메뉴 건너뛰기




Volumn 31, Issue 2, 2016, Pages 123-132

PK/PD analysis of a novel pH-dependent antigen-binding antibody using a dynamic antibody-antigen binding model

Author keywords

FcRn; Monoclonal antibody; pH dependent antigen binding; PK PD; TMDD

Indexed keywords

MONOCLONAL ANTIBODY; ANTIGEN; PROTEIN BINDING;

EID: 84961230926     PISSN: 13474367     EISSN: 18800920     Source Type: Journal    
DOI: 10.1016/j.dmpk.2015.12.007     Document Type: Article
Times cited : (9)

References (41)
  • 1
    • 84871622500 scopus 로고    scopus 로고
    • Therapeutic antibodies: Market considerations, disease targets and bioprocessing
    • J.G. Elvin, R.G. Couston, and C.F. van der Walle Therapeutic antibodies: market considerations, disease targets and bioprocessing Int J Pharm 440 2013 83 98
    • (2013) Int J Pharm , vol.440 , pp. 83-98
    • Elvin, J.G.1    Couston, R.G.2    Van Der Walle, C.F.3
  • 2
    • 84860896956 scopus 로고    scopus 로고
    • Marketed therapeutic antibodies compendium
    • J.M. Reichert Marketed therapeutic antibodies compendium MAbs 4 2012 413 415
    • (2012) MAbs , vol.4 , pp. 413-415
    • Reichert, J.M.1
  • 3
    • 0034663798 scopus 로고    scopus 로고
    • Crystal structure and immunoglobulin G binding properties of the human major histocompatibility complex-related Fc receptor
    • A.P. West Jr., and P.J. Bjorkman Crystal structure and immunoglobulin G binding properties of the human major histocompatibility complex-related Fc receptor Biochemistry 39 2000 9698 9708
    • (2000) Biochemistry , vol.39 , pp. 9698-9708
    • West, A.P.1    Bjorkman, P.J.2
  • 4
    • 0035012654 scopus 로고    scopus 로고
    • Crystal structure at 2.8 A of an FcRn/heterodimeric Fc complex: Mechanism of pH-dependent binding
    • W.L. Martin, A.P. West Jr., L. Gan, and P.J. Bjorkman Crystal structure at 2.8 A of an FcRn/heterodimeric Fc complex: mechanism of pH-dependent binding Mol Cell 7 2001 867 877
    • (2001) Mol Cell , vol.7 , pp. 867-877
    • Martin, W.L.1    West, A.P.2    Gan, L.3    Bjorkman, P.J.4
  • 5
    • 84876556946 scopus 로고    scopus 로고
    • Novel asymmetrically engineered antibody Fc variant with superior FcgammaR binding affinity and specificity compared with afucosylated Fc variant
    • F. Mimoto, T. Igawa, T. Kuramochi, H. Katada, S. Kadono, T. Kamikawa, and et al. Novel asymmetrically engineered antibody Fc variant with superior FcgammaR binding affinity and specificity compared with afucosylated Fc variant MAbs 5 2013 229 236
    • (2013) MAbs , vol.5 , pp. 229-236
    • Mimoto, F.1    Igawa, T.2    Kuramochi, T.3    Katada, H.4    Kadono, S.5    Kamikawa, T.6
  • 6
    • 84878931351 scopus 로고    scopus 로고
    • Targeting T cells to tumor cells using bispecific antibodies
    • S.R. Frankel, and P.A. Baeuerle Targeting T cells to tumor cells using bispecific antibodies Curr Opin Chem Biol 17 2013 385 392
    • (2013) Curr Opin Chem Biol , vol.17 , pp. 385-392
    • Frankel, S.R.1    Baeuerle, P.A.2
  • 7
    • 84884272080 scopus 로고    scopus 로고
    • Potential therapeutic roles for antibody mixtures
    • T.S. Raju, and W.R. Strohl Potential therapeutic roles for antibody mixtures Expert Opin Biol Ther 13 2013 1347 1352
    • (2013) Expert Opin Biol Ther , vol.13 , pp. 1347-1352
    • Raju, T.S.1    Strohl, W.R.2
  • 8
    • 84907983318 scopus 로고    scopus 로고
    • Enhanced neonatal Fc receptor function improves protection against primate SHIV infection
    • S.Y. Ko, A. Pegu, R.S. Rudicell, Z.Y. Yang, M.G. Joyce, X. Chen, and et al. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection Nature 514 2014 642 645
    • (2014) Nature , vol.514 , pp. 642-645
    • Ko, S.Y.1    Pegu, A.2    Rudicell, R.S.3    Yang, Z.Y.4    Joyce, M.G.5    Chen, X.6
  • 9
