Albumin-Binding Fusion Proteins in the Development of Novel Long-Acting Therapeutics

Fusion Protein Technologies for Biopharmaceuticals: Applications and Challenges

Volumn , Issue , 2013, Pages 179-190

  Walker, Adam ^a   Dunlevy, Gráinne ^a   Topley, Peter ^b  

^a Domantis   (United Kingdom)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Albumin binding FPs; Half life extension; Hydrophilic polymers; Nanobodies; Novel long acting

Indexed keywords

EID: 84886195275     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118354599.ch11     Document Type: Chapter

References (42)

1. Fee CJ, Van Altine JM. (2006) PEG-proteins: reaction engineering and separation issues. Chem. Eng. Sci. 61, 924-939.
2. Glue P, Fang JWS, Rouzier-Panis R, Raffanel C, Sabo R, Gupta SK, et al. and the Hepatitis C Intervention Therapy Group. (2000) Pegylated interferon-a2b: pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data. Clin. Pharmacol. Ther. 68, 556-567.
3. Wang Y, Youngster S, Grace M, Bausch J, Bordens R, Wyss DF. (2002) Structural and biological characterization of pegylated recombinant interferon alpha-2b and its therapeutic implications. Adv. Drug Deliv. Rev. 54, 547-570.
4. Morishita M, Leonard RC. (2008) Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. Expert Opin. Biol. Ther. 8, 993-1001.
5. Rytting M. (2010) Peg-asparaginase for acute lymphoblastic leukemia. Expert Opin. Biol. Ther. 10, 833-839.
6. Doherty DH, Rosendahl MS, Smith DJ, Hughes JM, Chlipala EA, Cox GN. (2005) Site-specific PEGylation of engineered cysteine analogs of recombinant human granulocyte-macrophage colony-stimulating factor. Bioconjug. Chem. 16, 1291-1298.
7. Peters T. (1977) Serum albumin: recent progress in the understanding of its structure and biosynthesis. Clin. Chem. 23, 5-12.
8. Chaudhury C, Brooks CL, Carter DC, Robinson JM, Anderson CL. (2006) Albumin binding to FcRn: Distinct from the FcRn-IgG interaction. Biochemistry 45, 4983-4990.
9. Syed S, Schuyler PD, Kulczycky M, Sheffield WP. (1997) Potent antithrombin activity and delayed clearance from the circulation characterize recombinant hirudin genetically fused to albumin. Blood 89, 3243-3252.
10. Yeh P, Landais D, Lemaitre, M, Maury, I, Crenne, J, Becquart, J, et al. Design of yeast-secreted albumin derivatives for human therapy: biological and antiviral properties of a serum albumin-CD4 genetic conjugate. Proc. Natl. Acad. Sci. USA 89, 1904-1908.
11. Matthews JE, Stewart MW, De Boever EH, Dobbins RL, Hodge RJ, Walker SE, et al. and for the Albiglutide Study Group. (2008) Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in patients with type 2 diabetes. J. Clin. Endocrinol. Metab. 93, 4810-4817.
12. Osborn BL, Olsen HS, Nardelli B, Murray JH, Zhou JXH, Garcia A, et al. (2002) Pharmacokinetic and pharmacodynamic studies of a human serum albumin-interferon-a fusion protein in cynomolgus monkeys. J. Pharmacol. Exp. Ther. 303, 540-548.
13. Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval DG, et al. (2008) Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology 48, 407-417.
14. Zhao HL, Xue C, Wang Y, Li XY, Xiong XH, Yao XQ, et al. (2007) Circumventing the heterogeneity and instability of human serum albumin-interferon-a2b fusion protein by altering its orientation. J. Biotechnol. 131, 245-252.
15. Ward ES, Güssow D, Griffiths AD, Jones PT,Winter G. (1989) Binding activities of a repertoire of single immunoglobulin variable domains secreted from Escherichia coli. Nature 341, 544-546.
16. Jespers L, Schon O, Famm K, Winter G. (2004) Aggregationresistant domain antibodies selected on phage by heat denaturation. Nat. Biotechnol. 22, 1161-1165.
17. Jespers L, Schon O, James LC, Veprinstev D,Winter G. Crystal Structure of HEL4, a soluble, refoldable human VH single domain with a germ-line scaffold. J. Mol. Biol. 337, 893-903.
18. Ewert S, Cambillau C, Conrath K, Plückthun A. (2002) Biophysical properties of camelid VHH domains compared to those of human VH3 domains. Biochemistry 41, 3628-3636.
19. Holt LJ, Basran A, Jones K, Chorlton J, Jespers L, Brewis ND, et al. (2008) Anti-serum albumin domain antibodies for extending the half-lives of short lived drugs. Protein Eng. Des. Sel. 21, 283-288.
