October 29, 2017 - CANbridge released CAN008 Taiwan Phase I clinical data for the treatment of GBM on 2017 China BioMed Innovation and Investment Conference held in Suzhou. This is the first time for CANbridge to publicly release the Phase I clinical data.
As one of lead products being developed by CANbridge, CAN008 is a fully human fusion protein consisting of the extracellular domain of CD95 fused to the Fc region of human IgG 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 July 2016, Taiwan Food and Drug Administration (TFDA) has approved the Investigational New Drug (IND) application for a Phase I/II clinical study of CAN008, plus temozolomide (TMZ), during and after radiation therapy, in patients with newly-diagnosed GBM. CAN008 is FIRST 1st line study for GBM with innovative biological drug.
Phase I study is an open-label, dose-escalation clinical trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy. Phase I study will enroll 9-12 patients. At present, we have completed 10 patients’ enrollment and they’re all under continuous treatment.
Interim safety report showed no SAE happened. The most serious severity of TEAE was classified as grade 2. All TEAEs were unrelated to CAN008. No actions of CAN008/TMZ/RT reduced or interrupted or withdrawn due to any TEAE. DLT was not observed in both CAN008 200mg Cohort and CAN008 400mg Cohort. No ADA was detected. SMC recommended treatment dosage for CAN008 China Phase II study.
Dr. James Xue, CANbridge Chairman and CEO said: "based on the current data which have provided sufficient clinical evidence to prove the safety and efficiency of CAN008, we have more confidence for the upcoming Phase II/III clinical trial to be launched in China mainland in 2018. CANbridge will push forward the clinical development for CAN008 and bring more breaking through companion diagnostic and treatment options for Chinese GBM patients to benefit Chinese cancer patients as soon as possible."
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 and Macau, which was recently expanded to include Taiwan.
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 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 immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, 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.
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.