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