CANbridge Life Sciences, a biopharmaceutical company, announced that the first patient was dosed in the phase I/II trial of its lead candidate, CAN-008, for the treatment of newly-diagnosed glioblastoma multiforme (GBM), in Taiwan.  The patient was treated at Linkou Chang Gung Memorial Hospital, in Taipei, Taiwan.

CAN-008, CANbridge’s lead candidate, is an immunotherapy that enhances the immune system response to cancer and inhibits tumour cell growth.  The study design consists of an open-label, dose-escalation phase I trial, and a multi-center, double-blind, randomized, placebo-controlled phase II trial. The phase I trial will evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. The phase II trial will evaluate efficacy and safety. The combined phase I/II trial will enroll a total of 55 patients.   CANbridge expects to report phase I safety data after mid-2017.

“CANbridge is now a clinical stage company, delivering on our mission to develop Western drug candidates for Asian markets,” said James Xue, CANbridge CEO. “It is of particular value to us that CAN-008 shows promise in glioblastoma multiforme, a terrible cancer that has had no new front-line treatments approved, anywhere in the world, since 1999. We are proud to bring a potentially new treatment option to this underserved group of patients.”

“I am honoured to lead this well-designed, high-quality clinical trial,” said principal investigator (PI) Kuo-Chen Wei, MD, Professor of Neurosurgery, Vice Chairman of Cancer Center, and Director of Brain Tumor Division, Linkou Chung Gung Memorial Hospital. “We look forward to doing all we can to explore CAN-008’s potential to make a meaningful difference in the treatment of GBM patients.”

CAN-008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumour necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumour cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s 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. The license was later  expanded to include Taiwan.

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).