CARsgen Launches First-in-Class Anti-Claudin18.2 CAR-T Clinical Trial

SHANGHAI, Aug. 10, 2017 /PRNewswire/ -- CARsgen Therapeutics (CARsgen), a global leader in developing chimeric antigen receptor T-cell (CAR-T cell) therapies for solid tumors, today announced its first-in-class anti-Claudin18.2-CAR-T cell therapy for gastric and pancreatic cancers has entered into phase-I clinical trial and starts patients recruitment at Changhai Hospital of Shanghai, a renowned hospital of global reputation for expertise on gastroesophageal and related cancer.

Commenting on their cooperation with CARsgen on this Claudin18.2-CAR-T clinical trial, Oncologist Xianbao Zhan, Ph.D & MD, Chief of Oncology at the hospital and principal investigator on this study, said, "It is designed to develop and deliver innovative solutions and bring hope to people who are suffering from refractory and/or relapsed gastric and pancreatic cancers all over the world."

"The Claudin18.2 program marks another major breakthrough of CARsgen following the world's first anti-GPC3-CAR-T trial for hepatocelluar carcinoma (HCC) initiated in 2015," said Dr.Zonghai Li, President and CEO of the company.

The company's proprietary humanized antibody exhibited promising affinity between an antibody and an epitope, while maintaining steady specificity of which molecule reacts against certain antigenic determinants and not with others. The pre-clinical study also showed that the anti-Claudin18.2 CAR-T cell therapy combines both high safety and anti-tumor activity.

Claudin18.2 belongs to a unique family of membrane proteins that make tight junctions. Previous research has shown that its expression in healthy tissues is strictly confined to short-lived differentiated epithelial cells of the gastric mucosa, but is abundant in a variety of human malignancies including gastric, pancreatic, and esophageal cancer, which qualify CLDN18.2 as a highly attractive target to develop safe and potent cancer immunotherapies.

Gastric and pancreatic cancer are among the malignancies with the highest unmet medical needs. Gastric cancer is the second leading cause of cancer deaths worldwide, and as the World Health Organization (WHO) presented in 2015, the total number of annual global gastric cancer deaths is estimated to exceed 754,000. Pancreatic cancer, with a mortality rate that closely parallels incidence, kills over 200,000 patients a year around the world, according to a Lancet report in 2016. These challenges highlight the urgent demand for novel, safe and effective therapies.

"In the future, we will continue to advance the clinical trial and facilitate its translation into robust clinical benefits," said Li.

About CARsgen Therapeutics

CARsgen Therapeutics is a rapidly growing bio-tech start-up with the original CAR-T therapy discovery expertise, competitive GMP manufacturing capability, and global clinical development experience. CARsgen commits to delivering the most advanced yet affordable cell therapies to patients with unmet medical needs. With broad discovery pipeline across solid tumor and hematology malignancies, CARsgen proceeds the clinical development with a clear focus in CAR-T therapy for solid tumors. Several of its pioneering CAR-T cell therapies, anti-GPC3 CAR-T for hepatocellular carcinoma (HCC), anti-GPC3 CAR-T for squamous lung cancer (SLC), cancer-specific anti-EGFR CAR-T for glioblastoma multiforme (GBM) and first-in-class anti-Claudin18.2-CAR-T for gastric and pancreatic cancer, have all entered early clinical development.

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