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| Research Progress in Preparation and Clinical Application of Therapeutic Human Antibodies |
CHEN Xiu-xiu1,2,WU Cheng-lin2,ZHOU Li-jun1,2,**( ) |
1 Department of Naval Clinical Medicine, Anhui Medical University, Beijing 100048, China
2 Central Laboratory of the Sixth Medical Center, General Hospital of the Chinese People’s Liberation Army, Beijing 100048, China; |
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Abstract As important therapeutic drugs, human antibodies have been widely applied in clinical therapy in recent years. At present, the range of clinical application has gradually expanded from tumors, autoimmune diseases and chronic inflammation to cardiovascular diseases and infection, Compared with conventional therapy, the advantages of antibody therapy are specificity and high efficiency, which provides a new choice for the treatment of diseases. The entire structure of the human antibody is encoded by the human antibody gene, the human antibody gradually becomes the first choice for the development of therapeutic antibodies for avoiding the adverse reactions caused by the long-term application of the heterologous protein. The main preparation techniques and clinical application progress of therapeutic human antibodies are reviewed. At the same time, the disadvantages of human antibody preparation technology are also discussed to provide references and ideas for the development of human antibodies.
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Received: 30 January 2019
Published: 12 November 2019
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Corresponding Authors:
Li-jun ZHOU
E-mail: hzzhoulj@126.com
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| [1] |
Frenzel A, Schirrmann T, Hust M . Phage display-derived human antibodies in clinical development and therapy. MAbs, 2016,8(7):1177-1194.
|
|
|
| [2] |
Carter P J, Lazar G A . Next generation antibody drugs:pursuit of the ‘high-hanging fruit’. Nat Rev Drug Discov, 2018,17(3):197-223.
|
|
|
| [3] |
Smith G P . Filamentous fusion phage:novel expression vectors that display cloned antigens on the virion surface. Science, 1985,228(4705):1315-1317.
|
|
|
| [4] |
McCafferty J, Griffiths A D, Winter G , et al. Phage antibodies:filamentous phage displaying antibody variable domains. Nature, 1990,348(6301):552-554.
|
|
|
| [5] |
de Haard H J, van Neer N, Reurs A , et al. A large non-immunized human Fab fragment phage library that permits rapid isolation and kinetic analysis of high affinity antibodies. J Biol Chem, 1999,274(26):18218-18230.
|
|
|
| [6] |
Brezski R J, Georgiou G . Immunoglobulin isotype knowledge and application to Fc engineering. Curr Opin Immunol, 2016,40:62-69.
|
|
|
| [7] |
Rahbarnia L, Farajnia S, Babaei H , et al. Evolution of phage display technology: from discovery to application. J Drug Target, 2017,25(3):216-224.
|
|
|
| [8] |
Lampreht T U, Horvat S , Cemazar M. transgenic mouse models in cancer research. Front Oncol, 2018,8:268.
|
|
|
| [9] |
Bruggemann M, Caskey H M, Teale C , et al. A repertoire of monoclonal antibodies with human heavy chains from transgenic mice. Proc Natl Acad Sci USA, 1989,86(17):6709-6713.
|
|
|
| [10] |
Lonberg N, Taylor L D, Harding F A , et al. Antigen-specific human antibodies from mice comprising four distinct genetic modifications. Nature, 1994,368(6474):856-859.
|
|
|
| [11] |
Green L L, Hardy M C , Maynard-Currie C E , et al.Antigen-specific human monoclonal antibodies from mice engineered with human Ig heavy and light chain YACs. Nat Genet, 1994,7(1):13-21.
|
|
|
| [12] |
Jakobovits A, Amado R G, Yang X , et al. From xenomouse technology to panitumumab, the first fully human antibody product from transgenic mice. Nat Biotechnol, 2007,25(10):1134-1143.
|
|
|
| [13] |
Poole R M, Vaidya A . Ramucirumab:first global approval. Drugs, 2014,74(9):1047-1058.
