Beyond Allometry: Assessing Translational PK/PD Modeling for Human Projection of a Nonlinear Immune Cell Directed ADC

  • Highlighting the translational uncertainty of nonlinear, target mediated ADC PK in first-in human prediction
  • Integrating preclinical ADC data and clinical data points from parental antibody to improve accuracy of translation
  • Leveraging population PK/RO simulations to inform TAK-500 human exposure, receptor occupancy, and pharmacologically active dose selection