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 Ⅰ/Ⅱ 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 Ⅲ trial in advanced gastric cancer which screened its first patient in October 2020.
Recently,
Lindis Biotech, partner of LintonPharm, initiated a dose-finding Phase Ⅰ trial with
catumaxomab in NMIBC patients in Germany (clinicaltrials.gov: NCT04819399) and reported an excellent
safety profile, which supports the conduct of the Phase Ⅰ/Ⅱ 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.
[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