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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14 Jul 2017 18:49
To predict unpredictable: a platform for modeling of the high-selective oncology drugs was created
Moscow, Russia, July 14, 2017. The scientists from BIND RUS and InSysBio (www.insysbio.ru) published a joint research of the new class of anti-oncology treatment in the Journal of Controlled Release. Unique nanoparticles enriched with medications can deliver its content targeted to the tumor site, and the parameters of their effectiveness are programmed during the forming phase.
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25 Jul 2017 13:50
InSysBio LLC Announce Renewal of Agreement with ASTEX Pharmaceuticals Inc.
Moscow, Russia, July 25, 2017 – InSysBio LLC (www.insysbio.ru), one of the pioneers in Quantitative Systems Pharmacology (QSP) modeling and simulation for drug development, announced today a renewal of multi-year Master Service Agreement with ASTEX Pharmaceuticals, Inc.
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25 Jul 2017 17:37
InSysBio will present at the American Conference on Pharmacometrics (ACoP8)!
Moscow, Russia, July 26, 2017. - Event announcement. This year the scientific team of InSysBio will make 9 poster presentations in conjunction with leading pharmaceutical companies at ACoP8. Also at the special session "QSP Modular design - Approaches to speed up the QSP model development" Oleg Demin Jr will hold a workshop on modeling with the Immune Response Template (IRT) platform.
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