메뉴 건너뛰기




Volumn 89, Issue 2, 2011, Pages 283-290

Translational pharmacokinetics and pharmacodynamics of an FcRn-variant anti-CD4 monoclonal antibody from preclinical model to phase i study

Author keywords

[No Author keywords available]

Indexed keywords

CD4 ANTIBODY; FC RECEPTOR; IMMUNOGLOBULIN M ANTIBODY; MTRX 1011A; RHEUMATOID FACTOR; TRX 1; UNCLASSIFIED DRUG;

EID: 78951478220     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.311     Document Type: Article
Times cited : (41)

References (32)
  • 1
    • 32244436150 scopus 로고    scopus 로고
    • Pharmacokinetics/ pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers
    • Ng, C.M., Stefanich, E., Anand, B.S., Fielder, P.J. & Vaickus, L. Pharmacokinetics/ pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers. Pharm. Res. 23, 95-103 (2006).
    • (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
  • 2
    • 33746876321 scopus 로고    scopus 로고
    • Sugar determines antibody activity
    • Burton, D.R. & Dwek, R.A. Immunology. Sugar determines antibody activity. Science 313, 627-628 (2006).
    • (2006) Science , vol.313 , pp. 627-628
    • Burton, D.R.1    Immunology, A.D.R.2
  • 3
    • 60749099736 scopus 로고    scopus 로고
    • Functional characterization of N297a, A murine surrogate for low-fc binding anti-human CD3 antibodies
    • Chao, D.T., Ma, X., Li, O., Park, H. & Law, D. functional characterization of N297a, A murine surrogate for low-fc binding anti-human CD3 antibodies. Immunol. Invest. 38, 76-92 (2009).
    • (2009) Immunol. Invest. , vol.38 , pp. 76-92
    • Chao, D.T.1    Ma, X.2    Li, O.3    Park, H.4    Law, D.5
  • 4
    • 0026519686 scopus 로고
    • Therapy with monoclonal antibodies. an in vivo model for the assessment of therapeutic potential
    • Isaacs, J.D., Clark, M.R., Greenwood, J. & Waldmann, H. Therapy with monoclonal antibodies. an in vivo model for the assessment of therapeutic potential. J. Immunol. 148, 3062-3071 (1992).
    • (1992) J. Immunol. , vol.148 , pp. 3062-3071
    • Isaacs, J.D.1    Clark, M.R.2    Greenwood, J.3    Waldmann, H.4
  • 5
    • 0026567110 scopus 로고
    • Multiple binding sites on the CH2 domain of IgG for mouse fc gamma R11
    • Lund, J. et al. Multiple binding sites on the CH2 domain of IgG for mouse fc gamma R11. Mol. Immunol. 29, 53-59 (1992).
    • (1992) Mol. Immunol. , vol.29 , pp. 53-59
    • Lund, J.1
  • 6
    • 0000146003 scopus 로고
    • A theoretical model of gammaglobulin catabolism
    • Brambell, F.W., Hemmings, W.A. & Morris, I.G. a theoretical model of gammaglobulin catabolism. Nature 203, 1352-1354 (1964).
    • (1964) Nature , vol.203 , pp. 1352-1354
    • Brambell, F.W.1    Hemmings, W.A.2    Morris, I.G.3
  • 7
    • 0029927482 scopus 로고    scopus 로고
    • Abnormally short serum half-lives of IgG in beta 2-microglobulin- deficient mice
    • Ghetie, V., Hubbard, J.G., Kim, J.K., Tsen, M.F., Lee, Y. & Ward, E.S. abnormally short serum half-lives of IgG in beta 2-microglobulin-deficient mice. Eur. J. Immunol. 26, 690-696 (1996).
    • (1996) Eur. J. Immunol. , vol.26 , pp. 690-696
    • Ghetie, V.1    Hubbard, J.G.2    Kim, J.K.3    Tsen, M.F.4    Lee, Y.5    Ward, E.S.6
  • 8
    • 0029891262 scopus 로고    scopus 로고
    • The protection receptor for IgG catabolism is the beta2-microglobulin- containing neonatal intestinal transport receptor
