Boehringer Ingelheim and CANbridge Life Sciences announced that both parties have signed an agreement for the manufacture of CAN-017, an ErbB3 (HER3) inhibitory antibody to treat esophageal squamous cell cancer (ESCC), CANbridge plans to initiate a Phase IIa clinical trial for the treatment of ESCC in Greater China.
ESCC is the most prevalent form of esophageal cancer worldwide, with a high incidence in China and other Asian and developing countries. Every year, there are over 450,000 new cases diagnosed and over 50 percent of these cases are occurring in China.
CANbridge acquired worldwide rights (exclusive of North America) to CAN-017 from the US company AVEO Oncology, where it was being developed as AV-203, and had completed a successful Phase I study in patients with solid tumor cancers. With the acquistion of CAN-017, CANbridge plans to expand outside of Asia for the first time, bringing the therapy to regions where ESCC patients have few options, after demonstrating proof-of-concept in China.
“Boehringer Ingelheim is a truly global manufacturer of biologics, capable of executing the intricacies of CAN-017 manufacture and meeting the requirements of the regulatory authorities,” said James Xue, CANbridge Chairman and CEO. “It is a powerful ally for CANbridge as we look to advance the promising Western drug candidates we develop in Asia to other parts of the world, where patients are underserved. With the help of the manufacturing agreement with Boehringer Ingelheim, we look forward to bringing the new drug to China as early as possible.”
“We are excited to enter into this important agreement with CANbridge Life Sciences. Boehringer Ingelheim is a leading player in developing and manufacturing biopharmaceuticals,” said David Preston, Chairman and CEO of Boehringer Ingelheim mainland China, Hong Kong and Tai Wan, commented. “With our world-class bioprocess capabilities, we will help CANbridge and more biopharma enterprises step up efforts to bring innovative bio-medicines to the market and benefit patients quickly.
China initiated a pilot Marketing Authorization Holder (MAH) program in 10 provinces and municipalities recently, providing breakthrough policies breakthrough and a legal basis for biopharma CMO. Boehringer Ingelheim China was selected as one of the first biopharma CMO pilot projects in China as part of the MAH trial. Boehringer Ingelheim Biopharmaceuticals China will leverage its advanced manufacturing platform and management expertise to help Chinese enterprises bring their products into the global markets.
Filed Under: Drug Discovery