20. Walker A, Dunlevy G, Rycroft D, Topley P, Holt LJ, Herbert T, et al. (2010) Anti-serum albumin domain antibodies in the development of highly potent, efficacious and long-acting interferon. Protein Eng. Des. Sel. 23, 271-278.
21. Durocher Y, Perret S, Kamen A. (2002) High-level and highthroughput recombinant protein production by transient transfection of suspension-growing human 293-EBNA1 cells. Nucleic Acids Res. 2, E9.
22. Loignon M, Perret S, Kelly J, Boulais D, Cass B, Bisson L, et al. (2008) Stable high volumetric production of glycosylated human recombinant IFNalpha2b in HEK293 cells. BMC Biotechnol. 8, 1-16.
23. Nilson BHK, Solomon A, Björck L, Åkerström B. (1992) Protein L from Peptostreptococcus magnus binds to the κ light chain variable domain. J. Biol. Chem. 267, 2234-2239.
24. Jankowski WJ, Von Muenchhausen W, Sulkowski E, Carter WA. (1976) Binding of human interferons to immobilised Cibacron blue F3GA: the nature of molecular interaction. Biochemistry 15, 5182-5187.
25. Kassab A, Yavuz H, Odabasi M, Denizli A. (2000) Human serum albumin chromatography by Cibacron Blue F3GA derived microporous polyamide hollow-fiber affinity membranes. J. Chromatogr. B 746, 123-132.
26. nullmouse: an excellent recipient mouse model for engraftment of human cells. Blood 100, 3175-3182.
27. Krepler C, Certa U,Wachek V, Jansen B,Wolf K, Pehamberger H. (2004) Pegylated and conventional interferon-a induce comparable transcriptional responses and inhibition of tumor growth in a human melanoma SCID mouse xenotransplantation model. J. Invest. Dermatol. 123, 664-669.
28. Hamers-Casterman C, Atarhouch T, Muyldermans S, Robinson G, Hamers C, Bajyana Songa E, et al. (1993) Naturally occurring antibodies devoid of light chains. Nature 363, 446-448.
29. Muyldermans S, Baral TN, Cortez Retamozzo V, De Baetselier P, De Genst E, Kinne J, et al. (2009) Camelid immunoglobulins and nanobody technology. Vet. Immunol. Immunopathol. 128, 178-183.
30. Muyldermans S, Lauwereys M. (1999) Unique single-domain antigen binding fragments derived from naturally occurring camel heavy-chain antibodies. J. Mol. Recognit. 12, 131-140.
31. Muyldermans S, Cambillau C, Wyns L. (2001) Recognition of antigens by single-domain antibody fragments: The superfluous luxury of paired domains. Trends Biochem. Sci. 26, 230-235.
32. De Genst E, Silence K, Decanniere K, Conrath K, Loris R, Kinne J, et al. (2006) Molecular basis for the preferential cleft recognition by dromedary heavy-chain antibodies. Proc. Natl. Acad. Sci. USA 103, 4586-4591.
33. Nguyen VK, Desmyter A, Muyldermans S. (2001) Functional heavy-chain antibodies in camelidae. Adv. Immunol. 79, 261-296.
34. Tijink BM, Laeremans T, Budde M, Stigter-van Walsum M, Dreier T, De Haard HJ, et al. (2008) Improved tumor targeting of anti-epidermal growth factor receptor Nanobodies through albumin binding: taking advantage of modular Nanobody technology. Mol. Cancer Ther. 7, 2288-2297.
35. Dennis MS, Zhang M, Meng G, Kadkhodayan M, Kirchhofer D, Combs D, et al. (2002) Albumin binding as a general strategy for improving the pharmacokinetics of proteins. J. Biol. Chem. 277, 35035-35043.
36. Dennis MS, Jin H, Dugger D, Yang R, McFarland L, Ogasawara A, et al. (2007) Imaging tumors with an albumin-binding Fab, a novel tumor-targeting agent. Cancer Res. 67, 255-261.
37. Nguyen A, Reyes AE, Zhang M, McDonald P, Wong WL, Damico LA, et al. (2006) The pharmacokinetics of an albuminbinding Fab (AB.Fab) can be modulated as a function of affinity for albumin. Protein Eng. Des. Sel. 19, 291-297.
38. Dumelin CE, Trüssel S, Buller F, Trachsel E, Bootz F, Zhang Y, et al. (2008) A portable albumin binder from a DNA-encoded chemical library. Angew. Chem. Int. Ed. 47, 3196-3201.
39. Trüssel S, Dumelin C, Frey K, Villa A, Buller F, Neri D. (2009) New strategy for the extension of the serum half-life of antibody fragments. Bioconjug. Chem. 20, 2286-2292.
40. Constantinou A, Epenetos AA, Hrezcuk-Hirst D, Jain S, Deonarain MP. (2008) Modulation of antibody pharmacokinetics by chemical polysialylation. Bioconjug. Chem. 19, 643-650.
41. Constantinou A, Chen C, Deonarain MP. (2010) Modulating the pharmacokinetics of therapeutic antibodies. Biotechnol. Lett. 32, 609-622.
42. Schellenberger V, Wang C, Geething NC, Spink BJ, Campbell A, To W, et al. (2009) A recombinant polypeptide extends the in vivo half-life of peptides and proteins in a tunable manner. Nat. Biotechnol. 27, 1186-1192.