LINTONPHARM
13.4.2021 14:02:12 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 that China’s health authority, National Medical Products Administration (NMPA) authorized the company to proceed with a Phase 1/2 clinical trial (clinicaltrials.gov: NCT04799847 ) evaluating the safety and efficacy of catumaxomab in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure. This is LintonPharm’s second clinical program evaluating catumaxomab. In July 2020, the company announced authorization of a Phase 3 trial in advanced gastric cancer which screened its first patient in October 2020.
Recently, Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase 1 trial with catumaxomab in NMIBC patients in Germany (clinicaltrials.gov: NCT04819399 ) and reported an excellent safety profile, which supports the conduct of the Phase 1/2 trial in China.
“Regulatory clearance to move forward with our clinical program evaluating catumaxomab in bladder cancer is another significant milestone for LintonPharm and supports our goal of exploring the potential for this targeted therapy in a broad range of cancers,” said Robert Li, Ph.D., DABT, Co-founder and CEO of LintonPharm. “Patients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function. New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients.”
Bladder cancer is the 10th most common cancer worldwide. In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period [1] . NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer [2] . Transurethral resection of bladder tumor (TURBT) is the current standard of treatment for NMIBC. Relapse is common after TURBT (up to 70 percent at five years) and as a result, patients often undergo multiple surgical procedures over a longer period [2] . Intravesical BCG is commonly used as an adjuvant treatment after TURBT. However, a large number of patients experience tumor recurrence, which is referred to as BCG failure [3] . Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.
About Catumaxomab
Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. This bispecific 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 destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.
Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer.
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. LintonPharm, in collaboration with Lindis Biotech, is developing catumaxomab for use in a broad range of cancers globally. Additionally, LintonPharm is developing a next generation bispecific antibody platform to provide a more robust manufacturing and drug design and increased flexibility to individualize the design of each molecule. The current pipeline includes several treatments in development for blood cancer and solid tumors. For more information, please visit www.lintonpharm.com/ .
[1]. World Health Organization (WHO). Globocan 2020. Global Cancer Observatory. Accessed January 7, 2021. https://gco.iarc.fr/
[2]. Kamat AM, Hahn NM, Efstathiou JA, et al. (2016) Bladder cancer. Lancet 2016. 388: 2796-810. http://dx.doi.org/10.1016/S0140-6736(16)30512-8
[3]. Kikuchi E, Hayakawa N, Futumoto K, Shigeta K, Matsumoto K. (2020) Bacillus Calmette–Guerin-unresponsive non-muscle-invasive bladder cancer: Its definition and future therapeutic strategies. International Journal of Urology. 27, 108-116. doi:10.1111/iju.14153
View source version on businesswire.com: https://www.businesswire.com/news/home/20210413005114/en/
Link:
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
Vena To Acquire Acterys, Creating a New Category of Enterprise Performance Management: Orchestrated Planning3.2.2026 17:00:00 CET | Press release
The acquisition unites finance foresight and IT innovation in the first Microsoft-native Orchestrated Planning environment, helping enterprises plan better and achieve more by turning strategy into aligned execution in real time. Vena, the only complete FP&A platform powered by agentic AI and purpose-built to amplify the Microsoft technology ecosystem, today announced it has entered into a definitive agreement to acquire Managility Pty Ltd, operating as Acterys (“Acterys”), the industry’s leading Power BI–based operational planning and app development platform, subject to customary closing conditions and regulatory approval. This acquisition unlocks a category-defining way for enterprises to combine planning, analytics, and application development within the Microsoft tools they already trust to run their business. By combining Vena’s Excel-native financial planning and analysis (FP&A) capabilities with Acterys’ proprietary Power BI write-back engine and unified analytics within Micros
Volante Technologies named a Leader in Gartner® Magic Quadrant™ for Banking Payment Hub Platforms3.2.2026 16:15:00 CET | Press release
Volante believes its solutions provide complete always-on payment processing support for banks and financial institutions across all tiers Volante Technologies, the global leader in Payments as a Service (PaaS), today announced its recognition as a Leader in the 2026 Gartner® Magic Quadrant™ for Banking Payment Hub Platforms, which evaluates vendors based on Ability to Execute and Completeness of Vision. In Volante’s view, Gartner positioned them as a Leader based on their capacity to support enterprise-scale payment processing in banks and financial institutions across multiple regions, deployment models, and operational environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203149834/en/ This graphic was published by Gartner, Inc. as part of a larger research document and should be evaluated in the context of the entire document. As the highest positioned provider in Ability to Execute, Volante believes its AI-pow
Toptal Ranked #1 Most Reliable Professional Services Company in America by Newsweek3.2.2026 16:00:00 CET | Press release
Toptal, the world’s largest fully remote workforce, has been ranked the #1 most reliable professional services company in America on the America’s Most Reliable Companies 2026 list by Newsweek and Statista. The list ranks top US companies based on trust, dependability, and consistent performance in their industry. In Newsweek’s ranking of 300 companies across all industries, Toptal took 10th place, right behind Bank of America and Oracle, which tied for 9th. As the most reliable professional services organization in America, Toptal, which ranked 11th in absolute rankings across all companies, placed well ahead of companies like Accenture (33), Deloitte (39), and Cognizant (66). The America’s Most Reliable Companies 2026 ranking is based on an independent survey of more than 80,000 evaluations submitted by 2,400 business decision-makers at America’s largest companies, including Apple, Dropbox, Johnson & Johnson, and UPS, making this recognition an especially meaningful indicator of prod
HTEC Research Reveals the Real AI Scaling Challenge: It’s Not the Technology3.2.2026 15:46:00 CET | Press release
Global executive survey finds AI momentum is real—but leadership alignment, capability gaps, and ROI clarity are slowing enterprise impact AI has moved from ambition to action. Every organization is deploying it. Yet for most enterprises, the real challenge is only just beginning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203951136/en/ HTEC, a global AI‑first provider of software and hardware design and engineering services, released Executive Summary: A Cross‑Industry View of the State of AI in 2025, a global research report capturing how senior executives are navigating the next phase of AI transformation—and why scaling value remains elusive. Today, HTEC, a global AI‑first provider of software and hardware design and engineering services, released Executive Summary: A Cross‑Industry View of the State of AI in 2025, a global research report that captures how senior executives are navigating the next phase of AI tra
Yubico Reveals 265% ROI and 99.99% Reduction in Risk of Exposure to Addressable Breach Risk Costs According to Total Economic Impact Study3.2.2026 15:00:00 CET | Press release
Effectiveness of Yubico’s technology: $5.3 million Net Present Value and $7.3 million in total benefits over three years, driven by 80% faster authentication and reduced help desk burden Yubico (NASDAQ STOCKHOLM: YUBICO), a modern cybersecurity company and creator of the most secure passkeys, today announced the results of a commissioned Total Economic Impact™ (TEI) of Yubico YubiKeys study conducted by Forrester Consulting. The study, comprised of interviews with global enterprises with over 5,000 employees, found that a composite organization based on interviewed customers achieved a 265% return on investment (ROI) and a net present value (NPV) of $5.3 million over three years by replacing traditional multi-factor authentication (MFA) and one-time passwords (OTPs) with phishing-resistant YubiKeys. In an era of high-quality deepfakes and generative AI-driven extortion, the study shows a critical shift in cybersecurity: traditional MFA is no longer sufficient to stop modern MFA-bypass
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