Host Responses, The Pirbright Institute, Woking, United Kingdom.
Integrated Drug Development, Certara, Radnor, PA, United States.
Front Immunol. 2024 Oct 31;15:1471412. doi: 10.3389/fimmu.2024.1471412. eCollection 2024.
Assessing the pharmacokinetics of monoclonal antibodies (mAbs) in relevant animal models is essential for designing improved formulations and developing mAb delivery platforms. We have established the pig, a large natural host animal for influenza with many similarities to humans, as a robust model for testing the therapeutic efficacy of anti-influenza mAbs and evaluating mAb delivery platforms. Here, we compared the pharmacokinetic characteristics of two anti-influenza hemagglutinin mAbs, human 2-12C and porcine pb27, in Göttingen minipigs and Landrace × Large White outbred pigs. Minipigs offer the advantage of a more stable weight, whereas outbred pigs are more readily available but exhibit rapid growth. Outbred pigs and minipigs showed similar pharmacokinetics and a similar porcine pb27 half-life (half-life of 15.7 days for outbred pigs and 16.6 days for minipigs). In contrast, the half-life of human 2-12C was more rapid in two of the minipigs but not in the outbred pigs, correlating with the development of antidrug antibodies in the two minipigs. Our results demonstrate that both outbred pigs and minipigs are appropriate models for pharmacokinetic studies and the evaluation of mAb delivery platforms, potentially bridging the gap between small animals and human trials.
评估单克隆抗体(mAbs)在相关动物模型中的药代动力学对于设计改良制剂和开发 mAb 递送平台至关重要。我们已经建立了猪作为流感的大型天然宿主动物模型,该模型与人类有许多相似之处,可用于测试抗流感 mAb 的治疗效果和评估 mAb 递送平台。在这里,我们比较了两种抗流感血凝素 mAb(人源 2-12C 和猪源 pb27)在哥廷根小型猪和长白×大白杂交猪中的药代动力学特征。小型猪具有体重更稳定的优势,而杂交猪则更容易获得,但生长迅速。杂交猪和小型猪表现出相似的药代动力学特征,猪源 pb27 的半衰期也相似(杂交猪的半衰期为 15.7 天,小型猪的半衰期为 16.6 天)。相比之下,在两只小型猪中,人源 2-12C 的半衰期更快,但在杂交猪中则不然,这与这两只小型猪中抗药抗体的产生有关。我们的结果表明,杂交猪和小型猪都是药代动力学研究和 mAb 递送平台评估的合适模型,可能缩小了小动物和人体试验之间的差距。