BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences and Amoy Diagnostics announced that they have entered into a strategic partnership to develop a companion diagnostic assay for CANbridge’s lead candidate, CAN008, a fully human Fc fusion protein. Previous clinical work, in a Phase II trial conducted in Europe, demonstrated a significant overall survival benefit for recurrent glioblastoma multiforme (GBM) patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2. CAN008 is currently in a Phase I/II clinical study in GBM patients in Taiwan. CANbridge plans to initiate a CAN008 Phase II trial in GBM in China in 2018. The patients will be screened for the CAN008 biomarkers to determine trial enrollment eligibility.
“We are pleased to partner with AmoyDx, a leader in providing highly-reliable and effective diagnostic solutions to clinical practices in China,” said James Xue, CANbridge Chairman and CEO. “AmoyDx’s diagnostic CD95 IHC and CpG2 qPCR kits will provide CANbridge with personalized medicine tools in the Phase II trial to deliver optimized treatment to GBM patients as early as possible.”
“We are excited that our diagnostic technology will play a key role in the CAN008 clinical development,” said Dr. Li-Mou Zheng, Chairman and CEO of AmoyDx. “We believe that the joint effort by CANbridge and AmoyDx could help to realize the therapeutic potential of CAN008 in critically-ill GBM patients in China sooner. AmoyDx has multiple existing strategic partnerships with multi-national corporations providing diagnostic products and services in China and other countries. The CANbridge – AmoyDx collaboration is the first in which both parties are innovative Chinese companies with leadership positions in their respective fields.”
CAN-008 is a fully human fusion protein which consists of the extracellular domain of CD95, fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s previous developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.
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 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 develop 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 will be developed as CAN008. CANbridge also holds a worldwide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV-203, 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.