CANbridge Life Sciences will partner with Amoy Diagnostics Co., Ltd. (AmoyDx) to develop a companion diagnostic for its lead candidate, the glioblastoma multiforme (GBM) treatment CAN008, the companies said today, through a collaboration whose value was not disclosed.
“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 Chairman and CEO Li-Mou Zheng, Ph.D., said in a statement.
AmoyDx focuses on molecular diagnostics for oncology precision medicine using its ADx-ARMS and Super-ARMS technologies. ADx-ARMS is a real-time PCR technology designed to detect mutations in target DNA that is amplified with mutation-specific PCR primers, with the mutant amplicons detected with a novel fluorescent probe.
Super-ARMS EGFR kit is a real-time PCR-based test designed to identify ctDNA EGFR mutation in plasma samples for patients with advanced or metastatic non-small cell lung cancer. The kit offers an upgraded version of ADx-ARMS technology, with an optimized reaction system designed to rapidly and accurately detect low percentage of mutant ctDNA in a background of wild-type DNA.
AmoyDx's portfolio of molecular diagnostic kits include assays for EGFR, RAS, ALK, BRAF, PIK3CA and ROS1. The tests were first approved by the China Food and Drug Administration and are CE certified.
The company supplies its tests to more than 300 hospitals in China and 50 countries worldwide. AmoyDx also provides diagnostic products and services for drug development, plus clinical studies in gene tissue and blood testing, to global partners that include AstraZeneca, Boehringer Ingelheim, Pfizer, Merck KGaA, and Illumina.
CAN008 is a fully human Fc fusion protein consisting 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 family. By blocking it, CAN-008 is designed to restore the immune system's anti-tumor response and inhibits invasive tumor cell growth.
CAN008 is now under study in a Phase I/II clinical trial in GBM patients in Taiwan, China, with plans to launch a Phase II trial in glioblastoma in China next year.
“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,” added James Xue, CANbridge chairman and CEO.
According to CANbridge, an earlier Phase II trial conducted in Europe by the drug's previous developer, Apogenix, showed CAN008 to have a significant overall survival benefit for recurrent GBM patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2.
In July 2015, CANbridge acquired an exclusive license from Apogenix to develop, manufacture and commercialize CAN-008 (formerly APG101) for GBM and other indications, in China, Hong Kong and Macau. The license territory was recently expanded to include Taiwan, China.