A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer Therapy.

@article{Liang2020ANP,
  title={A Novel Pharmacodynamic Biomarker and Mechanistic Modeling Facilitate the Development of Tovetumab, a Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor Alpha, for Cancer Therapy.},
  author={Meina L. Liang and Bing Wang and Amy K. Schneider and Inna Vainshtein and Lorin K. Roskos},
  journal={The AAPS journal},
  year={2020},
  volume={23 1},
  pages={
          4
        }
}
Tovetumab (MEDI-575) is a fully human IgG2κ monoclonal antibody that specifically binds to human platelet-derived growth factor receptor alpha (PDGFRα) and blocks receptor signal transduction by PDGF ligands. The affinity of tovetumab determined using surface plasmon resonance technology and flow cytometry demonstrated comparable binding affinity for human and monkey PDGFRα. In single and repeat-dose monkey pharmacokinetic-pharmacodynamic (PK-PD) studies, tovetumab administration resulted in… 
Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation
TLDR
This review summarizes the recent advances and future direction of M&S-based approaches to the quantitative prediction of human PKPD for mAbs and discusses more complex mechanistic models, such as the quantitative systemics pharmacology model.

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