메뉴 건너뛰기




Volumn 21-22, Issue , 2016, Pages 85-93

Translational immunotoxicology of immunomodulatory monoclonal antibodies

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOMODULATING AGENT; IMMUNOSUPPRESSIVE AGENT; MONOCLONAL ANTIBODY; IMMUNOLOGIC FACTOR;

EID: 85003881388     PISSN: None     EISSN: 17406749     Source Type: Journal    
DOI: 10.1016/j.ddtec.2016.08.002     Document Type: Review
Times cited : (5)

References (44)
  • 1
    • 84931269017 scopus 로고    scopus 로고
    • Therapeutic human monoclonal antibodies in inflammatory diseases
    • [1] Kotsovilis, S., Andreakos, E., Therapeutic human monoclonal antibodies in inflammatory diseases. Methods Mol Biol 106 (2014), 37–59.
    • (2014) Methods Mol Biol , vol.106 , pp. 37-59
    • Kotsovilis, S.1    Andreakos, E.2
  • 2
    • 84928062583 scopus 로고    scopus 로고
    • Immune checkpoint blockade: a common denominator approach to cancer therapy
    • [2] Topalian, S.L., Drake, C.G., Pardoll, D.M., Immune checkpoint blockade: a common denominator approach to cancer therapy. Cancer Cell 27 (2015), 450–456.
    • (2015) Cancer Cell , vol.27 , pp. 450-456
    • Topalian, S.L.1    Drake, C.G.2    Pardoll, D.M.3
  • 3
    • 84955182846 scopus 로고    scopus 로고
    • Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety?
    • [3] Murdaca, G., Spanò, F., Contatore, M., Guastalla, A., Penza, E., Magnani, O., et al. Immunogenicity of infliximab and adalimumab: what is its role in hypersensitivity and modulation of therapeutic efficacy and safety?. Expert Opin Drug Saf 15 (2016), 43–52.
    • (2016) Expert Opin Drug Saf , vol.15 , pp. 43-52
    • Murdaca, G.1    Spanò, F.2    Contatore, M.3    Guastalla, A.4    Penza, E.5    Magnani, O.6
  • 4
    • 85003857560 scopus 로고    scopus 로고
    • A link between long-term natalizumab dosing in MS and PML: putting the puzzle together
    • [4] Major, E.O., Nath, A., A link between long-term natalizumab dosing in MS and PML: putting the puzzle together. Neurol Neuroimmunol Neuroinflamm, 3(3), 2016, e235, 10.1212/NXI.0000000000000235.
    • (2016) Neurol Neuroimmunol Neuroinflamm , vol.3 , Issue.3 , pp. e235
    • Major, E.O.1    Nath, A.2
  • 5
    • 84897568616 scopus 로고    scopus 로고
    • Managing cytokine release syndrome associated with novel T cell-engaging therapies
    • [5] Maude, S.L., Barrett, D., Teachey, D.T., Grupp, S.A., Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J 20 (2014), 119–122.
    • (2014) Cancer J , vol.20 , pp. 119-122
    • Maude, S.L.1    Barrett, D.2    Teachey, D.T.3    Grupp, S.A.4
  • 6
    • 84959060166 scopus 로고    scopus 로고
    • Enhancing the safety of antibody-based immunomodulatory cancer therapy without compromising therapeutic benefit: can we have our cake and eat it too?
    • [6] Ryan, J.M., Wasser, J.S., Adler, A.J., Vella, A.T., Enhancing the safety of antibody-based immunomodulatory cancer therapy without compromising therapeutic benefit: can we have our cake and eat it too?. Expert Opin Biol Ther 16 (2016), 655–674.
    • (2016) Expert Opin Biol Ther , vol.16 , pp. 655-674
    • Ryan, J.M.1    Wasser, J.S.2    Adler, A.J.3    Vella, A.T.4
  • 7
    • 78650578346 scopus 로고    scopus 로고
    • Acute infusion reactions induced by monoclonal antibody therapy
    • [7] Maggi, E., Vultaggio, A., Matucci, A., Acute infusion reactions induced by monoclonal antibody therapy. Expert Rev Clin Immunol 7 (2011), 55–63.
