CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a phase I/II clinical study of CAN-008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed glioblastoma multiforme (GBM).

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 approximately 55 patients. The phase I portion of the trial will commence in August 2016.

“The approval of our first human clinical trial marks CANbridge’s transition to a clinical stage company, validating our business strategy and regulatory approach to develop promising Western drug candidates for underserved conditions in the Asian market,” said James Xue PhD, CANbridge chairman and CEO. “That we will be moving forward in a front-line setting is also good news for glioblastoma patients in Taiwan, and the rest of Asia, who have very few treatment options.”

“This approval by the TFDA is a very important step in the development of CAN008 for patients with glioblastoma multiforme (GBM) brain tumors,” said Mark Goldberg, MD, CANbridge acting chief medical officer. “Glioblastoma multiforme is a devastating type of brain tumor. Better therapies are desperately needed. We are pleased to be able to move the clinical program forward and hope that CAN008 will prove to be an important advance, improving outcomes for patients with GBM.”

CAN-008 is a fully human 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 (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 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.