References
- Reilly RM. ImmunoPET to optimize the dose of monoclonal antibodies for cancer therapy - How much is enough? J Nucl Med. 2019;60:899–10. doi:https://doi.org/10.2967/jnumed.119.225854.
- Saber H, Del Valle P, Ricks TK, Leighton JK. An FDA oncology analysis of CD3 bispecific constructs and first-in-human dose selection. Regul Toxicol Pharmacol. 2017;90:144–52. doi:https://doi.org/10.1016/j.yrtph.2017.09.001.
- Saber H, Gudi R, Manning M, Wearne E, Leighton JK. An FDA oncology analysis of immune activating products and first-in-human dose selection. Regul Toxicol Pharmacol. 2016;81:448–56. doi:https://doi.org/10.1016/j.yrtph.2016.10.002.
- Menke-van der Houven van Oordt CW, McGeoch A, Bergstrom M, McSherry I, Smith DA, Cleveland M, Al-Azzam W, Chen L, Verheul H, Hoekstra OS, et al. ImmunoPET imaging to assess target engagement: experience from (89)Zr-anti-HER3 mAb (GSK2849330) in patients with solid tumors. J Nucl Med. 2019;60:902–09. doi:https://doi.org/10.2967/jnumed.118.214726.
- Stewart JJ, Green CL, Jones N, Liang M, Xu Y, Wilkins DE, Moulard M, Czechowska K, Lanham D, McCloskey TW, et al. Role of receptor occupancy assays by flow cytometry in drug development. Cytometry B Clin Cytom. 2016;90(2):110–16. doi:https://doi.org/10.1002/ccc.21355.
- Vainshtein I, Schneider AK, Sun B, Schwickart M, Roskos LK, Liang M. Multiplexing of receptor occupancy measurements for pharmacodynamic biomarker assessment of biopharmaceuticals. Cytometry B Clin Cytom. 2016;90(2):128–40. doi:https://doi.org/10.1002/cyto.b.21319.
- Litwin V, Green C, Stewart JJ. Receptor occupancy by flow cytometry. Cytometry B Clin Cytom. 2016;90(2):108–09. doi:https://doi.org/10.1002/cyto.b.21364.
- Liang M, Schwickart M, Schneider AK, Vainshtein I, Del Nagro C, Standifer N, Roskos LK. Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development. Cytometry B Clin Cytom. 2016;90(2):117–27. doi:https://doi.org/10.1002/cyto.b.21259.
- Deng R, Bumbaca D, Pastuskovas CV, Boswell CA, West D, Cowan KJ, Chiu H, McBride J, Johnson C, Xin Y, et al. Preclinical pharmacokinetics, pharmacodynamics, tissue distribution, and tumor penetration of anti-PD-L1 monoclonal antibody, an immune checkpoint inhibitor. MAbs. 2016;8(3):593–603. doi:https://doi.org/10.1080/19420862.2015.1136043.
- Meno-Tetang GM, Lowe PJ. On the prediction of the human response: a recycled mechanistic pharmacokinetic/pharmacodynamic approach. Basic Clin Pharmacol Toxicol. 2005;96(3):182–92. doi:https://doi.org/10.1111/j.1742-7843.2005.pto960307.x.
- Schlucker S, Salehi M, Bergner G, Schutz M, Strobel P, Marx A, Petersen I, Dietzek B, Popp J. Immuno-surface-enhanced coherent anti-stokes Raman scattering microscopy: immunohistochemistry with target-specific metallic nanoprobes and nonlinear Raman microscopy. Anal Chem. 2011;83(18):7081–85. doi:https://doi.org/10.1021/ac201284d.
- Alsaid H, Skedzielewski T, Rambo MV, Hunsinger K, Hoang B, Fieles W, Long ER, Tunstead J, Vugts DJ, Cleveland M, et al. Non invasive imaging assessment of the biodistribution of GSK2849330, an ADCC and CDC optimized anti HER3 mAb, and its role in tumor macrophage recruitment in human tumor-bearing mice. PLoS One. 2017;12(4):e0176075. doi:https://doi.org/10.1371/journal.pone.0176075.
- Burvenich IJG, Lee FT, Cartwright GA, O’Keefe GJ, Makris D, Cao D, Gong S, Chueh AC, Mariadason JM, Brechbiel MW, et al. Molecular imaging of death receptor 5 occupancy and saturation kinetics in vivo by humanized monoclonal antibody CS-1008. Clin Cancer Res. 2013;19(21):5984–93. doi:https://doi.org/10.1158/1078-0432.Ccr-12-3104.
- Orcutt KD, Adams GP, Wu AM, Silva MD, Harwell C, Hoppin J, Matsumura M, Kotsuma M, Greenberg J, AM S, et al. Molecular simulation of receptor occupancy and tumor penetration of an antibody and smaller scaffolds: application to molecular imaging. Mol Imaging Biol. 2017;19(5):656–64. doi:https://doi.org/10.1007/s11307-016-1041-y.
- Heskamp S, Raave R, Boerman O, Rijpkema M, Goncalves V, Denat F. (89)Zr-Immuno-Positron Emission tomography in oncology: state-of-the-art (89)Zr radiochemistry. Bioconjug Chem. 2017;28(9):2211–23. doi:https://doi.org/10.1021/acs.bioconjchem.7b00325.
- Sugyo A, Aung W, Tsuji A, Sudo H, Takashima H, Yasunaga M, Matsumura Y, Saga T, Higashi T. Anti‑tissue factor antibody‑mediated immuno‑SPECT imaging of tissue factor expression in mouse models of pancreatic cancer. Oncol Rep. 2019;41(4):2371–78. doi:https://doi.org/10.3892/or.2019.7017.
