LINTONPHARM
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
New Study Further Validates Environmental Benefits of Floor Refinishing Compared to Replacement12.11.2025 12:00:00 CET | Press release
Renovation of hard flooring surfaces, such as wood and resilient, saves up to 92 percent in CO2 emissions and up to 98 percent in energy usage A recent report and lifecycle assessment (LCA) conducted by IVL Swedish Environmental Research Institute confirms refinishing hard flooring surfaces, including wood, vinyl and linoleum, is more sustainable for the environment than replacing the flooring surfaces. This new study, which was conducted for the German market, is the next step of research inspired from a previous 2019 study conducted in Sweden. Both studies aim to evaluate the environmental impact of replacing a worn, damaged or outdated flooring surface compared to refinishing the flooring surface which may include sanding, finishing, staining, or painting. Bona, a global, family-owned company that supplies products for installing, renovating, maintaining, and restoring premium floors, commissioned this new study to build on the findings from a 2019 Swedish study. The new research fo
PUMA Relaunches Company Magazine CATch UP to Showcase the Best of the Brand12.11.2025 10:00:00 CET | Press release
Sports company PUMA has relaunched its online company magazine CATch UP to provide journalists, investors, retailers, athletes and sports enthusiasts with a window into the world of PUMA and insights into the company’s new strategic priorities, as the brand starts its transformation journey. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251112815459/en/ Sports company PUMA has relaunched its online company magazine CATch UP to provide journalists, investors, retailers, athletes and sports enthusiasts with a window into the world of PUMA and insights into the company’s new strategic priorities, as the brand starts its transformation journey. The online magazine, which is available on puma-catchup.com, has received a thorough visual makeover and will focus on the stories that highlight the company’s innovations, sports, history, corporate culture and the strategic priorities that are being implemented to establish PUMA as a T
CWAN Report: Insurance Industry’s $2.7 Trillion Shift to Alternative Investments Creates Technology Gap12.11.2025 10:00:00 CET | Press release
CWAN Analysis of 400 Insurers Shows Some Insurers Now Allocate 40-50% in ‘Alternatives’ Clearwater Analytics (NYSE: CWAN), the most comprehensive technology platform for investment management, today released industry research revealing that alternative investments have fundamentally transformed from a fringe strategy to a portfolio cornerstone, now comprising nearly one-third of the US insurance industry’s assets – representing approximately $2.7 trillion – as insurers abandon traditional portfolio strategies. Similar structural shifts are also emerging across the UK and continental Europe as insurers pursue diversification, yield and liability-matching under Solvency II and evolving capital rules. The report, “Are ‘Alternatives’ Still Alternative?”, combines industry-wide NAIC data with analysis of approximately 400 CWAN insurers representing $4.4 trillion in combined assets, including UK and European insurers on the CWAN platform, providing granular insight into alternative investmen
INNIO to Power UK Grid Stability with Landmark Project Near London12.11.2025 09:00:00 CET | Press release
One of the world’s largest high-speed gas engine power plants will provide 450 MW of scalable power Power plant to support grid stability in Southeast England, powering up to 1 million homes near London INNIO Group and Clarke Energy are helping to deliver one of the world’s largest high-speed gas engine peaking power plants in Thurrock, England. The two companies already signed a contract to this effect in 2024. The 450-MW flexible generation facility is being constructed by Statera Energy, a leading developer, owner, and operator of flexible energy assets. With full operations targeted for late 2026, it is expected to provide enough power for up to 1 million homes in Southeast England—helping to support the UK’s energy resilience strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251112767813/en/ Thurrock Flexible Generation Project (c) Statera Energy As the UK transitions to renewables, grid stability is more critica
Visa Direct Stablecoin Payouts Pilot Speeds Up Access to Funds for Creators & Gig Workers12.11.2025 09:00:00 CET | Press release
New Visa Direct pilot sends USD-backed stablecoin payouts directly to stablecoin wallets, giving creators and gig workers faster access to their funds. At Web Summit today, Visa Inc. (V) announced a breakthrough pilot allowing businesses and platforms to send payouts directly to recipients’ stablecoin wallets. For businesses using Visa Direct, payouts can be funded in fiat currency, while recipients can choose to receive their funds in USD-backed stablecoins like USDC, transforming the speed and accessibility of global payouts. This innovation expands the reach of Visa Direct by providing creators, freelancers, and marketplaces with a stable store of value and faster access to funds - even in markets facing currency volatility or limited banking infrastructure. “Launching stablecoin payouts is about enabling truly universal access to money in minutes - not days - for anyone, anywhere in the world,” said Chris Newkirk, President, Commercial & Money Movement Solutions, Visa. “Whether it’
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