Vivosim

VivoSim Labs delivers human-relevant safety and efficacy testing for ADCs and other advanced modalities in 3D models built entirely from primary human cells. NAMkind™ Liver (hepatocyte, stellate, Kupffer, endothelial) and NAMkind™ Intestine (ileum and colon, dosed basolaterally to mimic IV exposure) express relevant targets, so they deconvolute what actually drives toxicity — intact conjugate, free payload, or naked antibody — and separate on-target from off-target liability. Across a panel spanning trastuzumab emtansine, deruxtecan and rezetecan, gemtuzumab ozogamicin, and vedotin- and mafodotin-based ADCs, model calls tracked observed clinical hepatotoxicity and diarrhea and resolved linker-, DAR- and payload-driven differences in risk; an ADC against a target absent from the models gave no signal while its free payload was toxic, confirming target-dependent rather than nonspecific readouts. Against validated small-molecule reference sets, liver reads 91% accuracy / 90% sensitivity / 95% specificity and intestine 96% / 97% / 93%, placing each candidate on a margin-of-safety scale versus clinical Cmax. Flexible 7–21 day dosing supports combination and multi-cycle regimens. Diseased-donor liver models extend the same platform to antifibrotic efficacy, benchmarked against clinical-stage successes and failures.