Translational strategies for development of monoclonal antibodies from discovery to the clinic

Drug Discovery Today

Volumn 14, Issue 5-6, 2009, Pages 298-305

  Tabrizi, Mohammad A ^a   Bornstein, Gadi Gazit ^b   Klakamp, Scott L ^a   Drake, Andrew ^a   Knight, Richard ^b   Roskos, Lorin ^a  

^a MEDIMMUNE   (United States)

^b ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ANTIBODY AFFINITY; ANTIBODY RESPONSE; ANTIGEN ANTIBODY COMPLEX; ANTIGEN ANTIBODY REACTION; CROSS REACTION; DRUG ANTIGENICITY; DRUG DESIGN; DRUG EFFICACY; DRUG POTENCY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; MONKEY; NONHUMAN; REVIEW; TUMOR XENOGRAFT;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DECISION MAKING; DRUG DELIVERY SYSTEMS; DRUG DESIGN; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; HUMANS; TIME FACTORS;

EID: 61649112477     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2008.12.008     Document Type: Review

References (68)

1. LaMerie Business, Intelligence www.lamerie.com (February 2007) Top 20 Biologics - a biopharmaceutical R&D pipeline list
2. PHARMACEUTICAL BUSINESS review ONLINE www.pharmaceutical-business-review.com (October 2007) Monoclonal antibody market growth set to outstrip small molecules
3. Burrill G.S. Biotech 2007. Life Sciences: A Global Transformation (2007), Burrill Life Sciences Media Group LLC, USA pp. 64-121 (Chapter 3)
4. Tabrizi M.A., and Roskos LK. Preclinical and clinical safety of monoclonal antibodies. Drug Discov. Today 12 (2007) 540-547
5. Newsome B.W., and Ernstoff M.S. The clinical pharmacology of therapeutic monoclonal antibodies in the treatment of malignancy; have the magic bullets arrived?. Br. J. Clin. Pharmacol. 66 (2008) 6-19
6. Lalonde R.L., et al. Model-based drug development. Clin. Pharmacol. Therapeut. 82 (2007) 21-32
7. Taylor R.P., and Lindorfer M.A. Immunotherapeutic mechanisms of anti-CD20 monoclonal antibodies. Curr. Opin. Immunol. 20 (2008) 444-449
8. Tabrizi M.A., et al. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov. Today 11 (2006) 81-88
9. Tabrizi M.A., and Roskos L.K. Exposure-response relationships for therapeutic biologic products. In: Meibohem B. (Ed). Pharmacokinetics and Pharmacodynamics of Biotech Drugs (2006), Wiley 295-327
10. Canziani G.A., et al. Kinetic screening of antibodies from crude hybridoma samples using Biacore. Anal. Biochem. 325 (2004) 301-307
11. Safsten P., et al. Screening antibody/antigen interactions in parallel using Biacore A100. Anal. Biochem. 353 (2006) 181-190
12. Chapman K., et al. Preclinical safety testing of monoclonal antibodies: the significance of species relevance. Nat. Rev. Drug Discov. 6 (2007) 120-126
13. Rich R.L., and Myszka D.G. Advances in surface plasmon resonance biosensor analysis. Curr. Opin. Biotechnol. 11 (2000) 54-61
14. Karlsson R., and Falt A. Experimental design for kinetic analysis of protein-protein interactions with surface plasmon resonance biosensors. J. Immunol. Methods 200 (1997) 121-133
15. Morton T.A., and Myszka D.G. Kinetic analysis of macromolecular interactions using surface plasmon resonance biosensors. Methods Enzymol. 295 (1998) 268-294
16. Roskos L. Molecular engineering II: antibody affinity. In: Dubel S. (Ed). Handbook of Therapeutic Antibodies vol. 1 (2007), Wiley-VCH, Weinheim, Germany pp. 145-169 (Chapter 7)
17. Drake A.W., et al. Characterizing high-affinity antigen/antibody complexes by kinetic- and equilibrium methods. Anal. Biochem. 328 (2004) 35-43
18. Myszka D.G. Improving biosensor analysis. J. Mol. Recognit. 12 (1999) 279-284
