CANBRIDGE submits IND application to Taiwan FDA
CANbridge Life Sciences 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.
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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.
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Separately, CANbridge announced that it signed a partnership agreement with WuXi Biologics, a wholly-owned subsidiary of WuXi AppTec, for the manufacture of CAN-008 in China, in preparation for a glioblastoma IND submission to the China Food and Drug Administration (CFDA).
The CFDA has recently initiated a Market Authorization Holder (MAH) pilot program to accelerate regulatory approval in China.