Functional humanization of immunoglobulin heavy constant gamma 1 Fc domain human FCGRT transgenic mice

References

• Morell A, Terry WD, Waldmann TA. Metabolic properties of IgG subclasses in man. J Clin Invest. 1970;49:673–8. doi:https://doi.org/10.1172/JCI106279.
   PubMed Web of Science ®Google Scholar
• Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol. 2007;7:715–25.
   PubMed Web of Science ®Google Scholar
• Pyzik M, Sand KMK, Hubbard JJ, Andersen JT, Sandlie I, Blumberg RS. The neonatal Fc receptor (FcRn): a misnomer? Frontiers in Immunology. Published online 2019 Jul 10.
   Web of Science ®Google Scholar
• Huang C. Receptor-Fc fusion therapeutics, traps, and MIMETIBODY™ technology. Current Opinion in Biotechnology. 2009;20:692–99. doi:https://doi.org/10.1016/j.copbio.2009.10.010.
   PubMed Web of Science ®Google Scholar
• Kontermann RE. Strategies for extended serum half-life of protein therapeutics. Current Opinion in Biotechnology. 2011;22:868–76. doi:https://doi.org/10.1016/j.copbio.2011.06.012.
   PubMed Web of Science ®Google Scholar
• Kuo TT, Aveson VG. Neonatal Fc receptor and IgG-based therapeutics. mAbs. 2011;3:422–30. doi:https://doi.org/10.4161/mabs.3.5.16983.
   PubMed Web of Science ®Google Scholar
• Ober RJ, Radu CG, Ghetie V, Ward ES. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. International Immunology. 2001;13:1551–59. doi:https://doi.org/10.1093/intimm/13.12.1551.
   PubMed Web of Science ®Google Scholar
• Zhou J, Mateos F, Ober RJ, Ward ES. Conferring the binding properties of the mouse MHC class I-related receptor, FcRn, onto the human ortholog by sequential rounds of site-directed mutagenesis. J Mol Biol. 2005;345:1071–81. doi:https://doi.org/10.1016/j.jmb.2004.11.014.
   PubMed Web of Science ®Google Scholar
• Petkova SB, Akilesh S, Sproule TJ, Christianson GJ, Al Khabbaz H, Brown AC, Presta LG, Meng YG, Roopenian DC. Enhanced half-life of genetically engineered human IgG1 antibodies in a humanized FcRn mouse model: potential application in humorally mediated autoimmune disease. Int Immunol. 2006;18:1759–69. doi:https://doi.org/10.1093/intimm/dxl110.
   PubMed Web of Science ®Google Scholar
• Dostalek M, Prueksaritanont T, Kelley RF. Pharmacokinetic de-risking tools for selection of monoclonal antibody lead candidates. mAbs. 2017;9:756–66. doi:https://doi.org/10.1080/19420862.2017.1323160.
   PubMed Web of Science ®Google Scholar
• Tam SH, McCarthy SG, Brosnan K, Goldberg KM, Scallon BJ. Correlations between pharmacokinetics of IgG antibodies in primates vs. FcRn-transgenic mice reveal a rodent model with predictive capabilities. mAbs. 2013;5:397–405. doi:https://doi.org/10.4161/mabs.23836.
   PubMed Web of Science ®Google Scholar
• Haraya K, Tachibana T, Nanami M, Ishigai M. Application of human FcRn transgenic mice as a pharmacokinetic screening tool of monoclonal antibody. Xenobiotica. 2014;44:1127–34. doi:https://doi.org/10.3109/00498254.2014.941963.
   PubMed Web of Science ®Google Scholar
• Avery LB, Wang M, Kavosi MS, Joyce A, Kurz JC, Fan YY, Dowty ME, Zhang M, Zhang Y, Cheng A, et al. Utility of a human FcRn transgenic mouse model in drug discovery for early assessment and prediction of human pharmacokinetics of monoclonal antibodies. mAbs. 2016;8:1064–78. doi:https://doi.org/10.1080/19420862.2016.1193660.
   PubMed Web of Science ®Google Scholar
• Betts A, Keunecke A, van Steeg TJ, van der Graaf PH, Avery LB, Jones H, Berkhout J. Linear pharmacokinetic parameters for monoclonal antibodies are similar within a species and across different pharmacological targets: a comparison between human, cynomolgus monkey and hFcRn Tg32 transgenic mouse using a population-modeling approach. mAbs. 2018;10:751–64. doi:https://doi.org/10.1080/19420862.2018.1462429.
   PubMed Web of Science ®Google Scholar
• Brambell FWR, Hemmings WA, Morris IG. A theoretical model of γ-globulin catabolism. Nature. 1964;203:1352–55. doi:https://doi.org/10.1038/2031352a0.
