WuXi Biologics, an open-access biologics technology company, and Immune Pharmaceuticals, a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases, have entered into a development and manufacturing agreement for the production of bertilimumab, Immune’s first-in-class anti-eotaxin-1 monoclonal antibody.
Bertilimumab is designed to block the protein eotaxin-1, which is responsible for causing inflammation in a significant number of diseases. Immune recently completed a phase 2a trial of bertilimumab in patients with moderate-to-extensive bullous pemphigoid (BP), plans to launch a pivotal study in BP in 2019 and is continuing to enroll subjects in an ongoing phase 2 trial in ulcerative colitis.
The new partnership between the companies combines Immune’s background in immunology research and development with WuXi Biologics’ experience in biologics late-stage development and commercial manufacturing to expedite the program towards potential global product approval.
WuXi Biologics will scale the new bertilimumab manufacturing process to 2,000 liters, which can support the planned clinical development program and potential future commercial needs. WuXi also will serve as the fill/finish manufacturer for bertilimumab.
Current timelines call for initiating Good Manufacturing Practice (GMP) production in the second quarter of 2019, with supplies released for clinical use in the third quarter of 2019.
“This is an extremely important milestone for the bertilimumab program, as we have secured clinical manufacturing not only for our planned pivotal phase 2/3 trial in bullous pemphigoid, but for future trials in ulcerative colitis, asthma, and other indications,” Tony Fiorino, M.D., Ph.D., chief medical and operating officer of Immune, said. “We believe WuXi Biologics is well-positioned to meet foreseeable bertilimumab production demand. We have hit the ground running with WuXi Biologics and have already begun working on the technology transfer.”
Dr. Chris Chen, CEO of WuXi Biologics said the company’s integrated development and manufacturing service across both biologics drug substance and fill finish will expedite development of the late-stage clinical program and that WuXi’s global supply chain in four countries, including China, Ireland, Singapore, and the United States, “will ensure that every patient who needs this critical medicine will have access.”
(Source: WuXi Biologics)
Filed Under: Drug Discovery
