CANbridge Pharmaceuticals Inc. announced that the CAN008 (asunercept) Phase 2 trial for the treatment of glioblastoma multiforme (GBM) in China is fully enrolled, with a total of 117 patients. The multi-center, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of CAN008 plus temozolomide (TMZ) during and after radiation therapy in newly diagnosed patients and is a potentially registrational trial. Five-year follow-up data from the CAN008 Phase 1 trial showed 67% overall survival in the high-dose group and a median 17.95 months of progression-free survival in newly diagnosed GBM patients.

The data were presented at the ESMO Sarcoma and Rare Cancers Annual Meeting in March. Interim data from the CAN008 Phase 2 GBM China trial is expected in mid-2023. CAN008 (asunercept) is a CD95-Fc fusion protein that binds to the CD95 ligand to block the interaction between the ligand and the CD95 receptor.

CAN008 has a unique dual mechanism of action. It inhibits both the invasive growth and migration of tumor cells, which could reduce the T-cell apoptosis, thereby enhancing 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 received a Class 1 New Drug Designation by the National Medical Products Administration.

CANbridge holds the rights to develop CAN008 for any indication in Greater China and is currently conducting a CAN008 Phase 2 trial in GBM in China.