In this poster, we detail how Certara, in collaboration with ModeX Therapeutics, developed a next-generation systems pharmacology model to translate complex in vitro and in vivo data into actionable clinical dosing insights. This case study highlights how QSP modeling for trispecific antibodies enables the harmonization of preclinical data and physiological system parameters to predict a safe and effective first-in-human (FIH) dose for a novel trispecific T-cell activator. The work demonstrates how T-cell engager modeling can de-risk early clinical development and accelerate multispecific antibody development programs.

What You’ll Learn

• How QSP modeling integrates binding, cytokine release, cytotoxicity assays, and NHP PK data
• How mechanistic translational modeling informs FIH dosing of complex multispecific biologics
• How in vitro human cell sensitivity shaped dose predictions and why bound-receptor metrics were essential
• How the molecule’s unique design was represented mechanistically to anticipate clinical behavior