WuXi Biologics & Immune Pharmaceuticals Announce Late-Phase Development & Manufacturing Partnership
WuXi Biologics and Immune Pharmaceuticals recently announced 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 leading expertise in immunology research and development with WuXi Biologics’ expertise 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 Biologics will also 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,” commented Tony Fiorino, MD, PhD, Chief Medical and Operating Officer of Immune. “We are pleased to be working with WuXi Biologics on the scale-up and production of bertilimumab, given its extensive experience in the manufacture of monoclonal antibodies and its vast production capacity. 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.”
“We are excited that our partner Immune Pharmaceuticals switched from a global CMO leader to WuXi Biologics to bring this innovative first-in-class therapy to patients suffering from immuno-inflammatory diseases,” said Dr. Chris Chen, CEO of WuXi Biologics. “Our integrated development and manufacturing service across both biologics drug substance and fill finish will expedite development of this important late-stage clinical program. In addition, our robust and premier-quality 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.”
WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information, visit www.wuxibiologics.com.
Immune Pharmaceuticals, Inc. is a biopharmaceutical company developing novel therapeutic agents for the treatment of immunologic and inflammatory diseases. Immune’s lead program, bertilimumab, is a first-in-class, human monoclonal antibody that binds eotaxin-1, a chemokine that attracts eosinophils to the site of inflammation. By blocking eotaxin-1, bertilimumab may prevent the migration and activation of eosinophils and other cells, thus blocking an important inflammatory pathway active in a variety of allergic and immune diseases. Bertilimumab has shown promising clinical activity in bullous pemphigoid and has been studied in other conditions including allergic rhinitis and ulcerative colitis, and may have application in other diseases, including atopic dermatitis, asthma, and other diseases. Immune is also developing NanoCyclo, a nano-encapsulated formulation of cyclosporin, which is in late stage preclinical development for atopic dermatitis and psoriasis. For more information, visit www.immunepharma.com.
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