The main mechanism of action for T cell engaging bispecifics is to crosslinking T cells and tumor cells by binding to receptors on each cell type. The translational PKPD strategy needs to be able to capture this mechanism and reflect the potential biological differences between nonclinical and clinical setting. I will discuss how quantitative systems pharmacology modeling strategies can be used for translational PKPD and efficacy prediction to accelerate clinical development.
Learning Objectives:
Understand the challenges of preclinical to clinical translation for T cell engager bispecific
Review approaches used for translation and starting dose selection for bispecifics
Learn how can QSP model can be used for translation and support clinical study dose selection through case studies