CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the company’s Current Good Manufacturing Practice (CGMP) manufacturing facility located at the Research Triangle Park (RTP) in North Carolina, the United States of America (“The RTP GMP Manufacturing Facility”) has started GMP production of autologous CAR T-cell products and successfully released the first GMP batch for the clinical trials.
The RTP GMP Manufacturing Facility, with a total gross floor area of approximately 3,300 sq.m, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually to support clinical studies and early commercial launch in North America and Europe. “I am very pleased to announce that the RTP Manufacturing Facility has achieved the company’s target of releasing the clinical batches for the U.S. patient use in Q3, 2022,” said Mr. Richard Daly, President of CARsgen Therapeutics Corporation. “CARsgen is rapidly expanding the in-house capacity of manufacturing and quality testing in the United States. The company will accelerate the ongoing clinical studies by providing more promising CAR T-cell products to the global patients.”
“The successful release of the first U.S. patient product at the RTP GMP Manufacturing Facility is a remarkable milestone for CARsgen and our trusted partners,” added by Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited. “By taking the advantage of the vertically integrated production at CARsgen, our world-class CMC team could complete the global technology transfer from our China manufacturing facility and then advance to the clinical manufacturing effectively. The commencement of clinical production at the RTP GMP Manufacturing Facility will greatly reduce current risks of global supply chain shortage and strengthen the value chain of CARsgen.”
Apart from several ongoing clinical studies in China, the company has two active INDs, including a Phase 2 pivotal study of CT053 for relapsed/refractory multiple myeloma and a Phase 1b study of CT041 for advanced gastric and pancreatic cancers, both cleared by the U.S. FDA and the Health Canada. In fact, CARsgen is the only CAR T company to have received RMAT and PRIME designations for both heme (CT053) and solid (CT041) tumor therapies.