A multiscale physiologically based pharmacokinetic model to support mRNA-encoded BiTE therapy in cancer treatment

Pub. type
Scientific paper
Pub. date
September 9, 2025
Authors
Giada Fiandaca
Elio Campanile
Lorena Leonardelli
Elisa Pettinà
Stefano Giampiccolo
Elizabeth J. Carstens
Lorenzo Dasti
Natascia Zangani
Luca Marchetti
Link
View on ScienceDirect

In the field of cancer therapy, bispecific T cell engagers (BiTEs) have demonstrated significant potential. However, their clinical application is constrained by challenges in production and limited plasma half-life. In vitro-transcribed (IVT) mRNA formulations emerge as a promising alternative, offering adaptability and cost-efficiency. Yet, the intricate relationship between mRNA dosage, antibody production, and the distribution of mRNA and proteins requires a deeper understanding. To address these issues, we present a novel physiologically based pharmacokinetic (PBPK) model to characterize the pharmacokinetics of BiTEs. This model predicts the distribution patterns of both recombinant and mRNA-encoded BiTEs by extending an established PBPK model with a hierarchical multiscale framework calibrated and validated using preclinical data from existing literature. The extended PBPK model can be adapted to various mRNA-based therapeutic formulations, facilitating in-silico exploration of different drug administration scenarios. It can provide valuable support for optimizing dose and schedule and allows the efficient investigation of drug distribution at a whole-body scale. This approach promises to enhance the personalization and effectiveness of cancer therapies, reduce research time and costs, and significantly advance the development of mRNA-based BiTEs for cancer treatment.