   PubMed Web of Science ®Google Scholar
• Stein C, Kling L, Proetzel G, Roopenian DC, de Angelis MH, Wolf E, Rathkolb B. Clinical chemistry of human FcRn transgenic mice. Mamm Genome. 2012;23:259–69. doi:https://doi.org/10.1007/s00335-011-9379-6.
   PubMedGoogle Scholar
• Foote J, Winter G. Antibody framework residues affecting the conformation of the hypervariable loops. Journal of Molecular Biology. 1992;224:487–99. doi:https://doi.org/10.1016/0022-2836(92)91010-M.
   PubMed Web of Science ®Google Scholar
• Goldenberg MM. Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer. Clinical Therapeutics. 1999;21:309–18. doi:https://doi.org/10.1016/S0149-2918(00)88288-0.
   PubMed Web of Science ®Google Scholar
• Klein-Schneegans AS, Kuntz L, Fonteneau P, Loor F. Serum concentrations of IgM, IgG1, IgG2b, IgG3 and IgA in C57BL 6 mice and their congenics at the lpr (lymphoproliferation) locus. Journal of Autoimmunity. 1989;2:869–75. doi:https://doi.org/10.1016/0896-8411(89)90013-9.
   PubMed Web of Science ®Google Scholar
• Roopenian DC, Sun VZ. Clinical ramifications of the MHC family Fc receptor FcRn. J Clin Immunol. 2010;30:790–97. doi:https://doi.org/10.1007/s10875-010-9458-6.
   PubMed Web of Science ®Google Scholar
• Zhu X, Meng G, Dickinson BL, Li X, Mizoguchi E, Miao L, Wang Y, Robert C, Wu B, Smith PD, et al. MHC class I-related neonatal Fc receptor for IgG is functionally expressed in monocytes, intestinal macrophages, and dendritic cells. Journal of Immunology. 2001;166:3266–76. doi:https://doi.org/10.4049/jimmunol.166.5.3266.
   PubMed Web of Science ®Google Scholar
• Akilesh S, Christianson GJ, Roopenian DC, Shaw AS. Neonatal FcR expression in bone marrow-derived cells functions to protect serum IgG from catabolism. J Immunol. 2007;179:4580–88. doi:https://doi.org/10.4049/jimmunol.179.7.4580.
   PubMed Web of Science ®Google Scholar
• Kobayashi K, Qiao S, Yoshida M, Baker K, Lencer WI, Blumberg RS. An FcRn-dependent role for anti-flagellin immunoglobulin G in pathogenesis of colitis in mice. Gastroenterology. 2009;137(1746–56.e1). doi:https://doi.org/10.1053/j.gastro.2009.07.059.
   Google Scholar
• Richter WF, Christianson GJ, Frances N, Grimm HP, Proetzel G, Roopenian DC. Hematopoietic cells as site of first-pass catabolism after subcutaneous dosing and contributors to systemic clearance of a monoclonal antibody in mice. mAbs. 2018;10:803–13. doi:https://doi.org/10.1080/19420862.2018.1458808.
   PubMed Web of Science ®Google Scholar
• Liu X, Ye L, Christianson GJ, Yang J-Q, Roopenian DC, Zhu X. NF-kappaB signaling regulates functional expression of the MHC class I-related neonatal Fc receptor for IgG via intronic binding sequences. Journal of Immunology (Baltimore, Md: 1950). 2007;179:2999–3011. doi:https://doi.org/10.4049/jimmunol.179.5.2999.
   PubMed Web of Science ®Google Scholar
• Guo J, Li F, Qian S, Bi D, He Q, Jin H, Luo R, Li S, Meng X, Li Z, et al. TGEV infection up-regulates FcRn expression via activation of NF-kappaB signaling. Sci Rep. 2016;6:32154. doi:https://doi.org/10.1038/srep32154.
   PubMed Web of Science ®Google Scholar
• Cervenak J, Doleschall M, Bender B, Mayer B, Schneider Z, Doleschall Z, Zhao Y, Bősze Z, Hammarström L, Oster W, et al. NFkappaB induces overexpression of bovine FcRn: a novel mechanism that further contributes to the enhanced immune response in genetically modified animals carrying extra copies of FcRn. mAbs. 2013;5:860–71. doi:https://doi.org/10.4161/mabs.26507.
   PubMed Web of Science ®Google Scholar
• Wang Y, Zhang WY, Hu S, Lan F, Lee AS, Huber B, Lisowski L, Liang P, Huang M, de Almeida PE, et al. Genome editing of human embryonic stem cells and induced pluripotent stem cells with zinc finger nucleases for cellular imaging. Circ Res. 2012;111:1494–503. doi:https://doi.org/10.1161/CIRCRESAHA.112.274969.
   PubMedGoogle Scholar