CANbridge Completes Chinese Glioblastoma Biomarker Study For Lead Candidate, CAN008

Plans to Initiate Phase I/II Trial in Taiwan in 2016

BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it has completed a biomarker study in Chinese patients with glioblastoma multiforme (GBM) for expression of CD95 ligand, the target of its first candidate for clinical development, CAN008, also known as APG101. The study demonstrated a high degree of CD95 ligand expression consistency between geographically diverse Chinese and Western GBM patients. CAN008 is a fully-human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) superfamily. By blocking the CD95 ligand, CAN008 restores the immune response against tumors and inhibits invasive tumor cell growth.

“In a Phase II study conducted in Europe, CAN008 showed an improved overall survival benefit in patients with relapsed glioblastoma, especially among patients who expressed the CD95 ligand.”

Based on this confirmatory biomarker study, CANbridge plans to initiate a CAN008 Phase I/II study in newly-diagnosed GBM in Taiwan and expects to dose the first patient in the second half of 2016. In other news, CANbridge announced that it has expanded the licensed territories from Germany’s Apogenix (www.apogenix.com), which is developing APG101 in all other territories, to include Taiwan. In July 2015, CANbridge entered into an exclusive license agreement with Apogenix to develop, manufacture and commercialize APG101 in GBM, with options for other indications, in China, Hong Kong and Macao. Both companies are privately held.

“The study showing the correlation between Western and Chinese biomarker expression validates our belief that CAN008 is a strong candidate for glioblastoma treatment development in Taiwan and other Chinese territories,” said Mark Goldberg, MD, CANbridge Chief Medical Officer and practicing hematologist and oncologist at Brigham and Women’s Hospital and Dana Farber Cancer Institute. “In a Phase II study conducted in Europe, CAN008 showed an improved overall survival benefit in patients with relapsed glioblastoma, especially among patients who expressed the CD95 ligand.”

“The results from the biomarker study pave the way for us to advance to our first clinical trial in Asia, executing on our mission to bring promising Western drug candidates to underserved Chinese markets,” said James Xue, CANbridge Chairman and CEO. “Brain cancer mortality rates are among the ten highest cancer death rates in China, where the treatment options are even more limited than in the West. We look forward to initiating one of the first immuno-oncology clinical treatment programs in the greater China region for this deadly cancer.”

About Glioblastoma

Glioblastoma multiforme is the most lethal form of brain cancer and the hardest to treat. It is the only grade IV glioma by World Health Organization classification. Current standard-of-care consists of surgical resection of the tumor, followed by radiation and chemotherapy. The five-year survival rate is less than 3%, with the third-highest mortality rate, after pancreatic and lung cancer. In China, glioblastoma incidence is predicted to grow from 1.75 per 100,000 people in 2014, to 2.05 per 100,000 in 2024, which represents a 17% increase.

About CANbridge Life Sciences

CANbridge Life Sciences, Ltd. is a 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). 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 an exclusive licensing agreement with U.S.-based Azaya Therapeutics, Inc., to develop and commercialize ATI-1123 in China, for the treatment of non-small cell lung cancer and other solid tumors. 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, and a license with Apogenix to develop, manufacture and commercialize immuno-oncology therapy, APG101, for the treatment of glioblastoma multiforme, and other potential indications, in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge intends to initiate a Phase I/II study in newly-diagnosed glioblastoma multiforme patients in Taiwan in the second half of 2016.

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.

CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com