Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies

Drug Discovery Today: Technologies

Volumn 21-22, Issue , 2016, Pages 75-83

  Kamath, Amrita V ^a  

^a GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ANALYTIC METHOD; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; DRUG ABSORPTION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG SAFETY; HUMAN; IMMUNOGENICITY; NONHUMAN; PHARMACODYNAMICS; PHARMACOKINETIC PARAMETERS; PREDICTION; REVIEW; ANIMAL; BIOLOGICAL MODEL; TRANSLATIONAL RESEARCH;

ANIMALS; ANTIBODIES, MONOCLONAL; HUMANS; MODELS, BIOLOGICAL; TRANSLATIONAL MEDICAL RESEARCH;

EID: 85004011395     PISSN: None     EISSN: 17406749     Source Type: Journal    
DOI: 10.1016/j.ddtec.2016.09.004     Document Type: Review

References (63)

1. [1] Reichert, J.M., Antibodies to watch in 2016. mAbs 8:2 (2016), 197–204.
2. [2] Wang, W., Wang, E.Q., Balthasar, J.P., Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 84 (2008), 548–558.
3. [3] Deng, R., Jin, F., Prabhu, S., Iyer, S., Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?. Expert Opin Drug Metab Toxicol 8 (2012), 141–160.
4. [4] Morgan, P., Van Der Graaf, P.H., Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discovery Today 17 (2012), 419–424.
5. [5] Danhof, M., de Lange, E.C., Della Pasqua, O.E., Ploeger, B.A., Voskuyl, R.A., Mechanism-based pharmacokinetic pharmacodynamic (PK-PD) modeling in translational drug research. Trends Pharmacol Sci 29 (2008), 186–191.
6. [6] Levy, G., Pharmacologic target-mediated drug disposition. Clin Pharmacol Ther 56 (1994), 248–252.
7. [7] Richter, W.F., Bhansali, S.G., Morris, M.E., Mechanistic determinants of biotherapeutics absorption following SC administration. AAPS J 14 (2012), 559–570.
8. [8] Vugmeyster, Y., Xu, X., Theil, F.P., Khawli, L.A., Leach, M.W., Pharmacokinetics and toxicology of therapeutic proteins: advances and challenges. World J Biol Chem 3 (2012), 73–92.
9. [9] Dirks, N.L., Meibohm, B., Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 49 (2010), 633–659.
10. [10] Shah, D.K., Betts, A.M., Antibody biodistribution coefficients: inferring tissue concentrations of monoclonal antibodies based on the plasma concentrations in several preclinical species and human. mAbs 5 (2013), 297–305.
11. [11] Thurber, G.M., Schmidt, M.M., Wittrup, K.D., Factors determining antibody distribution in tumors. Trends Pharmacol Sci 29 (2008), 57–61.
12. [12] Den Broeder, A., van de Putte, L., Rau, R., Schattenkirchner, M., Van Riel, P., Sander, O., et al. A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-alpha antibody adalimumab (D2E7) in patients with rheumatoid arthritis. J Rheumatol 29 (2002), 2288–2298.
13. [13] Lu, J.F., Bruno, R., Eppler, S., Novotny, W., Lum, B., Gaudreault, J., Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol 62 (2008), 779–786.
14. [14] Lowe, P.J., Tannenbaum, S., Gautier, A., Jimenez, P., Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Br J Clin Pharmacol 68 (2009), 61–76.
15. [15] Glassman, P.M., Balthasar, J.P., Mechanistic considerations for the use of monoclonal antibodies for cancer therapy. Cancer Biol Med 11 (2014), 20–33.
16. [16] Roopenian, D.C., Akilesh, S., FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 7 (2007), 715–725.
17. [17] Yeung, Y.A., Leabman, M.K., Marvin, J.S., Qiu, J., Adams, C.W., Lien, S., Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J Immunol 182 (2009), 7663–7671.
18. [18] Deng, R., Loyet, K.M., Lien, S., Iyer, S., DeForge, L.E., Theil, F.P., Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-alpha antibody and its neonatal Fc receptor variants in mice and cynomolgus monkeys. Drug Metab Dispos 38 (2010), 600–605.
19. [19] Robbie, G.J., Criste, R., Dall'acqua, W.F., Jensen, K., Patel, N.K., Losonsky, G.A., et al. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother 57 (2013), 6147–6153.
20. [20] Chan, A.C., Carter, P.J., Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol 10 (2010), 301–316.
21. [21] Leabman, M.K., Meng, Y.G., Kelley, R.F., DeForge, L.E., Cowan, K.J., Iyer, S., Effects of altered FcγR binding on antibody pharmacokinetics in cynomolgus monkeys. mAbs 5 (2013), 896–903.
