CANBridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that the China Food and Drug Administration (CFDA) has approved the Investigational New Drug (IND) application for a Phase II/III clinical study of lead candidate, CAN008. It’s a multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety profiles of weekly CAN008 + re-radiation therapy (rRT) in patients with glioblastoma (GBM). The study primary endpoint is overall survival (OS) determined from randomization. It is a biomarker-guided study. CANbridge anticipates dosing the first patient later this year.

The company made public interim safety results from the ongoing CAN008 GBM Phase I trial in Taiwan, China in November 2017. The trial has since completed Phase I enrollment, with a total of 10 patients. Up to date, no CAN008 related serious adverse events (SAE’s) were reported in the study.

"CFDA IND approval of CAN008 is great news for Chinese patients," said Professor Tao Jiang, MD, Beijing Tiantan hospital and Chairman of the Chinese Medical Doctor Association and Society for Neuro-Oncology, "Glioblastoma multiforme is an aggressive and highly-malignant cancer with few treatment options in China. I hope the trial can be initiated soon, since we all know the safety report of Phase I Taiwan, China study, conducted by CANbridge, was impressive."

"CFDA approval of this trial marks a major milestone for CANbridge," said James Xue PhD, Chairman and CEO, CANbridge Life Sciences. "CAN008, our lead candidate, is the first innovative drug in Class I we have advanced to a clinical trial program in mainland China. We hope it will provide new and effective treatment for glioblastoma multiforme, which is a severely underserved medical condition in Asia." Class I, one of the new CFDA classifications, covers innovative drugs, with new chemical entities of clinical value, that have never been approved anywhere in the world.

About Glioblastoma Multiforme (GBM)

Glioblastoma multiforme is an aggressive brain cancer caused by malignant tumors that develop in the supportive tissue of the brain (astrocyte cells). Fed by the brain’s blood supply, it is extremely fast-growing and difficult to treat, as the tumors are composed of multiple cell types that respond differently to different treatment. Current standard-of-care is surgery, to remove the tumor, followed by concurrent temozolamide (TMZ) and radiation therapy. In Western countries, GBM affects 2-to-3 per 100,000 people per year, and accounts for 52% of all primary brain tumors, according to the American Association of Neurological Surgeons. Median survival, with standard-of-care, is about 14.6 months and the two-year survival rate is 30%.

In China, GBM affects 5 in 100,000 people on average, per year, with a mean 14-16 month mean survival rate. The number of new cases is expected to increase with the aging population.

About CAN008

CAN008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN008 for GBM and other indications, in China, Hong Kong, S.A.R., China and Macau, S.A.R., China, which was recently expanded to include Taiwan, China.

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a clinical-staged bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan, China). CANbridge develops partnerships with Western bio-pharmaceutical companies with clinical-stage pharmaceutical, medical device or diagnostic products that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to commercialize, drug and device products that are approved in their home markets for commercialization in China and North Asia.

CANbridge has exclusive rights to develop and commercialize Puma Biotechnology’s NERLYNX® (neratinib) in China, Taiwan, China, Hong Kong, S.A.R., China and Macau, S.A.R., China (collectively, greater China), which was approved by the FDA in 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. CANbridge plans to target HER2-positive cancers, including breast and gastric. CANbridge has a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macau, S.A.R., China, Hong Kong, S.A.R., China and Taiwan, China, where it is being developed as CAN008, and a world-wide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV203, renamed by CANbridge as CAN017. CANbridge also has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments.

Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions.

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