CANbridge Pharmaceuticals CAN008 Phase 2 Trial for Treatment of Glioblastoma Multiforme (GBM) in China Reaches Full Enrollment

• Recent CAN008 Phase 1 Follow-Up Data Showed 67% 5-Year Overall Survival in High-Dose Cohort, Reported at ESMO Sarcoma and Rare Cancers

BEIJING, China & BURLINGTON, Mass.–(BUSINESS WIRE)–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, 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.

”Treatment with CAN008 significantly improved progression-free survival in the Phase 2 clinical trial of recurrent glioblastoma conducted by Apogenix in Germany,” said Wenbin Li, Director of Comprehensive Treatment Ward of Neuro-Oncology, Beijing Tiantan Hospital, Capital Medical University, principal investigator of the study. “The recently published long-term follow up data from newly diagnosed GBM patients in the CAN008 Phase 1 clinical trial is also encouraging, with 4 of the 7 patients in the 400mg/week dose group still alive at 5 years. We are pleased to have completed enrollment in the Phase 2 trial of CAN008, which we believe is a promising treatment that could provide new hope to patients. Thank you to all of the researchers and staff who helped ensure that patients got their medications during the difficult COVID-19 prevention and control period and to the patients, who put their trust in us.”

“We are delighted to have reached full enrollment in our Phase 2 glioblastoma trial for our first-in-class candidate, CAN008, in China, “ said James Xue, Ph.D., founder, chairman and CEO of CANbridge Pharmaceuticals Inc. “In addition, we are greatly encouraged by the five-year overall survival data of 67% in the high-dose group from our Phase 1 trial and look forward to the furthering the clinical development of CAN008 for patients in China.”

About CAN008

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.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. (HKEX:1228) global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies for rare disease and rare oncology. CANbridge has a differentiated drug portfolio, with three approved drugs and a pipeline of 10 assets, targeting prevalent rare disease and rare oncology indications that have unmet needs and significant market potential. These include Hunter syndrome and other lysosomal storage disorders, complement-mediated disorders, hemophilia A, metabolic disorders, rare cholestatic liver diseases and neuromuscular diseases, as well as glioblastoma multiforme. The CANbridge Next-Generation Innovation and Process Development Facility is developing novel, potentially curative, gene therapies for rare genetic diseases, including Pompe disease, Fabry disease, spinal muscular atrophy (SMA) and other neuromuscular conditions, and collaborates with world-leading researchers and biotech companies. Animal data from the SMA gene therapy was presented in 2022 at the American Society for Gene and Cell Therapy (ASGCT), the European Society for Gene and Cell Therapy (ESGCT) and the World Muscle Congress. CANbridge global partners include: Apogenix, GC Pharma, Mirum, Wuxi Biologics, Privus, UMass Chan Medical School, the University of Washington School of Medicine and Scriptr Global.

For more on CANbridge Pharmaceuticals Inc., please go to: www.canbridgepharma.com.

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Contacts

U.S. Investor Relations:
Chris Brinzey

ICR Westwicke

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China Investor Relations
CANbridge Pharmaceuticals Inc.

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Media:
Deanne Eagle

Planet Communications

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