CANbridge Life Sciences, a biopharmaceutical company developing Western drug candidates in China and North Asia, announced that the China National Drug Administration (CNDA) has approved the Investigational New Drug (IND) application for a Phase Ib/III clinical study of CAN017 in esophageal squamous cell cancer (ESCC). The Phase Ib/extension study is a multicenter, open label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CAN017 in combination with chemotherapy as the second line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
ESCC is the most prevalent form of esophageal cancer, with 50 percent of the cases occurring in China. The CAN017 IND approval is a key milestone for CANbridge and the second one this year, following the IND approval to commence a trial in CAN008 in glioblastoma multiforme (GBM) in April.
Tumor on the esophagus tissue. (Credit: shutterstock)
CAN017 is an ErbB3 (HER3) inhibitory antibody humanized IgG1/κ ERBB3 inhibitory antibody that completed a first-in-human Phase I clinical trial in patients with advanced solid tumors in US patients. In preclinical work, CAN017 showed potential for the treatment of ESCC. Additional preclinical work, in human cancer models, found Neuregulin 1 (NRG1) gene expression to be a promising biomarker, with the potential to predict response to ERBB3 inhibition by CAN017.
“Standardized second-line therapy for advanced esophageal carcinoma is not available so far,” said Professor Lin Shen, vice-president of Beijing Cancer Hospital. “There is no drug approved as targeted therapy for ESCC, which is prevalent among Chinese. It’s necessary and pressing to develop this investigational drug, with a defined target and biomarkers, for such unique unmet medical needs in China.”
“The CNDA approval to start our second trial in China in a single year illustrates CANbridge’s commitment to bring promising treatments to underserved populations and our emergence as a commercial-stage biopharmaceutical company with a strong clinical pipeline,” said James Xue, PhD, MBA, CANbridge Chairman, president and CEO. “We plan to commence our multi-center clinical trial in CAN017 in esophageal squamous cell cancer this year, as well as to continue to explore other potential CAN017 indications which show promise preclinically.”
(Source: CANbridge Life Sciences)
Filed Under: Oncology