- Bensch F, van der Veen EL, Lub-de Hooge MN, Jorritsma-Smit A, Boellaard R, Kok IC, Oosting SF, Schröder CP, Hiltermann TJN, van der Wekken AJ, et al. (89)Zr-atezolizumab imaging as a non-invasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018;24(12):1852–58. doi:https://doi.org/10.1038/s41591-018-0255-8.
- England CG, Ehlerding EB, Hernandez R, Rekoske BT, Graves SA, Sun H, Liu G, McNeel DG, Barnhart TE, Cai W. Preclinical pharmacokinetics and biodistribution studies of 89Zr-Labeled pembrolizumab. J Nucl Med. 2017;58(1):162–68. doi:https://doi.org/10.2967/jnumed.116.177857.
- Mandikian D, Takahashi N, Lo AA, Li J, Eastham-Anderson J, Slaga D, Ho J, Hristopoulos M, Clark R, Totpal K, et al. relative target affinities of T-Cell-dependent bispecific antibodies determine biodistribution in a solid tumor mouse model. Mol Cancer Ther. 2018;17(4):776–85. doi:https://doi.org/10.1158/1535-7163.MCT-17-0657.
- Moek KL, Waaijer SJH, Kok IC, Suurs FV, Brouwers AH, Menke-van der Houven van Oordt CW, Wind TT, Gietema JA, Schröder CP, Mahesh SVK, et al. (89)Zr-labeled bispecific T-cell engager AMG 211 PET shows AMG 211 accumulation in CD3-rich tissues and clear, heterogeneous tumor uptake. Clin Cancer Res. 2019;25(12):3517–27. doi:https://doi.org/10.1158/1078-0432.CCR-18-2918.
- Carrasquillo JA, Fine BM, Pandit-Taskar N, Larson SM, Fleming SE, Fox JJ, Cheal SM, O’Donoghue JA, Ruan S, Ragupathi G, et al. Imaging patients with metastatic castration-resistant prostate cancer using 89Zr-DFO-MSTP2109A anti-steap1 antibody. J Nucl Med. 2019;60(11):1517–23. doi:https://doi.org/10.2967/jnumed.118.222844.
- Yu S, Zhang J, Yan Y, Yao X, Fang L, Xiong H, Liu Y, Chu Q, Zhou P, Wu K. A novel asymmetrical anti-HER2/CD3 bispecific antibody exhibits potent cytotoxicity for HER2-positive tumor cells. J Exp Clin Cancer Res. 2019;38(1):355. doi:https://doi.org/10.1186/s13046-019-1354-1.
- Vugts DJ, Heuveling DA, Stigter-van Walsum M, Weigand S, Bergstrom M, van Dongen GA, Nayak TK. Preclinical evaluation of 89Zr-labeled anti-CD44 monoclonal antibody RG7356 in mice and cynomolgus monkeys: prelude to Phase 1 clinical studies. MAbs. 2014;6(2):567–75. doi:https://doi.org/10.4161/mabs.27415.
- Marquez BV, Ikotun OF, Zheleznyak A, Wright B, Hari-Raj A, Pierce RA, Lapi SE. Evaluation of (89)Zr-pertuzumab in Breast cancer xenografts. Mol Pharm. 2014;11(11):3988–95. doi:https://doi.org/10.1021/mp500323d.
- Shultz LD, Ishikawa F, Greiner DL. Humanized mice in translational biomedical research. Nat Rev Immunol. 2007;7(2):118–30. doi:https://doi.org/10.1038/nri2017.
- de Vries Schultink AHM, Doornbos RP, Bakker ABH, Bol K, Throsby M, Geuijen C, Maussang D, Schellens JHM, Beijnen JH, Huitema ADR. Translational PK-PD modeling analysis of MCLA-128, a HER2/HER3 bispecific monoclonal antibody, to predict clinical efficacious exposure and dose. Invest New Drugs. 2018;36(6):1006–15. doi:https://doi.org/10.1007/s10637-018-0593-x.
- Patlak CS, Blasberg RG, Fenstermacher JD. Graphical evaluation of blood-to-brain transfer constants from multiple-time uptake data. J Cereb Blood Flow Metab. 1983;3(1):1–7. doi:https://doi.org/10.1038/jcbfm.1983.1.
- Zeglis BM, Lewis JS. The bioconjugation and radiosynthesis of 89Zr-DFO-labeled antibodies. J Vis Exp. 2015:96. doi:https://doi.org/10.3791/52521.
- Deshayes E, Ladjohounlou R, Le Fur P, Pichard A, Lozza C, Boudousq V, Sevestre S, Jarlier M, Kashani R, Koch J, et al. Radiolabeled antibodies against mullerian-inhibiting substance receptor, Type II: new tools for a theranostic approach in ovarian cancer. J Nucl Med. 2018;59(8):1234–42. doi:https://doi.org/10.2967/jnumed.118.208611.
- Bergstrom M. The use of microdosing in the development of small organic and protein therapeutics. J Nucl Med. 2017;58(8):1188–95. doi:https://doi.org/10.2967/jnumed.116.188037.
- Ilan E, Velikyan I, Sandstrom M, Sundin A, Lubberink M. Tumor-to-blood ratio for assessment of somatostatin receptor density in neuroendocrine tumors using (68)Ga-DOTATOC and (68)Ga-DOTATATE. J Nucl Med. 2020;61(2):217–21. doi:https://doi.org/10.2967/jnumed.119.228072.