CARsgen Therapeutics (CARsgen), a global leader in developing chimeric antigen receptor T-cell (CAR-T cell) therapies for solid tumors, has announced the opening of its new manufacturing facility in Shanghai.
The facility features state-of-art capabilities to manufacture vectors and CAR-T cells to support CARsgen clinical programs. Upon completion of its final inspections, the 33,000-square-foot facility is expected to become China’s first CAR-T cell manufacturing platform that is in strict compliance with current good manufacturing procedure (cGMP) regulations of China Food and Drug Administration (CFDA).
“This facility marks a significant milestone of CARsgen as it embedded our leading expertise and insights into CAR-T cell manufacturing. We have already developed a strong CAR-T portfolio for treatment of many solid tumors including liver cancer, lung cancer, gastric cancer, pancreatic cancer,etc.,” said Dr. Zonghai Li, President and CEO of CARsgen. “Next,we plan to submit about 5 Investigational New Drug (IND) applications to CFDA and get at least one IND approval from US FDA by the end of 2018, all requiring a reliable supply of clinical-quality CAR-T cells. So I think this facility will definitely further enhance our clinical research and speed up our IND submission.”
CARsgen Therapeutics, one of the leading players for CAR-T cell therapeutics, is committed to bringing its proprietary immunotherapy to fight against a broad range of solid and hematologic tumors in China and worldwide. Founded in 2014, the company completed B series of financing of $30M in early 2016. Two of its pioneering CAR-T cell therapies, anti-GPC3 CAR-T for hepatocellular carcinoma (HCC) and cancer-specific anti-EGFR CAR-T for glioblastoma multiforme (GBM) have entered clinical trials. And some clinical data of the anti-GPC3 CAR-T cell therapeutics will be presented in ASCO, 2017.