November 25, 2019
InSysBio, a pioneer in Quantitative Systems Pharmacology (QSP), modeling and simulation for drug development, announced the launch of application ‘PK/RO simulator for anti-PD-1 mAbs’. The application is based on the model allowing to predict pharmacokinetics and target binding in human for therapeutic antibodies against PD-1 receptor.
Complexity of novel therapeutics based on monoclonal antibodies makes the challenges in selection of first-in-human study dose or optimal dose due to their molecular properties. The aim of this work was to develop a minimal PBPK model of mAb disposition that will be capable to predict pharmacokinetics and target receptor occupancy (RO) in plasma and in the site of action on example of anti-PD-1 blocking antibodies such nivolumab, pembrolizumab, INCMGA00012 (MGA012), dostarlimab (TSR-042), MEDI0680 and sintilimab (IBI308).
Simulations showed that high doses with long period between administrations help to achieve higher peak RO in tumor but with that demonstrate lower trough RO. It seems like average receptor occupancy in tumor will be roughly similar over period of time. Q2W regimen provides more sustainable RO in tumor than Q3W regimen during administration of similar doses.
About InSysBio
InSysBio is a Quantitative Systems Pharmacology (QSP) company located in Moscow, Russia (INSYSBIO LLC) and Edinburgh, UK (INSYSBIO UK LIMITED). InSysBio was founded in 2004 and has an extensive track record of helping pharmaceutical companies to make right decisions on the critical stages of drug research and development by application of QSP modeling. InSysBio’s innovative QSP approach has already become a part of the drug development process implemented by our strategic partners: there are more than 100 completed projects in collaboration with leaders of pharmaceutical industry. For more information about InSysBio, its solutions and services, visit www.insysbio.com.
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03 Dec 2019 15:35
InSysBio QSP model for BTK inhibitors will be presented at the 61 ASH Annual Meeting
QSP model of BTK inhibitors developed by InSysBio in collaboration with BeiGene will be presented as a poster by Srikumar Sahasranaman from Beigene at 61st American Society of Hematology (ASH) Annual Meeting & Exposition. The model describes marketed BTK inhibitors (ibrutinib and acalabrutinib) and zanubrutinib, a BTK inhibitor which recently received accelerated approval from the FDA as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
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