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VivoSim Presents Data Showing Superiority to Competition in NAM Liver Tox Prediction at European Toxicology Meeting

VIVS
  • VivoSim Labs announced that data on its 3D human tissue models will be featured in two presentations at the ESTIV 2026 conference in Maastricht, Netherlands, running from June 29 to July 2, 2026.
  • The company's AI-enabled NAMkind™ Liver platform demonstrated >90% sensitivity in detecting true positive liver toxicity cases, surpassing the 50-65% sensitivity of traditional animal models.
  • VivoSim's liver toxicology methods achieved fewer than 5% false positives, a significant improvement over current methodologies which can result in >10% false positives leading to the rejection of viable drug candidates.
  • The NAMkind™ Liver spheroid model achieved 91% predictive accuracy, 90% sensitivity, 95% specificity, & 99% precision when benchmarked against a clinical dataset of 92 small-molecule compounds.
  • The NAMkind™ GI model successfully resolved mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea by integrating multiple endpoints including barrier function.
  • VivoSim's platforms differentiated ADC toxicity risks based on structural properties, identifying exposure-dependent, payload-driven injury in the GI model & linker stability/payload permeability risks in the Liver model.
  • The FDA is actively encouraging the shift from animal testing to human-relevant New Approach Methodologies (NAMs), with its April 2025 Roadmap reported to be successfully stimulating pharma uptake.
  • Key executives stated that the models help avoid costly failures in drug development, potentially saving clients $50M-$200M & years of lost time per missed safety signal.
  • Beyond small molecules, VivoSim is establishing competitive advantages in complex modalities including antibodies, siRNA, & gene therapies, with extensive testing on Antibody Drug Conjugates (ADCs).
  • VivoSim operates from San Diego, CA, & anticipates accelerated adoption of its 3D human tissue models following regulatory changes favoring non-animal NAM methods.