LINTONPHARM
15.7.2020 22:32:05 CEST | 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 It was later voluntarily withdrawn from the market for commercial reasons.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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200715005898/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sharjah Unveils Uruk: A New Generation of Sustainable Cities Built for the Post-AI Era29.10.2026 19:15:00 CET | Press release
In the presence of His Highness Sheikh Dr. Sultan bin Mohammed Al Qasimi, Supreme Council Member and Ruler of Sharjah, and Her Highness Sheikha Bodour bint Sultan Al Qasimi, President of American University of Sharjah and Chairperson of Sharjah Research, Technology and Innovation Park, a pioneering model for a new generation of cities designed for the post-AI era called “Uruk.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029129346/en/ H.H. Sheikh Dr. Sultan bin Mohammed Al Qasimi, Ruler of Sharjah, during the inauguration of “Uruk” (Photo: AETOSWire) The project was revealed at the opening of the second edition of Sharjah Next, through a strategic partnership between Sharjah Research, Technology and Innovation Park (SPARK), American University of Sharjah (AUS) and SEE Holding, bringing together their capabilities in innovation, scientific research and sustainable urban development. Uruk introduces a new vision for urba
Motive and Vivo Brazil Win 2026 Leading Lights Award for Network API Monetization29.10.2026 17:35:00 CET | Press release
Award recognizes live GSMA Open Gateway deployment replacing SMS OTP with SIM-based silent authentication Motive, a global leader in entitlement, connected device and service management and Vivo Brazil, Brazil’s largest operator and part of the Telefónica Group, have won the 2026 Light Reading Leading Lights Award for Outstanding Use Case: Network API Monetization for the first commercial scale deployment of SIM-based silent authentication in Latin America. SMS OTP remains relevant as an authentication method due to its broad reach, working on virtually any type of mobile device. SIM-based silent authentication takes this experience a step further by eliminating the need to receive and manually enter codes. The result is a simpler, more seamless user journey that reduces friction and can help lower abandonment rates while increasing customer conversion and retention. Using Motive’s CAMARA-compliant Entitlement Server, Vivo can now verify a subscriber’s phone number directly without req
REV Ocean Appoints Paul Baribault as CEO Ahead of 2027 Global Operations29.10.2026 15:45:00 CET | Press release
Global conservation and philanthropic leader to spearhead REV Ocean's next chapter, connecting world-class science with international collaboration and ocean protection REV Ocean has appointed Paul Baribault as Chief Executive Officer as the organization moves towards the international debut of its 195-metre research vessel in Rio de Janeiro in April 2027, alongside the UN Ocean Decade Conference. One of the world's largest privately owned research and exploration vessels, REV represents a major philanthropic investment in ocean science. With nine laboratories, advanced deep-sea exploration vehicles and dedicated collaboration facilities, it is designed to give scientists access to world-class research infrastructure and connect their discoveries with the people and institutions able to drive ocean protection. Baribault joins as REV Ocean moves from a decade of engineering and construction into international operations. His mandate will be to build the international partnerships, fundi
Holder Partners Launches Strategic Communications Practice and Appoints Ali Ponte as Director and Practice Lead29.10.2026 15:15:00 CET | Press release
The new practice connects strategic communications and stakeholder engagement with Holder Partners’ capabilities in investigations, disputes, cybersecurity, due diligence and risk advisory. Holder Partners, a multidisciplinary consulting and advisory firm, today announced the launch of its Strategic Communications practice and the appointment of Ali Ponte as Director and Practice Lead. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027701219/en/ Ali Ponte, Director and Practice Lead of Holder Partners’ Strategic Communications practice. The practice advises leading companies and institutions, their boards, senior executives and counsel on communications, reputation and stakeholder considerations in complex matters and periods of significant change or opportunity. Each engagement is tailored to the client’s objectives and, where relevant, draws on Holder Partners’ broader advisory capabilities. Its strategic counsel, infor
Accertify Formalizes Partner Ecosystem as Fraud, Payments, and Chargebacks Converge Into a Single Risk Surface29.10.2026 15:00:00 CET | Press release
New partner program brings payment providers, orchestrators, commerce platforms, and consultancies together around the industry's largest fraud data community Accertify, a leading fraud decisioning provider whose Predictive Yes Platform helps merchants say yes to more good customers, more revenue, and more growth, today announced the launch of the Accertify Partner Program, a formalized partnership ecosystem connecting payment providers, orchestrators, commerce platforms, and consultancies to Accertify’s network-powered fraud intelligence. Partners can join through two tracks. The Referral track lets partners make a single introduction while Accertify handles the sale, implementation, and support. The Reseller track lets partners sell Accertify on their own contract and own the client relationship and margin. Partners that integrate with Accertify follow a defined certification path, so clients get a tested, supported connection from day one. Every client a partner brings joins a conso
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom