Boehringer Ingelheim CDMO providing CMC services for Ph Ib/III trial of cancer antibody
CANbridge Life Sciences is a privately-held biotech company headquartered in Beijing, China.
The company earlier this week announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China for its drug candidate CAN017.
Boehringer Ingelheim’s contract development and manufacturing business (CDMO) BioXcellence will be providing the chemistry, manufacturing, and control (CMC) services for CAN017 – an ErbB3 (HER3) inhibitory antibody for the treatment of esophageal squamous cell cancer (ESCC).
The companies initiated the collaboration in August 2016 for CAN017, for which CANbridge acquired the development rights for after the completion of Phase I trial in the US.
Following the successful CTA approval, CAN017 is now moving into a Phase Ib/III study in China.
Boehringer Ingelheim spokesperson Matthias Reinig said the CDMO was chosen in part because it’s “not only a leading company in terms of compounds – 30 compounds that we helped to develop and contract manufacture are on the market – but also [because] we’ve been in the business for quite a while.”
“This mix of things made us attractive for CANbridge to engage with us in a deeper partnership,” he told us.
For local approvals, Reinig noted that local know-how is key: “With the relatively high investment that we’ve taken in China, it’s crucial for us to find Chinese partners who need these services and competencies that we’re ramping up there,” he added.
“This is about tighter and more seamless collaboration than you could probably do if you did it across borders,” Reinig said.
Biopharma China operations
Boehringer Ingelheim's BioXcellence business is China's first international biopharmaceutical contract manufacturer, providing process development, clinical trials, and product supply services, according to the company.
The company’s Shanghai-based “Oasis” facility was developed following an investment of more than €70m and is now “running at full steam,” Reinig explained.
Boehringer Ingelheim had been operating its good manufacturing practice (GMP) clinical material supply at 100L and 500L scales since 2014 at its “BioLab” facility.
Following the inauguration of the Oasis facility in May 2017, it now provides clinical and commercial supply on a 2000L single-use bioreactor scale.
According to the company, the facility is designed to flexibly add additional 2000L single-use bioreactors and fill/finish capabilities to meet increasing market demand.