    • Junghans, R.P. & anderson, C.L. The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor. Proc. Natl. Acad. Sci. U.S.A. 93, 5512-5516 (1996).
    • (1996) Proc. Natl. Acad. Sci. U.S.A. , vol.93 , pp. 5512-5516
    • Junghans, R.P.1    Anderson, C.L.2
  • 9
    • 0029856774 scopus 로고    scopus 로고
    • Increased clearance of IgG in mice that lack beta 2-microglobulin: Possible protective role of fcRn
    • Israel, E.J., Wilsker, D.F., Hayes, K.C., Schoenfeld, D. & Simister, N.E. Increased clearance of IgG in mice that lack beta 2-microglobulin: possible protective role of fcRn. Immunology 89, 573-578 (1996).
    • (1996) Immunology , vol.89 , pp. 573-578
    • Israel, E.J.1    Wilsker, D.F.2    Hayes, K.C.3    Schoenfeld, D.4    Simister, N.E.5
  • 10
    • 0037379288 scopus 로고    scopus 로고
    • The MHC class I-like IgG receptor controls perinatal IgG transport IgG homeostasis and fate of IgG-fc-coupled drugs
    • Roopenian, D.C. et al. The MHC class I-like IgG receptor controls perinatal IgG transport, IgG homeostasis, And fate of IgG-fc-coupled drugs. J. Immunol. 170, 3528-3533 (2003).
    • (2003) J. Immunol. , vol.170 , pp. 3528-3533
    • Roopenian, D.C.1
  • 11
    • 0037415556 scopus 로고    scopus 로고
    • The major histocompatibility complex-related fc receptor for IgG (fcRn) binds albumin and prolongs its lifespan
    • Chaudhury, C. et al. The major histocompatibility complex-related fc receptor for IgG (fcRn) binds albumin and prolongs its lifespan. J. Exp. Med. 197, 315-322 (2003).
    • (2003) J. Exp. Med. , vol.197 , pp. 315-322
    • Chaudhury, C.1
  • 12
    • 32444438731 scopus 로고    scopus 로고
    • Elimination mechanisms of therapeutic monoclonal antibodies
    • Tabrizi, M.A., Tseng, C.M. & Roskos, L.K. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today 11, 81-88 (2006).
    • (2006) Drug Discov. Today , vol.11 , pp. 81-88
    • Tabrizi, M.A.1    Tseng, C.M.2    Roskos, L.K.3
  • 13
    • 3843133934 scopus 로고    scopus 로고
    • The clinical pharmacology of therapeutic monoclonal antibodies
    • Roskos, L.K., Davis, C.G. & Schwab, G.M. The clinical pharmacology of therapeutic monoclonal antibodies. Drug Dev. Res. 61, 108-120 (2004).
    • (2004) Drug Dev. Res. , vol.61 , pp. 108-120
    • Roskos, L.K.1    Davis, C.G.2    Schwab, G.M.3
  • 14
    • 54249138516 scopus 로고    scopus 로고
    • Monoclonal antibody pharmacokinetics and pharmacodynamics
    • Wang, W., Wang, E.Q. & Balthasar, J.P. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin. Pharmacol. Ther. 84, 548-558 (2008).
    • (2008) Clin. Pharmacol. Ther. , vol.84 , pp. 548-558
    • Wang, W.1    Wang, E.Q.2    Balthasar, J.P.3
  • 15
    • 40349116242 scopus 로고    scopus 로고
    • Population pharmacokinetic data analysis of three phase i studies of matuzumab A humanised anti-EGfR monoclonal antibody in clinical cancer development
    • Kuester, K., Kovar, A., Lüpfert, C., Brockhaus, B. & Kloft, C. Population pharmacokinetic data analysis of three phase I studies of matuzumab, A humanised anti-EGfR monoclonal antibody in clinical cancer development. Br. J. Cancer 98, 900-906 (2008).
    • (2008) Br. J. Cancer , vol.98 , pp. 900-906
    • Kuester, K.1    Kovar, A.2    Lüpfert, C.3    Brockhaus, B.4    Kloft, C.5
  • 16
    • 23744475396 scopus 로고    scopus 로고
