Strohl WR. Fusion proteins for half-life extension of biologics as a strategy to make biobetters. BioDrugs. 2015;29(4):215–39.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Vaishya R, Khurana V, Patel S, Mitra AK. Long-term delivery of protein therapeutics. Expert Opin Drug Deliv. 2015;12(3):415–40.

Article  CAS  PubMed  Google Scholar 

Kontermann RE. Strategies for extended serum half-life of protein therapeutics. Curr Opin Biotechnol. 2011;22(6):868–76.

Article  CAS  PubMed  Google Scholar 

Duivelshof BL, Murisier A, Camperi J, Fekete S, Beck A, Guillarme D, D’Atri V. Therapeutic Fc-fusion proteins: current analytical strategies. J Sep Sci. 2021;44(1):35–62.

Article  CAS  PubMed  Google Scholar 

Wilkinson I, Hale G. Systematic analysis of the varied designs of 819 therapeutic antibodies and Fc fusion proteins assigned international nonproprietary names. mAbs. 2022;14(1):2123299.

Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol. 2007;7(9):715–25.

Article  CAS  PubMed  Google Scholar 

Spencer-Green G. Etanercept (Enbrel): update on therapeutic use. Ann Rheum Dis. 2000;59(90001):46i–49.

Article  Google Scholar 

Goffe B, Cather JC. Etanercept: an overview. J Am Acad Dermatol. 2003;49(2, Supplement):105–11.

Article  Google Scholar 

Zhou H. Clinical pharmacokinetics of etanercept: a fully humanized soluble recombinant tumor necrosis factor receptor fusion protein. J Clin Pharmacol. 2005;45(5):490–7.

Article  CAS  PubMed  Google Scholar 

Jafari R, Zolbanin NM, Rafatpanah H, Majidi J, Kazemi T. Fc-fusion proteins in therapy: an updated view. Curr Med Chem. 2017;24(12):1228–37.

Article  CAS  PubMed  Google Scholar 

Liu L. Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins. Protein Cell. 2018;9(1):15–32.

Article  CAS  PubMed  Google Scholar 

Siriwattananon K, Manopwisedjaroen S, Kanjanasirirat P, Budi Purwono P, Rattanapisit K, Shanmugaraj B, Smith DR, Borwornpinyo S, Thitithanyanont A, Phoolcharoen W. Development of plant-produced recombinant ACE2-Fc fusion protein as a potential therapeutic agent against SARS-CoV-2. Front Plant Sci. 2021;11:604663.

Article  PubMed  PubMed Central  Google Scholar 

Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jiménez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupančić-Šalek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022;6(11):3422–32.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Malec L, Van Damme A, Chan AKC, Spasova M, Jain N, Sensinger C, Dumont J, Lethagen S, Carcao M, Peyvandi F. Recombinant factor VIII Fc fusion protein for first-time immune tolerance induction: final results of the verITI-8 study. Blood. 2023;141(16):1982–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Guo M, Wang R, Geng J, Li Z, Liu M, Lu X, Wei J, Liu M. Human TFF2-Fc fusion protein alleviates DSS-induced ulcerative colitis in C57BL/6 mice by promoting intestinal epithelial cells repair and inhibiting macrophage inflammation. Inflammopharmacology. 2023;31(3):1387–404.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Heise T, Chien J, Beals JM, Benson C, Klein O, Moyers JS, Haupt A, Pratt EJ. Pharmacokinetic and pharmacodynamic properties of the novel basal insulin Fc (insulin efsitora alfa), an insulin fusion protein in development for once-weekly dosing for the treatment of patients with diabetes. Diabetes Obes Metab. 2023;25(4):1080–90.

Article  CAS  PubMed  Google Scholar 

Jin J, Cui G, Mi N, Wu W, Zhang X, Xiao C, Wang J, Qiu X, Han M, Li Z, Wang L, Lu T, Niu H, Wu Z, Li J. Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. Eur J Pharm Sci. 2023;185:106448.

Article  CAS  PubMed  Google Scholar 

Nilvebrant J, Hober S. The albumin-binding domain as a scaffold for protein engineering. Comput Struct Biotechnol J. 2013;6:e201303009.

Article  PubMed  PubMed Central  Google Scholar 

Fala L. Tanzeum (Albiglutide): a once-weekly GLP-1 receptor agonist subcutaneous injection approved for the treatment of patients with type 2 diabetes. Am Health Drug Benefits. 2015;8(Spec Feature):126–30.

PubMed  PubMed Central  Google Scholar 

Vilsbøll T, Agersø H, Krarup T, Holst JJ. Similar elimination rates of glucagon-like peptide-1 in obese type 2 diabetic patients and healthy subjects. J Clin Endocrinol Metab. 2003;88(1):220–4.