    • 17644441947 scopus 로고    scopus 로고
    • The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: Efficacy, safety, and pharmacokinetics
    • J. Corne, R. Djukanovic, L. Thomas, J. Warner, L. Botta, B. Grandordy, and et al. The effect of intravenous administration of a chimeric anti-IgE antibody on serum IgE levels in atopic subjects: efficacy, safety, and pharmacokinetics J Clin Invest 99 1997 879 887
    • (1997) J Clin Invest , vol.99 , pp. 879-887
    • Corne, J.1    Djukanovic, R.2    Thomas, L.3    Warner, J.4    Botta, L.5    Grandordy, B.6
  • 10
    • 84869798948 scopus 로고    scopus 로고
    • Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies
    • D.L. Mortensen, S. Prabhu, E.G. Stefanich, S. Kadkhodayan-Fischer, T.R. Gelzleichter, D. Baker, and 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
    • (2012) MAbs , vol.4 , pp. 724-731
    • Mortensen, D.L.1    Prabhu, S.2    Stefanich, E.G.3    Kadkhodayan-Fischer, S.4    Gelzleichter, T.R.5    Baker, D.6
  • 11
    • 84871156077 scopus 로고    scopus 로고
    • A phase 1, randomized, placebo-controlled, dose-escalation study of an anti-IL-13 monoclonal antibody in healthy subjects and mild asthmatics
    • P. Hodsman, C. Ashman, A. Cahn, E. De Boever, N. Locantore, A. Serone, and et al. A phase 1, randomized, placebo-controlled, dose-escalation study of an anti-IL-13 monoclonal antibody in healthy subjects and mild asthmatics Br J Clin Pharmacol 75 2013 118 128
    • (2013) Br J Clin Pharmacol , vol.75 , pp. 118-128
    • Hodsman, P.1    Ashman, C.2    Cahn, A.3    De Boever, E.4    Locantore, N.5    Serone, A.6
  • 12
    • 78649656830 scopus 로고    scopus 로고
    • Pharmacokinetics of anti-hepcidin monoclonal antibody Ab 12B9m and hepcidin in cynomolgus monkeys
    • J.J. Xiao, W. Krzyzanski, Y.M. Wang, H. Li, M.J. Rose, M. Ma, and et al. Pharmacokinetics of anti-hepcidin monoclonal antibody Ab 12B9m and hepcidin in cynomolgus monkeys AAPS J 12 2010 646 657
    • (2010) AAPS J , vol.12 , pp. 646-657
    • Xiao, J.J.1    Krzyzanski, W.2    Wang, Y.M.3    Li, H.4    Rose, M.J.5    Ma, M.6
  • 13
    • 20044381863 scopus 로고    scopus 로고
    • Phase I investigation of recombinant anti-human vascular endothelial growth factor antibody in patients with advanced cancer
    • G.C. Jayson, C. Mulatero, M. Ranson, J. Zweit, A. Jackson, L. Broughton, and et al. Phase I investigation of recombinant anti-human vascular endothelial growth factor antibody in patients with advanced cancer Eur J Cancer 41 2005 555 563
    • (2005) Eur J Cancer , vol.41 , pp. 555-563
    • Jayson, G.C.1    Mulatero, C.2    Ranson, M.3    Zweit, J.4    Jackson, A.5    Broughton, L.6
  • 14
    • 79958849218 scopus 로고    scopus 로고
    • Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: Sustained efficacy and improved survival
    • R.J. Kelly, A. Hill, L.M. Arnold, G.L. Brooksbank, S.J. Richards, M. Cullen, and et al. Long-term treatment with eculizumab in paroxysmal nocturnal hemoglobinuria: sustained efficacy and improved survival Blood 117 2011 6786 6792
    • (2011) Blood , vol.117 , pp. 6786-6792
    • Kelly, R.J.1    Hill, A.2    Arnold, L.M.3    Brooksbank, G.L.4    Richards, S.J.5    Cullen, M.6
  • 16
    • 78149320579 scopus 로고    scopus 로고
    • Antibody recycling by engineered pH-dependent antigen binding improves the duration of antigen neutralization
    • T. Igawa, S. Ishii, T. Tachibana, A. Maeda, Y. Higuchi, S. Shimaoka, and et al. Antibody recycling by engineered pH-dependent antigen binding improves the duration of antigen neutralization Nat Biotechnol 28 2010 1203 1207
    • (2010) Nat Biotechnol , vol.28 , pp. 1203-1207
    • Igawa, T.1    Ishii, S.2    Tachibana, T.3    Maeda, A.4    Higuchi, Y.5    Shimaoka, S.6
  • 17
    • 84877147797 scopus 로고    scopus 로고
