CANbridge Submits Investigational New Drug Application to Taiwan Food and Drug Administration for CAN-008 Phase I/II Trial in GlioblastomaSelects WuXi Biologics to Manufacture CAN-008 for the China Market
CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it has completed the Investigational New Drug (IND) application to the Taiwan Food and Drug Administration (TFDA) 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 will consist 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. CANbridge anticipates that the trial will commence in August 2016.
CAN-008 is a fully human fusion protein 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.
Separately, CANbridge announced that it signed a partnership agreement with WuXi Biologics, a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, for the manufacture of CAN-008 in China…, for the manufacture of CAN-008 in China, in preparation for a glioblastoma IND submission to the China Food and Drug Administration (renamed NMPA) . The CFDA (now the NMPA) has recently initiated a Market Authorization Holder (MAH) pilot program to accelerate regulatory approval in China.
“This is CANbridge’s first IND submission and marks our imminent transition to a clinical-stage company,” said James Xue, CANbridge Chairman and CEO. “We are delighted to join forces with WuXi Biologics, which will manufacture CAN-008 for the Chinese market, where we plan to begin the pre-clinical work immediately, preparatory to an IND submission.”
“WuXi Biologics congratulates CANbridge for its rapid advancement to a clinical-stage company,” commented Chris Chen, PhD, Chief Executive Officer, WuXi Biologics. “We are thrilled to work with CANbridge to manufacture this important first-in-class biological drug candidate for the Chinese market, demonstrating the enabling power of our world-class proprietary biologics platform. By partnering with innovative companies, such as CANbridge, we will make life-saving biologics more affordable and available to the Chinese patients.”