doi: 10.1007/s40265-014-0244-2
|
|
|
| [14] |
Shirley M . Olaratumab:first global approval. Drugs, 2017,77(1):107-112.
|
|
|
| [15] |
Cemiplimab Approved for treatment of CSCC. Cancer Discov, 2018,8(12):F2.
|
|
|
| [16] |
Busse P J, Farkas H, Banerji A , et al. Lanadelumab for the prophylactic treatment of hereditary angioedema with C1 inhibitor deficiency:a review of preclinical and phase i studies. Bio Drugs, 2019,33(1):33-43.
|
|
|
| [17] |
Lounder D T ,Bin Q,de Min C,, et al.Treatment of refractory hemophagocytic lymphohistiocytosis with emapalumab despite severe concurrent infections. Blood Adv, 2019,3(1):47-50.
|
|
|
| [18] |
Citri A, Yarden Y . EGF-ERBB signalling:towards the systems level. Nat Rev Mol Cell Biol, 2006,7(7):505-516.
|
|
|
| [19] |
Chua Y J, Cunningham D . Panitumumab. Drugs Today (Barc), 2006,42(11):711-719.
|
|
|
| [20] |
Chen Q, Cheng M, Wang Z , et al. The efficacy and safety of panitumumab plus irrinotecan-based chemotherapy in the treatment of metastatic colorectal cancer: a meta-analysis. Medicine (Baltimore), 2016,95(50):e5284.
|
|
|
| [21] |
AlDallal S M . Ofatumumab—a valid treatment option for chronic lymphocytic leukemia patients. Ther Clin Risk Manag, 2017,13:905-907.
|
|
|
| [22] |
Barth M J, Mavis C, Czuczman M S , et al. Ofatumumab exhibits enhanced in vitro and in vivo activity compared to rituximab in preclinical models of mantle cell lymphoma. Clin Cancer Res, 2015,21(19):4391-4397.
|
|
|
| [23] |
Palumbo A, Chanan-Khan A, Weisel K , et al. Daratumumab,bortezomib,and dexamethasone for multiple myeloma. N Engl J Med, 2016,375(8):754-766.
|
|
|
| [24] |
Specenier P . Ipilimumab in melanoma. Expert Rev Anticancer Ther, 2016,16(8):811-826.
|
|
|
| [25] |
Tsai K K, Zarzoso I, Daud A I . PD-1 and PD-L1 antibodies for melanoma. Hum Vaccin Immunother, 2014,10(11):3111-3116.
|
|
|
| [26] |
Sharma P, Allison J P . The future of immune checkpoint therapy. Science, 2015,348(6230):56-61.
|
|
|
| [27] |
Larkin J, Chiarion-Sileni V, Gonzalez R , et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med, 2015,373(1):23-34.
|
|
|
| [28] |
Flamant M, Paul S, Roblin X . Golimumab for the treatment of ulcerative colitis. Expert Opin Biol Ther, 2017,17(7):879-886.
|
|
|
| [29] |
Reich K, Armstrong A W, Foley P , et al. Efficacy and safety of guselkumab,an anti-interleukin-23 monoclonal antibody,compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment:Results from the phase III,double-blind,placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol, 2017,76(3):418-431.
|
|
|
| [30] |
Alten R, Gram H, Joosten L A , et al. The human anti-IL-1 beta monoclonal antibody ACZ885 is effective in joint inflammation models in mice and in a proof-of-concept study in patients with rheumatoid arthritis. Arthritis Res Ther, 2008,10(3):R67.
|
|
|
| [31] |
Gram H . Preclinical characterization and clinical development of ILARIS(R) (canakinumab) for the treatment of autoinflammatory diseases. Curr Opin Chem Biol, 2016,32:1-9.
|
|
|
| [32] |
Thompson P L, Nidorf S M . Anti-inflammatory therapy with canakinumab for atherosclerotic disease:lessons from the CANTOS trial. J Thorac Dis, 2018,10(2):695-698.
