On March 1, 2021 CARsgen Therapeutics Holdings Limited, a clinical-stage biopharmaceutical company, reported that the European Commission (EC) has granted orphan designation for CT041, CARsgen’s first-in-class Claudin 18.2 (CLDN18.2) targeted CAR-T product candidate for the treatment of gastric cancer (Press release, Carsgen Therapeutics, MAR 1, 2021, View Source [SID1234575883]). CT041 consists of the patient’s own T cells, genetically modified to express a humanized anti-CLDN18.2 chimeric antigen receptor (CAR) to treat patients with CLDN18.2-positive tumors.
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"The orphan medicinal product designation of CT041 by the EC is another important recognition of CARsgen’s commitment to the development of CAR T-cell treatment for patients with advanced gastric cancer," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to the World Health Organization, over one million new cases of gastric adenocarcinoma are expected each year, and it is the seventh most prevalent cancer type worldwide [1]. Despite the development of novel therapies, gastric cancer is still a disease with one of the highest unmet medical needs. We reaffirm our long-standing commitment to cancer patients worldwide by expanding upon our CT041 clinical trial data to advance novel, safe and effective immunotherapies."
The EC grants orphan drug designation to investigational treatments for rare conditions, those affecting fewer than five in 10,000 people in the European Union. Treatments that meet the European Medicines Agency’s orphan designation criteria qualify for incentives to encourage advancement of drug development.
CT041 is the first CLDN18.2-targeted CAR T-cell treatment that has received Investigational New Drug (IND) clearance by the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China. Three open-label, multicenter, Phase 1b clinical trials (NCT04404595, NCT04581473, and NCT03874897) to evaluate the safety and efficacy of autologous CT041 cell treatment in patients with advanced gastric, gastroesophageal, or pancreatic adenocarcinoma are currently underway.