Introduction to current and future protein therapeutics: A protein engineering perspective

Experimental Cell Research

Volumn 317, Issue 9, 2011, Pages 1261-1269

  Carter, Paul J ^a  

^a GENENTECH INC   (United States)

Author keywords

Antibody therapeutics; Engineered protein scaffolds; Fc fusion proteins; Protein therapeutics

Indexed keywords

ADALIMUMAB; ANTIBODY CONJUGATE; BEVACIZUMAB; BISPECIFIC ANTIBODY; ETANERCEPT; FC RECEPTOR; GEMTUZUMAB OZOGAMICIN; HUMAN INSULIN; HYBRID PROTEIN; INFLIXIMAB; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; MACROGOL; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RANIBIZUMAB; RECOMBINANT PROTEIN; RITUXIMAB; ROMIPLOSTIM; SCAFFOLD PROTEIN; TRASTUZUMAB;

DRUG CONJUGATION; DRUG EFFICACY; DRUG SAFETY; IMMUNOGENICITY; PRIORITY JOURNAL; PROTEIN ENGINEERING; PROTEIN MODIFICATION; REVIEW;

EID: 79955666020     PISSN: 00144827     EISSN: 10902422     Source Type: Journal    
DOI: 10.1016/j.yexcr.2011.02.013     Document Type: Review

References (69)

