Search bioRxiv⌕ Search

Biology subjects

Kraft, T. E.

Publications and source records attributed to Kraft, T. E..

2 recordsLinked to original sources

Spatial architecture of complex antibody formats dictates pharmacokinetics via FcRn-recycling

Complex antibody formats are advancing in the biotherapeutic landscape to address the need for multi-specificity, tailored valency, and novel mechanisms of action. However, understanding how non-canonical architectures impact fundamental pharmacokinetic pathways remains a critical challenge. While canonical IgGs experience steric hindrance at the endosomal membrane during FcRn engagement, whether -- and how strongly -- this constraint impacts FcRn-mediated recycling across the expanding diversity of non-canonical antibody architectures has remained unknown. By systematically evaluating a diverse panel of rationally designed antibody geometries utilizing orthogonal in vitro assays we demonstrate that spatial layout profoundly influences FcRn-recycling efficiency; inverting the antibody structure by positioning the Fab-domains to the C-terminus (invertbodies) maximizes recycling, whereas crowding the N-terminus severely impairs it. In contrast, non-specific endocytosis was only modestly and inconsistently affected by Fab number, dependent on the Fv-sequence, but not by the spatial architecture itself. Notably, antibody architecture and affinity-enhancing Fc-FcRn mutations act independently yet cooperatively, ultimately revealing a physiological recycling ceiling. These FcRn-recycling dynamics translate with high fidelity to in vivo clearance (CL) in a humanized FcRn mouse model. Across the antibody panel, architecture drove a near 15-fold variance in CL, an effect that collapsed in FcRn-knockout mice. As proof of concept, we applied the invertbody design to a variant of the marketed antibody golimumab, achieving a three-fold reduction in clearance without compromising potency. These findings reveal the magnitude and predictability with which the antibody architecture governs FcRn-recycling and non-specific CL, establishing a rational, generalizable framework to optimize the pharmacokinetics of biotherapeutics.

pharmacology and toxicology↗

Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies

This study explores the impact of antibody surface charge on tissue distribution into various tissues including tumor. Tumor-bearing mice were dosed intravenously with a mixture comprising three antibodies engineered to carry negative charge patches, a balanced charge distribution, or positive patches, respectively. Tissue levels were analyzed with a specific LC-MS/MS method. In addition, the antibody mix was administered to non-tumor bearing mice. Muscle and skin interstitial fluid were obtained by centrifugation and analyzed by LC-MS/MS. An in-vitro endothelium model was explored for its feasibility to mimic the observed distribution differences. A balanced charge distribution was optimal in terms of total tumor exposure, while in other tissues negatively charged and balanced charged antibodies gave similar results. In contrast, positive charge patches generally result in increased serum clearance but markedly enhance tumor and organ uptake, leading to higher tissue-to-serum ratios. The uptake and availability in the interstitial space were confirmed by specific assessment of antibody levels in the interstitial fluid of muscle and skin, with similar charge impact as in total tissue. The in vitro model was able to differentiate the transport propensity of this series of antibody variants. In summary, our results show the differential effects of charge patches on an antibody surface on biodistribution and tumor uptake. These insights may help in the design of molecules with biodistribution properties tailored to their purpose and an optimized safety profile.

cancer biology↗