Monomeric Fc fusions: Impact on pharmacokinetic and biological activity of protein therapeutics

BioDrugs

Volumn 20, Issue 3, 2006, Pages 151-160

  Dumont, Jennifer A ^a   Low, Susan C ^a   Peters, Robert T ^a   Bitonti, Alan J ^a  

^a Syntonix Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; BETA INTERFERON; BLOOD CLOTTING FACTOR 9; ERYTHROPOIETIN; FC RECEPTOR; FOLLITROPIN; HYBRID PROTEIN; IMMUNOGLOBULIN;

AREA UNDER THE CURVE; DRUG ACTIVITY; DRUG DELIVERY SYSTEM; DRUG HALF LIFE; HUMAN; IN VITRO STUDY; NONHUMAN; PRIORITY JOURNAL; PROTEIN EXPRESSION; REVIEW;

ANIMALS; DRUG DELIVERY SYSTEMS; ERYTHROPOIETIN; FACTOR IX; HISTOCOMPATIBILITY ANTIGENS CLASS I; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; INTERFERON-ALPHA; INTERFERON-BETA; LUNG; PROTEIN BINDING; PROTEIN TRANSPORT; RECEPTORS, FC; RECOMBINANT FUSION PROTEINS;

EID: 33744937065     PISSN: 11738804     EISSN: 11738804     Source Type: Journal    
DOI: 10.2165/00063030-200620030-00002     Document Type: Review

References (67)

