Pharma Focus America

CANbridge Pharmaceuticals to Continue CAN008 Phase 2 Trial for Glioblastoma Multiforme (GBM) in China Based on Independent Data Monitoring Committee's Interim Analysis

Tuesday, July 04, 2023

CANbridge Pharmaceuticals, a global biopharmaceutical company specializing in the research, development, and commercialization of transformative therapies for rare diseases and oncology, has announced its plan to continue the Phase 2 study of CAN008 in Chinese patients with newly diagnosed glioblastoma multiforme (GBM). The decision is based on the interim analysis recommendation of an independent data monitoring committee. CANbridge Pharmaceuticals, Inc. (1228.HK), with a strong presence in China, remains dedicated to advancing innovative treatments for GBM and other challenging medical conditions.

We are pleased to receive the recommendation from the independent data monitoring committee to continue the CAN008 Phase 2 trial for glioblastoma multiforme in China, based on their interim data analysis," commented Dr. James Xue, founder, chairman, and CEO of CANbridge Pharmaceuticals Inc. He further expressed, "Glioblastoma is a challenging cancer with limited treatment options and poor patient outcomes. Our commitment remains steadfast in advancing the development of CAN008 as a potential new therapy for patients in China.

The Phase 2 trial is a double-blinded study involving 119 participants who were randomly assigned to receive either intravenous CAN008 400 mg or placebo in addition to standard-of-care chemoradiotherapy. Prior to treatment, all participants underwent surgical excision of the GBM tumor. The treatment regimen includes a 6-week course of triple therapy (temozolomide, radiotherapy, and CAN008 or placebo), followed by a 1-month rest period. This is then followed by a 12-month course of dual therapy (temozolomide and CAN008 or placebo), and subsequently monotherapy (CAN008 or placebo) until disease progression, treatment intolerance, death, or withdrawal. The primary endpoint of the study is progression-free survival (PFS), with overall survival (OS) being a secondary endpoint.

CAN008, also known as asunercept, is a CD95-Fc fusion protein that works by binding to the CD95 ligand, thereby preventing its interaction with the endogenous CD95 receptor. The dual mechanism of action of CAN008 inhibits tumor cell invasion, migration, and T-cell apoptosis, leading to enhanced immune recognition of cancer. Previous clinical trial data for asunercept in glioblastoma multiforme have demonstrated favorable safety, extended survival, and improved quality of life.

Asunercept has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for the treatment of glioblastoma multiforme. Additionally, it has been accepted into the EMA's PRIME (Priority Medicines) program, which supports the development of medicines targeting unmet medical needs. In China, CAN008 has received Class 1 New Drug classification from the National Medical Products Administration. CANbridge Pharmaceuticals holds the rights to develop and commercialize CAN008 for any indication in Greater China and is currently conducting a Phase 2 trial for glioblastoma multiforme in China.

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