    • Pharmacokineticpharmacodynamic- efficacy analysis of efalizumab in patients with moderate to severe psoriasis
    • Ng, C.M., Joshi, A., Dedrick, R.L., Garovoy, M.R. & Bauer, R.J. Pharmacokineticpharmacodynamic- efficacy analysis of efalizumab in patients with moderate to severe psoriasis. Pharm. Res. 22, 1088-1100 (2005).
    • (2005) Pharm. Res. , vol.22 , pp. 1088-1100
    • Ng, C.M.1    Joshi, A.2    Dedrick, R.L.3    Garovoy, M.R.4    Bauer, R.J.5
  • 18
    • 77950265888 scopus 로고    scopus 로고
    • Pharmacokinetics of humanized monoclonal anti-tumor necrosis factor-{alpha} antibody and its neonatal fc receptor variants in mice and cynomolgus monkeys
    • Deng, R. et al. 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, 600-605 (2010).
    • (2010) Drug Metab. Dispos. , vol.38 , pp. 600-605
    • Deng, R.1
  • 19
    • 33747631571 scopus 로고    scopus 로고
    • Properties of human IgG1s engineered for enhanced binding to the neonatal fc receptor (fcRn)
    • Dall'acqua, W.F., Kiener, P.A. & Wu, H. Properties of human IgG1s engineered for enhanced binding to the neonatal fc receptor (fcRn). J. Biol. Chem. 281, 23514-23524 (2006).
    • (2006) J. Biol. Chem. , vol.281 , pp. 23514-23524
    • Dall'Acqua, W.F.1    Kiener, P.A.2    Wu, H.3
  • 20
    • 77951027408 scopus 로고    scopus 로고
    • A therapeutic anti-VEGf antibody with increased potency independent of pharmacokinetic half-life
    • Yeung, Y.A. et al. a therapeutic anti-VEGf antibody with increased potency independent of pharmacokinetic half-life. Cancer Res. 70, 3269-3277 (2010).
    • (2010) Cancer Res. , vol.70 , pp. 3269-3277
    • Yeung, Y.A.1
  • 21
    • 0032825426 scopus 로고    scopus 로고
    • A population pharmacokinetic-pharmacodynamic analysis of single doses of clenoliximab in patients with rheumatoid arthritis
    • Mould, D.R. et al. a population pharmacokinetic-pharmacodynamic analysis of single doses of clenoliximab in patients with rheumatoid arthritis. Clin. Pharmacol. Ther. 66, 246-257 (1999).
    • (1999) Clin. Pharmacol. Ther. , vol.66 , pp. 246-257
    • Mould, D.R.1
  • 22
    • 0036160920 scopus 로고    scopus 로고
    • CD4 coating, but not CD4 depletion, Is a predictor of efficacy with primatized monoclonal anti-CD4 treatment of active rheumatoid arthritis
    • Mason, U. et al. CD4 coating, But not CD4 depletion, Is a predictor of efficacy with primatized monoclonal anti-CD4 treatment of active rheumatoid arthritis. J. Rheumatol. 29, 220-229 (2002).
    • (2002) J. Rheumatol. , vol.29 , pp. 220-229
    • Mason, U.1
  • 23
    • 0030063898 scopus 로고    scopus 로고
    • 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
    • Choy, E.H. 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. 39, 52-56 (1996).
    • (1996) Arthritis Rheum. , vol.39 , pp. 52-56
    • Choy, E.H.1
  • 24
    • 0030938368 scopus 로고    scopus 로고
    • Structure of human IgM rheumatoid factor fab bound to its autoantigen IgG fc reveals a novel topology of antibody-antigen interaction
    • Corper, A.L. et al. Structure of human IgM rheumatoid factor fab bound to its autoantigen IgG fc reveals a novel topology of antibody-antigen interaction. Nat. Struct. Biol. 4, 374-381 (1997).
    • (1997) Nat. Struct. Biol. , vol.4 , pp. 374-381
    • Corper, A.L.1
  • 25
    • 0026502690 scopus 로고
