Long-Term Data from CANbridge Pharmaceuticals CAN008 Phase 1/2 Trial in Glioblastoma Multiforme Shows 67% Five-Year Overall Survival Rate Compared to 8.2% in Institutional Database

BEIJING & 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 long-term follow up data from the Phase 1/2 study of CAN008 (asunercept) plus temozolomide/radiotherapy (TMZ/RT) in newly diagnosed glioblastoma multiforme (GBM) showed a long-term survival rate of 67% at five years, three years after the trial ended. The data will be presented as a poster at the European Society of Medical Oncologists (ESMO) Sarcoma and Rare Cancers Annual Congress, March 20-22, in Lugano, Switzerland. The study was conducted at Chang Gung Memorial Hospital, Taoyuan, Taiwan, the site of the clinical study. The principal investigator is Wei Kuo-Chen MD, Professor, formerly at Chang Gung Memorial Hospital and now at New Taipei City Tucheng Hospital.

In the study, “Long term follow-up to the phase I/II study of CAN008 plus standard chemoradiotherapy treatment in patients with newly diagnosed glioblastoma multiforme,” researchers reported that four out of the nine newly diagnosed glioblastoma multiforme patients treated in the CAN008 Phase 1/2 trial at this lead site were alive at the five-year follow up, three years after the completion of the trial. All four of the surviving patients were in the high-dose cohort of the trial, which received 400 mg of CAN008 in addition to standard temozolomide/radiotherapy (TMZ/RT). The overall survival rate of the high-dose CAN008 group was 83% at two years and 67% at three, four and five years. This compares to an overall survival rate in the institutional GBM database⁽¹⁾ (n=218) of 34.3% at two years, 19.5% at three years, 16.1% at four years and 8.2% at five years. In addition, the high-dose CAN008 cohort saw a median progression-free survival of 17.95 months. This compares to a historical median progression-free survival of 6.9 months for GBM patients on standard-of-care (TMZ/RT) (Stupp et al, 2009). The researchers also reported that a high tumor mutation burden and DNAH family gene mutation were associated with a favorable response to CAN008 treatment.

CAN008 is currently in an ongoing Phase 2 trial in glioblastoma multiforme (GBM) in China. An interim data analysis is expected in mid-2023.

“We are pleased to see a median progression-free-survival of 17.95 months in CAN008 glioblastoma multiforme patients, more than double the historical median PFS for standard-of-care GBM patients, and that 67% of the CAN008 high-dose patients were alive after five years, in a cancer where patients typically progress very rapidly and survival rates are dismal,” said Gerry Cox, M.D., Ph.D., chief medical officer and chief development strategist at CANbridge and a study author. “Glioblastoma multiforme is one of the deadliest cancers, with survival rates of less than 15 months, few treatment advances and a high unmet medical need.”

“While this is a small study, we are extremely encouraged by the high five-year survival rate of patients in our CAN008 Phase 1/2 trial, three years after its completion, in glioblastoma multiforme, a cancer with typically poor outcomes,” said James Xue, Ph.D., CANbridge founder, chairman and CEO. “We look forward to the continued development of lead candidate, CAN008, currently in a Phase 2 GBM trial in China, and to bringing this potentially new and promising treatment to brain cancer patients.”

POSTER INFORMATION

Title: “Long term follow-up to the phase I/II study of CAN008 plus standard chemoradiotherapy treatment in patients with newly diagnosed glioblastoma multiforme”

Authors: Ian Yi-Feng Chang, PhD, Hong-Chieh Tsai, MD, PhD, Chia-Hua Chen, PhD., Hsiu-Chi Chen, MSc, Chia-Wen Huang, MSc, Gerald. F. Cox, MD, PhD, Fang-Min Huang, MD, You-Yu Lin, PhD, Ko-Ting Chen, MD, PhD, Ya-Jui Lin, MD, PhD, Kuo-Chen Wei, MD

Poster #2P

Poster Session: March 20-22

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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1. Linkou Chang Gung Memorial Hospital, Taiwan, institutional database.

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