CARsgen releases first clinical batch of CAR T cells from its RTP GMP manufacturing facility in North Carolina
SHANGHAI–(BUSINESS WIRE)–CARsgen Therapeutics Holdings Limited (stock code: 2171.HK), a company focused on innovative CAR T therapies for the treatment of hematological malignancies and solid tumors, announces that the company Manufacturing plant in accordance with Current Good Manufacturing Practices (CGMP) located at Research Triangle Park (RTP) in North Carolina, United States of America (“The RTP GMP Manufacturing Facility”) commenced GMP production of autologous CAR T-cell products and successfully launched the first GMP batch for clinical trials.
The RTP GMP manufacturing facility, with a total gross floor area of approximately 3,300 m², will provide CARsgen with additional manufacturing capacity of autologous CAR T-cell products for 700 patients per year to support clinical studies and launch early commercialization in North America and Europe. “I am very pleased to report that the RTP manufacturing facility has achieved the company’s goal of releasing clinical batches to US patients in the third quarter of 2022,” said Mr. Richard Daly, President of CARsgen Therapeutics Corporation. . “CARsgen is rapidly expanding in-house manufacturing and quality testing capability in the United States. The company will accelerate ongoing clinical studies by delivering more promising CAR T-cell products to patients worldwide. »
“The successful launch of the first product for US patients at the RTP GMP manufacturing facility is a remarkable milestone for CARsgen and our trusted partners,” added Dr. Zonghai Li, Founder, Chairman, Chief Executive Officer and scientific director. of CARsgen Therapeutics Holdings Limited. “By leveraging CARsgen’s vertically integrated production, our world-class CMC team was able to complete global technology transfer from our manufacturing facility in China and then efficiently move into clinical manufacturing. The start of clinical production at the RTP GMP manufacturing facility will significantly reduce current global supply chain shortage risks and strengthen CARsgen’s value chain.
In addition to several ongoing clinical studies in China, the company has two active INDs, including a pivotal Phase 2 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 US FDA. and Health Canada. In fact, CARsgen is the only CAR T company to have received RMAT and PRIME designations for both hemic (CT053) and solid (CT041) tumor therapies.
About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company with operations in China and the United States focused on innovative CAR T-cell therapies for the treatment of hematological malignancies and solid tumors. The company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials and commercial scale manufacturing. CARsgen has in-house developed new technologies and a product pipeline with global rights to address key challenges of CAR T-cell therapies, such as improving the safety profile, improving efficacy in the treatment of solid tumors and reducing treatment costs. The company’s vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.