    • (2011) Expert Rev Clin Immunol , vol.7 , pp. 55-63
    • Maggi, E.1    Vultaggio, A.2    Matucci, A.3
  • 8
    • 40849142102 scopus 로고    scopus 로고
    • Cetuximab-induced anaphylaxis and IgE specific for galactose α-1,3-galactose
    • [8] Chung, C.H., Mirakhur, B., Chan, E., Le, Q.T., Berlin, J., Morse, M., et al. Cetuximab-induced anaphylaxis and IgE specific for galactose α-1,3-galactose. N Engl J Med 358 (2008), 1109–1117.
    • (2008) N Engl J Med , vol.358 , pp. 1109-1117
    • Chung, C.H.1    Mirakhur, B.2    Chan, E.3    Le, Q.T.4    Berlin, J.5    Morse, M.6
  • 10
    • 84900486102 scopus 로고    scopus 로고
    • Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases
    • [10] Brennan, F.R., 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.
    • (2014) Drug Dev Res , vol.75 , pp. 115-161
    • Brennan, F.R.1    Cauvin, A.2    Tibbitts, J.3    Wolfreys, A.4
  • 11
    • 78650880904 scopus 로고    scopus 로고
    • Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Step 2. Addendum
    • Available at:
    • [11] ICHS6 (R1), Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Step 2. Addendum. 2009 Available at: http://www.ich.org/LOB/media/MEDIA5784.pdf.
    • (2009)
    • ICHS6 (R1)1
  • 12
    • 84969903981 scopus 로고    scopus 로고
    • Available at:
    • [12] ICHS8, Immunotoxicity studies for human pharmaceuticals, 2005 Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S8/Step4/S8_Guideline.pdf.
    • (2005) Immunotoxicity studies for human pharmaceuticals
    • ICHS81
  • 13
    • 73849137192 scopus 로고    scopus 로고
    • Recent advances in the understanding of drug-mediated infusion reactions and cytokine release syndrome
    • [13] Walker, M., Makropoulos, D., Achuthanandam, R., Bugelski, P.J., Recent advances in the understanding of drug-mediated infusion reactions and cytokine release syndrome. Curr Opin Drug Discov Dev 13 (2010), 124–135.
    • (2010) Curr Opin Drug Discov Dev , vol.13 , pp. 124-135
    • Walker, M.1    Makropoulos, D.2    Achuthanandam, R.3    Bugelski, P.J.4
  • 14
    • 84894644075 scopus 로고    scopus 로고
    • Cytokine release assays: current practices and future directions
    • [14] Finco, D., Grimaldi, C., Fort, M., Walker, M., Kiessling, A., Wolf, B., et al. Cytokine release assays: current practices and future directions. Cytokine 66 (2014), 143–155.
    • (2014) Cytokine , vol.66 , pp. 143-155
    • Finco, D.1    Grimaldi, C.2    Fort, M.3    Walker, M.4    Kiessling, A.5    Wolf, B.6
  • 15
    • 84867988873 scopus 로고    scopus 로고
    • A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans
    • [15] Wolf, B., Morgan, H., Krieg, J., Gani, Z., Milicov, A., Warncke, M., et al. A whole blood in vitro cytokine release assay with aqueous monoclonal antibody presentation for the prediction of therapeutic protein induced cytokine release syndrome in humans. Cytokine 60 (2012), 828–837.
    • (2012) Cytokine , vol.60 , pp. 828-837
    • Wolf, B.1    Morgan, H.2    Krieg, J.3    Gani, Z.4    Milicov, A.5    Warncke, M.6
  • 16
    • 37749032491 scopus 로고    scopus 로고
    • ‘Cytokine storm’ in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics
    • [16] Stebbings, R., Findlay, L., Edwards, C., Eastwood, D., Bird, C., North, D., et al. ‘Cytokine storm’ in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics. J Immunol 179 (2006), 3325–3331.
