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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19 Mar 2025 15:40
The project aims at mechanistic modeling of antibodies to predict pharmacokinetics and target occupancy in cerebrospinal fluid
InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, announces its collaboration with discoveric bio alpha, a biotechnology company taking next generation antibody technologies into Alzheimer’s Disease
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26 Mar 2025 00:12
InSysBio to participate in AACR 2025
InSysBio announces its participation in AACR Annual Meeting 2025 which is to be held from April 25-30, 2025, at McCormick Place Convention Center, Chicago, Illinois, USA. InSysBio team is going to present their QSP modeling services and software to optimize drug development at Booth #4845 and 3 posters in frames of the Meeting
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31 Mar 2025 15:17
Now the Immunological Synapse submodels are meaningfully improved
InSysBio launches Immune Response Template (IRT) version 3.7.0. IRT represents a QSP platform of immune system, simultaneously, being a tool for development of models related to immune system. IRT v.3.7.0 gets a range of new features.
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