CANbridge Life Sciences Submits Investigational New Drug Application for CAN017 Trial in Esophageal Squamous Cell Cancer (ESCC) in China
Beijing, China, December 21, 2017 — CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it has submitted an Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA) for a Phase Ib/III clinical study of CAN017 in esophageal squamous cell cancer (ESCC). ESCC is the most prevalent form of esophageal cancer, but occurs primarily in Asia, with 50% of the cases occurring in China. The IND is CANbridge’s second CFDA submission in 2017, following that of lead candidate, CAN008, for glioblastoma, in July.
CAN017 is an ErbB3 (HER3) inhibitory antibody candidate. Preclinical work showed a potential to treat ESCC. CANbridge acquired the worldwide development rights (excluding North America) from US-based AVEO in 2016, after CAN017 (then called AV-203) had completed a US Food and Drug Administration-approved Phase I trial in solid tumors.
“We are pleased and proud to submit our second IND to the China FDA in 2017, which both meets our projected timeline and is a great accomplishment for a young biopharmaceutical company in a single year,” said James Xue, PhD, MBA, CANbridge Chairman, President and CEO. “Esophageal squamous cell cancer is a large indication in China, and other parts of Asia, for which there is virtually no treatment. We plan to develop CAN017 in China first, then bring it to other regions where patients are also extremely underserved. Additionally, preclinical data suggests CAN017 may have potential in the treatment of additional oncology indications. We will continue to explore this as we move forward with the ESCC clinical program in China.”
CANbridge also announced that it has entered into a strategic partnership with Amoy Diagnostics Co., Ltd. (AmoyDx) to develop a CAN017 biomarker companion diagnostic. Preclinical data indicates that high Neuregulin 1 (NRG1) gene expression in ESCC tumors correlates to improved CAN017 response rates in animals, making it a possible biomarker for CAN017 in ESCC.
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, which is the most prevalent form in the West, leaving ESCC patients with few options.
Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights to ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits, including but not limited to, EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, approved by the CFDA and CE certified as well.
In European EMQN and Chinese PQCC programs, AmoyDx has been the No.1 test kit supplier for multiple years with the highest accuracy rate. Currently, AmoyDx serves an extensive domestic and international oncology network, reaching over 300 hospitals in China and 50 countries all over the world. Every year, hundreds of thousands of cancer patients benefit from AmoyDx products. AmoyDx is strategic partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical studies in gene tissue and blood testing. For more information, please visit the website: www.amoydx.com.
About CANbridge Life Sciences
CANbridge Life Sciences, Ltd. is a 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 an agreement with EUSA Pharma, to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it is being developed as CAN008, and a world-wide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, renamed by CANbridge as CAN017.
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.
CANbridge Life Sciences