Monoclonal antibody therapeutics: history and future

Current Opinion in Pharmacology - Tập 12 - Trang 615-622 - 2012
Nicholas APS Buss1, Simon J Henderson1, Mary McFarlane1, Jacintha M Shenton1, Lolke de Haan1
1Biologics Safety Assessment, MedImmune, Granta Park, Cambridge CB21 6GH, UK

Tài liệu tham khảo

Kohler, 1975, Continuous cultures of fused cells secreting antibody of predefined specificity, Nature, 256, 495, 10.1038/256495a0 Ober, 2001, Differences in promiscuity for antibody–FcRn interactions across species: implications for therapeutic antibodies, Int Immunol, 13, 1551, 10.1093/intimm/13.12.1551 Stern, 2005, Overview of monoclonal antibodies in cancer therapy: present and promise, Crit Rev Oncol Hematol, 54, 11, 10.1016/j.critrevonc.2004.10.011 Morrison, 1984, Chimeric human antibody molecules: mouse antigen-binding domains with human constant region domains, Proc Natl Acad Sci USA, 81, 6851, 10.1073/pnas.81.21.6851 Presta, 2006, Engineering of therapeutic antibodies to minimize immunogenicity and optimize function, Adv Drug Deliv Rev, 58, 640, 10.1016/j.addr.2006.01.026 Jones, 1986, Replacing the complementarity-determining regions in a human antibody with those from a mouse, Nature, 321, 522, 10.1038/321522a0 McCafferty, 1990, Phage antibodies: filamentous phage displaying antibody variable domains, Nature, 348, 552, 10.1038/348552a0 Winter, 1994, Making antibodies by phage display technology, Annu Rev Immunol, 12, 433, 10.1146/annurev.iy.12.040194.002245 Vaughan, 1996, Human antibodies with sub-nanomolar affinities isolated from a large non-immunized phage display library, Nat Biotechnol, 14, 309, 10.1038/nbt0396-309 Vaughan, 1998, Human antibodies by design, Nat Biotechnol, 16, 535, 10.1038/nbt0698-535 Hoet, 2005, Generation of high-affinity human antibodies by combining donor-derived and synthetic complementarity-determining-region diversity, Nat Biotechnol, 23, 344, 10.1038/nbt1067 Jostock, 2004, Rapid generation of functional human IgG antibodies derived from Fab-on-phage display libraries, J Immunol Methods, 289, 65, 10.1016/j.jim.2004.03.014 Boulianne, 1984, Production of functional chimaeric mouse/human antibody, Nature, 312, 643, 10.1038/312643a0 Lonberg, 1994, Antigen-specific human antibodies from mice comprising four distinct genetic modifications, Nature, 368, 856, 10.1038/368856a0 Green, 1994, Antigen-specific human monoclonal antibodies from mice engineered with human Ig heavy and light chain YACs, Nat Genet, 7, 13, 10.1038/ng0594-13 Baker, 2010, Immunogenicity of protein therapeutics: the key causes, consequences and challenges, Self Nonself, 1, 314, 10.4161/self.1.4.13904 De Groot, 2008, Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates, Curr Opin Pharmacol, 8, 620, 10.1016/j.coph.2008.08.002 Lonberg, 2008, Fully human antibodies from transgenic mouse and phage display platforms, Curr Opin Immunol, 20, 450, 10.1016/j.coi.2008.06.004 Nelson, 2010, Development trends for human monoclonal antibody therapeutics, Nat Rev Drug Discov, 9, 767, 10.1038/nrd3229 Natsume, 2008, Engineered antibodies of IgG1/IgG3 mixed isotype with enhanced cytotoxic activities, Cancer Res, 68, 3863, 10.1158/0008-5472.CAN-07-6297 An, 2009, IgG2m4, an engineered antibody isotype with reduced Fc function, MAbs, 1, 572, 10.4161/mabs.1.6.10185 Abès, 2010, Impact of glycosylation on effector functions of therapeutic IgG, Pharmaceuticals, 3, 146, 10.3390/ph3010146 Strohl, 2009, Optimization of Fc-mediated effector functions of monoclonal antibodies, Curr Opin Biotechnol, 20, 685, 10.1016/j.copbio.2009.10.011 Chan, 2010, Therapeutic antibodies for autoimmunity and inflammation, Nat Rev Immunol, 10, 301, 10.1038/nri2761 Hinton, 2004, Engineered human IgG antibodies with longer serum half-lives in primates, J Biol Chem, 279, 6213, 10.1074/jbc.C300470200 Hinton, 2006, An engineered human IgG1 antibody with longer serum half-life, J Immunol, 176, 346, 10.4049/jimmunol.176.1.346 Dall’Acqua, 2006, Properties of human IgG1s engineered for enhanced binding to the neonatal Fc receptor (FcRn), J Biol Chem, 281, 23514, 10.1074/jbc.M604292200 Salfeld, 2007, Isotype selection in antibody engineering, Nat Biotechnol, 25, 1369, 10.1038/nbt1207-1369 Stapleton, 2011, Competition for FcRn-mediated transport gives rise to short half-life