WuXi Biologics, Immune Pharmaceuticals in mAb Development and Mfg Pact
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WuXi Biologics, part of WuXi AppTec, a Shanghai, China-headquartered contract service provider, has formed a development and manufacturing pact with Immune Pharmaceuticals, a New York-headquartered clinical-stage biopharmaceutical company focused on inflammatory diseases and cancers, for producing bertilimumab, Immune Pharmaceuticals’ anti-eotaxin-1 monoclonal antibody.

Bertilimumab is designed to block the protein eotaxin-1, which is responsible for causing inflammation in a number of diseases, according to information from WuXi Biologics. Immune Pharmaceuticals recently completed a Phase IIa 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 II trial in ulcerative colitis.

WuXi Biologics will scale the new bertilimumab manufacturing process to 2,000 liters, which it says 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 GMP production in the second quarter of 2019 with supplies released for clinical use in the third quarter of 2019.

Source: WuXi Biologics

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