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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01 Oct 2018 12:23
InSysBio Announces Continuation of Collaboration with MedImmune for Quantitative Systems Pharmacology Modeling in Systemic Lupus Erythematosus
InSysBio, a pioneer in Quantitative Systems Pharmacology (QSP), modeling and simulation for drug development, announced today an extension of a collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for QSP modeling in systemic lupus erythematosus (SLE). The goal is to support the clinical development of anifrolumab, an investigational monoclonal antibody against the type I interferon receptor, by modeling the contributions of key cell types involved in the pathophysiology of lupus that are associated with the type I interferon dysregulation commonly seen with the disease.
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02 Oct 2018 14:05
InSysBio to present at ACoP9
InSysBio announces their participation at Ninth American Conference on Pharmacometrics (ACoP9), to be held October 7th to 10th, 2018, at the Loews Coronado Bay Resort near San Diego, CA. The theme of ACoP9 is “Modeling without Bounds”. InSysBio welcomes visitors at the booth #23.
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09 Oct 2018 15:29
InSysBio starts training course “Modeling for systems biology and biomedicine”
InSysBio expert modelers Dr. Galina Lebedeva, Dr. Tatiana Karelina, Dr. Evgeny Metelkin and Dr. Oleg Demin will give the course “Modeling for systems biology and biomedicine” at the Faculty of bioengineering and bioinformatics, Lomonosov Moscow State University.
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19 Oct 2018 15:49
InSysBio to present at BiotechClub 2018
InSysBio announces their participation at BiotechClub 2018 conference to be held on October 26th at Hyatt Regency Moscow Petrovsky Park. The theme of BiotechClub 2018 is “From Systems Biology to Systems Medicine”.
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24 Oct 2018 13:49
InSysBio to present at ICSB 2018
InSysBio announces their participation at 19th International Conference on Systems Biology (ICSB 2018) to be held October 28th to November 1st, 2018 in Lyon, France.
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