CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the NMPA

SHANGHAI,March 1,2019 -- CARsgen Therapeutics,a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer,today announced that one of its leading drug candidates,CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM),has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA).

"At the American Society of Hematology meeting in December 2018,our collaborator,Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells byChina'sNMPA is of great significance to CARsgen," said Dr. Zonghai Li,founder,CEO and CSO of CARsgen. "According to JAMA Oncology,in 2016,there were about 130,000 cases of myeloma,which means from 1990 to 2016,incident cases of myeloma increased by 126% globally[1]and despitethe development ofnovel therapies,multiple myelomaremainsincurableand newtreatmentoptions are needed.As part of the CT053 development plan,we also intend to submit an IND application for BCMA-CAR-T cells to the U.S. FDA in 2019. Our goal is to continue the development of novel,safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

References:

[1]JAMA Oncol.2018;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128.

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development and commercialization of CAR-T therapeutics for unmet medical need. The company has collaborated with top hospitals in China to launch several First-in-Human studies such as CAR-GPC3-T for hepatocellular carcinoma and squamous lung cancer,CAR-EGFR/EGFRvIII-T for glioblastoma multiforme and CAR-Claudin18.2-T for gastric and pancreatic cancer.

For more information,please visit:www.carsgen.com

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