The new article “Dose Selection for DuoBody®-CD40x4-1BB (GEN1042/BNT312) Using a mPBPK/RO Model Leveraging Preclinical and Clinical Data” by Gaurav Bajaj, Dmitry Shchelokov, Oleg Demin Jr, Homer C. Adams 3rd, Yan Feng, Leonid Gibiansky, Saskia van der Lee, Anandhi Johri, Merzu Belete, Alexander Muik, Porntula Panorchan, Özlem Türeci, Uğur Sahin, Tahamtan Ahmadi, Manish Gupta, Oleg Demin, Craig Thalhauser was published in CPT: Clinical Pharmacology & Therapeutics on May 10, 2025.
Dmitry Shchelokov, Senior Modeler, highlights, "This work is devoted to a comprehensive approach to dose selection for GEN1042 (Duo Body®-CD40x4-1BB), a bispecific antibody that activates immune cells by simultaneous binding to CD40 and 4-1BB. Optimizing dose for bispecific antibodies is a non–trivial task, since the formation of trimolecular complexes upon binding to targets which is believed to mediate the effect cannot be quantified in vivo. The usage of a minimal physiologically based pharmacokinetic (mPBPK) model in combination with a receptor occupancy (RO) model allowed to justify the dose range at which a therapeutic effect is expected in a clinical trial."
The PBPK/RO model file is presented in the article. The model was developed using Heta compiler and can be transformed into different formats with its help.
Learn more about Heta Project: hetalang.github.io
About InSysBio
InSysBio is a group of Quantitative Systems Pharmacology (QSP) companies located in Limassol, Cyprus (INSYSBIO CY Ltd) 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 cutting-edge 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 and innovative biotech companies. For more information about InSysBio, its solutions and services, visit www.insysbio.com
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03 Aug 2020 16:00
InSysBio to share new data in frames of its Open Source QSP model of COVID-19
InSysBio has received a new set of results in framework of development of QSP model of COVID-19 describing virus and host cell life cycles, innate and adoptive immune response and possible therapeutic treatments.
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06 Aug 2020 17:51
InSysBio to update its Cytocon DB and to present version 1.2.6.6
InSysBio is glad to present Cytocon DB 1.2.6.6! Cytocon DB team has reviewed 39 articles to introduce new data. It should be outlined that the total number of concentrations within the Database has already exceeded 10 thousand!
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20 Aug 2020 17:18
InSysBio to present the new version of Immune Response Template
IRT 3.2.0 acquires new models and extended annotations
(Moscow – 20.08.2020) InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, presents the new version of its Immune Response Template (IRT). IRT is an efficient and useful tool to boost and facilitate the development of QSP models in immunology and immuno-oncology therapeutic areas. By this point IRT has been developed into a fully-fledged database but InSysBio constantly goes further in its software advancement.
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