Herein, we describe the generation and characterization of BI 655066, a novel, highly potent neutralizing anti-interleukin-23 (IL23) monoclonal antibody in clinical development for autoimmune conditions, including psoriasis and Crohn's disease. IL23 is a key driver of the differentiation, maintenance, and activity of a number of immune cell subsets, including T helper 17 (Th17) cells, which are believed to mediate the pathogenesis of several immune-mediated disorders. Thus, IL23 neutralization is an attractive therapeutic approach. Designing an antibody for clinical activity and convenience for the patient requires certain properties, such as high affinity, specificity, and solubility. These properties were achieved by directed design of the immunization, lead identification, and humanization procedures. Favorable substance and pharmacokinetic properties were established by biophysical assessments and studies in cynomolgus monkeys.

本文中，我们描述了BI 655066的产生和表征，BI 655066是一种针对自身免疫性疾病（包括牛皮癣和克罗恩氏病）的临床开发中的新型，高效中和性抗白介素23（IL23）单克隆抗体。IL23是许多免疫细胞亚群（包括T辅助17（Th17）细胞）的分化，维持和活性的关键驱动力，据信它们可介导几种免疫介导的疾病的发病机制。因此，IL23中和是一种有吸引力的治疗方法。设计具有临床活性和患者便利性的抗体需要某些特性，例如高亲和力，特异性和溶解性。这些特性是通过针对性的免疫设计，导线鉴定和人源化程序来实现的。