Article  PubMed  Google Scholar 

Tan H, Su W, Zhang W, Zhang J, Sattler M, Zou P. Albumin-binding domain extends half-life of glucagon-like peptide-1. Eur J Pharmacol. 2021;890:173650.

Article  CAS  PubMed  Google Scholar 

Xia J, Gao G, Zhang C, Ying J, Li J. Albumin-binding DARPins as scaffold improve the hypoglycemic and anti-obesity effects of exendin-4 in vivo. Eur J Pharm Sci. 2023;185:106422.

Article  CAS  PubMed  Google Scholar 

Xu D, Wu H, Zhou C. Fusion of parathyroid hormone (1–34) to an albumin-binding domain improves osteogenesis. J Drug Deliv Sci Technol. 2023;79:104019.

Article  CAS  Google Scholar 

Bern M, Nilsen J, Ferrarese M, Sand KMK, Gjølberg TT, Lode HE, Davidson RJ, Camire RM, Bækkevold ES, Foss S, Grevys A, Dalhus B, Wilson J, Høydahl LS, Christianson GJ, Roopenian DC, Schlothauer T, Michaelsen TE, Moe MC, Lombardi S, Pinotti M, Sandlie I, Branchini A, Andersen JT. An engineered human albumin enhances half-life and transmucosal delivery when fused to protein-based biologics. Sci Transl Med. 2020;12(565):eabb0580.

Article  CAS  PubMed  Google Scholar 

Tao H-Y, Wang R-Q, Sheng W-J, Zhen Y-S. The development of human serum albumin-based drugs and relevant fusion proteins for cancer therapy. Int J Biol Macromol. 2021;187:24–34.

Article  CAS  PubMed  Google Scholar 

Sockolosky JT, Kivimäe S, Szoka FC. Fusion of a short peptide that binds immunoglobulin G to a recombinant protein substantially increases its plasma half-life in mice. PLoS ONE. 2014;9(7):e102566.

Article  PubMed  PubMed Central  Google Scholar 

Amidzadeh Z, Rismani E, Shokrgozar MA, Rahimi H, Golkar M. In silico design of fusion keratinocyte growth factor containing collagen-binding domain for tissue engineering application. J Mol Graph Model. 2023;118:108351.

Article  CAS  PubMed  Google Scholar 

Plückthun A. Designed ankyrin repeat proteins (DARPins): binding proteins for research, diagnostics, and therapy. Ann Rev Pharmacol Toxicol. 2015;55(1):489–511.

Article  Google Scholar 

Arlotta KJ, Owen SC. Antibody and antibody derivatives as cancer therapeutics. WIREs Nanomedicine Nanobiotechnol. 2019;11(5):e1556.

Article  Google Scholar 

Labrijn AF, Janmaat ML, Reichert JM, Parren PWHI. Bispecific antibodies: a mechanistic review of the pipeline. Nat Rev Drug Disc. 2019;18(8):585–608.

Article  CAS  Google Scholar 

Ma J, Mo Y, Tang M, Shen J, Qi Y, Zhao W, Huang Y, Xu Y, Qian C. Bispecific antibodies: from research to clinical application. Front Immunol. 2021;12:626616.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007;45(2):27–37.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Vial T, Descotes J. Clinical toxicity of cytokines used as haemopoietic growth factors. Drug Saf. 1995;13(6):371–406.

Article  CAS  PubMed  Google Scholar 

Martomo SA, Lu D, Polonskaya Z, Luna X, Zhang Z, Feldstein S, Lumban-Tobing R, Almstead DK, Miyara F, Patel J. Single-dose anti-PD-L1/IL-15 fusion protein KD033 generates synergistic antitumor immunity with robust tumor-immune gene signatures and memory responses. Mol Cancer Ther. 2021;20(2):347–56.

Article  CAS  PubMed  Google Scholar 

Zhou Y, Quan G, Liu Y, Wang Z, Shi N, Wu Y, Liu Q, Gao X, Zhang R, Luo L. Anti-Claudin18.2-IL-21 fusion protein bifunctional molecule has more powerful anti-tumor effect and better safety. Int Immunopharmacol. 2023;115:109634.

Article  CAS  PubMed  Google Scholar 

Venetz D, Koovely D, Weder B, Neri D. Targeted reconstitution of cytokine activity upon antigen binding using split cytokine antibody fusion proteins. J Biol Chem. 2016;291(35):18139–47.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Quijano-Rubio A, Bhuiyan AM, Yang H, Leung I, Bello E, Ali LR, Zhangxu K, Perkins J, Chun J-H, Wang W, Lajoie MJ, Ravichandran R, Kuo Y-H, Dougan SK, Riddell SR, Spangler JB, Dougan M, Silva D-A, Baker D. A split, conditionally active mimetic of IL-2 reduces the toxicity of systemic cytokine therapy. Nat Biotechnol. 2023;41(4):532–40.

Article  CAS  PubMed