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LintonPharm Announces Authorization from China Health Authority to Proceed with a Phase 1/2 Trial Evaluating Catumaxomab for the RX of Non-Muscle Invasive Bladder Cancer

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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 the 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. 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. Radical cystectomy (RC) is usually recommended after BCG failure, but many physicians and patients refrain from RC in favor of preserving bladder function.

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 have 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.

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