1. Walsh G. Biopharmaceutical benchmarks 2010. Nat. Biotechnol. 2010, 28:917-924.
2. Leader B., Baca Q.J., Golan D.E. Protein therapeutics: a summary and pharmacological classification. Nat. Rev. Drug Discov. 2008, 7:21-39.
3. Nicolaides N.C., Sass P.M., Grasso L. Advances in targeted therapeutic agents. Expert Opin. Drug Discov. 2010, 5:1123-1140.
4. Reichert J.M. Metrics for antibody therapeutics development. mAbs 2010, 2:695-700.
5. Reichert J.M. Antibodies to watch in 2010. mAbs 2010, 2:28-45.
6. Chan A.C., Carter P.J. Therapeutic antibodies for autoimmunity and inflammation. Nat. Rev. Immunol. 2010, 10:301-316.
7. Goeddel D.V., Kleid D.G., Bolivar F., Heyneker H.L., Yansura D.G., Crea R., Hirose T., Kraszewski A., Itakura K., Riggs A.D. Expression in Escherichia coli of chemically synthesized genes for human insulin. Proc. Natl Acad. Sci. USA 1979, 76:106-110.
8. Vigneri R., Squatrito S., Sciacca L. Insulin and its analogs: actions via insulin and IGF receptors. Acta Diabetol. 2010, 47:271-278.
9. Freeman J.S. Insulin analog therapy: improving the match with physiologic insulin secretion. J. Am. Osteopath. Assoc. 2009, 109:26-36.
10. Solá R.J., Griebenow K. Glycosylation of therapeutic proteins: an effective strategy to optimize efficacy. BioDrugs 2010, 24:9-21.
11. Elliott S., Lorenzini T., Asher S., Aoki K., Brankow D., Buck L., Busse L., Chang D., Fuller J., Grant J., Hernday N., Hokum M., Hu S., Knudten A., Levin N., Komorowski R., Martin F., Navarro R., Osslund T., Rogers G., Rogers N., Trail G., Egrie J. Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat. Biotechnol. 2003, 21:414-421.
12. Kiss Z., Elliott S., Jedynasty K., Tesar V., Szegedi J. Discovery and basic pharmacology of erythropoiesis-stimulating agents (ESAs), including the hyperglycosylated ESA, darbepoetin alfa: an update of the rationale and clinical impact. Eur. J. Clin. Pharmacol. 2010, 66:331-340.
13. Huang C. Receptor-Fc fusion therapeutics, traps, and MIMETIBODY technology. Curr. Opin. Biotechnol. 2009, 20:692-699.
14. Jazayeri J.A., Carroll G.J. Fc-based cytokines: prospects for engineering superior therapeutics. BioDrugs 2008, 22:11-26.
15. Kontermann R.E. Strategies to extend plasma half-lives of recombinant antibodies. BioDrugs 2009, 23:93-109.
16. Capon D.J., Chamow S.M., Mordenti J., Marsters S.A., Gregory T., Mitsuya H., Byrn R.A., Lucas C., Wurm F.M., Groopman J.E., Broder S., Smith D.H. Designing CD4 immunoadhesins for AIDS therapy. Nature 1989, 337:525-531.
17. Cines D.B., Yasothan U., Kirkpatrick P. Romiplostim. Nat. Rev. Drug Discov. 2008, 7:887-888.
18. Jevševar S., Kunstelj M., Porekar V.G. PEGylation of therapeutic proteins. Biotechnol. J. 2010, 5:113-128.
19. Veronese F.M., Mero A. The impact of PEGylation on biological therapies. BioDrugs 2008, 22:315-329.
20. Kresse G.B. Biosimilars - science, status, and strategic perspective. Eur. J. Pharm. Biopharm. 2009, 72:479-486.
21. Chapman A.P., Antoniw P., Spitali M., West S., Stephens S., King D.J. Therapeutic antibody fragments with prolonged in vivo half-lives. Nat. Biotechnol. 1999, 17:780-783.
22. Li J., Yang C., Xia Y., Bertino A., Glaspy J., Roberts M., Kuter D.J. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 2001, 98:3241-3248.
23. Bendele A., Seely J., Richey C., Sennello G., Shopp G. Short communication: renal tubular vacuolation in animals treated with polyethylene-glycol-conjugated proteins. Toxicol. Sci. 1998, 42:152-157.
24. Almagro J.C., Fransson J. Humanization of antibodies. Front. Biosci. 2008, 13:1619-1633.
25. Lonberg N. Fully human antibodies from transgenic mouse and phage display platforms. Curr. Opin. Immunol. 2008, 20:450-459.
26. Lonberg N. Human monoclonal antibodies from transgenic mice. Handb. Exp. Pharmacol. 2008, 69-97.
27. Thie H., Meyer T., Schirrmann T., Hust M., Dübel S. Phage display derived therapeutic antibodies. Curr. Pharm. Biotechnol. 2008, 9:439-446.
28. Kelley B. Industralization of mAb production technology. The bioprocess industry at a crossroads. mAbs 2009, 1:443-452.
29. Better M., Chang C.P., Robinson R.R., Horwitz A.H. Escherichia coli secretion of an active chimeric antibody fragment. Science 1988, 240:1041-1043.
30. Skerra A., Plückthun A. Assembly of a functional immunoglobulin Fv fragment in Escherichia coli. Science 1988, 240:1038-1041.
31. Carter P., Kelley R.F., Rodrigues M.L., Snedecor B., Covarrubias M., Velligan M.D., Wong W.L., Rowland A.M., Kotts C.E., Carver M.E., Yang M., Bourell J.H., Shepard H.M., Henner D. High level Escherichia coli expression and production of a bivalent humanized antibody fragment. Biotechnology 1992, 10:163-167.
32. Beck A., Wurch T., Bailly C., Corvaia N. Strategies and challenges for the next generation of therapeutic antibodies. Nat. Rev. Immunol. 2010, 10:345-352.
33. Chames P., Van Regenmortel M., Weiss E., Baty D. Therapeutic antibodies: successes, limitations and hopes for the future. Br. J. Pharmacol. 2009, 157:220-233.
34. Chan A.C., Carter P.J. Therapeutic antibodies for autoimmunity and inflammation. Nat. Rev. Immunol. 2010, 10:301-316.
35. Reichert J.M. Monoclonal antibodies as innovative therapeutics. Curr. Pharm. Biotechnol. 2008, 9:423-430.
36. Marschall A.L., Frenzel A., Schirrmann T., Schüngel M., Dübel S. Targeting antibodies to the cytoplasm. mAbs 2011, 3:3-16.
37. Lampson L. Monoclonal antibodies in neuro-oncology: getting past the blood-brain barrier. mAbs 2011, 3:156-163.