    • Engineered monoclonal antibody with novel antigen-sweeping activity in vivo
    • T. Igawa, A. Maeda, K. Haraya, T. Tachibana, Y. Iwayanagi, F. Mimoto, and et al. Engineered monoclonal antibody with novel antigen-sweeping activity in vivo PLoS One 8 2013 e63236
    • (2013) PLoS One , vol.8
    • Igawa, T.1    Maeda, A.2    Haraya, K.3    Tachibana, T.4    Iwayanagi, Y.5    Mimoto, F.6
  • 18
    • 85027938012 scopus 로고    scopus 로고
    • PH-dependent antigen-binding antibodies as a novel therapeutic modality
    • T. Igawa, F. Mimoto, and K. Hattori pH-dependent antigen-binding antibodies as a novel therapeutic modality Biochim Biophys Acta 1844 2014 1943 1950
    • (2014) Biochim Biophys Acta , vol.1844 , pp. 1943-1950
    • Igawa, T.1    Mimoto, F.2    Hattori, K.3
  • 19
    • 33745053380 scopus 로고    scopus 로고
    • The application of mechanism-based PK/PD modeling in pharmacodynamic-based dose selection of muM17, a surrogate monoclonal antibody for efalizumab
    • B. Wu, A. Joshi, S. Ren, and C. Ng The application of mechanism-based PK/PD modeling in pharmacodynamic-based dose selection of muM17, a surrogate monoclonal antibody for efalizumab J Pharm Sci 95 2006 1258 1268
    • (2006) J Pharm Sci , vol.95 , pp. 1258-1268
    • Wu, B.1    Joshi, A.2    Ren, S.3    Ng, C.4
  • 20
    • 32244436150 scopus 로고    scopus 로고
    • Pharmacokinetics/pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers
    • C.M. Ng, E. Stefanich, B.S. Anand, P.J. Fielder, and L. Vaickus Pharmacokinetics/pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers Pharm Res 23 2006 95 103
    • (2006) Pharm Res , vol.23 , pp. 95-103
    • Ng, C.M.1    Stefanich, E.2    Anand, B.S.3    Fielder, P.J.4    Vaickus, L.5
  • 21
    • 84877885008 scopus 로고    scopus 로고
    • Agonistic TAM-163 antibody targeting tyrosine kinase receptor-B: Applying mechanistic modeling to enable preclinical to clinical translation and guide clinical trial design
    • Y. Vugmeyster, C. Rohde, M. Perreault, R.E. Gimeno, and P. Singh Agonistic TAM-163 antibody targeting tyrosine kinase receptor-B: applying mechanistic modeling to enable preclinical to clinical translation and guide clinical trial design MAbs 5 2013 373 383
    • (2013) MAbs , vol.5 , pp. 373-383
    • Vugmeyster, Y.1    Rohde, C.2    Perreault, M.3    Gimeno, R.E.4    Singh, P.5
  • 22
    • 77949739818 scopus 로고    scopus 로고
    • The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis
    • A.M. Betts, T.H. Clark, J. Yang, J.L. Treadway, M. Li, M.A. Giovanelli, and 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
    • (2010) J Pharmacol Exp Ther , vol.333 , pp. 2-13
    • Betts, A.M.1    Clark, T.H.2    Yang, J.3    Treadway, J.L.4    Li, M.5    Giovanelli, M.A.6
  • 23
    • 84889828313 scopus 로고    scopus 로고
    • The effect of pH dependence of antibody-antigen interactions on subcellular trafficking dynamics
    • S.C. Devanaboyina, S.M. Lynch, R.J. Ober, S. Ram, D. Kim, A. Puig-Canto, and et al. The effect of pH dependence of antibody-antigen interactions on subcellular trafficking dynamics MAbs 5 2013 851 859
    • (2013) MAbs , vol.5 , pp. 851-859
    • Devanaboyina, S.C.1    Lynch, S.M.2    Ober, R.J.3    Ram, S.4    Kim, D.5    Puig-Canto, A.6
  • 24
    • 84859510090 scopus 로고    scopus 로고
    • Increasing serum half-life and extending cholesterol lowering in vivo by engineering antibody with pH-sensitive binding to PCSK9
    • J. Chaparro-Riggers, H. Liang, R.M. DeVay, L. Bai, J.E. Sutton, W. Chen, and et al. Increasing serum half-life and extending cholesterol lowering in vivo by engineering antibody with pH-sensitive binding to PCSK9 J Biol Chem 287 2012 11090 11097
    • (2012) J Biol Chem , vol.287 , pp. 11090-11097
