CARsgen Therapeutics Receives IND Clearance from the NMPA for AB011 Humanized Claudin18.2 Monoclonal Antibody

CARsgen Therapeutics, a clinical-stage biopharmaceutical company committed to discovering and developing a combined platform of Chimeric Antigen Receptor T (CAR-T) cell therapies and monoclonal antibodies for cancer, today announced that one of its leading drug candidates, AB011 humanized claudin18.2 monoclonal antibody for the treatment of patients suffering from advanced gastric and pancreatic adenocarcinoma, has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) in China.

"We are excited to be moving AB011 into clinical development as a potentially best-in-class monoclonal antibody against claudin18.2, a rational target with outstanding properties for development of a monoclonal antibody product," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "Currently, patients with advanced gastric and pancreatic cancer have a poor prognosis, and there's a clear unmet medical need for better treatment options. We look forward to beginning the clinical investigation of AB011, which has shown promising results in preclinical models. We intend to submit an IND application for AB011 to the U.S. FDA in 2020."

AB011 is the first humanized monoclonal antibody targeting claudin18.2 entering clinical trials. Claudin18.2 is a stomach-specific isoform of claudin-18 (1-3). Histologically, it is only expressed in short-lived differentiated cells and not expressed in the stem cell zone of the stomach mucosa. Pathologically, it is highly expressed in a variety of cancer types, including gastric and pancreatic cancer. These characteristics suggest that claudin18.2 is a rational target for cancer.

References:

1.  Jiang H, Shi Z, Wang P, Wang C, Yang L, Du G, et al. Claudin18.2 - specific chimeric antigen receptor engineered T cells for the treatment of gastric cancer. J Natl Cancer Inst 2019;111:409-18.

2.  Osanai M, Takasawa A, Murata M, Sawada N. Claudins in cancer: bench to bedside. Pflugers Arch 2017;469:55–67.

3.  Soini Y. Expression of claudins 1, 2, 3, 4, 5 and 7 in various types of tumours. Histopathology 2005; 46:551–60.

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development and commercialization of CAR-T and monoclonal antibody therapeutics for unmet medical needs. 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.