-in-class CAR T-cell 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-cell 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-cell clinical trials for the treatment of relapsed/refractory tumors, including CAR-claudin18.2 for gastric and pancreatic cancer, CAR-GPC3 for hepatocellular carcinoma (HCC) and squamous lung cancer and CAR-EGFR/EGFRvIII for glioblastoma. CARsgen also has ongoing clinical CAR T-cell programs with a fully human CAR-BCMA for multiple myeloma and a humanized CAR-CD19 for leukemia.

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Source: CARsgen Therapeutics

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