19. Van Regenmortel M.H.V. Improving the quality of biacore-based affinity measurements. In: Brown F., and Mire-Sluis A.R. (Eds). Immunogenicity of Therapeutic Biological Products. Dev. Biol. 112 (2003), Karger, Basel 141-151
20. Blake II R.C., et al. Automated kinetic exclusion assays to quantify protein binding interactions in homogenous solution. Anal. Biochem. 272 (1999) 123-134
21. Blake R.C., et al. Covalent and noncovalent modifications induce allosteric binding behavior in a monoclonal antibody. Biochemistry 46 (2007) 1573-1586
22. Darling R.J., and Brault P.-A. Kinetic exclusion assay technology: characterization of molecular interactions. Assay Drug Dev. Technol. 2 (2004) 647-657
23. Drake A.W., and Klakamp S.L. A rigorous multiple independent binding site model for determining cell-based equilibrium dissociation constants. J. Immunol. Methods 318 (2007) 147-152
24. Gordon I.L. Scatchard analysis of fluorescent concanavalin A binding to lymphocytes. Cytometry 20 (1995) 238-244
25. Martin R.B. Disadvantages of double reciprocal plots. J. Chem. Educ. 74 (1997) 1238-1240
26. Carter P., et al. Identification and validation of cell surface antigens for antibody targeting in oncology. Endocrine-Related Cancer 11 (2004) 659-687
27. Lavery K.S., and King T.H. Antisense and RNAi: powerful tools in drug target discovery and validation. Curr. Opin. Drug Discov. Dev. 6 (2003) 561-569
28. Boese Q., et al. siRNA as a tool for streamlining functional genomic studies. Targets 2 (2003) 93-100
29. Tornell J., and Snaith M. Transgenic systems in drug discovery: from target identification to humanized mice. Drug Discov. Today 7 (2002) 461-470
30. Kitano H. Cancer as a robust system: implications for anticancer therapy. Nat. Rev. Cancer 4 (2004) 227-235
31. Carter P.J. Potent antibody therapeutics by design. Nat. Rev. Immunol. 6 (2006) 343-357
32. Cragg M.S., et al. Signaling antibodies in cancer therapy. Curr. Opin. Immunol. 11 (1999) 541-547
33. Adams G.P., and Weiner L.M. Monoclonal antibody therapy of cancer. Nat. Biotechnol. 23 (2005) 1147-1157
34. Franklin M.C., et al. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 5 (2004) 317-328
35. Willett C.G., et al. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat. Med. 10 (2004) 145-147
36. Takeda K., et al. Combination antibody-based cancer immunotherapy. Cancer Sci. 98 (2007) 1297-1302
37. Prete M., et al. Biological therapy with monoclonal antibodies: a novel treatment approach to autoimmune disease. Clin. Exp. Med. 5 (2005) 141-160
38. Shields R.L., et al. High resolution mapping of the binding site on human IgG1 for F gamma RI, Fc gamma RII, Fc gamma RIII and FcRn and design of IgG1 variants with improved binding to the Fc gamma R. J. Biol. Chem. 276 (2001) 6591-6604
39. Witzig T.E., et al. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J. Clin. Oncol. 20 (2002) 2453-2463
40. Wu A.M., and Senter P.D. Arming antibodies: prospects and challenges for immunoconjugates. Nat. Biotechnol. 23 (2005) 1137-1146
41. Khazeli M.B., et al. Human immune response to monoclonal antibodies. J. Immunother. 15 (1994) 42-52
42. Green L.L., et al. Antigen-specific human monoclonal antibodies from mice engineered with human Ig heavy and light chain YACs. Nat. Genet. 7 (1994) 13-21
43. Lonberg N., et al. Antigen-specific human antibodies from mice comprising four distinct genetic modifications. Nature 368 (1994) 856-859
44. Bruggemann M., et al. Human antibody production in transgenic mice: expression from 100 kb of the human IgH locus. Eur. J. Immunol. 21 (1991) 1323-1326
