LintonPharm Announces Authorization From China Health Authority to Proceed With a Global Phase 3 Trial Evaluating Catumaxomab in Advanced Gastric Cancer
15.7.2020 23:30:00 EEST | Business Wire | Press release
LintonPharm Co. Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T-cell engaging bispecific antibodies for cancer immunotherapy, today announced the China National Medical Products Administration (NMPA) authorized the company to proceed with a Phase III trial (clinicaltrials.gov: NCT04222114) for catumaxomab in patients with peritoneal carcinomatosis, a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity.
The two-stage, multi-center, open-label, randomized, controlled registrational clinical trial will evaluate the safety and efficacy of an intraperitoneal infusion of the bi-specific antibody catumaxomab into the abdominal cavity in patients with peritoneal carcinomatosis. LintonPharm also recently received Clinical Trial Application (CTA) authorization for the same indication from the Taiwan Ministry of Health and Welfare (MOHW) and the Korea Ministry of Food and Drug Safety (MFDS).
“We are excited to re-initiate clinical development of catumaxomab which we believe may have benefit in a broad range of cancers,” said Robert Li, co-founder and CEO of LintonPharm. “Our initial development strategy is based on a robust foundation of clinical data that support the therapeutic potential of catumaxomab in advanced gastric cancer.”
Catumaxomab was the first T-cell engaging bispecific antibody approved by the European Medicines Agency (EMA) in 2009 for the treatment of malignant ascites, a fluid buildup in the peritoneal cavity that indicates the presence of malignant cells. It was later voluntarily withdrawn from the market for commercial reasons.
“Gastric cancer is the sixth most common cancer globally. Approximately 70 percent of patients are located in China and the majority of these patients are diagnosed with late stage disease. Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients,” said Dr. Horst Lindhofer, co-founder and Chief Scientific Officer of LintonPharm.
About Advanced Gastric Cancer with Peritoneal Carcinomatosis
Gastric cancer is the sixth most common cancer globally with an estimated incidence of 1,033,701 cases and 782,685 deaths in 2018.1 About 70 percent of gastric cancer patients are located in China, with 679,100 new cases and 489,000 deaths2 in 2015. More than 70 percent of Chinese patients are diagnosed with late stage (stage III or IV) gastric cancer. Peritoneal carcinomatosis (PC) is one of the primary causes of death in late stage gastric cancer. Approximately 20 percent of patients are diagnosed with PC before or during surgery, and more than 50 percent of patients are diagnosed with PC after cancer reduction surgery. The prognosis for gastric cancer with PC is extremely poor, with an expected survival of less than one year3. Current therapies for gastric cancer include trastuzumab for Her2 positive patients and systemic chemotherapies (1st line and 2nd line). There are limited options for patients who fail frontline therapies, especially for those who developed PC.
About Catumaxomab
Catumaxomab is a trifunctional bispecific antibody which originated from Lindis Biotech’s Triomab platform. 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 against tumor cells due to the unique FcγR binding and activation profile.
Catumaxomab was first approved by the EMA in 2009 for the treatment of malignant ascites (MA). MA is manifested as the abnormal accumulation of fluid in the peritoneal cavity, which develops from the proliferation of peritoneal carcinomatosis tumor cells in the cavity. There are various cancers that generate MA, for example ovarian, gastric, pancreatic and colorectal cancers. Patients with MA are usually diagnosed in the advanced stages of disease and their quality of life is greatly impaired. Currently, these patients face an extremely poor prognosis with a median overall survival of one to six months.
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. The company’s lead development program is with catumaxomab, a clinically validated bispecific antibody which was the first approved T-cell engager, and its associated Triomab technology platform. LintonPharm, in collaboration with Lindis Biotech, is also developing a next generation bispecific antibody platform known as Fleximab which aims to provide better CMC developability and less immunogenicity. The LintonPharm pipeline includes several treatments in development for blood cancer and solid tumors that use the Triomab and Fleximab platforms. For more information, please visit www.lintonpharm.com.
References
- Freddie Bray et. al., Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J. Clin. 2018; 68: 394-424.
- Wanqing Chen et. al., Cancer Statistics in China, 2015. CA Cancer J. Clin 2016; 66: 115-132
- China anti-cancer Association, Gastric Cancer, China Experts Consensus on Gastric Cancer with Peritoneal Carcinomatosis Prevention and Treatment;Chin J Gastrointest Surg, May 2017, Vol. 20, No. 5.
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