1. Ashkenazi A, Capon DJ, Ward RH. Immunoadhesions. Int Rev Immunol 1993; 10: 219-27
2. Chamow SM, Ashkenazi A. Immunoadhesions: principles and applications. Trends Biotechnol 1996 Feb; 14: 52-60
3. Fisher CJ, Agosti JM, Opal SM, et al. Treatment of septic shock with the tumor necrosis factor receptor: Fc fusion protein. N Engl J Med 1996; 334 (26): 1697-702
4. Ellis CN, Krueger GG. Treatment of chronic plaque psoriasis by selective targeting of memory effector T lymphocytes. N Engl J Med 2001 Jul; 345 (4): 248-55
5. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med 2005 Sept; 353 (11): 1114-23
6. Bitonti AJ, Dumont JA, Low SC, et al. Pulmonary delivery of an erythropoietin Fc fusion protein in non-human primates through an immunoglobulin transport pathway. Proc Natl Acad Sci U S A 2004 Jun; 101 (26): 9763-8
7. Dumont JA, Bitonti AJ, Clark D, et al. Delivery of an erythropoietin-Fc fusion protein by inhalation in humans through an immunoglobulin transport pathway. J Aerosol Med 2005; 18 (3): 294-303
8. Brambell FWR, Hemmings WA, Morris IG. A theoretical model of γ-globulin catabolism. Nature 1964 Sep; 203: 1352-5
9. Brambell FWR. The transmission of immunity from mother to young and the catabolism of immunoglobulins. Lancet 1966 Nov; 2 (7473): 1087-93
10. Fahey JL, Robinson AG. Factors controlling serum γ-globulin concentration. J Exp Med 1963; 118: 845-68
11. Simister NE, Rees AR. Isolation and characterization of an Fc receptor from neonatal rat small intestine. Eur J Immunol 1985; 15: 733-8
12. Simister NE, Mostov KE. An Fc receptor structurally related to MHC class I antigens. Nature 1989 Jan; 337: 184-7
13. Ghetie V, Hubbard JG, Kim JK, et al. Abnormally short serum half-lives of IgG in beta 2-microglobulin-deficient mice. Eur J Immunol 1996 Mar; 26 (3): 690-6
14. Junghans RP, Anderson CL. The protection receptor for IgG catabolism is the beta2-microglobulin-containing neonatal intestinal transport receptor. Proc Natl Acad Sci U S A 1996 May; 93: 5512-6
15. Israel EJ, Wilsker DF, Hayes KC, et al. Increased clearance of IgG in mice that lack beta 2-microglobulin; possible protective role of FcRn. Immunology 1996; 89: 573-8
16. Israel EJ, Patel VK, Taylor SF, et al. Requirement for a β2 -microglobulin-associated Fc receptor for acquisition of maternal IgG by fetal and neonatal mice. J Immunol 1995; 154: 6246-51
17. Kim JK, Tsen M, Ghetie V, et al. Catabolism of the murine IgG1 molecule: evidence that both CH2-CH3 domain interfaces are required for persistence of IgG1 in the circulation of mice. Scand J Immunol 1994; 40: 457-65
18. Weng Z, Gulukota K, Vaughn DE, et al. Computational determination of the structure of rat Fc bound to the neonatal Fc receptor. J Mol Biol 1998; 282: 217-25
19. West AP, Bjorkman PJ. Crystal structure and immunoglobulin G binding properties of the human major histocompatibility complex-related Fc receptor. Biochemistry 2000; 39: 9698-708
20. Kim JK, Firan M, Radu CG, et al. Mapping the site on human IgG for binding of the MHC class I-related receptor, FcRn. Eur J Immunol 1999; 29: 2819-25
21. Rodewald R, Kraehenbuhl JP. Receptor-mediated transport of IgG. J Cell Biol 1984; 99 (1): 159S-64S
22. Roberts DM, Guenthert M, Rodewald R. Isolation and characterization of the Fc receptor from the fetal yolk sac of the rat. J Cell Biol 1990 Nov; 111: 1867-76
23. Simister NE, Story CM, Chen HL, et al. An IgG-transporting Fc receptor expressed in the syncytiotrophoblast of human placenta. Eur J Immunol 1996; 26: 1527-31
24. Israel EJ, Taylor S, Wu Z, et al. Expression of the neonatal Fc receptor, FcRn, on human intestinal epithelial cells. Immunology 1997; 92: 69-74
25. Spiekermann GM, Finn PW, Ward ES, et al. Receptor-mediated immunoglobulin G transport across mucosal barriers in adult life: functional expression of FcRn in the mammalian lung. J Exp Med 2002 Aug; 196 (3): 303-10
26. Haymann JP, Levraud JP, Bouet S, et al. Characterization and localization of the neonatal Fc receptor in adult human kidney. J Am Soc Nephrol 2000; 11: 632-9
27. Borvak J, Richardson J, Medesan C, et al. Functional expression of the MHC class I-related receptor, FcRn, in endothelial cells of mice. Int Immunol 1998; 10 (9): 1289-98
28. Antohe F, Radulescu L, Gafencu A, et al. Expression of functionally active FcRn and the differentiated bi-directional transport of IgG in human placental endothelial cells. Hum Immunol 2001; 62: 93-105
29. Ward ES, Zhou J, Ghetie V, et al. Evidence to support the cellular mechanism involved in serum IgG homeostasis in humans. Int Immunol 2003; 15 (2): 187-95
30. Ober RJ, Martinez C, Vaccaro C, et al. Visualizing the site and dynamics of IgG salvage by the MHC class I-related receptor, FcRn. J Immunol 2004; 172: 2021-9
31. Flaharty KK. Clinical pharmacology of recombinant human erythropoietin (r-HuEPO). Pharmacotherapy 1990; 10 (2): 9S-14S
32. Flaharty KK, Caro J, Erslev A, et al. Pharmacokinetics and erythropoietic response to human recombinant erythropoietin in healthy men. Clin Pharmacol Ther 1990 May; 47 (5): 557-64
33. Martin WL, West Jr AP, Gan L, et al. Crystal structure at 2.8 angstroms of an FcRn/heterodimeric Fc complex: mechanism of pH-dependent binding. Mol Cell 2001 Apr; 7: 867-77