45. Thomas K.R., and Capecchi M.R. Site-directed mutagenesis by gene targeting in mouse embryo-derived stem cells. Cell 51 (1987) 503-512
46. Lute K.D., et al. Human CTLA4 knock-in mice unravel the quantitative link between tumor immunity and autoimmunity induced by anti-CTLA-4 antibodies. Blood 106 (2005) 3127-3133
47. Hoffman R.M. Orthotopic metastatic mouse models for anticancer drug discovery and evaluation: a bridge to the clinic. Invest. New Drugs 17 (1999) 343-359
48. Steel G.G., et al. The response to chemotherapy of a variety of human tumour xenografts. Br. J. Cancer 47 (1983) 1-13
49. Carmeliet P., and Jain R.K. Angiogenesis in cancer and other diseases. Nature 407 (2000) 249-257
50. Hood J.D., and Cheresh D.A. Building a better Trap. Proc. Natl. Acad. Sci. U. S. A. 100 (2003) 8624-8625
51. ICH S6 (1997) Preclinical safety evaluation of biotechnology-derived pharmaceuticals. www.ich.org/LOB/media/MEDIA503.pdf
52. EXPERT SCIENTIFIC GROUP ON PHASE-ONE CLINICAL TRIAL (2006) www.dh.gov.uk
53. Guidance for Industry. Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (2005), US Department of Health and Human Services, Food and Drug Administration
54. Saif M.W., and Kim R. Incidence and management of cutaneous toxicities associated with cetuximab. Expert Opin. Drug Safety 6 (2007) 175-182
55. Foon, et al. Preclinical and clinical evaluation of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody. Int. J. Radiat. Oncol. Biol. Phys. 58 (2004) 984-990
56. Pande A., et al. Hypertension secondary to anti-angiogenic therapy: experience with bevacizumab. Anticancer Res. 27 (2007) 3465-3470
57. Weinberg, et al. Development and regulation of monoclonal antibody products: challenges and opportunities. Cancer Metastasis Rev. 24 (2004) 569-584
58. European Medicinal agency, EMEA (2006) Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins (Doc.Ref.EMEA/CHMP/BMWP/14327/2006)
59. Barbosa M.D.F.S., and Celis E. Immunogenicity of protein therapeutics and the interplay between tolerance and antibody responses. Drug Discov. Today 12 (2007) 674-681
60. De Groot A.S., et al. Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates. Curr. Opin. Pharmacol. 8 (2008) 620-626
61. Keffer J., et al. Transgenic mice expressing human tumour necrosis factor: a predictive genetic model of arthritis. EMBO J. 10 (1991) 4025-4031
62. Ruffin C.G., and Busch B.E. Omalizumab: a recombinant humanized anti-IgE antibody for allergic asthma. Am. J. Health Syst. Pharm. 61 (2004) 1449-1459
63. Mortensen D.L., et al. Pharmacokinetics and pharmacodynamics of multiple weekly subcutaneous efalizumab doses in patients with plaque psoriasis. J. Clin. Pharmacol. 45 (2005) 286-298
64. Milgrom B., et al. Treatment of allergic asthma with monoclonal anti-IgE antibody. rhuMAb-E25 Study Group. N. Engl. J. Med. 341 (1999) 1966-1973
65. Saban R., et al. Huamn FcERI-IgG and humanized anti-IgE monoclonal antibody MaE11 block passive sensitization of human and rhesus monkey lung. J. Allergy Clin. Immunol. 94 (1994) 836-843
66. Bauer R.J., et al. Population pharmacokinetics and pharmacodynamics of the anti-CD11a antibody hu1124 in human subjects with psoriasis. J. Pharmacokinet. Biopharm. 27 (1999) 397-420
67. Coffey G., et al. In vitro internalization, intracellular transport, and clearance of an anti-CD11a antibody (Raptiva) by human T-cells. J. Pharmacol. Exp. Ther. 310 (2004) 896-904
68. Coffey G.P., et al. Tissue distribution and receptor-mediated clearance of anti-CD11a antibody in mice. Drug Metab. Dispos. 33 (2005) 623-629