BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a biopharmaceutical company developing Western drug candidates in China and North Asia, announced that the China National Drug Administration (CNDA) has approved the Investigational New Drug (IND) application for a Phase Ib/III clinical study of CAN017 in esophageal squamous cell cancer (ESCC). The Phase Ib/extension study is a multicenter, open label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CAN017 in combination with chemotherapy as the second line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). ESCC is the most prevalent form of esophageal cancer, with 50% of the cases occurring in China. The CAN017 IND approval is a key milestone for CANbridge and the second one this year, following the IND approval to commence a trial in CAN008 in glioblastoma multiforme (GBM) in April.
CAN017 is an ErbB3 (HER3) inhibitory antibody humanized IgG1/κ ERBB3 inhibitory antibody that completed a first-in-human Phase I clinical trial in patients with advanced solid tumors in US patients. In preclinical work, CAN017 showed potential for the treatment of ESCC. Additional preclinical work, in human cancer models, found Neuregulin 1 (NRG1) gene expression to be a promising biomarker, with the potential to predict response to ERBB3 inhibition by CAN017.
“Standardized second-line therapy for advanced esophageal carcinoma is not available so far,” said Professor Lin Shen, Vice-President of Beijing Cancer Hospital. “There is no drug approved as targeted therapy for ESCC, which is prevalent among Chinese. It’s necessary and pressing to develop this investigational drug, with a defined target and biomarkers, for such unique unmet medical needs in China.”
“The CNDA approval to start our second trial in China in a single year illustrates CANbridge’s commitment to bring promising treatments to underserved populations and our emergence as a commercial-stage biopharmaceutical company with a strong clinical pipeline,” said James Xue, PhD, MBA, CANbridge Chairman, President and CEO. “We plan to commence our multi-center clinical trial in CAN017 in esophageal squamous cell cancer this year, as well as to continue to explore other potential CAN017 indications which show promise preclinically. “
About Esophageal Squamous Cell Cancer (ESCC)
Esophageal squamous cell cancer (ESCC) is the most common form of esophageal cancer. According to the World Health Organization, it is also the eighth-most common cancer globally, with over 450,000 new cases diagnosed each year. However, ESCC occurs predominantly in China, which is widely believed to have 50% of the cases, as well as in other parts of Asia. Most esophageal cancer treatments address the adenocarcinoma form of the cancer, most prevalent form in the West, leaving ESCC patients with few options.
About CANbridge Life Sciences
CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia, or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia.
CANbridge has exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China), which was approved by the FDA, in 2017, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and which CANbridge is developing as CAN030. CANbridge plans to target HER2-positive cancers, including breast and gastric. CANbridge has a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, which CANbridge is developing as CAN008, for the treatment of glioblastoma multiforme (GBM) in greater China. CANbridge received China National Drug Administration (CNDA) approval to commence a Phase II/III Trial in GBM in mainland China, which it expects to initiate later this year. CANbridge has a world-wide license (ex-North America) to develop, manufacture and commercialize AVEO Oncology’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, which it will develop as CAN017. CANbridge also has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments. Caphosol was approved for commercialization by the CNDA.
Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions.
CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.