of human IgG3 and offers therapeutic potential, Nat Commun, 2, 599, 10.1038/ncomms1608 Aalberse, 2002, IgG4 breaking the rules, Immunology, 105, 9, 10.1046/j.0019-2805.2001.01341.x Labrijn, 2009, Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo, Nat Biotechnol, 27, 767, 10.1038/nbt.1553 Bloom, 1997, Intrachain disulfide bond in the core hinge region of human IgG4, Protein Sci, 6, 407, 10.1002/pro.5560060217 Lu, 2008, The effect of a point mutation on the stability of IgG4 as monitored by analytical ultracentrifugation, J Pharm Sci, 97, 960, 10.1002/jps.21016 Webb, 2011, Pharma interest surges in antibody drug conjugates, Nat Biotechnol, 29, 297, 10.1038/nbt0411-297 DeFrancesco, 2011, Seattle genetics rare cancer drug sails through accelerated approval, Nat Biotechnol, 29, 851, 10.1038/nbt1011-851 Junttila, 2011, Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer, Breast Cancer Res Treat, 128, 347, 10.1007/s10549-010-1090-x Hamann, 2002, Gemtuzumab ozogamicin, a potent and selective anti-CD33 antibody–calicheamicin conjugate for treatment of acute myeloid leukemia, Bioconjug Chem, 13, 47, 10.1021/bc010021y Sanderson, 2005, In vivo drug-linker stability of an anti-CD30 dipeptide-linked auristatin immunoconjugate, Clin Cancer Res, 11, 843, 10.1158/1078-0432.843.11.2 Alley, 2008, Contribution of linker stability to the activities of anticancer immunoconjugates, Bioconjug Chem, 19, 759, 10.1021/bc7004329 Shen, 2012, Conjugation site modulates the in vivo stability and therapeutic activity of antibody–drug conjugates, Nat Biotechnol, 30, 184, 10.1038/nbt.2108 Zhao, 2011, Synthesis and evaluation of hydrophilic linkers for antibody–maytansinoid conjugates, J Med Chem, 54, 3606, 10.1021/jm2002958 Pedersen, 2010, Sym004: a novel synergistic anti-epidermal growth factor receptor antibody mixture with superior anticancer efficacy, Cancer Res, 70, 588, 10.1158/0008-5472.CAN-09-1417 Mabry, 2010, Therapeutic bispecific antibodies: the selection of stable single-chain fragments to overcome engineering obstacles, IDrugs, 13, 543 Müller, 2010, Bispecific antibodies for cancer immunotherapy current perspectives, BioDrugs, 24, 89, 10.2165/11530960-000000000-00000 Linke, 2010, Catumaxomab: clinical development and future directions, MAbs, 2, 129, 10.4161/mabs.2.2.11221 Staerz, 1985, Hybrid antibodies can target sites for attack by T cells, Nature, 314, 628, 10.1038/314628a0 Baeuerle, 2009, BiTE: teaching antibodies to eng age T-cells for cancer therapy, Curr Opin Mol Ther, 11, 22 Banks, 2002, Passage of amyloid beta protein antibody across the blood–brain barrier in a mouse model of Alzheimer's disease, Peptides, 23, 2223, 10.1016/S0196-9781(02)00261-9 Pestalozzi, 2000, Trastuzumab in CSF, J Clin Oncol, 18, 2349, 10.1200/JCO.2000.18.11.2349 Stemmler, 2007, Ratio of trastuzumab levels in serum and cerebrospinal fluid is altered in HER2-positive breast cancer patients with brain metastases and impairment of blood–brain barrier, Anticancer Drugs, 18, 23, 10.1097/01.cad.0000236313.50833.ee Frank, 2011, Strategies for enhancing antibody delivery to the brain, Biochim Biophys Acta, 1816, 191 Patel, 2009, Getting into the brain: approaches to enhance brain drug delivery, CNS Drugs, 23, 35, 10.2165/0023210-200923010-00003 Silva, 2008, Nanotechnology approaches to crossing the blood–brain barrier and drug delivery to the CNS, BMC Neurosci, 10, S4, 10.1186/1471-2202-9-S3-S4 Yu, 2011, Boosting brain uptake of a therapeutic antibody by reducing its affinity for a transcytosis target, Sci Transl Med, 3, 84ra44, 10.1126/scitranslmed.3002230 Boado, 2010, IgG-single chain Fv fusion protein therapeutic for Alzheimer's disease: expression in CHO cells and pharmacokinetics and brain delivery in the rhesus monkey, Biotechnol Bioeng, 105, 627, 10.1002/bit.22576 Abulrob, 2005, The blood–brain barrier transmigrating single domain antibody: mechanisms of transport and antigenic epitopes in human brain endothelial cells, J Neurochem, 95, 1201, 10.1111/j.1471-4159.2005.03463.x Rutgers, 2011, Transmigration of beta amyloid specific heavy chain antibody fragments across the in vitro blood–brain barrier, Neuroscience, 190, 37, 10.1016/j.neuroscience.2011.05.076 Brambell, 1964, A theoretical model of gamma-globulin catabolism, Nature, 203, 1352, 10.1038/2031352a0