Immunogenicity of protein therapeutics

Hoyer, 1993, Factor VIII inhibitors: a continuing problem, J. Lab. Clin. Med., 121, 385 Hoyer, 1995, Factor VIII inhibitors, Curr. Opin. Hematol., 2, 365, 10.1097/00062752-199502050-00007 Haselbeck, 2003, Epoetins: differences and their relevance to immunogenicity, Curr. Med. Res. Opin., 19, 430, 10.1185/030079903125002063 Diamond, 2003, Speculations on the immunogenicity of self-proteins, Dev. Biol. (Basel), 112, 29 Test, 2001, Increased immunogenicity and induction of class switching by conjugation of complement C3d to pneumococcal serotype 14 capsular polysaccharide, Infect. Immun., 69, 3031, 10.1128/IAI.69.5.3031-3040.2001 Zubler, 2001, Naive and memory B cells in T cell-dependent and T-independent responses, Springer Semin. Immunopathol., 23, 405, 10.1007/s281-001-8167-7 Reveille, 2006, The genetic basis of autoantibody production, Autoimmun. Rev., 5, 389, 10.1016/j.autrev.2005.10.012 Jegerlehner, 2007, TLR9 signaling in B cells determines class switch recombination to IgG2a, J. Immunol., 178, 2415, 10.4049/jimmunol.178.4.2415 Christensen, 2005, Toll-like receptor 9 controls anti-DNA autoantibody production in murine lupus, J. Exp. Med., 202, 321, 10.1084/jem.20050338 Zamora, 2006, Papillomavirus-like particles are an effective platform for amyloid-beta immunization in rabbits and transgenic mice, J. Immunol., 177, 2662, 10.4049/jimmunol.177.4.2662 Bachmann, 1993, The influence of antigen organization on B cell responsiveness, Science, 262, 1448, 10.1126/science.8248784 Rosenberg, 2006, Effects of protein aggregates: an immunologic perspective, AAPS J., 8, E501, 10.1208/aapsj080359 Braun, 1997, Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice, Pharm. Res., 14, 1472, 10.1023/A:1012193326789 Josic, 1999, Degradation products of factor VIII which can lead to increased immunogenicity, Vox Sang., 77, 90, 10.1159/000056726 Barbosa, 2006, Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity, Clin. Immunol., 118, 42, 10.1016/j.clim.2005.08.017 Koren, 2007, Clinical validation of the “in-silico” prediction of immunogenicity of a human recombinant therapeutic protein, Cell. Immunol., 124, 26 So, 1997, Depression of T cell epitope generation by stabilizing hen lysozyme, J. Biol. Chem., 272, 32136, 10.1074/jbc.272.51.32136 So, 1996, Reduced immunogenicity of monomethoxypolyethylene glycol-modified lysozyme for activation of T cells, Immunol. Lett., 49, 91, 10.1016/0165-2478(95)02488-3 Rosenberg, 2003, Immunogenicity of biological therapeutics: a hierarchy of concerns, Dev. Biol. (Basel), 112, 15 Koren, 2002, Immune responses to therapeutic proteins in humans- clinical significance, assessment and prediction, Curr. Pharm. Biotechnol., 3, 349, 10.2174/1389201023378175 Casadevall, 2002, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N. Engl. J. Med., 14, 469, 10.1056/NEJMoa011931 Nissenson, 2001, Novel erythropoiesis stimulating protein for managing the anemia of chronic kidney disease, Am. J. Kidney Dis., 38, 1390, 10.1053/ajkd.2001.29264 Prabhakar, 1997, Antibodies to recombinant human erythropoietin causing pure red cell aplasia, Clin. Nephrol., 47, 331 Boven, 2005, The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes, Kidney Int., 67, 2346, 10.1111/j.1523-1755.2005.00340.x Mire-Sluis, 2004, Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products, J. Immunol. Methods, 289, 1, 10.1016/j.jim.2004.06.002 Gupta, 2007, Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics, J. Immunol. Methods, 321, 1, 10.1016/j.jim.2006.12.004 Hermeling, 2005, Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b, Pharm. Res., 22, 1997, 10.1007/s11095-005-8177-9 Chackerian, 2002, Determinants of autoantibody induction