On October 29, 2025 InSysBio, one of the world’s pioneers of Quantitative Systems Pharmacology (QSP) modeling, reported its collaboration with BeOne Medicines, a global oncology company.
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Mechanistic PK/RO modeling will be leveraged to support the selection of the optimal recommended phase 2 dose by predicting the dynamics of the various complexes formed when the BGB-B2033 binds to its targets. BGB-B2033, a GPC3 x 4-1BB bispecific antibody, is currently in early clinical development by BeOne Medicines.
"This project represents a valuable opportunity to apply our cutting-edge modeling approach since determining the optimal dose for therapies expected to exhibit a bell-shaped dose-response relationship poses a significant challenge," said Oleg Demin Jr, Scientific Director, InSysBio. "InSysBio’s QSP modeling expertise can help to address this issue. Namely, we have developed generic mechanistic PK/RO model for multispecific antibodies that accelerates project timelines and improves efficiency. Moreover, FDA’s Project Optimus encourages the application of mechanistic modeling approaches such as QSP to guide the selection of optimal dose in oncology."
(Press release, BeOne Medicines, OCT 29, 2025, View Source [SID1234657119])