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
Crown Bioscience and Turbine Partner to Connect AI-Driven Prediction with Organoid Validation in Translational Oncology21.4.2026 14:30:00 CEST | Press release
Crown Bioscience, a global contract research organization (CRO) and a JSR Life Sciences company, today announced a strategic partnership with Turbine, a leading virtual biology company, to advance translational oncology research by integrating Turbine’s in silico Virtual Assays with its Tumor Organoid Assays based on HUB Organoid Technology. This collaboration establishes a connected workflow that enables researchers to move more efficiently from hypothesis to validation. Turbine’s Virtual Assays simulate biological response across thousands of biological samples and hundreds of drugs, generating predictive insights to identify and prioritize targets, therapies, and combinations. The predictions will be enhanced through the incorporation of multimodal and drug response data from hundreds of tumor organoid models at Crown Bioscience. Together, the companies create a closed-loop approach linking prediction with validation, improving predictive accuracy, reducing experimental burden, whil
Responding to Customer Demand, Starlink High-Speed Connectivity Now Available as an Aftermarket Option on the Cessna Citation Ascend; 560XL Series Achieves EASA Certification21.4.2026 14:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced at AERO Friedrichshafen the availability of Starlink highspeed connectivity as an aftermarket upgrade for the Cessna Citation Ascend, the newest aircraft in the bestselling Cessna Citation 560XL series, following the Federal Aviation Administration’s issuance of AeroMech’s Supplemental Type Certificate (STC). In addition, the Cessna Citation 560 XL fleet — including the XLS Gen 2, XLS+, XLS and Excel — has received European Union Aviation Safety Agency (EASA) certification for Starlink installation at Textron Aviation’s European service centers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260420017406/en/ Responding to customer demand, Starlink high-speed connectivity now available as an Aftermarket option on the Cessna Citation Ascend; 560XL series achieves EASA certification AeroMech’s STC utilizes Starlink’s high-speed internet technology connec
Moody’s Advances Decision-Grade Credit Intelligence Across Enterprise AI Workflows, Powered by Microsoft 365 Copilot21.4.2026 14:00:00 CEST | Press release
Moody’s decision-grade intelligence now available directly in the AI-powered tools where market participants work Moody’s Corporation (NYSE: MCO) today announced the next phase of its strategic partnership with Microsoft, integrating Moody’s decision-grade intelligence directly into Microsoft AI solutions. The milestone expands the collaboration from co-innovation to scaled, workflow-embedded distribution of Moody’s decision-grade intelligence across the enterprise environments where its customers work every day. “For over 115 years, Moody’s has served as the intelligence layer that financial professionals turn to when making consequential decisions,” said Rob Fauber, President and Chief Executive Officer of Moody’s. “By embedding that intelligence directly into Microsoft’s AI solutions at enterprise scale, we’re making decision-grade analysis available not just to specialists, but to every person across an organization who needs it.” The integrations operate across two channels. Using
Redslim expands its global footprint into Latin America21.4.2026 14:00:00 CEST | Press release
Redslim, a specialist in end-to-end data management solutions and an Astorg portfolio company, today announced its expansion into the Latin America (LATAM) region, marking the next step in its growth strategy to support multinational brands and retailers across every major market. Following its recent expansion into APAC, this move reinforces Redslim’s momentum in building a truly global presence, reflecting growing demands from international clients for a trusted partner delivering reliable and AI-ready data and insights at scale. The expansion includes the appointment of Alejandro Merlo as Regional Director and Javier Gonzalez as Regional Manager for the region. Latin America represents a strong growth opportunity for global consumer brands, but also one of the most complex data environments. Rapid digital adoption and shifting consumer behaviours are driving demand for reliable market intelligence, while fragmented retailer structures and country-specific data landscapes make consis
Adtran’s SDG router portfolio receives FCC conditional approval, supporting ongoing broadband expansion21.4.2026 14:00:00 CEST | Press release
News summary: FCC approval exempts Adtran’s SDG router portfolio from Covered List restrictions through October 1, 2027 Decision enables uninterrupted shipments, authorizations and deployments across current and next-generation SDG platforms Regulatory clarity supports long-term SDG investment and rollout planning Adtran today announced that its service delivery gateway (SDG) carrier-grade router portfolio has received conditional approval from the FCC’s Public Safety and Homeland Security Bureau, formally exempting the platforms from FCC Covered List restrictions through October 1, 2027. The decision places Adtran among the first router manufacturers to achieve this designation under the FCC’s national security review process. By ensuring continued access to Adtran’s SDG technology, the approval enables service providers to maintain deployment momentum, reduce operational risk and invest confidently in the long-term expansion of broadband networks while navigating evolving regulatory
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