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 It was later voluntarily withdrawn from the market for commercial reasons.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
Industrial Decarbonization: Calderion, WenCo and Terravent Invest in Graforce to Scale Plasma Pyrolysis Globally25.2.2026 08:07:00 CET | Press release
The investor consortium comprising the Paris-based Next Generation Fuels Industrial & Technological fund Calderion (Audacia), alongside infrastructure developer Terravent and WenCo Family Office, announces the closing of a strategic double-digit million-euro financing round for Berlin-based Graforce GmbH. The investment is dedicated to the industrial scale-up of Graforce’s proprietary plasma pyrolysis technology, addressing the growing global demand for cost-efficient low-carbon hydrogen, syngas, and carbon removal solutions that are compatible with existing industrial infrastructures. Disruptive alternative to conventional processes Graforce’s technology aims at replacing CO₂-intensive legacy routes such as steam reforming and classical gasification. By applying plasma to methane, biogas, flare gas, and landfill gas, the process converts these streams into their valuable molecular components instead of emitting them. The result is a high-efficiency production of clean hydrogen and syn
Mevion Medical Systems Announces CE Marking of the MEVION S250-FIT™ Proton Therapy System, Expanding Global Access to Compact Proton Therapy25.2.2026 08:00:00 CET | Press release
CE Marking enables marketing and clinical use of the world’s first and only LINAC vault-ready proton therapy system across the European Union Mevion Medical Systems, the global leader in compact proton therapy, today announced that the MEVION S250-FIT Proton Therapy System has successfully completed the conformity assessment process and has received CE Marking under Regulation (EU) 2017/745 (EU MDR). This regulatory milestone enables the marketing, sale, and clinical use of the MEVION S250-FIT system throughout the European Union, building on the system’s existing U.S. FDA 510(k) clearance granted in September 2025. The MEVION S250-FIT is the first and only proton therapy system designed to fit into a standard radiation therapy vault. By enabling cancer centers to use their existing infrastructure, the MEVION S250-FIT dramatically reduces the cost, complexity, and timeline traditionally associated with proton therapy adoption. This opens a new pathway for hospitals and cancer centers a
Bureau Veritas:Sector-Leading Organic Revenue Growth of 6.5% in FY 202525.2.2026 07:30:00 CET | Press release
Strong margin improvement to 16.3% in FY 2025Positive growth outlook with continued margin expansion in 2026New EUR 200 million share buyback Bureau Veritas (BOURSE:BVI): 2025 key figures1 › Full-year revenue of EUR 6,466.4 million, up 6.5% organically (with 6.3% organic growth in Q4). At constant currency, the growth was up 7.3% year-on-year and up 3.6% on a reported basis, › Adjusted operating profit of EUR 1,052.9 million, up 5.7% versus EUR 996.2 million in FY 2024, representing an adjusted operating margin of 16.3%, up 32 basis points year-on-year and up 51 basis points at constant currency, › Operating profit of EUR 992.4 million, up 6.3% versus EUR 933.4 million in FY 2024, › Adjusted net profit of EUR 631.4 million, up 1.7% versus EUR 620.7 million in FY 2024, › Adjusted EPS stood at EUR 1.42 in 2025, with a 2.8% increase versus FY 2024 (EUR 1.38 per share) and up 9.2% at constant currency, › Attributable net profit of EUR 588.0 million, up 3.3% versus EUR 569.4 million in FY 2
Galderma Announces Triple Approval of New State-of-the-Art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics25.2.2026 07:00:00 CET | Press release
Regulatory authorities in the European Union (EU), the United States (U.S.), and Canada have approved a new state-of-the-art Restylane®syringe for use with a range of Restylane NASHA® lidocaine products in multiple indications in the face and in the hands1-3 Developed in collaboration with aesthetic practitioners, its innovative ergonomic design features a cushioned finger grip and thumb rest, to improve practitioner experience through better injection comfort and control, helping them deliver consistently premium results 4-7 The syringe’s carton packaging is the first in the industry to be made from 100% recyclable paper, and reaffirms Galderma’s commitment to sustainability and environmental responsibility 8 These approvals demonstrate Galderma’s strong heritage in Injectable Aesthetics, and its commitment to continuing to drive innovation in the field Galderma (SIX: GALD), today announced that regulatory authorities in the EU, the U.S., and Canada have approved a new state-of-the-ar
Azafaros Announces Publication of Preclinical Efficacy Data with Nizubaglustat in GM2 Gangliosidosis25.2.2026 07:00:00 CET | Press release
Preclinical proof-of-concept data in GM2 gangliosidosis demonstrated survival benefit, functional improvement and target engagementResults are published in the 7 January issue of the Journal of Inherited Metabolic DiseaseNizubaglustat is currently in Phase 3 registrational studies in GM1/GM2 gangliosidoses and Niemann-Pick type C disease (NPC) Azafaros, a company aiming to become a leader in lysosomal storage disorders (LSDs), focused on addressing especially neurological symptoms, today announced the publication of proof-of-concept preclinical data with its lead product, nizubaglustat, in GM2 gangliosidosis. The data, published in the 7 January issue of the Journal of Inherited Metabolic Disease in collaboration with the laboratory of Dr. Jagdeep Walia, Department of Pediatrics, Queen's University, Kingston, Canada, reinforce nizubaglustat’s potential to address unmet needs in rare LSDs and build on existing preclinical and clinical evidence. The preclinical study tested nizubaglustat
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