38. Zlokovic B.V. The blood-brain barrier in health and chronic neurodegenerative disorders. Neuron 2008, 57:178-201.
39. Sedalacek H.-H., Seemann G., Hoffmann D., Czech J., Lorenz P., Kolar C., Bosslet K. Antibodies as Carriers of Cytotoxicity 1992, Karger, Munich, Germany.
40. Schmidt M.M., Wittrup K.D. A modeling analysis of the effects of molecular size and binding affinity on tumor targeting. Mol. Cancer Ther. 2009, 8:2861-2871.
41. Ackerman M.E., Pawlowski D., Wittrup K.D. Effect of antigen turnover rate and expression level on antibody penetration into tumor spheroids. Mol. Cancer Ther. 2008, 7:2233-2240.
42. Hurwitz H., Fehrenbacher L., Novotny W., Cartwright T., Hainsworth J., Heim W., Berlin J., Baron A., Griffing S., Holmgren E., Ferrara N., Fyfe G., Rogers B., Ross R., Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N. Engl. J. Med. 2004, 350:2335-2342.
43. Slamon D.J., Leyland-Jones B., Shak S., Fuchs H., Paton V., Bajamonde A., Fleming T., Eiermann W., Wolter J., Pegram M., Baselga J., Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 2001, 344:783-792.
44. Weiner L.M., Surana R., Wang S. Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nat. Rev. Immunol. 2010, 10:317-327.
45. Norman D.J., Chatenoud L., Cohen D., Goldman M., Shield C.F. Consensus statement regarding OKT3-induced cytokine-release syndrome and human antimouse antibodies. Transplant. Proc. 1993, 25:89-92.
46. Arrell D.K., Terzic A. Network systems biology for drug discovery. Clin. Pharmacol. Ther. 2010, 88:120-125.
47. Barabási A.L., Gulbahce N., Loscalzo J. Network medicine: a network-based approach to human disease. Nat. Rev. Genet. 2011, 12:56-68.
48. Kresse G.B. Biosimilars - science, status, and strategic perspective. Eur. J. Pharm. Biopharm. 2009, 72:479-486.
49. Carter P.J. Potent antibody therapeutics by design. Nat. Rev. Immunol. 2006, 6:343-357.
50. Nisonoff A., Mandy W.J. Quantitative estimation of the hybridization of rabbit antibodies. Nature 1962, 194:355-359.
51. Linke R., Klein A., Seimetz D. Catumaxomab: clinical development and future directions. mAbs 2010, 2:129-136.
52. Bargou R., Leo E., Zugmaier G., Klinger M., Goebeler M., Knop S., Noppeney R., Viardot A., Hess G., Schuler M., Einsele H., Brandl C., Wolf A., Kirchinger P., Klappers P., Schmidt M., Riethmüller G., Reinhardt C., Baeuerle P.A., Kufer P. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science 2008, 321:974-977.
53. Marvin J.S., Zhu Z. Recombinant approaches to IgG-like bispecific antibodies. Acta Pharmacol. Sin. 2005, 26:649-658.
54. Alley S.C., Okeley N.M., Senter P.D. Antibody-drug conjugates: targeted drug delivery for cancer. Curr. Opin. Chem. Biol. 2010, 14:529-537.
55. Carter P.J., Senter P.D. Antibody-drug conjugates for cancer therapy. Cancer J. 2008, 14:154-169.
56. Younes A., Bartlett N.L., Leonard J.P., Kennedy D.A., Lynch C.M., Sievers E.L., Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N. Engl. J. Med. 2010, 363:1812-1821.
57. Niculescu-Duvaz I. Trastuzumab emtansine, an antibody-drug conjugate for the treatment of HER2+ metastatic breast cancer. Curr. Opin. Mol. Ther. 2010, 12:350-360.
58. Ghetie V., Popov S., Borvak J., Radu C., Matesoi D., Medesan C., Ober R.J., Ward E.S. Increasing the serum persistence of an IgG fragment by random mutagenesis. Nat. Biotechnol. 1997, 15:637-640.
59. Presta L.G. Molecular engineering and design of therapeutic antibodies. Curr. Opin. Immunol. 2008, 20:460-470.
60. Zalevsky J., Chamberlain A.K., Horton H.M., Karki S., Leung I.W.L., Sproule T.J., Lazar G.A., Roopenian D.C., Desjarlais J.R. Enhanced antibody half-life improves in vivo activity. Nat. Biotechnol. 2010, 28:157-159.
61. Igawa T., Ishii S., Tachibana T., Maeda A., Higuchi Y., Shimaoka S., Moriyama C., Watanabe T., Takubo R., Doi Y., Wakabayashi T., Hayasaka A., Kadono S., Miyazaki T., Haraya K., Sekimori Y., Kojima T., Nabuchi Y., Aso Y., Kawabe Y., Hattori K. Antibody recycling by engineered pH-dependent antigen binding improves the duration of antigen neutralization. Nat. Biotechnol. 2010, 28:1203-1207.
62. Kubota T., Niwa R., Satoh M., Akinaga S., Shitara K., Hanai N. Engineered therapeutic antibodies with improved effector functions. Cancer Sci. 2009, 100:1566-1572.
63. Cartron G., Watier H., Golay J., Solal-Celigny P. From the bench to the bedside: ways to improve rituximab efficacy. Blood 2004, 104:2635-2642.
64. Binz H.K., Amstutz P., Plückthun A. Engineering novel binding proteins from nonimmunoglobulin domains. Nat. Biotechnol. 2005, 23:1257-1268.
65. Gebauer M., Skerra A. Engineered protein scaffolds as next-generation antibody therapeutics. Curr. Opin. Chem. Biol. 2009, 13:245-255.
66. Nuttall S.D., Walsh R.B. Display scaffolds: protein engineering for novel therapeutics. Curr. Opin. Pharmacol. 2008, 8:609-615.
67. Zuraw B., Yasothan U., Kirkpatrick P. Ecallantide. Nat. Rev. Drug Discov. 2010, 9:189-190.
68. Walker A., Dunlevy G., Rycroft D., Topley P., Holt L.J., Herbert T., Davies M., Cook F., Holmes S., Jespers L., Herring C. Anti-serum albumin domain antibodies in the development of highly potent, efficacious and long-acting interferon. Protein Eng. Des. Sel. 2010, 23:271-278.
69. Holt L.J., Basran A., Jones K., Chorlton J., Jespers L.S., Brewis N.D., Tomlinson I.M. Anti-serum albumin domain antibodies for extending the half-lives of short lived drugs. Protein Eng. Des. Sel. 2008, 21:283-288.