22. [22] Mortensen, D.L., Prabhu, S., Stefanich, E.G., Kadkhodayan-Fischer, S., Gelzleichter, T.R., Baker, D., et al. Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies. mAbs 4 (2012), 724–731.
23. [23] Berinstein, N.L., Grillo-López, A.J., White, C.A., Bence-Bruckler, I., Maloney, D., Czuczman, M., et al. Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 9 (1998), 995–1001.
24. [24] Uchida, J., Hamaguchi, Y., Oliver, J.A., Ravetch, J.V., Poe, J.C., Haas, K.M., et al. The innate mononuclear phagocyte network depletes B lymphocytes through Fc receptor-dependent mechanisms during anti-CD20 antibody immunotherapy. J Exp Med 199 (2004), 1659–1669.
25. [25] Boswell, C.A., Tesar, D.B., Mukhyala, K., Theil, F.P., Fielder, P.J., Khawli, L.A., Effects of charge on antibody tissue distribution and pharmacokinetics. Bioconjug Chem 21 (2010), 2153–2163.
26. [26] Hotzel, I., Theil, F.P., Bernstein, L.J., Prabhu, S., Deng, R., Quintana, L., et al. A strategy for risk mitigation of antibodies with fast clearance. mAbs 4 (2012), 753–760.
27. [27] Sharma, V.K., Patapoff, T.W., Kabakoff, B., Pai, S., Hilario, E., Zhang, B., et al. In silico selection of therapeutic antibodies for development: viscosity, clearance, and chemical stability. Proc Natl Acad Sci 111 (2014), 18601–18606.
28. [28] Gadkar, K., Yadav, D.B., Zuchero, J.Y., Couch, J.A., Kanodia, J., Kenrick, M.K., et al. Mathematical PKPD and safety model of bispecific TfR/BACE1 antibodies for the optimization of antibody uptake in brain. Eur J Pharm Biopharm 101 (2016), 53–61.
29. [29] Wittrup, K.D., Thurber, G.M., Schmidt, M.M., Rhoden, J.J., Practical theoretic guidance for the design of tumor-targeting agents. Methods Enzymol 503 (2012), 255–268.
30. [30] Bussiere, J.L., Species selection considerations for preclinical toxicology studies for biotherapeutics. Expert Opin Drug Metab Toxicol 4 (2008), 871–877.
31. [31] Andersen, J.T., Daba, M.B., Berntzen, G., Michaelsen, T.E., Sandlie, I., Cross-species binding analyses of mouse and human neonatal Fc receptor show dramatic differences in immunoglobulin G and albumin binding. J Biol Chem 285 (2010), 4826–4836.
32. [32] Ober, R.J., Radu, C.G., Ghetie, V., Ward, E.S., Differences in promiscuity for antibody–FcRn interactions across species: implications for therapeutic antibodies. Int Immunol 13 (2001), 1551–1559.
33. [33] Avery, L.B., Wang, M., Kavosi, M.S., Joyce, A., Kurz, J.C., Fan, Y.Y., 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 8 (2016), 1064–1078.
34. [34] Proetzel, G., Roopenian, D.C., Humanized FcRn mouse models for evaluating pharmacokinetics of human IgG antibodies. Methods 65 (2014), 148–153.
35. [35] Xin, Y., Bai, S., Damico-Beyer, L.A., Jin, D., Liang, W.C., Wu, Y., et al. Anti-neuropilin-1 (MNRP1685A): unexpected pharmacokinetic differences across species, from preclinical models to humans. Pharm Res 29 (2012), 2512–2521.
36. [36] Vugmeyster, Y., Szklut, P., Wensel, D., Ross, J., Xu, X., Awwad, M., et al. Complex pharmacokinetics of a humanized antibody against human amyloid beta peptide, anti-abeta Ab2, in nonclinical species. Pharm Res 28 (2011), 1696–1706.
37. [37] Bumbaca, D., Wong, A., Drake, E., Reyes, A.E., Lin, B.C., Stephan, J.P., et al. Highly specific off-target binding identified and eliminated during the humanization of an antibody against FGF receptor 4. mAbs 3 (2011), 376–386.
38. [38] Brennan, F., Cauvin, A., Tibbitts, J., Wolfreys, A., Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases. Drug Dev Res 75 (2014), 115–161.
39. [39] Santostefano, M.J., Kirchner, J., Vissinga, C., Fort, M., Lear, S., Pan, W.J., et al. Off-target platelet activation in macaques unique to a therapeutic monoclonal antibody. Toxicol Pathol 40 (2012), 899–917.
40. [40] Kropshofer, H., Richter, W.F., Immunogenicity: its impact on ADME of therapeutic biologics. Zhou, H., Theil, F.P., (eds.) ADME and translational pharmacokinetics/pharmacodynamics of therapeutic proteins, 2016, Wiley, 147–158.
41. [41] Chen, X., Hickling, T., Kraynov, E., Kuang, B., Parng, C., Vicini, P., A mathematical model of the effect of immunogenicity on therapeutic protein pharmacokinetics. AAPS J 15 (2013), 1141–1154.