    • Chaparro-Riggers, J.1    Liang, H.2    DeVay, R.M.3    Bai, L.4    Sutton, J.E.5    Chen, W.6
  • 27
    • 8244226656 scopus 로고    scopus 로고
    • Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response
    • L.P. Boulet, K.R. Chapman, J. Cote, S. Kalra, R. Bhagat, V.A. Swystun, and et al. Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response Am J Respir Crit Care Med 155 1997 1835 1840
    • (1997) Am J Respir Crit Care Med , vol.155 , pp. 1835-1840
    • Boulet, L.P.1    Chapman, K.R.2    Cote, J.3    Kalra, S.4    Bhagat, R.5    Swystun, V.A.6
  • 28
    • 0242585330 scopus 로고    scopus 로고
    • Pharmacokinetics of total immunoglobulin G and immunoglobulin G subclasses in patients undergoing replacement therapy for primary immunodeficiency syndromes
    • M.A. Alyanakian, E. Bernatowska, J.M. Scherrmann, P. Aucouturier, and J.L. Poplavsky Pharmacokinetics of total immunoglobulin G and immunoglobulin G subclasses in patients undergoing replacement therapy for primary immunodeficiency syndromes Vox Sang 84 2003 188 192
    • (2003) Vox Sang , vol.84 , pp. 188-192
    • Alyanakian, M.A.1    Bernatowska, E.2    Scherrmann, J.M.3    Aucouturier, P.4    Poplavsky, J.L.5
  • 29
    • 34248187996 scopus 로고    scopus 로고
    • Phase I pharmacokinetic and biologic correlative study of mapatumumab, a fully human monoclonal antibody with agonist activity to tumor necrosis factor-related apoptosis-inducing ligand receptor-1
    • A.W. Tolcher, M. Mita, N.J. Meropol, M. von Mehren, A. Patnaik, K. Padavic, and et al. Phase I pharmacokinetic and biologic correlative study of mapatumumab, a fully human monoclonal antibody with agonist activity to tumor necrosis factor-related apoptosis-inducing ligand receptor-1 J Clin Oncol 25 2007 1390 1395
    • (2007) J Clin Oncol , vol.25 , pp. 1390-1395
    • Tolcher, A.W.1    Mita, M.2    Meropol, N.J.3    Von Mehren, M.4    Patnaik, A.5    Padavic, K.6
  • 30
    • 59449094255 scopus 로고    scopus 로고
    • Volociximab, a chimeric monoclonal antibody that specifically binds alpha5beta1 integrin: A phase I, pharmacokinetic, and biological correlative study
    • A.D. Ricart, A.W. Tolcher, G. Liu, K. Holen, G. Schwartz, M. Albertini, and et al. Volociximab, a chimeric monoclonal antibody that specifically binds alpha5beta1 integrin: a phase I, pharmacokinetic, and biological correlative study Clin Cancer Res 14 2008 7924 7929
    • (2008) Clin Cancer Res , vol.14 , pp. 7924-7929
    • Ricart, A.D.1    Tolcher, A.W.2    Liu, G.3    Holen, K.4    Schwartz, G.5    Albertini, M.6
  • 31
    • 84910019975 scopus 로고    scopus 로고
    • Application of human FcRn transgenic mice as a pharmacokinetic screening tool of monoclonal antibody
    • K. Haraya, T. Tachibana, M. Nanami, and M. Ishigai Application of human FcRn transgenic mice as a pharmacokinetic screening tool of monoclonal antibody Xenobiotica 44 2014 1127 1134
    • (2014) Xenobiotica , vol.44 , pp. 1127-1134
    • Haraya, K.1    Tachibana, T.2    Nanami, M.3    Ishigai, M.4
  • 32
    • 84877898507 scopus 로고    scopus 로고
    • Correlations between pharmacokinetics of IgG antibodies in primates vs. FcRn-transgenic mice reveal a rodent model with predictive capabilities
    • S.H. Tam, S.G. McCarthy, K. Brosnan, K.M. Goldberg, and B.J. Scallon Correlations between pharmacokinetics of IgG antibodies in primates vs. FcRn-transgenic mice reveal a rodent model with predictive capabilities MAbs 5 2013 397 405
    • (2013) MAbs , vol.5 , pp. 397-405
    • Tam, S.H.1    McCarthy, S.G.2    Brosnan, K.3    Goldberg, K.M.4    Scallon, B.J.5
  • 33
    • 0027320006 scopus 로고
    • Enhancement of the biologic effects of interleukin-3 in vivo by anti-interleukin-3 antibodies
