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
Incyte Announces the European Commission Approval of Zynyz® (retifanlimab) for the First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)6.3.2026 22:42:00 CET | Press release
- Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) is the first systemic treatment for adult patients with advanced SCAC in Europe- The EC approval is based on results of the POD1UM-303 study which showed that adult patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment compared to chemotherapy alone.1 Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). “The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meur
Dfns Launches Payouts6.3.2026 21:27:00 CET | Press release
Dfns today announced the launch of Payouts, a new API enabling institutions to convert stablecoins to fiat and route payouts across multiple bank accounts while keeping wallet-level governance and controls in place. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260305327930/en/ Convert stablecoins to fiat and settle payouts to bank accounts in 94 countries, today. Solving the problem of single-rail off-ramps Today, most fintechs and institutions still hard-wire a single payout provider into their stack, or rely on vertically integrated models that bundle routing, pricing, custody, and settlement together. That approach may be convenient early on, but it creates structural problems at scale: weak price discovery because there is no competitive pressure on margins, limited auditability because routing decisions are opaque, and operational fragility because a single provider degradation in any corridor requires architectural i
Klarna Group Plc Clarifies Mechanics of March 9 Lock-Up Expiration6.3.2026 20:23:00 CET | Press release
Klarna Group plc (NYSE: KLAR) today issues the following clarification to ensure investors and market participants have accurate information regarding the mechanics of its lock-up expiration on March 9, 2026, the processes required before pre-IPO shares can be traded on the NYSE, and the prior liquidity opportunities already available to shareholders. This release contains only factual descriptions of the Company's share structure and applicable processes. It does not constitute guidance or a projection of any kind regarding future trading volumes, share price, or the intentions of any shareholder and speaks only as of the date of this press release. 1. 335 million locked-up shares — but two different categories Of the 378 million total ordinary shares outstanding, approximately 335 million are subject to lock-up restrictions expiring March 9, 2026. However, these shares fall into two distinct categories governed by separate sets of regulations. A. 159 million shares (48% of locked-up
Lone Star Funds Announces Agreement to Acquire the Capsules & Health Ingredients Division of Lonza Group AG6.3.2026 18:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has entered into a definitive agreement to acquire the Capsules & Health Ingredients (“CHI”) division of Lonza Group AG. As part of the transaction, Lonza will retain a 40% equity position in the business. Headquartered in Basel, Switzerland, CHI operates globally across the Americas, Europe and Asia Pacific. The business comprises three segments: Hard Empty Capsules: leading global manufacturer of gelatin and plant-based capsules offering a broad range of innovative solutions for pharmaceutical and nutraceutical customers. Dosage Form Solutions: end-to-end development and manufacturing platform serving nutraceutical and pharmaceutical customers. Health Ingredients: provider of branded, science-backed nutrition ingredients serving joint health, energy and active lifestyle markets. Lone Star believes CHI is a high-quality, globally recognized platform with strong technical capabilities, different
Sutherland Launches FinAI Hub to Industrialize Agentic AI for Banking and Financial Services6.3.2026 14:00:00 CET | Press release
A domain-trained AI agent workforce enables production-scale AI across regulated financial institution operations Today, Sutherland announced the launch of Sutherland FinAI Hub, an enterprise Agentic AI platform built exclusively for Banking and Financial Services. As financial institutions accelerate AI adoption, many initiatives remain confined to pilots, unable to scale across legacy systems and core operations. Sutherland FinAI Hub is designed to help close that gap. FinAI Hub is an innovation ecosystem where Sutherland works with clients to design, prototype, and scale Agentic AI workflows across core operations. At launch, the platform brings together a large and expanding workforce of domain-trained AI agents purpose-built for financial institutions, supporting functions across retail banking, payments, cards, consumer and commercial lending, servicing, back office, risk and compliance functions. These modular agents can operate independently or be orchestrated across end-to-end
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