On July 3, 2023 CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, reported that, based on the interim analysis recommendation of the independent data monitoring committee, it plans to continue the ongoing Phase 2 study of CAN008 in patients with newly diagnosed glioblastoma multiforme (GBM) in China to completion (Press release, CANbridge Life Sciences, JUL 3, 2023, View Source [SID1234633035]).
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"We are pleased that the independent data monitoring committee made the recommendation to continue the CAN008 Phase 2 glioblastoma multiforme trial in China, based on their analysis of the interim data," said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. "Glioblastoma is an intractable cancer with poor patient outcomes under standard-of-care. We look forward to continuing to develop CAN008 as a potentially new treatment for patients in China."
About the CAN008 Phase 2 Trial in glioblastoma multiforme (GBM)
The Phase 2 double-blinded study enrolled 119 subjects who were randomized 2:1 to receive intravenous CAN008 400 mg or placebo, in addition to standard-of-care chemoradiotherapy. All subjects underwent surgical excision of the GBM tumor prior to treatment. During the course of the study, they receive a 6-week course of triple therapy(temozolomide, radiotherapy and CAN008 or placebo), followed by a 1-month rest, then a 12-month course of dual therapy (temozolomide and CAN008 or placebo), and then monotherapy (CAN008 or placebo) until progression of disease, intolerability to treatment, death, or withdrawal. The primary endpoint is progression-free survival (PFS), and the secondary endpoint is overall survival (OS).
About CAN008
CAN008 (asunercept) is a CD95-Fc fusion protein that binds to the CD95 ligand and blocks the interaction between the ligand and the endogenous CD95 receptor. CAN008 has a unique dual mechanism of action, inhibiting both the invasive growth and migration of tumor cells, as well as T-cell apoptosis, which enhances immune recognition of the cancer. Earlier asunercept glioblastoma multiforme (GBM) clinical trial data showed favorable safety and tolerability, prolonged survival and improved quality-of-life.
Asunercept has been granted US FDA Orphan Drug Designation and Orphan Medicinal Product Designation by the European Medicines Agency (EMA) for GBM. It has also been accepted into the EMA’s PRIME (Priority Medicines) program, which provides support to medicines that could address unmet medical needs. In China, CAN008 has been classified as a Class 1 New Drug by the National Medical Products Administration. CANbridge holds the rights to develop and commercialize CAN008 for any indication in Greater China and is currently conducting a CAN008 Phase 2 trial in GBM in China.