CANbridge and AmoyDx enter into strategic partnership for CAN008 companion diagnostic development

On May 16, 2017 CANbridge Life Sciences and Amoy Diagnostics reported 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 (Press release, CANbridge Life Sciences, MAY 16, 2017, View Source [SID1234519169]). 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.

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"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 andCpG2 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."

About CAN008

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.