Business Wire

LintonPharm Announces Authorization From China Health Authority to Proceed With a Global Phase 3 Trial Evaluating Catumaxomab in Advanced Gastric Cancer

Share

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 It was later voluntarily withdrawn from the market for commercial reasons.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 2018.1About 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

  1. 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.
  2. Wanqing Chen et. al., Cancer Statistics in China, 2015. CA Cancer J. Clin 2016; 66: 115-132
  3. 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.

Contact information

Media:
Tara Cooper
The Grace Communication Group
tara@gracegroup.us
650-303-7306

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Taulia’s Darcy Douglas Named One of the Top Women in Supply Chain23.9.2020 19:30:00 CESTPress release

Taulia, the leader in working capital technology solutions, has today announced Darcy Douglas, VP of Professional Services, has been listed as a recipient of Supply & Demand Chain Executive’s first Women in Supply Chain award. The award recognizes female leaders in the supply chain industry who have demonstrated a commitment to excellence in their respective roles and also supporting other women to develop their careers and skills. Darcy has been at Taulia for ten years and her leadership has helped the company grow from a small start-up to an established market leader in the supply chain finance industry. During her time at Taulia, Darcy has spearheaded the creation of three leadership and professional development programs that help Taulians boost their skills and enhance their careers. Specifically, Darcy created the Leadership Initiative for Taulia (LIFT) program for women, which includes a mentoring program, education classes, and other activities, to inspire development and leader

DC Secretary Announces Proposed Amendments to DC Rules23.9.2020 17:22:00 CESTPress release

DC Administration Services, Inc., in its capacity as DC Secretary, has today published to the DC website proposed amendments to the Deliverable Obligation and External Review provisions of the DC Rules. Any Eligible Market Participant may provide comments on the proposed amendments to the DC Rules until 5:00pm EDT Tuesday, September 29, 2020. The proposed amendments to the DC Rules, together with additional information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. Other inquires may be directed to Mark Ferraris at mark.ferraris@citadelspv.com View source version on businesswire.com: https://www.businesswire.com/news/home/20200923005724/en/Contact information Mark Ferraris mark.ferraris@citadelspv.com

CORRECTING and REPLACING SES Becomes Microsoft Azure Orbital Founding Connectivity Partner23.9.2020 15:38:00 CESTPress release

Second paragraph of release dated September 22, 2020 should read: The first MEO and Earth Observation gateways will be located in the United States; in Phoenix, Arizona and Quincy, Washington respectively.(instead of ... located in Phoenix, Arizona, United States and Quincy, Western Australia respectively). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005927/en/ SES Becomes Microsoft Azure Orbital Founding Connectivity Partner (Photo: Business Wire) The updated release reads: SES BECOMES MICROSOFT AZURE ORBITAL FOUNDING CONNECTIVITY PARTNER SES’s proven low-latency MEO managed services to be part of Microsoft’s new multi-orbit satellite connectivity integrated with Azure, promising optimized cloud application performance for O3b mPOWER customers SES today announced it has joined as the medium Earth orbit (MEO) connectivity partner for Microsoft Azure Orbital, Microsoft’s new managed service enabling network operators

CORRECTING and REPLACING SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement23.9.2020 15:36:00 CESTPress release

Eighth paragraph of release dated September 22, 2020 should read: The two companies will make joint investments in Azure Orbital ground stations for the MEO and Earth Observation segments that SES will deploy and manage based on its industry expertise, with the first Earth Observation gateway being located at Quincy, Washington in the United States. (instead of ... with the first Earth Observation gateway being located at Quincy, Western Australia.). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200922005930/en/ SES Advances Digital Transformation with Cloud-First Strategy, Expanded Agreement (Photo: Business Wire) The updated release reads: SES ADVANCES DIGITAL TRANSFORMATION WITH CLOUD-FIRST STRATEGY, EXPANDED AGREEMENT Multi-year agreement with Microsoft includes Azure Orbital integration, SES’s expanded use of Azure and joint development of new video and data connectivity services SES today announced plans to significan

Former World Head of State to Address Attendees at Everbridge’s COVID-19: Road to Recovery (R2R) Symposium, Joining Dr. Anthony Fauci, Sir Richard Branson, and Dr. Sanjay Gupta as Keynotes, October 14-15, 202023.9.2020 15:29:00 CESTPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced that a former World Head of State will address attendees to its Autumn 2020 “COVID-19 R2R: The Road to Recovery” virtual leadership summit to be held October 14-15, 2020, covering the path forward amid the COVID-19 pandemic. The addition of a former World Head of State represents the latest in a top-tier line-up of leading experts and C-level executives who will share their perspectives on best practices for the safe reintegration of people back to work, campuses and public spaces; the restoration of revenue-generating operations; and the protection of citizens on a countrywide scale amid the coronavirus pandemic. Keynote speakers include presidential advisor and Director of the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH) Dr. Anthony Fauci, Virgin Group Founder Sir Richard Branson, and renowned neurosurgeon and CNN Chie

Global Travel Industry Embracing Autonomous UVD Robots23.9.2020 15:02:00 CESTPress release

With the latest forecast by the U.S. Travel Association by Tourism Economics predicting $505 billion in losses globally through the end of 2020, UVD Robots announced its autonomous disinfecting robot is being increasingly deployed within hotels, railways, and airports globally. UVD Robots’ mobile, fully autonomous robot integrates UVC light and a large number of disinfection-specialized apps to disinfect against viruses and bacteria not only on surfaces, but the air as well, providing a fully comprehensive infection control and prevention solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200923005177/en/ “Right now it’s critical for the hospitality industry to not only enhance how we protect travelers but also provide them with reassurance that we’re taking every possible step from check-in to check-out,” said Trish Berry, General Manager, YOTEL Boston. An extension of YOTEL’s operation #SmartStay safety measures, the