Industrial Math Modeling Center Seminar: Model-Informed Drug Development of the Masked Anti-PD-L1 Antibody CX-072
Industrial Math Modeling Center Seminar
Model-Informed Drug Development of the Masked Anti-PD-L1 Antibody CX-072
Dr. Marissa Renardy
Senior Scientist-Modeler
Applied BioMath
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Abstract:
CX‑072 is an anti‑PD‑L1 (programmed death ligand 1) Probody therapeutic (Pb-Tx) designed to be preferentially activated by proteases in the tumor microenvironment and not in healthy tissue. In this work, a quantitative systems pharmacology (QSP) model that captured known mechanisms of Pb-Tx activation, biodistribution, elimination, and target engagement, and was used to inform clinical translation. The QSP model was used to estimate a targeted intact minimum drug concentration range that would result in 95% receptor occupancy in the tumor. Preliminary population pharmacokinetics (POPPK) and exposure-response (ER) analyses suggested that a dose of 800mg every two weeks would ensure that >95% of patients would meet or exceed the targeted minimum intact drug concentration, and that a lower dose would not significantly improve the safety profile. This work supported a fixed 800mg dose for evaluation in phase II clinical trials.
Speaker Bio:
Marissa Renardy earned her Ph.D. in Mathematics in 2018 from The Ohio State University, where she studied mathematical models in cell biology. She then went on to a postdoctoral position at University of Michigan, where she studied within-host and epidemiological models of tuberculosis. She is now a senior scientist at Applied BioMath, where she provides modeling and simulation services to accelerate and de-risk drug research and development.
Intended Audience:
Undergraduates, graduates, and experts. Those with interest in the topic.
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