LintonPharm announces first patient dosed in Phase 1 clinical trial of catumaxomab for Non-Muscle-Invasive Bladder Cancer unresponsive to Bacillus Calmette-Guerin

Guangzhou, China--(ANTARA/Business Wire)- 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 the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

“The initiation of our Phase 1 trial of catumaxomab for the treatment of NMIBC is an important step in our clinical program evaluating catumaxomab as 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 need new therapies due to the limitations of current treatments which bring poor prognosis, such as high rates of tumor recurrence, bladder dysfunction and lifelong intervention. Based on encouraging pre-clinical data and clinical experience with patients who’ve received catumaxomab in the past through the compassionate use program, we are hopeful that catumaxomab will be a very promising immunotherapy candidate for patients with NMIBC BCG failure.”

A recent publication indicated clinical benefits of catumaxomab as compassionate use in patients with EpCAM-positive recurrent NMIBC. It is noted that catumaxomab was well tolerated and presented promising performance in tumor control [1]. Based on the data and the developmental potential, catumaxomab could provide a feasible, safe, and efficacious therapy for NMIBC patients, if approved.

Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases in 2020 and roughly 75 percent are diagnosed as NMIBC [2][3]. Currently, the mainstay treatments of NMIBC include transurethral resection, chemotherapy and intravesical BCG [3].

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 (clinicaltrials.gov: NCT04222114).

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 has developed multiple bispecific antibody platforms with a great potential of refined safety and efficacy profiles, long-lasting vaccinal effects and CMC efficiency. The current pipeline includes several treatments in development for blood cancer and solid tumors. The leading molecule, catumaxomab is being evaluated in clinical trials for both advanced gastric cancer and non-muscle invasive bladder cancer. For more information, please visit www.lintonpharm.com.

[1]. Ruf P, Bauer HW, Schoberth A, Kellermann C, Lindhofer H (2021). First time intravesically administered trifunctional antibody catumaxomab in patients with recurrent non muscle invasive bladder cancer indicates high tolerability and local immunological activity. Cancer Immunology, Immunotherapy. http://doi.org/10.1007/s00262-021-02930-7

[2]. World Health Organization (WHO). Globocan 2020. Global Cancer Observatory. Accessed January 7, 2021. https://gco.iarc.fr/

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Tim Hay

The Grace Communication Group

tim@gracegroup.us

Mia He

LintonPharm

jingyi.he@lintonpharm.com