by conjugated papillomavirus virus-like particles, J. Immunol., 169, 6120, 10.4049/jimmunol.169.11.6120 Gooding, 1985, Detection of host-derived contaminants in products of recombinant DNA technology in E. coli: a comparison of silver-staining and immunoblotting, J. Pharm. Pharmacol., 37, 781, 10.1111/j.2042-7158.1985.tb04968.x Zwickl, 1991, Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys, Fundam. Appl. Toxicol., 16, 275, 10.1016/0272-0590(91)90112-H Jaber, 2007, Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T cell assays, J. Pharm. Biomed. Anal., 43, 1256, 10.1016/j.jpba.2006.10.023 Kamate, 2007, Depletion of CD4+/CD25high regulatory T cells might enhance or uncover factor VIII-specific T cell responses in healthy individuals, J. Thromb. Haemost., 5, 611, 10.1111/j.1538-7836.2007.02336.x Steere, 2006, Antibiotic-refractory Lyme arthritis is associated with HLA-DR molecules that bind a Borrelia burgdorferi peptide, J. Exp. Med., 203, 961, 10.1084/jem.20052471 McMurry, 2007, Diversity of Francisella tularensis Schu4 antigens recognized by T lymphocytes after natural infections in humans: Identification of candidate epitopes for inclusion in a rationally designed tularemia vaccine, Vaccine, 25, 3179, 10.1016/j.vaccine.2007.01.039 De Groot, 2005, From genome to vaccine – new immunoinformatics tools for vaccine design, Methods, 34, 425, 10.1016/j.ymeth.2004.06.004 Van Walle, 2007, Gansemans Y, Parren PW, Stas P, Lasters I. Immunogenicity screening in protein drug development, Expert Opin. Biol. Ther., 7, 405, 10.1517/14712598.7.3.405 De Groot, 2005, De-immunization of therapeutic proteins by T cell epitope modification, Dev. Biol. (Basel), 122, 171 Klitgaard, 2006, Reduced susceptibility of recombinant polyclonal antibodies to inhibitory anti-variable domain antibody responses, J. Immunol., 177, 3782, 10.4049/jimmunol.177.6.3782 Depil, 2006, Peptide-binding assays and HLA II transgenic Abeta degrees mice are consistent and complementary tools for identifying HLA II-restricted peptides, Vaccine, 24, 2225, 10.1016/j.vaccine.2005.11.048 Kong, 1996, HLA-DRB1 polymorphism determines susceptibility to autoimmune thyroiditis in transgenic mice: definitive association with HLA-DRB1*0301 (DR3) gene, J. Exp. Med., 184, 1167, 10.1084/jem.184.3.1167 Pan, 1998, HLA-DR4 (DRB1*0401) transgenic mice expressing an altered CD4- binding site: specificity and magnitude of DR4-restricted T cell response, J. Immunol., 161, 2925, 10.4049/jimmunol.161.6.2925 Shirai, 1995, CTL responses of HLA-A2.1-transgenic mice specific for hepatitis C viral peptides predict epitopes for CTL of humans carrying HLA-A2.1, J. Immunol., 154, 2733, 10.4049/jimmunol.154.6.2733 Man, 1995, Definition of a human T cell epitope from influenza A non-structural protein 1 using HLA-A2.1 transgenic mice, Int. Immunol., 7, 597, 10.1093/intimm/7.4.597 Charo, 2001, DNA immunization of HLA transgenic mice with a plasmid expressing mycobacterial heat shock protein 65 results in HLA class I- and II-restricted T cell responses that can be augmented by cytokines, Hum. Gene Ther., 12, 1797, 10.1089/104303401750476285 Ishioka, 1999, Utilization of MHC class I transgenic mice for development of minigene DNA vaccines encoding multipleHLA-restricted CTL epitopes, J. Immunol., 162, 3915, 10.4049/jimmunol.162.7.3915 Livingston, 2001, Optimization of epitope processing enhances immunogenicity of multiepitope DNA vaccines, Vaccine, 19, 4652, 10.1016/S0264-410X(01)00233-X Ottesen, 1994, The potential immunogenicity of human insulin and insulin analogues evaluated in a transgenic mouse model, Diabetologia, 37, 1178, 10.1007/BF00399790 Palleroni, 1997, Interferon immunogenicity: preclinical evaluation of interferon-alpha 