    • (2006) J Immunol , vol.179 , pp. 3325-3331
    • Stebbings, R.1    Findlay, L.2    Edwards, C.3    Eastwood, D.4    Bird, C.5    North, D.6
  • 17
    • 68849119066 scopus 로고    scopus 로고
    • Alternative strategies for toxicity testing of species-specific biopharmaceuticals
    • [17] Bussiere, J.L., Martin, P., Horner, M., Couch, J., Flaherty, M., Andrews, L., et al. Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Int J Toxicol 28 (2009), 230–253.
    • (2009) Int J Toxicol , vol.28 , pp. 230-253
    • Bussiere, J.L.1    Martin, P.2    Horner, M.3    Couch, J.4    Flaherty, M.5    Andrews, L.6
  • 18
    • 33646734488 scopus 로고    scopus 로고
    • Loss of Siglec expression on T lymphocytes during human evolution
    • [18] Nguyen, D.H., Hurtado-Ziola, N., Gagneux, P., Varki, A., Loss of Siglec expression on T lymphocytes during human evolution. Proc Natl Acad Sci USA 103 (2006), 7765–7770.
    • (2006) Proc Natl Acad Sci USA , vol.103 , pp. 7765-7770
    • Nguyen, D.H.1    Hurtado-Ziola, N.2    Gagneux, P.3    Varki, A.4
  • 20
    • 77956304908 scopus 로고    scopus 로고
    • Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells
    • [20] Eastwood, D., Findlay, L., Poole, S., Bird, C., Wadhwa, M., Moore, M., et al. Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T-cells. Br J Pharmacol 161 (2010), 512–526.
    • (2010) Br J Pharmacol , vol.161 , pp. 512-526
    • Eastwood, D.1    Findlay, L.2    Poole, S.3    Bird, C.4    Wadhwa, M.5    Moore, M.6
  • 21
    • 84864279250 scopus 로고    scopus 로고
    • Rapid regulatory T-cell response prevents cytokine storm in CD28 superagonist treated mice
    • [21] Gogishvili, T., Langenhorst, D., Lühder, F., Elias, F., Elflein, K., Dennehy, K.M., et al. Rapid regulatory T-cell response prevents cytokine storm in CD28 superagonist treated mice. PLoS ONE, 4(2), 2009, e4643, 10.1371/journal.pone.0004643.
    • (2009) PLoS ONE , vol.4 , Issue.2 , pp. e4643
    • Gogishvili, T.1    Langenhorst, D.2    Lühder, F.3    Elias, F.4    Elflein, K.5    Dennehy, K.M.6
  • 22
    • 84455172814 scopus 로고    scopus 로고
    • Predicting cytokine storms: it's about density
    • [22] Frigault, M.J., June, C.H., Predicting cytokine storms: it's about density. Blood, 118, 2011, 672.
    • (2011) Blood , vol.118 , pp. 672
    • Frigault, M.J.1    June, C.H.2
  • 23
    • 84920569758 scopus 로고    scopus 로고
    • Upregulation of FcγRIIb on monocytes is necessary to promote the superagonist activity of TGN1412
    • [23] Hussain, K., Hargreaves, C.E., Roghanian, A., Oldham, R.J., Chan, H.T., Mockridge, C.I., et al. Upregulation of FcγRIIb on monocytes is necessary to promote the superagonist activity of TGN1412. Blood 125 (2015), 102–110.
    • (2015) Blood , vol.125 , pp. 102-110
    • Hussain, K.1    Hargreaves, C.E.2    Roghanian, A.3    Oldham, R.J.4    Chan, H.T.5    Mockridge, C.I.6
  • 24
    • 33748515685 scopus 로고    scopus 로고
    • IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions
    • [24] Rogers, K.A., Scinicariello, F., Attanasio, R., IgG Fc receptor III homologues in nonhuman primate species: genetic characterization and ligand interactions. J Immunol 177 (2006), 3848–3856.
    • (2006) J Immunol , vol.177 , pp. 3848-3856
    • Rogers, K.A.1    Scinicariello, F.2    Attanasio, R.3
  • 25
    • 84860330201 scopus 로고    scopus 로고
    • Different adaptations of IgG effector function in human and nonhuman primates and implications for therapeutic antibody treatment
    • [25] Warncke, M., Calzascia, T., Coulot, M., Balke, N., Touil, R., Kolbinger, F., et al. Different adaptations of IgG effector function in human and nonhuman primates and implications for therapeutic antibody treatment. J Immunol 188 (2012), 4405–4411.