    • A.T. Jones, and H.J. Ziltener Enhancement of the biologic effects of interleukin-3 in vivo by anti-interleukin-3 antibodies Blood 82 1993 1133 1141
    • (1993) Blood , vol.82 , pp. 1133-1141
    • Jones, A.T.1    Ziltener, H.J.2
  • 34
    • 0024474425 scopus 로고
    • Phase I study of recombinant human tumor necrosis factor alpha in advanced malignant disease
    • T. Moritz, N. Niederle, J. Baumann, D. May, E. Kurschel, R. Osieka, and et al. Phase I study of recombinant human tumor necrosis factor alpha in advanced malignant disease Cancer Immunol Immunother 29 1989 144 150
    • (1989) Cancer Immunol Immunother , vol.29 , pp. 144-150
    • Moritz, T.1    Niederle, N.2    Baumann, J.3    May, D.4    Kurschel, E.5    Osieka, R.6
  • 35
    • 84879555640 scopus 로고    scopus 로고
    • Elevated concentration of oxidized LDL together with poor cardiorespiratory and abdominal muscle fitness predicts metabolic syndrome in young men
    • J. Kosola, J.P. Vaara, M. Ahotupa, H. Kyrolainen, M. Santtila, N. Oksala, and et al. Elevated concentration of oxidized LDL together with poor cardiorespiratory and abdominal muscle fitness predicts metabolic syndrome in young men Metabolism 62 2013 992 999
    • (2013) Metabolism , vol.62 , pp. 992-999
    • Kosola, J.1    Vaara, J.P.2    Ahotupa, M.3    Kyrolainen, H.4    Santtila, M.5    Oksala, N.6
  • 36
    • 0017193927 scopus 로고
    • The metabolism of IgE. Studies in normal individuals and in a patient with IgE myeloma
    • T.A. Waldmann, A. Iio, M. Ogawa, O.R. McIntyre, and W. Strober The metabolism of IgE. Studies in normal individuals and in a patient with IgE myeloma J Immunol 117 1976 1139 1144
    • (1976) J Immunol , vol.117 , pp. 1139-1144
    • Waldmann, T.A.1    Iio, A.2    Ogawa, M.3    McIntyre, O.R.4    Strober, W.5
  • 37
    • 0018193792 scopus 로고
    • IgE receptors on human basophils. Relationship to serum IgE concentration
    • F.J. Malveaux, M.C. Conroy, N.F. Adkinson Jr., and L.M. Lichtenstein IgE receptors on human basophils. Relationship to serum IgE concentration J Clin Invest 62 1978 176 181
    • (1978) J Clin Invest , vol.62 , pp. 176-181
    • Malveaux, F.J.1    Conroy, M.C.2    Adkinson, N.F.3    Lichtenstein, L.M.4
  • 38
    • 84893653708 scopus 로고    scopus 로고
    • Mechanistic pharmacokinetic/target engagement/pharmacodynamic (PK/TE/PD) modeling in deciphering interplay between a monoclonal antibody and its soluble target in cynomolgus monkeys
    • W. Wang, X. Wang, R. Doddareddy, D. Fink, T. McIntosh, H.M. Davis, and et al. Mechanistic pharmacokinetic/target engagement/pharmacodynamic (PK/TE/PD) modeling in deciphering interplay between a monoclonal antibody and its soluble target in cynomolgus monkeys AAPS J 16 2014 129 139
    • (2014) AAPS J , vol.16 , pp. 129-139
    • Wang, W.1    Wang, X.2    Doddareddy, R.3    Fink, D.4    McIntosh, T.5    Davis, H.M.6
  • 39
    • 77649211091 scopus 로고    scopus 로고
    • Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects
    • Z. Xu, Q. Wang, Y. Zhuang, B. Frederick, H. Yan, E. Bouman-Thio, and et al. Subcutaneous bioavailability of golimumab at 3 different injection sites in healthy subjects J Clin Pharmacol 50 2010 276 284
    • (2010) J Clin Pharmacol , vol.50 , pp. 276-284
    • Xu, Z.1    Wang, Q.2    Zhuang, Y.3    Frederick, B.4    Yan, H.5    Bouman-Thio, E.6
  • 40
    • 84877036468 scopus 로고    scopus 로고
    • Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies
    • Y. Zhu, Q. Wang, B. Frederick, E. Bouman-Thio, J.C. Marini, M. Keen, and et al. Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies Clin Drug Investig 33 2013 291 301
    • (2013) Clin Drug Investig , vol.33 , pp. 291-301
    • Zhu, Y.1    Wang, Q.2    Frederick, B.3    Bouman-Thio, E.4    Marini, J.C.5    Keen, M.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.