Flow cytometry and receptor occupancy in immune-oncology

References

• Stewart JJ, Green CL, Jones N, et al. Role of receptor occupancy assays by flow cytometry in drug development. Cytometry B Clin Cytom. 2016;90(2):110–116.
   PubMed Web of Science ®Google Scholar
• Liang M, Schwickart M, Schneider AK, et al. Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development. Cytometry B Clin Cytom. 2016;90(2):117–127.
   PubMed Web of Science ®Google Scholar
• Schwickart M, Chavez C, Henderson S, et al. Evaluation of assay interference and interpretation of CXCR4 receptor occupancy results in a preclinical study with MEDI3185, a fully human antibody to CXCR4. Cytometry B Clin Cytom. 2016;90(2):209–219.
   PubMed Web of Science ®Google Scholar
• Choy EH, Pitzalis C, Cauli A, et al. Percentage of anti-CD4 monoclonal antibody-coated lymphocytes in the rheumatoid joint is associated with clinical improvement. Implications for the development of immunotherapeutic dosing regimens. Arthritis Rheum. 1996;39(1):52–56.
   PubMed Web of Science ®Google Scholar
• Vermeire S, O’Byrne S, Keir M, et al. Etrolizumab as induction therapy for ulcerative colitis: a randomised, controlled, phase 2 trial. Lancet. 2014;384(9940):309–318.
   PubMed Web of Science ®Google Scholar
• Freeman DJ, McDorman K, Ogbagabriel S, et al. Tumor penetration and epidermal growth factor receptor saturation by panitumumab correlate with antitumor activity in a preclinical model of human cancer. Mol Cancer. 2012;11(1):47.
   PubMed Web of Science ®Google Scholar
• Gupta S, Indelicato SR, Jethwa V, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007;321(1–2):1–18.
   PubMed Web of Science ®Google Scholar
• Latek R, Fleener C, Lamian V, et al. Assessment of belatacept-mediated costimulation blockade through evaluation of CD80/86-receptor saturation. Transplantation. 2009;87(6):926–933.
   PubMed Web of Science ®Google Scholar
• Lowe PJ, Hijazi Y, Luttringer O, et al. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development. Xenobiotica. 2007;37(10–11):1331–1354.
   PubMed Web of Science ®Google Scholar
• Ma A, Dun H, Song L, et al. Pharmacokinetics and pharmacodynamics of ASKP1240, a fully human anti-CD40 antibody, in normal and renal transplanted Cynomolgus monkeys. Transplantation. 2014;97(4):397–404.
   PubMed Web of Science ®Google Scholar
• Mao C-P, Brovarney MR, Dabbagh K, et al. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013;8(11):e80533.
   PubMed Web of Science ®Google Scholar
• Woska JR Jr., Last-Barney K, Rothlein R, et al. Small molecule LFA-1 antagonists compete with an anti-LFA-1 monoclonal antibody for binding to the CD11a I domain: development of a flow-cytometry-based receptor occupancy assay. J Immunol Methods. 2003;277(1–2):101–115.
   PubMed Web of Science ®Google Scholar
• Wyant T, Lackey A, Green M. Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist. J Transl Med. 2008;6(1):76.
   PubMed Web of Science ®Google Scholar
• Sakhdari A, Mujib S, Vali B, et al. Tim-3 negatively regulates cytotoxicity in exhausted CD8+ T cells in HIV infection. PLoS One. 2012;7(7):e40146.
   PubMed Web of Science ®Google Scholar
• de Vries Schultink AHM, Doornbos RP, Bakker ABH, et al. 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):1006–1015.
   PubMed Web of Science ®Google Scholar
• Martin T, Strickland S, Glenn M, et al. Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma. Blood Cancer J. 2019;9(4):41.
   PubMed Web of Science ®Google Scholar
• Sikic BI, Lakhani N, Patnaik A, et al. First-in-human, first-in-class phase I trial of the anti-CD47 antibody Hu5F9-G4 in patients with advanced cancers. J Clin Oncol. 2019;37(12):946–953.
   PubMed Web of Science ®Google Scholar
• Suchard SJ, Davis PM, Kansal S, et al. A monovalent anti-human CD28 domain antibody antagonist: preclinical efficacy and safety. J Immunol. 2013;191(9):4599–4610.
   PubMed Web of Science ®Google Scholar
• Brahmer JR, Drake CG, Wollner I, et al. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010;28(19):3167–3175.
   PubMed Web of Science ®Google Scholar
• Advani A, Coiffier B, Czuczman MS, et al. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin’s lymphoma: results of a phase I study. J Clin Oncol. 2010;28(12):2085–2093.
   PubMed Web of Science ®Google Scholar
• Waibler Z, Sender LY, Merten C, et al. Signaling signatures and functional properties of anti-human CD28 superagonistic antibodies. PLoS One. 2008;3(3):e1708.
   PubMed Web of Science ®Google Scholar
• Zheng Y, Scheerens H, Davis JC, et al. Translational pharmacokinetics and pharmacodynamics of an FcRn-variant anti-CD4 monoclonal antibody from preclinical model to phase I study. Clin Pharmacol Ther. 2011;89(2):283–290.
