Le Lézard
Classified in: Health
Subject: FDA

CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA


SHANGHAI, June 19, 2019 /PRNewswire/ -- 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 United States Food and Drug Administration (FDA). CT053 has also received IND clearance from the National Medical Products Administration in China four months ago and is the subject of an ongoing phase I clinical trial.

"At the 5th Annual Immunotherapy in Myeloma Scientific Workshop in Denver, Colorado, CARsgen provided an update of the clinical data of CT053 and showed that as of Feb. 28, 2019, 87.5% of the patients showed overall response to the treatment. 70.8% of the patients had complete response and no grade 3 or higher cytokine release syndrome (CRS) was observed in 24 heavily pre-treated patients with rrMM. The IND clearance of CT053 by the U.S. FDA is of great significance to patients" 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 despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. 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

SOURCE CARsgen Therapeutics Co. Ltd.


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