China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug Administration (FDA) has requested its US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for CT053, CT041, and CT071 on hold. These chimeric antigen receptor (CAR)-T therapies are on hold pending the FDA’s conclusion after inspecting the manufacturing facility in Durham, North Carolina. CARsgen has pledged to conduct a comprehensive inspection and improve the facilities in accordance with current Good Manufacturing Practice (cGMP) and to cooperate closely with the FDA to address any issues.
CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy, has received Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation (ODD) in the United States, Priority Medicines (PRIME) and ODD in the European Union (EU), and Breakthrough Therapy Designation (BTD) in China. In January of this year, CARsgen licensed the drug to Huadong Medicine for commercialization in mainland China in a deal worth RMB 1.225 billion.
CT041 (satricabtagene autoleucel), a Claudin18.2-targeted CAR-T product with RMAT and ODD in the US and PRIME and ODD in the EU, is in development for the treatment of Claudin 18.2-positive solid tumors, primarily adenocarcinoma of gastric cancer/esophagogastric junction, and pancreatic cancer.
CT071, developed through the CARcelerate platform, targets G protein-coupled receptor class C group 5 member D (GPRC5D), an ideal target for the treatment of multiple myeloma (MM) or primary plasma cell leukemia (PCL).- Flcube.com