    • (2012) J Immunol , vol.188 , pp. 4405-4411
    • Warncke, M.1    Calzascia, T.2    Coulot, M.3    Balke, N.4    Touil, R.5    Kolbinger, F.6
  • 26
    • 84555187199 scopus 로고    scopus 로고
    • Nonclinical evaluation of GMA161 – an antihuman CD16 (FcγRIII) monoclonal antibody for treatment of autoimmune disorders in CD16 transgenic mice
    • [26] Flaherty, M.M., MacLachlan, T.K., Troutt, M., Magee, T., Tuaillon, N., Johnson, S., et al. Nonclinical evaluation of GMA161 – an antihuman CD16 (FcγRIII) monoclonal antibody for treatment of autoimmune disorders in CD16 transgenic mice. Toxicol Sci 125 (2012), 299–309.
    • (2012) Toxicol Sci , vol.125 , pp. 299-309
    • Flaherty, M.M.1    MacLachlan, T.K.2    Troutt, M.3    Magee, T.4    Tuaillon, N.5    Johnson, S.6
  • 27
    • 37549036732 scopus 로고    scopus 로고
    • Fcγ receptors as regulators of immune responses
    • [27] Nimmerjahn, F., Ravetsch, J.V., Fcγ receptors as regulators of immune responses. Nat Rev Immunol 8 (2008), 34–47.
    • (2008) Nat Rev Immunol , vol.8 , pp. 34-47
    • Nimmerjahn, F.1    Ravetsch, J.V.2
  • 28
    • 0038732473 scopus 로고    scopus 로고
    • Species differences in the structure and the function of the immune system
    • [28] Haley, P.J., Species differences in the structure and the function of the immune system. Toxicology 188 (2003), 49–71.
    • (2003) Toxicology , vol.188 , pp. 49-71
    • Haley, P.J.1
  • 29
    • 60349087476 scopus 로고    scopus 로고
    • Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies
    • [29] Muller, P.Y., Brennan, F.R., Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin Pharmacol Ther 85 (2009), 247–258.
    • (2009) Clin Pharmacol Ther , vol.85 , pp. 247-258
    • Muller, P.Y.1    Brennan, F.R.2
  • 31
    • 77952189132 scopus 로고    scopus 로고
    • Overview of known non-human primate pathogens with potential to effect colonies used for toxicity testing
    • [31] Sasseville, V., Mansfield, K., Overview of known non-human primate pathogens with potential to effect colonies used for toxicity testing. J Immunotoxicol 7 (2009), 79–92.
    • (2009) J Immunotoxicol , vol.7 , pp. 79-92
    • Sasseville, V.1    Mansfield, K.2
  • 32
    • 77952208051 scopus 로고    scopus 로고
    • Bacterial infections in cynomolgus monkeys given small molecule immunomodulatory antagonists
    • [32] Price, K.D., Bacterial infections in cynomolgus monkeys given small molecule immunomodulatory antagonists. J Immunotoxicol 7 (2010), 128–137.
    • (2010) J Immunotoxicol , vol.7 , pp. 128-137
    • Price, K.D.1
  • 33
    • 41149131734 scopus 로고    scopus 로고
    • Testing human biologicals in animal host resistance models
    • [33] Burleson, G.R., Burleson, F.G., Testing human biologicals in animal host resistance models. J Immunotoxicol 5 (2008), 23–31.
    • (2008) J Immunotoxicol , vol.5 , pp. 23-31
    • Burleson, G.R.1    Burleson, F.G.2
  • 36
    • 84894107349 scopus 로고    scopus 로고
    • New insights into cancer immunoediting and its three component phases – elimination, equilibrium and escape
    • [36] Mittal, D., Gubin, M.M., Schreiber, R.D., Smyth, M.J., New insights into cancer immunoediting and its three component phases – elimination, equilibrium and escape. Curr Opin Immunol 27 (2014), 16–25.
