Sinclair Nanopig™: From Multi-Omics Characterization To Pharmacology And Toxicology Validation: Underline Drug Metabolism And Immune System

By Yafei Chen, NathanBivens, HongAn, BrianMooney, ThaoNguyen, Lyndon Coghill, ManoranjanSahoo, TimothyMadsen, NathanZuidhof, JenniferHorkman, LoisHaupt, MelissaEvans, Rebecca Campbell, IanVanterpool, Steve Mason, and Wendell Davis

Sinclair Nanopig™ was recently introduced by Altasciences as the next-generation non-rodent model for (bio)pharmaceutical safety assessment. We have generated and reported physiologic and toxicologic reference values of Nanopig, including limited growth rate and lower body weight, similar clinical pathology data, organ weights, and background microscopic findings compared to other minipig breeds (SOT 2023). Genome-based comparison of drug targets, along with quantitative tissue protein expression analysis, enables the systematic comparison of orthologous sequences of therapeutic targets (DNA or protein), allowing for rational predictions of pharmacology, cross-reactivity, and potential toxicity of human drugs in animal models, thus improving clinical translation and reducing drug attrition.

With increasing interest and demand for using Nanopig in drug development from the (bio)pharmaceutical industries, and in consideration of the 4R principle, this study aims to further provide genomic, proteomic, and functional characterization data of Nanopig as scientific justifications for human-relevant animal species selection to support regulatory pharmacology and drug safety assessment, as well as expanding translational knowledge to reduce and replace traditional non-rodent models in drug development.