42. [42] Ng, C.M., Loyet, K.M., Iyer, S., Fielder, P.J., Deng, R., Modeling approach to investigate the effect of neonatal Fc receptor binding affinity and anti-therapeutic antibody on the pharmacokinetic of humanized monoclonal anti-tumor necrosis factor-α IgG antibody in cynomolgus monkey. Eur J Pharm Sci 51 (2014), 51–58.
43. [43] Gómez-Mantilla, J.D., Trocóniz, I.F., Parra-Guillén, Z., Garrido, M.J., Review on modeling anti-antibody responses to monoclonal antibodies. J Pharmacokinet Pharmacodyn 41 (2014), 523–536.
44. [44] Lee, J.W., Kelley, M., King, L.E., Yang, J., Salimi-Moosavi, H., Tang, M.T., et al. Bioanalytical approaches to quantify total and free therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J 13 (2011), 99–110.
45. [45] DeSilva, B., Smith, W., Weiner, R., Kelley, M., Smolec, J., Lee, B., et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res 20 (2003), 1885–1900.
46. [46] van den Broek, I., Niessen, W.M., van Dongen, W.D., Bioanalytical LC–MS/MS of protein-based biopharmaceuticals. J Chromatogr B: Anal Technol Biomed Life Sci 929 (2013), 161–179.
47. [47] Boswell, C.A., Bumbaca, D., Fielder, P.J., Khawli, L.A., Compartmental tissue distribution of antibody therapeutics: experimental approaches and interpretations. AAPS J 14 (2012), 612–618.
48. [48] Xin, X., Vugmeyster, Y., Challenges and opportunities in absorption, distribution, metabolism, and excretion studies of therapeutic Biologics. AAPS J 14 (2012), 781–791.
49. [49] Wang, J., Iyer, S., Fielder, P.J., Davis, J.D., Deng, R., Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development. Biopharm Drug Dispos 37 (2016), 51–65.
50. [50] Mager, D.E., Woo, S., Jusko, W.J., Scaling pharmacodynamics from in vitro and preclinical animal studies to humans. Drug Metab Pharmacokinet 24 (2009), 16–24.
51. [51] Deng, R., Iyer, S., Theil, F.P., Mortensen, D.L., Fielder, P.J., Prabhu, S., Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned?. mAbs 3 (2011), 61–66.
52. [52] Dong, J.Q., Salinger, D.H., Endres, C.J., Gibbs, J.P., Hsu, C.P., Stouch, B.J., et al. Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction. Clin Pharmacokinet 50 (2011), 131–142.
53. [53] Benson, N., Van der Graff, P.H., The rise of systems pharmacology in drug discovery and development. Future Med Chem 6 (2014), 1731–1734.
54. [54] Gadkar, K., Kirouac, D.C., Mager, D.E., van der Graaf, P.H., Ramanujan, S., A six-stage workflow for robust application of systems pharmacology. CPT Pharmacomet Syst Pharmacol 5 (2016), 235–249.
55. [55] Danhof, M., Systems pharmacology – towards the modeling of network interactions. Eur J Pharm Sci 94 (2016), 4–14.
56. [56] Wang, W., Prueksaritanont, T., Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited. Biopharm Drug Dispos 31 (2010), 253–263.
57. [57] Ling, J., Zhou, H., Jiao, Q., Davis, H.M., Interspecies scaling of therapeutic monoclonal antibodies: initial look. J Clin Pharmacol 49 (2009), 1382–1402.
58. [58] Oitate, M., Masubuchi, N., Ito, T., Yabe, Y., Karibe, T., Aoki, T., et al. Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data. Drug Metab Pharmacokinet 26 (2011), 423–430.
59. [59] Kamath, A.V., Lu, D., Gupta, P., Jin, D., Xiang, H., Wong, A., et al. Preclinical pharmacokinetics of MEHD7945A, a novel EGFR/HER3 dual-action antibody, and prediction of its human pharmacokinetics and efficacious clinical dose. Cancer Chemother Pharmacol 69 (2012), 1063–1069.
60. [60] Gupta, P., Kamath, A.V., Park, S., Chiu, H., Lutman, J., Maia, M., et al. Preclinical pharmacokinetics of MHAA4549A, a human monoclonal antibody to influenza A virus, and the prediction of its efficacious clinical dose for the treatment of patients hospitalized with influenza A. mAbs 8 (2016), 991–997.
61. [61] Luu, K.T., Bergqvist, S., Chen, E., Hu-Lowe, D., Kraynov, E., A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition. J Pharmacol Exp Ther 341 (2012), 702–708.
62. [62] Betts, A.M., Clark, T.H., Yang, J., Treadway, J.L., Li, M., Giovanelli, M.A., et al. The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis. J Pharmacol Exp Ther 333 (2010), 2–13.
63. [63] Cao, Y., Jusko, W.J., Mechanistic physiologically based pharmacokinetic models in development of therapeutic monoclonal antibodies. Zhou, H., Theil, P., (eds.) ADME and translational pharmacokinetics/pharmacodynamics of therapeutic proteins, 2016, Wiley, 159–174.