27 December 2017 | News
CANbridge Life Sciences Submits Investigational New Drug Application for CAN017 Trial in Esophageal Squamous Cell Cancer (ESCC) In China
CANbridge Life Sciences is a bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia.
Company announced that it has submitted an Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA) for a Phase Ib/III clinical study of CAN017 in esophageal squamous cell cancer (ESCC).
ESCC is the most prevalent form of esophageal cancer, but occurs primarily in Asia, with 50% of the cases occurring in China.
The IND is CANbridge's second CFDA submission in 2017, following that of lead candidate, CAN008, for glioblastoma, in July.
CAN017 is an ErbB3 (HER3) inhibitory antibody candidate. Preclinical work showed a potential to treat ESCC.
CANbridge acquired the worldwide development rights (excluding North America) from US-based AVEO in 2016.
After CAN017 (then called AV-203) had completed a US Food and Drug Administration-approved Phase I trial in solid tumors.
CANbridge also announced that it has entered into a strategic partnership with Amoy Diagnostics Co.Ltd. (AmoyDx) to develop a CAN017 biomarker companion diagnostic.
Preclinical data indicates that high Neuregulin 1 (NRG1) gene expression in ESCC tumors correlates to improved CAN017 response rates in animals, making it a possible biomarker for CAN017 in ESCC.