LintonPharm Co. Ltd., a China-based clinical stage biopharmaceutical company focusing on the development of T-cell engaging bispecific antibodies for cancer immunotherapy, announced dosing of the first patient with gastric cancer in the stage I of the phase III trial of catumaxomab in Taiwan (China) on 6th October. Patients were also enrolled in South Korea recently. This global phase III trial is designed to evaluate the safety and efficacy of an intraperitoneal infusion of the bispecific antibody catumaxomab in patients with gastric cancer peritoneal carcinomatosis who are not suitable for systemic chemotherapy.

“This announcement represents a significant milestone for LintonPharm.” Co-founder, CEO of Linton, Dr. Robert Li said, “Most importantly, we believe this program has the potential to expand therapeutic options for the patients with gastric cancer.”

Gastric cancer is the third most common malignant tumor in China and one of the major causes of cancer deaths. Due to the limitation of diagnostic technology, more than 2/3 of patients are diagnosed with advanced gastric cancer (phase III or phase IV) with a 5-year survival rate of only 25%. A large percentage of gastric cancer patients will develop peritoneal carcinomatosis (about 70%) which results in a less than 5% 5-year survival rate and is one of the major causes of death of advanced gastric cancer.

Surgery is the primary treatment for gastric cancer, but nearly 20% of gastric cancer patients are diagnosed with peritoneal carcinomatosis before or during surgery, and more than 50% of patients in advanced stage have peritoneal carcinomatosis after radical resection. Currently, gastric cancer peritoneal carcinomatosis is incurable. Therefore, prolonging the overall survival is the key to treatment.

About Catumaxomab

Catumaxomab was first approved by EMA in 2009 for the treatment of malignant ascites. It was the global first T cell engaging bispecific antibody. The antibody binds to a transmembrane glycoprotein on the tumor cell--the epithelial cell adhesion molecule (EpCAM)--and CD3 on the T-cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab kills tumor cells by engaging T-cell and accessory cell mediated cytotoxicity and has potential to induce long-term vaccinal effects which has been verified in animal models.

The original indication of catumaxomab is currently under BLA re-submission to EMA. Catumaxomab is also authorized by Germany, China, Taiwan (China) and South Korea to conduct clinical trials in solid tumors.

About LintonPharm

LintonPharm Co., Ltd. is a clinical-stage, research-oriented biopharmaceutical company committed to developing innovative T cell engaging bispecific antibodies with the goal of turning malignant cancers into manageable and possibly curable diseases. LintonPharm, in collaboration with Lindis Biotech, will further expand new indications of catumaxomab in authorized regions and countries. On the basis of catumaxomab and its original platform Triomab, LintonPharm is also developing a next generation bispecific antibody platform known as Fleximab which aims to provide better CMC developability and less immunogenicity. The Fleximab pipeline includes several treatments in development for blood cancer and solid tumors.

References：

1.    Paul H. Sugarbaker, Gastric cancer: prevention and treatment of peritoneal metastases, Journal of Cancer Metastasis and Treatment 2018;4:7

2.    Wanqing Chen et. al., 2010 Annual report on status of cancer in China. Chinese Journal of Cancer Research. Chin J Cancer Res 2014;26(1):48-58

3.    中国抗癌协会胃癌专业委员会，胃癌腹膜转移防治中国专家共识；Chin J Gastrointest Surg, May 2017, Vol.20, No.5.