Anti-TNFα domain antibody construct CEP-37247

References

• Ward ES, Gussow D, Griffiths AD, Jones PT, Winter G. Binding activities of a repertoire of single immunoglobulin variable domains secreted from Escherichia coli. Nature 1989; 341:544 - 546
   PubMed Web of Science ®Google Scholar
• Holt LJ, Basran A, Jones K, Chorlton J, Jespers LS, Brewis ND, et al. Anti-serum albumin domain antibodies for extending the half-lives of short lived drugs. Protein Eng Des Sel 2008; 21:283 - 288
   PubMed Web of Science ®Google Scholar
• Feldmann M. Maini RN, Anti-TNFalpha therapy of rheumatoid arthritis: what have we learned?. Annu Rev Immunol 2001; 19:163 - 196
   PubMed Web of Science ®Google Scholar
• Hochberg MC, Lebwohl MG, Plevy SE, Hobbs KF, Yocum DE. The benefit/risk profile of TNF-blocking agents: findings of a consensus panel. Semin Arthritis Rheum 2005; 34:819 - 836
   PubMed Web of Science ®Google Scholar
• Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000; 343:1586 - 1593
   PubMed Web of Science ®Google Scholar
• Emery P, Genovese MC, van Vollenhoven R, Sharp JT, Patra K, Sasso EH. Less radiographic progression with adalimumab plus methotrexate versus methotrexate monotherapy across the spectrum of clinical response in early rheumatoid arthritis. J Rheumatol 2009; 36:1429 - 1441
   PubMed Web of Science ®Google Scholar
• La Merie Business Intelligence. Top 20 biologics—2008. R&D Pipeline News 2009 1:1 - 25
   Google Scholar
• Tansey MG, Szymkowski DE. The TNF superfamily in 2009: new pathways, new indications and new drugs. Drug Discov Today 2009; 14:1082 - 1088
   PubMed Web of Science ®Google Scholar
• Butler M. Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals. Appl Microbiol Biot 2005; 68:283 - 291
   PubMed Web of Science ®Google Scholar
• Langer ES. Trends in capacity utilization for therapeutic monoclonal antibody production. mAbs 2009; 1:151 - 156
   PubMed Web of Science ®Google Scholar
• Chensue SW,, Remick DG, Shmyr-Forsch C, Beals TF, Kunkel SL. Immunohistochemical demonstration of cytoplasmic and membrane-associated tumor necrosis factor in murine macrophages. Am J Pathol 1988; 133:564 - 572
   PubMed Web of Science ®Google Scholar
• Perez C, Albert I, DeFay K, Zachariades N, Gooding L, Kriegler M. A nonsecretable cell surface mutant of tumor necrosis factor (TNF) kills by cell-to-cell contact. Cell 1990; 63:251 - 258
   PubMed Web of Science ®Google Scholar
• Kinkhabwala M, Sehajpal P, Skolnik E, Smith D, Sharma VK, Vlassara H, et al. A novel addition to the T cell repertory. Cell surface expression of tumor necrosis factor/cachectin by activated normal human T cells. J Exp Med 1990; 171:941 - 946
   Google Scholar
• Luettig B, Decker T, Lohmann-Matthes ML. Evidence for the existence of two forms of membrane tumor necrosis factor: an integral protein and a molecule attached to its receptor. J Immunol 1989; 143:4034 - 4038
   PubMed Web of Science ®Google Scholar
• Dinarello CA. Differences between anti-tumor necrosis factor-alpha monoclonal antibodies and soluble TNF receptors in host defense impairment. J Rheumatol Suppl 2005; 74:40 - 47
   PubMedGoogle Scholar
• Keffer J, Probert L, Cazlaris H, Georgopoulos S, Kaslaris E, Kioussis D, et al. Transgenic mice expressing human tumour necrosis factor: a predictive genetic model of arthritis. EMBO J 1991; 10:4025 - 4031
   PubMed Web of Science ®Google Scholar
• Rau R, Sander O, van Riel P, van de Putte L, Hasler F, Zaug M, et al. Intravenous human recombinant tumor necrosis factor receptor p55-Fc IgG1 fusion protein Ro 45-2081 (lenercept): a double blind, placebo controlled dose-finding study in rheumatoid arthritis. J Rheumatol 2003; 30:680 - 690
   PubMed Web of Science ®Google Scholar
• Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther 2009; 11:1
   PubMed Web of Science ®Google Scholar
• Finckh A, Simard JF, Gabay C, Guerne PA. Evidence for differential acquired drug resistance to anti-tumour necrosis factor agents in rheumatoid arthritis. Ann Rheum Dis 2006; 65:746 - 752
   PubMed Web of Science ®Google Scholar
• Emi Aikawa N, de Carvalho JF, Artur Almeida Silva C, Bonfa E. Immunogenicity of Anti-TNF-alpha agents in autoimmune diseases. Clin Rev Allergy Immunol 2010; 38:82 - 89
   PubMed Web of Science ®Google Scholar
• Hyrich KL, Lunt M, Watson KD, Symmons DP, Silman AJ. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum 2007; 56:13 - 20
   PubMed Web of Science ®Google Scholar
• Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005; 36:3 - 10
   PubMed Web of Science ®Google Scholar
• Harding FA, Stickler MM, Razo J, Dubridge RB. The immunogenicity of humanized and fully human antibodies: residual immunogenicity resides in the CDR regions. mAbs 2:256 - 265
   PubMed Web of Science ®Google Scholar
• Tutuncu Z, Kavanaugh A, Zvaifler N, Corr M, Deutsch R, Boyle D. Fcgamma receptor type IIIA polymorphisms influence treatment outcomes in patients with inflammatory arthritis treated with tumor necrosis factor alpha-blocking agents. Arthritis Rheum 2005; 52:2693 - 2696
   PubMed Web of Science ®Google Scholar
• Louis E, El Ghoul Z, Vermeire S, Dall'Ozzo S, Rutgeerts P, Paintaud G, et al. Association between polymorphism in IgG Fc receptor IIIa coding gene and biological response to infliximab in Crohn's disease. Aliment Pharmacol Ther 2004; 19:511 - 959
   PubMed Web of Science ®Google Scholar
• Arora T, Padaki R, Liu L, Hamburger AE, Ellison AR, Stevens SR, et al. Differences in binding and effector functions between classes of TNF antagonists. Cytokine 2009; 45:124 - 131
   PubMed Web of Science ®Google Scholar
• Redlich K, Hayer S, Maier A, Dunstan CR, Tohidast-Akrad M, Lang S, et al. Tumor necrosis factor alpha-mediated joint destruction is inhibited by targeting osteoclasts with osteoprotegerin. Arthritis Rheum 2002; 46:785 - 792
   PubMed Web of Science ®Google Scholar
• Bessis N, Chiocchia G, Kollias G, Minty A, Fournier C, Fradelizi D, et al. Modulation of proinflammatory cytokine production in tumour necrosis factor-alpha (TNFalpha)-transgenic mice by treatment with cells engineered to secrete IL-4, IL-10 or IL-13. Clin Exp Immunol 1998; 111:391 - 696
   PubMed Web of Science ®Google Scholar
• Schett G, Hayer S, Tohidast-Akrad M, Schmid BJ, Lang S, Turk B, et al. Adenovirus-based overexpression of tissue inhibitor of metalloproteinases 1 reduces tissue damage in the joints of tumor necrosis factor alpha transgenic mice. Arthritis Rheum 2001; 44:2888 - 2898
   PubMed Web of Science ®Google Scholar
• Borth N, Strutzenberger K, Kunert R, Steinfellner W, Katinger H. Analysis of changes during subclone development and ageing of human antibody-producing heterohybridoma cells by northern blot and flow cytometry. J Biotechnol 1999; 67:57 - 66
   PubMed Web of Science ®Google Scholar
• Schlatter S, Stansfield SH, Dinnis DM, Racher AJ, Birch JR, James DC. On the optimal ratio of heavy to light chain genes for efficient recombinant antibody production by CHO cells. Biotechnol Prog 2005; 21:122 - 133
   PubMed Web of Science ®Google Scholar
• Jespers L, Schon O, James LC, Veprintsev D, Winter G. Crystal structure of HEL4, a soluble, refoldable human V(H) single domain with a germ-line scaffold. J Mol Biol 2004; 337:893 - 903
   PubMed Web of Science ®Google Scholar
• Chang DM, Chang SY, Yeh MK, Lai JH. The pharmacokinetics of interleukin-1 receptor antagonist in Chinese subjects with rheumatoid arthritis. Pharmacol Res 2004; 50:371 - 376
   PubMed Web of Science ®Google Scholar
• Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008; 117:244 - 279
   PubMed Web of Science ®Google Scholar
• Immunex Corporation. Nonclinical Pharmacology and Toxicology Review of BLA 98-0286 1998; www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm088697.pdf
   Google Scholar
• Abbott Laboratories. Pharmacology Review of BLA 125057/0 2002; www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm092772.pdf
   Google Scholar
• Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, et al. Efficacy, pharmacokinetic and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study. Clin Ther 2003; 25:1700 - 1721
   PubMed Web of Science ®Google Scholar
• Nestorov I. Clinical pharmacokinetics of TNF antagonists: how do they differ?. Semin Arthritis Rheum 2005; 34:12 - 18
   PubMed Web of Science ®Google Scholar
• Davies B, Morris T. Physiological parameters in laboratory animals and humans. Pharm Res 1993; 10:1093 - 1095
   PubMed Web of Science ®Google Scholar
• Wang AM, Creasey AA, Ladner MB, Lin LS, Strickler J, Van Arsdell JN, et al. Molecular cloning of the complementary DNA for human tumor necrosis factor. Science 1985; 228:149 - 154
   PubMed Web of Science ®Google Scholar
• Scallon BJ, Moore MA, Trinh H, Knight DM, Ghrayeb J. Chimeric anti-TNF-alpha monoclonal antibody cA2 binds recombinant transmembrane TNFalpha and activates immune effector functions. Cytokine 1995; 7:251 - 259
   PubMed Web of Science ®Google Scholar