The project aims at Quantitative Systems Pharmacology modeling of a T-cell engager to identify first-in-human dose and predict optimal step-up dosing regimen

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January 28, 2026

InSysBio, one of the world's pioneers of Quantitative Systems Pharmacology (QSP) modeling, announces the extension of collaboration with BeOne Medicines, a global oncology company.

In this project mechanistic translational modeling will be applied to support selection of minimal recommended starting dose and step-up dosing regimen to mitigate cytokine release syndrome and optimize dose-escalation clinical study design.

"Nowadays, trimer-based mechanistic modeling has become an essential tool to guide the selection of an appropriate starting dose for first-in-human trials of T-cell engagers, ensuring the dose is high enough to be effective while avoiding sub-therapeutic levels and multiple dose escalation steps," said Oleg Demin Jr, Head of Oncology and Immuno-Oncology, InSysBio. "InSysBio's generic QSP model for T-cell engagers mechanistically captures the difference between in vitro and clinical settings, supporting precise preclinical-to-clinical translation. Consequently, it allows prediction of not only the starting dose but also the step-up dosing regimen based on preclinical data."

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

October 2018
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1. 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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1. 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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1. 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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1. 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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1. 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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