2a, J Interferon Cytokine Res., 17, S23 Stewart, 1989, Transgenic mice as a model to test the immunogenicity of proteins altered by site-specific mutagenesis, Mol. Biol. Med., 6, 275 Hermeling, 2006, Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation, J. Pharm. Sci., 95, 1084, 10.1002/jps.20599 Basu, 2006, Structure-function engineering of interferon-beta-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEGylation, Bioconjugate Chem., 17, 618, 10.1021/bc050322y von Delwig, 2006, The impact of glycosylation on HLA-DR1-restricted T cell recognition of type II collagen in a mouse model, Arthritis Rheum., 54, 482, 10.1002/art.21565 Corthay, 1998, Epitope glycosylation plays a critical role for T cell recognition of type II collagen in collagen-induced arthritis, Eur. J. Immunol., 28, 2580, 10.1002/(SICI)1521-4141(199808)28:08<2580::AID-IMMU2580>3.0.CO;2-X Zambidis, 1996, Epitope-specific tolerance induction with an engineered immunoglobulin, Proc. Natl. Acad. Sci. U. S. A., 93, 5019, 10.1073/pnas.93.10.5019 Clark, 2000, Antibody humanization: a case of the ’Emperor's new clothes’?, Immunol. Today, 21, 397, 10.1016/S0167-5699(00)01680-7 Hwang, 2005, Immunogenicity of engineered antibodies, Methods, 36, 3, 10.1016/j.ymeth.2005.01.001 Kappler, 1987, T cell tolerance by clonal elimination in the thymus, Cell, 49, 273, 10.1016/0092-8674(87)90568-X Scanlan, 2001, Challenges to the development of antigen-specific breast cancer vaccines, Breast Cancer Res., 3, 95, 10.1186/bcr278 Mullbacher, 1992, Viral escape from immune recognition: multiple strategies of adenoviruses, Immunol. Cell Biol., 70, 59, 10.1038/icb.1992.9 Hill, 1997, Genetic analysis of host-parasite coevolution in human malaria, Philos. Trans. R. Soc. Lond. B Biol. Sci., 352, 1317, 10.1098/rstb.1997.0116 Vossen, 2002, Viral immune evasion: a masterpiece of evolution, Immunogenetics, 54, 527, 10.1007/s00251-002-0493-1 Tangri, 2005, Rationally engineered therapeutic proteins with reduced immunogenicity, J. Immunol., 174, 3187, 10.4049/jimmunol.174.6.3187 Hay, 2006, Current and future approaches to inhibitor management and aversion, Semin. Thromb. Hemost., 32, 15, 10.1055/s-2006-946910 Damschroder, 2007, Framework shuffling of antibodies to reduce immunogenicity and manipulate functional and biophysical properties, Mol. Immunol., 11, 3049, 10.1016/j.molimm.2006.12.019 Hellendoorn, 2004, Limiting the risk of immunogenicity by identification and removal of T cell epitopes (DeImmunisation™), Association for Immunotherapy of Cancer: Cancer Immunotherapy – 2nd Annual Meeting Mainz, Germany. 6–7 Might 2004, Cancer Cell Int., 4, S20, 10.1186/1475-2867-4-S1-S20 Staelens, 2006, Humanization by variable domain resurfacing and grafting on a human IgG4, using a new approach for determination of non-human like surface accessible framework residues based on homology modelling of variable domain, Mol. Immunol., 43, 1243, 10.1016/j.molimm.2005.07.018 Yeung, 2004, Elimination of an immunodominant CD4 T cell epitope in human IFN- does not result in an In vivo response directed at the subdominant epitope, J. Immunol., 172, 6658, 10.4049/jimmunol.172.11.6658 Mire-Sluis, A. ed. State of the art analytical methods for the characterization of biological products and assessment of comparability. Dev. Biol. (Basel) 122, 137–160 Hobeika, 2005, Enumerating antigen-specific T cell responses in peripheral blood: a comparison of peptide MHC Tetramer, ELISpot, and intracellular cytokine analysis, J. Immunother., 28, 63, 10.1097/00002371-200501000-00008 Tobery, 2006, A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV Type 1 gag vaccinated human subjects, AIDS Res. Hum. Retroviruses, 22, 1081, 10.1089/aid.2006.22.1081