Abstract
Preclinical cancer models are essential for assessing the safety and efficacy of new therapeutics. The goals of this review are to address the development of an in vivo cancer technology platform that provides a tool for addressing emerging preclinical regulatory processes required for advancing new therapeutics and devices for use into the clinic. Previous studies have established the utility of porcine models as an alternative large animal model for cancer research due to their similarity to human size, genetics, metabolism, and physiology. Additionally, tumorigenesis pathways are similar between human and pigs in that similar driver mutations are required for transformation. Due to their larger size porcine models can be harnessed for testing of new interventional devices and radiological/surgical approaches as well. Taken together, swine are a feasible option for preclinical therapeutic and device testing. This review provides insights into the value of in vivo porcine models to provide both toxicity and efficacy data to support pre-clinical trials. The article describes next generation large animal models for cancer research, focusing on how genetically engineered pigs—particularly the Oncopig® and mini-Oncopig can bridge the gap between lab experiments and real-world human clinical trials. Evidence is provided to demonstrate how these models address major shortcomings of traditional methods and help accelerate safe and effective cancer treatment development. The inducible transgenic Oncopig and mini-Oncopig develop site and cell and driver mutation specific tumors for preclinical human cancer that supports preclinical evaluation of novel drugs, biologicals, devices and locoregional therapies. The Wisconsin Mini-swine-Oncopig is a minipig nutritionally inducible metabolic diseases (fatty liver disease and obesity) in a small animal applicable for pharmaceutical evaluation. A final and important goal of this review is to demonstrate that such cancer models are consistent with the 3-Rs and support emerging new approach methodologies evaluations.