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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02 Aug 2021 16:17
InSysBio to take part in PharmSci360 2021
InSysBio announces its participation in AAPS 2021 PHARMSCI 360 which is to be held in Pennsylvania Convention Center, Philadelphia, PA, and Online 17-20 October, 2021. InSysBio team is going to present the update at the Virtual Booth (VB1) and 2 posters in frames of the Conference
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06 Aug 2021 15:38
InSysBio to participate in Biomarkers for Alzheimer’s Disease Summit
InSysBio will take part in Annual Biomarkers for Alzheimer’s Disease Summit, Digital Event which is going to be held August 24-26, 2021. InSysBio will present its Neurodegeneration modeling issues and Alzheimer’s Disease Platform update at its Virtual Booth! Moreover, Tatiana Karelina, Head of Neurodegenerative Diseases Modeling Team, will give a talk
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11 Aug 2021 15:50
InSysBio to launch its OpenSource HetaSimulator project
The new platform is a part of Heta-based QSP modeling infrastructure
[Moscow – 11.08.2021] InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, now presents HetaSimulator. It is a part of Heta project that embraces three components. HetaSimulator is an OpenSource simulation and parameters estimation platform for the Heta modeling language.
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18 Aug 2021 10:49
InSysBio to take part in PAGE 2021
InSysBio announces its participation in PAGE 2021 Online meeting which is to be held on the 2nd, 3rd, 6th, and 7th of September 2021. InSysBio team is going to present its latest development at the Virtual Exhibition e-booth and six posters
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