   PubMed Web of Science ®Google Scholar
• Bensinger W, Maziarz RT, Jagannath S, et al. A phase 1 study of lucatumumab, a fully human anti-CD40 antagonist monoclonal antibody administered intravenously to patients with relapsed or refractory multiple myeloma. Br J Haematol. 2012;159(1):58–66.
   PubMed Web of Science ®Google Scholar
• Byrd JC, Kipps TJ, Flinn IW, et al. Phase I study of the anti-CD40 humanized monoclonal antibody lucatumumab (HCD122) in relapsed chronic lymphocytic leukemia. Leuk Lymphoma. 2012;53(11):2136–2142.
   PubMed Web of Science ®Google Scholar
• Goldwater R, Keirns J, Blahunka P, et al. A phase 1, randomized ascending single-dose study of antagonist anti-human CD40 ASKP1240 in healthy subjects. Am J Transplant. 2013;13(4):1040–1046.
   PubMed Web of Science ®Google Scholar
• Tolcher AW, Sarantopoulos J, Patnaik A, et al. Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor 1. J Clin Oncol. 2009;27(34):5800–5807.
   PubMed Web of Science ®Google Scholar
• Kern B, Li W, Bono C, et al. Receptor occupancy and blocking of STAT5 signaling by an anti-IL-7 receptor α antibody in cynomolgus monkeys. Cytometry B Clin Cytom. 2016;90(2):191–198.
   PubMed Web of Science ®Google Scholar
• Fu J, Wang F, Dong L-H, et al. Receptor occupancy measurement of anti-PD-1 antibody drugs in support of clinical trials. Bioanalysis. 2019;11(14):1347–1358.
   PubMed Web of Science ®Google Scholar
• Vey N, Bourhis J-H, Boissel N, et al. A phase 1 trial of the anti-inhibitory KIR mAb IPH2101 for AML in complete remission. Blood. 2012;120(22):4317–4323.
   PubMed Web of Science ®Google Scholar
• Junker F, Gulati P, Wessels U, et al. A human receptor occupancy assay to measure anti-PD-1 binding in patients with prior anti-PD-1. Cytometry A. 2021. DOI:https://doi.org/10.1002/cyto.a.24334.
   Google Scholar
• Ribrag V, Dupuis J, Tilly H, et al. A dose-escalation study of SAR3419, an anti-CD19 antibody maytansinoid conjugate, administered by intravenous infusion once weekly in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res. 2014;20(1):213–220.
   PubMed Web of Science ®Google Scholar
• Lapusan S, Vidriales MB, Thomas X, et al. Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia. Invest New Drugs. 2012;30(3):1121–1131.
   PubMed Web of Science ®Google Scholar
• Green CL, Brown L, Stewart JJ, et al. Recommendations for the validation of flow cytometric testing during drug development: i instrumentation. J Immunol Methods. 2011;363(2):104–119.
   PubMed Web of Science ®Google Scholar
• Purvis N, Stelzer G. Multi-platform, multi-site instrumentation and reagent standardization. Cytometry. 1998;33(2):156–165.
   PubMedGoogle Scholar
• Perfetto SP, Ambrozak D, Nguyen R, et al. Quality assurance for polychromatic flow cytometry using a suite of calibration beads. Nat Protoc. 2012;7(12):2067–2079.
   PubMed Web of Science ®Google Scholar
• Brown L, Green CL, Jones N, et al. Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development. J Immunol Methods. 2015;418:1–8.
   PubMed Web of Science ®Google Scholar
• Canonico B, Betti M, Luchetti F, et al. Flow cytometric profiles, biomolecular and morphological aspects of transfixed leukocytes and red cells. Cytometry B Clin Cytom. 2010;78(4):267–278.
   PubMed Web of Science ®Google Scholar
• Davis C, Wu X, Li W, et al. Stability of immunophenotypic markers in fixed peripheral blood for extended analysis using flow cytometry. J Immunol Methods. 2011;363(2):158–165.
   PubMed Web of Science ®Google Scholar
• Hilt E, Sun YS, McCloskey TW, et al. Best practices for optimization and validation of flow cytometry-based receptor occupancy assays. Cytometry B Clin Cytom. 2020;100:63–71.
   PubMed Web of Science ®Google Scholar
• Cunliffe J, Derbyshire N, Keeler S, et al. An approach to the validation of flow cytometry methods. Pharm Res. 2009;26(12):2551–2557.
   PubMed Web of Science ®Google Scholar
• O’Hara DM, Xu Y, Liang Z, et al. Recommendations for the validation of flow cytometric testing during drug development: II assays. J Immunol Methods. 2011;363(2):120–134.
   PubMed Web of Science ®Google Scholar
• Wood B, Jevremovic D, Béné MC, et al. Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part V - assay performance criteria. Cytometry B Clin Cytom. 2013;84(5):315–323.
   PubMed Web of Science ®Google Scholar
• Litwin V, Oldaker T, Afonina E, et al. Validation of assays performed by flow cytometry. (1st ed. Wayne, PA. CLSI: CLSI document H62. Clinical Laboratory Standards Institute; 2021.
   Google Scholar
• Green CL, Stewart JJ, Högerkorp C-M, et al. Recommendations for the development and validation of flow cytometry-based receptor occupancy assays. Cytometry B Clin Cytom. 2016;90(2):141–149.
   PubMed Web of Science ®Google Scholar
• Agency EM. ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals Science Medicine Health. 2011 JUN;22.
   Google Scholar