CANbridge Pharmaceuticals Inc. announced that according to the top-line data of CAN008 Phase II clinical trial in patients with newly diagnosed glioblastoma multiforme (GBM), CAN008 did not provide additional benefit in progression-free survival or overall survival over placebo in patients receiving standard of care with temozolomide and radiotherapy. After due and careful consideration, the Company has decided to discontinue the development and further trials of CAN008 in the field of GBM. The Group will optimize its research and development pipeline to increase efficiency and preserve cash.

The savings from the discontinuation of the development of CAN008 in the field of GBM will be used to accelerate the commercialization of the two approved products Hunterase and Livmarli, as well as the development of other products of the Group, including without limitation, CAN106, which has shown positive preliminary results from the ongoing Phase 1b Paroxysmal Nocturnal Hemoglobinuria study, CAN103, which is undergoing a potential registrational trial in Gaucher patients, and selective gene therapy programs. The discontinuation of the development of CAN008 in the field of GBM will not have a material impact on the results of the Group. 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 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.