    • (2014) Curr Opin Immunol , vol.27 , pp. 16-25
    • Mittal, D.1    Gubin, M.M.2    Schreiber, R.D.3    Smyth, M.J.4
  • 38
    • 77953671996 scopus 로고    scopus 로고
    • Carcinogenicity assessment of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations
    • [38] Vahle, J.L., Finch, G.L., Heidel, S.M., Hovland, D.N., Jr, Ivens, I., Parker, S., et al. Carcinogenicity assessment of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations. Toxicol Pathol 38 (2010), 522–553.
    • (2010) Toxicol Pathol , vol.38 , pp. 522-553
    • Vahle, J.L.1    Finch, G.L.2    Heidel, S.M.3    Hovland, D.N.4    Jr5    Ivens, I.6    Parker, S.7
  • 39
    • 78650071290 scopus 로고    scopus 로고
    • Critical review of preclinical approaches to evaluate the potential of immunosuppressive drugs to influence human neoplasia
    • [39] Bugelski, P.J., Volk, A., Walker, M.R., Krayer, J.H., Martin, P., Descotes, J., Critical review of preclinical approaches to evaluate the potential of immunosuppressive drugs to influence human neoplasia. Int J Toxicol 29 (2010), 435–466.
    • (2010) Int J Toxicol , vol.29 , pp. 435-466
    • Bugelski, P.J.1    Volk, A.2    Walker, M.R.3    Krayer, J.H.4    Martin, P.5    Descotes, J.6
  • 40
    • 84953727196 scopus 로고    scopus 로고
    • HESI/FDA workshop on immunomodulators and cancer risk assessment: building blocks for a weight-of-evidence approach
    • [40] Lebrec, H., Brennan, F.R., Haggerty, H., Herzyk, D., Kamperschroer, C., Maier, C.C., et al. HESI/FDA workshop on immunomodulators and cancer risk assessment: building blocks for a weight-of-evidence approach. Regul Toxicol Pharmacol 75 (2016), 72–80.
    • (2016) Regul Toxicol Pharmacol , vol.75 , pp. 72-80
    • Lebrec, H.1    Brennan, F.R.2    Haggerty, H.3    Herzyk, D.4    Kamperschroer, C.5    Maier, C.C.6
  • 41
    • 84966290861 scopus 로고    scopus 로고
    • Integrated pharmacokinetic/pharmacodynamic analysis for determining the minimal anticipated biological effect level of a novel anti-CD28 receptor antagonist BMS-931699
    • [41] Yang, Z., Wang, H, Salcedo, T.W., Suchard, S.J., Xie, J.H., Schneeweis, L.A., et al. Integrated pharmacokinetic/pharmacodynamic analysis for determining the minimal anticipated biological effect level of a novel anti-CD28 receptor antagonist BMS-931699. J Pharmacol Exp Ther 355 (2015), 506–515.
    • (2015) J Pharmacol Exp Ther , vol.355 , pp. 506-515
    • Yang, Z.1    Wang2    Salcedo, T.W.3    Suchard, S.J.4    Xie, J.H.5    Schneeweis, L.A.6
  • 42
    • 84860854354 scopus 로고    scopus 로고
    • Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets
    • [42] Bugelski, P.J., Martin, P.L., Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets. Br J Pharmacol 166 (2012), 823–846.
    • (2012) Br J Pharmacol , vol.166 , pp. 823-846
    • Bugelski, P.J.1    Martin, P.L.2
  • 43
    • 84860866781 scopus 로고    scopus 로고
    • Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets
    • [43] Martin, P.L., Bugelski, P.J., Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets. Br J Pharmacol 166 (2012), 806–822.
    • (2012) Br J Pharmacol , vol.166 , pp. 806-822
    • Martin, P.L.1    Bugelski, P.J.2
  • 44
    • 84862743132 scopus 로고    scopus 로고
    • The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients
    • [44] Polson, A.G., Fuji, R.N., The successes and limitations of preclinical studies in predicting the pharmacodynamics and safety of cell-surface-targeted biological agents in patients. Br J Pharmacol 166 (2012), 1600–1602.
    • (2012) Br J Pharmacol , vol.166 , pp. 1600-1602
    • Polson, A.G.1    Fuji, R.N.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.