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 It was later voluntarily withdrawn from the market for commercial reasons.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



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

Pacific Drilling Commences Voluntary Chapter 11 Proceedings; Restructuring Support Agreement to Eliminate All $1.1 Billion of Bond Debt; World-wide Operations Expected to Continue as Usual31.10.2020 00:52:00 CETPress release

Pacific Drilling S.A. (NYSE: PACD) announced today that it and certain of its domestic and international subsidiaries have filed voluntary petitions for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of Texas and have entered into a restructuring support agreement with an ad hoc group of the largest holders of its outstanding bond debt. This consensual financial restructuring transaction will eliminate the Company’s approximately $1.1 billion in principal amount of outstanding bond debt through the cancellation and exchange of debt for new equity in the reorganized Company. The Company also announced today that it has repaid its $50 million first lien superpriority revolving credit agreement with Angelo, Gordon Energy Servicer, LLC, as administrative agent and the lenders party thereto. With approximately $120 million of cash and cash equivalents as of October 30, 2020, and seven of the most advanced high-spe

Homestead Capital Closes Fund III at Target, Surpasses $1 Billion in Cumulative AUM31.10.2020 00:07:00 CETPress release

Homestead Capital USA LLC (“Homestead”), a private equity firm investing in farmland in the United States, has held a final close of its third fund, Homestead Capital USA Farmland Fund III, L.P. (“Fund III”), with $596 million in capital commitments. With these additional commitments, the firm has surpassed $1 Billion in AUM across its three funds. “We are grateful for the support and opportunity to invest on behalf of our broad range of returning and new investors,” said Dan Little, Co-Founder and Co-CEO of Homestead. “We are humbled by our limited partners’ confidence in us as investors. Fund III represents an endorsement of our ability to drive positive investment outcomes and act as long-term stewards of our limited partners’ capital.” “The United States farmland market continues to undergo a transition that presents many attractive investment opportunities,” said Gabe Santos, also a Co-Founder and Co-CEO of Homestead. “Our strategy is uniquely suited to create value by utilizing o

Bennett Goodman and Avi Kalichstein Launch Hunter Point Capital to Invest in Alternative Investment Managers30.10.2020 19:03:00 CETPress release

Bennett Goodman and Avi Kalichstein today announced the formation of Hunter Point Capital LP (“HPC”), an independent investment firm seeking minority stakes in middle-market alternative asset managers. As part of the launch, HPC has formed a strategic partnership with a group of leading global investment entities associated with Jacob Rothschild. "I am thrilled to initiate this next phase of my career with such an exceptional team. Our HPC partnership seeks to leverage our collective expertise as investors and business builders to cultivate the next generation of outstanding investment franchises,” said Goodman. “Our goal is to help general partners achieve their long-term business objectives faster and with more certainty.” “At our core, Hunter Point Capital is focused on investment excellence. We seek managers with proven track records, who will benefit from a strategic, impact-oriented partner,” said Kalichstein. “There is an expanding universe of high-performing investment manageme

Code:n@xt: PROCAD to Lift the Veil on a New PLM Generation30.10.2020 17:31:00 CETPress release

On November 11, 2020, PRO.FILE next, the next product generation by PROCAD will be officially launched. At 11:00 AM EST, 10:00 AM CET, the groundbreaking, cloud-enabled platform for the digital transformation of business processes will be presented to the public for the first time at Code:n@xt, a must-attend event for anyone interested in digital transformation, information and product lifecycle management. PROCAD's managing directors, strategists, business developers, and developers will come together for Code:n@xt to present PRO.FILE next – whose code will change the world of PLM software. The online event will feature breakout sessions and a live demo of the new system, take a look at today's market demands and digital transformation trends, and give attendees the opportunity to chat with the company's experts. Where does digital transformation start? Where does a PLM platform as a Product Data Backbone fit into it? How do you build an information twin as a digital replica of a piec

INX Applies for Listing on the Canadian Securities Exchange (CSE)30.10.2020 14:00:00 CETPress release

INX Limited (“INX”) today announced its application for listing of its digital security, the INX Token, on the Canadian Securities Exchange (“CSE”). The listing application is subject to the approval of the CSE. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201030005313/en/ Shy Datika, Co-Founder and President at INX (Photo: Business Wire) INX recently launched the first SEC-registered digital security IPO for both retail and institutional investors. INX intends to use the net proceeds from the IPO for a launch of a regulated trading platform for digital assets and provide novel trading and capital raising financial instruments to enterprises in collaboration with traditional exchanges worldwide. The CSE is a proponent of exchange-listed digital securities and continues to work towards additional services in connection with the post-trade processes for these securities. Richard Carleton, CEO of the CSE has stated that “The

Veracyte Announces New Data Published in Journal of Clinical Oncology Suggest the Prosigna Breast Cancer Test’s Genomic Underpinning Drives Prognostic Performance30.10.2020 13:15:00 CETPress release

Veracyte, Inc., (Nasdaq: VCYT) announced today that findings from the first study evaluating the molecular drivers underlying multiple prognostic genomic breast cancer tests were published in the Journal of Clinical Oncology (JCO). Results suggest that the genomic underpinnings of Veracyte’s Prosigna® Breast Cancer Gene Signature Assay, particularly the test’s relative weighting of genes predicting tumor proliferation, may explain the classifier’s previously demonstrated, higher likelihood of predicting long-term risk of recurrence among certain breast cancer patients, compared to other breast cancer tests. The study compared the commercial forms of four breast cancer recurrence-risk tests: the PAM50-based Prosigna Risk of Recurrence (ROR), the Oncotype DX Risk Score (RS), EndoPredict (EP) and Breast Cancer Index (BCI). It expands upon a previous evaluation of these same tests using an identical dataset, which compared their ability to accurately predict 10-year distant disease recurre

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