    • Monoclonal IgM rheumatoid factors bind IgG at a discontinuous epitope comprised of amino acid loops from heavy-chain constant-region domains 2 and 3
    • Artandi, S.E., Calame, K.L., Morrison, S.L. & Bonagura, V.R. Monoclonal IgM rheumatoid factors bind IgG at a discontinuous epitope comprised of amino acid loops from heavy-chain constant-region domains 2 and 3. Proc. Natl. Acad. Sci. U.S.A. 89, 94-98 (1992).
    • (1992) Proc. Natl. Acad. Sci. U.S.A. , vol.89 , pp. 94-98
    • Artandi, S.E.1    Calame, K.L.2    Morrison, S.L.3    Bonagura, V.R.4
  • 26
    • 0023893172 scopus 로고
    • Antigenic specificities of human monoclonal and polyclonal IgM rheumatoid factors. the C gamma 2-C gamma 3 interface region contains the major determinants
    • Sasso, E.H., Barber, C.V., Nardella, F.A., Yount, W.J. & Mannik, M. antigenic specificities of human monoclonal and polyclonal IgM rheumatoid factors. The C gamma 2-C gamma 3 interface region contains the major determinants. J. Immunol. 140, 3098-3107 (1988).
    • (1988) J. Immunol. , vol.140 , pp. 3098-3107
    • Sasso, E.H.1    Barber, C.V.2    Nardella, F.A.3    Yount, W.J.4    Mannik, M.5
  • 27
    • 57749111624 scopus 로고    scopus 로고
    • Approximations of the targetmediated drug disposition model and identifiability of model parameters
    • Gibiansky, L., Gibiansky, E., Kakkar, T. & MA, P. approximations of the targetmediated drug disposition model and identifiability of model parameters. J. Pharmacokinet. Pharmacodyn. 35, 573-591 (2008).
    • (2008) J. Pharmacokinet. Pharmacodyn. , vol.35 , pp. 573-591
    • Gibiansky, L.1    Gibiansky, E.2    Kakkar, T.3    Ma, P.4
  • 29
    • 0000973544 scopus 로고    scopus 로고
    • Absolute bioavailability of TNf receptor fusion protein following subcutaneous injection in healthy volunteers
    • Lebsack, M.E., Hanna, R.K., Lange, M.A. Newman, A., Ji, W. & Korth-Bradley, J.M. absolute bioavailability of TNf receptor fusion protein following subcutaneous injection in healthy volunteers. Pharmacotherapy 17, 1118-1119 (1997).
    • (1997) Pharmacotherapy , vol.17 , pp. 1118-1119
    • Lebsack, M.E.1    Hanna, R.K.2    Lange, M.A.3    Newman, A.4    Ji, W.5    Korth-Bradley, J.M.6
  • 31
    • 23744450342 scopus 로고    scopus 로고
    • Monte Carlo parametric expectation maximization (MC-PEM) method for analyzing population pharmacokinetic/ pharmacodynamic (PK/PD) data
    • Kluwer academic Publishers, Boston, Ma
    • Bauer R.J. & Guzy S. Monte Carlo parametric expectation maximization (MC-PEM) method for analyzing population pharmacokinetic/ pharmacodynamic (PK/PD) data. In: Advanced Methods of Pharmacokinetic and Pharmacodynamic System Analysis, Vol. 3,135-163 (Kluwer academic Publishers, Boston, Ma, 2004).
    • (2004) Advanced Methods of Pharmacokinetic and Pharmacodynamic System Analysis , vol.3 , pp. 135-163
    • Bauer, R.J.1    Guzy, S.2
  • 32
    • 52549112649 scopus 로고    scopus 로고
    • Likelihood based approaches to handling data below the quantification limit using NONMEM VI
    • Ahn, J.E., Karlsson, M.O., Dunne, A. & Ludden, T.M. Likelihood based approaches to handling data below the quantification limit using NONMEM VI. J. Pharmacokinet. Pharmacodyn. 35, 401-421 (2008).
    • (2008) J. Pharmacokinet. Pharmacodyn. , vol.35 , pp. 401-421
    • Ahn, J.E.1    Karlsson, M.O.2    Dunne, A.3    Ludden, T.M.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.