On January 7, 2016 CANbridge Life Sciences reported that it has completed a biomarker study in Chinese patients with glioblastoma multiforme (GBM) for expression of CD95 ligand, the target of its first candidate for clinical development, CAN008, also known as APG101 (Press release, CANbridge Life Sciences, JAN 7, 2016, View Source [SID:1234510067]). The study demonstrated a high degree of CD95 ligand expression consistency between geographically-diverse Chinese and Western GBM patients. CAN008 is a fully-human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) superfamily. By blocking the CD95 ligand, CAN008 restores the immune response against tumors and inhibits invasive tumor cell growth.
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Based on this confirmatory biomarker study, CANbridge plans to initiate a CAN008 Phase I/II study in newly-diagnosed GBM in Taiwan and expects to dose the first patient in the second half of 2016. In other news, CANbridge announced that it has expanded the licensed territories from Germany’s Apogenix (www.apogenix.com), which is developing APG101 in all other territories, to include Taiwan. In July, CANbridge entered into an exclusive license agreement with Apogenix to develop, manufacture and commercialize APG101 in GBM, with options for other indications, in China, Hong Kong and Macao. Both companies are privately-held.
"The study showing the correlation between Western and Chinese biomarker expression validates our belief that CAN008 is a strong candidate for glioblastoma treatment development in Taiwan and other Chinese territories," said Mark Goldberg, MD, CANbridge Chief Medical Officer and practicing hematologist and oncologist at Brigham and Women’s Hospital and Dana Farber Cancer Institute. "In a Phase II study conducted in Europe, CAN008 showed an improved overall survival benefit in patients with relapsed glioblastoma, especially among patients who expressed the CD95 ligand."
"The results from the biomarker study pave the way for us to advance to our first clinical trial in Asia, executing on our mission to bring promising Western drug candidates to underserved Chinese markets," said James Xue, CANbridge Chairman and CEO. "Brain cancer mortality rates are among the ten highest cancer death rates in China, where the treatment options are even more limited than in the West. We look forward to initiating one of the first immuno-oncology clinical treatment programs in China for this deadly cancer.