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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04 Oct 2024 16:13
InSysBio to participate in SITC 2024
InSysBio announces its participation in SITC’s 39th Annual Meeting which is to be held from November 6-10, 2024, at George R. Brown Convention Center in Houston, TX, USA. InSysBio team is going to present its Mechanistic modeling services and tools to support development of immunotherapies at Booth #1032 and 3 posters in frames of the Meeting
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16 Oct 2024 19:36
InSysBio to take part in "An Introduction to QSP" event
InSysBio announces its participation in An Introduction to QSP, A UK QSP Network hybrid (in person/online) event which is to be held 17-20hrs 24th October 2024. Oleg Demin Jr, Scientific Director, Oncology & Immuno-Oncology, will discuss the prediction of the first-in-human dose for T-cell engagers using mechanistic modelling
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