34. Byron PR, Patton JS. Drug delivery via the respiratory tract. J Aerosol Med 1994; 7 (1): 49-75
35. Patton JS. Mechanisms of macromolecule absorption by the lungs. Adv Drug Deliv Rev 1996; 19: 3-36
36. Suarez S, Hickey AJ. Drug properties affecting aerosol behavior. Respir Care 2000 Jun; 45 (6): 652-66
37. Rubin BK. Therapeutic aerosols and airway secretions. J Aerosol Med 1996; 9 (1): 123-30
38. Knowles MR, Boucher RC. Mucus clearance as a primary innate defense mechanism for mammalian airways. J Clin Invest 2002 Mar; 109 (5): 571-7
39. Lillehoj ER, Kim KC. Airway mucus: its components and function. Arch Pharm Res 2002 Dec; 25 (6): 770-80
40. Desai MA, Mutlu M, Vadgama P. A study of macromolecular diffusion through native porcine mucus. Experientia 1992 Jan; 48 (1): 22-6
41. Williams MC. Endocytosis in alveolar type II cells: effect of charge and size of tracers. Proc Natl Acad Sci U S A 1984 Oct; 81: 6054-8
42. Noseworthy JH, Lucchinetti C, Rodriguez M, et al. Multiple Sclerosis. N Engl J Med 2000; 343 (13): 938-52
43. Wandinger KP, Sturzebecher CS, Bielekova B, et al. Complex immunomodulatory effects of interferon-beta in multiple sclerosis include the upregulation of T helper 1-associated marker genes. Ann Neurol 2001; 50 (3): 349-57
44. Sturzebecher S, Maibauer R, Heuner A, et al. Pharmacodynamic comparison of single doses of IFN-beta 1a and IFN-beta 1b in healthy volunteers. J Interferon Cytokine Res 1999; 19 (11): 1257-64
45. Buchwalder PA, Buclin T, Trinchard S, et al. Pharmacokinetics and pharmacodynamics of IFNβ-1a in healthy volunteers. J Interferon Cytokine Res 2000; 20 (10): 857-66
46. Rubinstein S, Familletti PC, Pestka S. Convenient assay for interferons. J Virol 1981; 37 (2): 755-8
47. Brassard DL, Grace MJ, Bordens RW. Interferon-alpha as an immunotherapeutic protein. J Leukoc Biol 2002; 71: 565-81
48. Kozlowski A, Harris MJ. Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Control Release 2001; 72: 217-24
49. Kinnula V, Mattson K, Cantell K. Pharmacokinetics and toxicity of inhaled human interferon-α in patients with lung cancer. J Interferon Res 1989; 9: 419-23
50. Giosue S, Casarini M, Ameglio F, et al. Minimal dose of aerosolized interferon-alpha in human subjects biological consequences and side-effects. Eur Respir J 1996; 9: 42-6
51. van Zandwijk N, Jassem E, Dubbelmann R, et al. Aerosol application of interferon-alpha in the treatment of bronchioloalveolar carcinoma. Eur J Cancer 1990; 26: 738-40
52. Davie EW, Fujikawa K, Kiesel W. The coagulation cascade: initiation, maintenance, and regulation. Biochem 1991 Oct; 30: 10363-70
53. Bolton-Maggs PH, Pasi KJ. Haemophilias A and B. Lancet 2003 May; 361: 1801-9
54. Gillies SD, Lan Y, Brunkhorst B, et al. Bi-functional cytokine fusion proteins for gene therapy and antibody-targeted treatment of cancer. Cancer Immunol 2002; 51 (8): 449-60
55. Goldenberg MM. Etanercept, a novel drug for the treatment of patients with severe, active rheumatoid arthritis. Clin Ther 1999; 21 (1): 75-87
56. Economides AN, Carpenter LR, Rudge JS, et al. Cytokine traps: multi-component, high-affinity blockers of cytokine action. Nat Med 2003; 9 (1): 47-52
57. Schaison G, Young J, Pholsena M, et al. Failure of combined follicle-stimulating hormone-testosterone administration to initiate and/or maintain spermatogenesis in men with hypogonadotropic hypogonadism. J Clin Endocrinol Metab 1993; 77 (6): 1545-9
58. Schoot DC, Harlin J, Shoham Z, et al. Recombinant follicle stimulating hormone and ovarian response in gonadotropin-deficient women. Hum Reprod 1994; 9 (7): 1237-42
59. Steelman SL, Pohley FM. Assay of the follicle stimulating hormone based on the augmentation with human chorionic gonadotropin. Endocrinology 1953; 53 (6): 604-16
60. Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem 1981; 50: 465-95
61. Jia XC, Hseuh AJW. Granulosa cell aromatase bioassay for follicle stimulating hormone: validation and application of the method. Endocrinology 1986; 119 (4): 1570-7
62. Keene JL, Matzuk MM, Otani T, et al. Expression of biologically active human follitropin in Chinese hamster ovary cells. J Biol Chem 1989; 264 (12): 2769-75
63. Low SC, Nunes SL, Bitonti AJ, et al. Oral and pulmonary delivery of FSH-Fc fusion proteins via neonatal Fc receptor-mediated transcytosis. Hum Reprod 2005 Apr; 20 (7): 1805-13
64. de Leeuw R, Mulders J, Voortman G, et al. Structure-function relationship of recombinant follicle stimulating hormone (Puregon). Mol Hum Reprod 1996; 2 (5): 361-9
65. le Cotonnec J-Y, Porchet HC, Beltrami V, et al. Clinical pharmacology of recombinant human follicle-stimulating hormone: II. Single doses and steady state pharmacokinetics. Fertil Steril 1994; 61 (4): 679-86
66. Porchet HC, le Cotonnec J-Y, Canali S, et al. Pharmacokinetics of recombinant human follicle stimulating hormone after intravenous, intramuscular and subcutaneous administration in monkeys, and comparison with intravenous administration of urinary follicle stimulating hormone. Drug Metab Dispos 1993; 21 (1): 144-50
67. Weinbauer GF, Simoni M, Hutchison JS, et al. Pharmacokinetics and pharmacodynamics of recombinant and urinary FSH in the male monkey (Macaca fasicularis). J Endocrinol 1994; 141 (1): 113-21