|
|
|
| [33] |
Rondeau J M, Ramage P, Zurini M , et al. The molecular mode of action and species specificity of canakinumab,a human monoclonal antibody neutralizing IL-1beta. MAbs, 2015,7(6):1151-1160.
|
|
|
| [34] |
Krause K, Tsianakas A, Wagner N , et al. Efficacy and safety of canakinumab in schnitzler syndrome:a multicenter randomized placebo-controlled study. J Allergy Clin Immunol, 2017,139(4):1311-1320.
|
|
|
| [35] |
Jokinen E . Obesity and cardiovascular disease. Minerva Pediatr, 2015,67(1):25-32.
|
|
|
| [36] |
Atanda A, Shapiro N L, Stubbings J , et al. Implementation of a new clinic-based, pharmacist-managed PCSK9 inhibitor consultation service. J Manag Care Spec Pharm, 2017,23(9):918-925.
|
|
|
| [37] |
Horton J D, Cohen J C, Hobbs H H.PCSK9:a convertase that coordinates LDL catabolism. J Lipid Res, 2009,50 Suppl: S172-S177.
|
|
|
| [38] |
Seidah N G, Awan Z, Chretien M , et al. PCSK9:a key modulator of cardiovascular health. Circ Res, 2014,114(6):1022-1036.
doi: 10.1161/CIRCRESAHA.114.301621
|
|
|
| [39] |
Cannon C P, Cariou B, Blom D , et al. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins:the ODYSSEY COMBO II randomized controlled trial. Eur Heart J, 2015,36(19):1186-1194.
|
|
|
| [40] |
Robinson J G, Farnier M, Krempf M , et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med, 2015,372(16):1489-1499.
|
|
|
| [41] |
Ascenzi P, Visca P, Ippolito G , et al. Anthrax toxin:a tripartite lethal combination. FEBS Lett, 2002,531(3):384-388.
|
|
|
| [42] |
Mazumdar S . Raxibacumab. MAbs, 2009,1(6):531-538.
|
|
|
| [43] |
Migone T S, Subramanian G M, Zhong J , et al. Raxibacumab for the treatment of inhalational anthrax. N Engl J Med, 2009,361(2):135-144.
|
|
|
| [44] |
Kufel W D, Devanathan A S, Marx A H , et al. Bezlotoxumab:a novel agent for the prevention of recurrent clostridium difficile infection. Pharmacotherapy, 2017,37(10):1298-1308.
|
|
|
| [45] |
Wilcox M H, Gerding D N, Poxton I R , et al. Bezlotoxumab for prevention of recurrent clostridium difficile infection. N Engl J Med, 2017,376(4):305-317.
|
|
|
| [46] |
Markham A . Erenumab:first global approval. Drugs, 2018,78(11):1157-1161.
|
|
|
| [47] |
Karsan N, Goadsby P J . Calcitonin gene-related peptide and migraine. Curr Opin Neurol, 2015,28(3):250-254.
|
|
|
| [48] |
Eftekhari S, Salvatore C A, Johansson S , et al. Localization of CGRP,CGRP receptor, PACAP and glutamate in trigeminal ganglion.relation to the blood-brain barrier. Brain Res, 2015,1600:93-109.
|
|
|
| [49] |
Schou W S, Ashina S, Amin F M , et al. Calcitonin gene-related peptide and pain:a systematic review. J Headache Pain, 2017,18(1):34.
|
|
|
| [50] |
Tepper S, Ashina M, Reuter U , et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised,double-blind,placebo-controlled phase 2 trial. Lancet Neurol, 2017,16(6):425-434.
|
|
|
| [51] |
Jain S, Yuan H, Spare N , et al. Erenumab in the treatment of migraine. Pain Manag, 2018,8(6):415-426.
|
|
|
| [52] |
Lamb Y N . Burosumab:first global approval. Drugs, 2018,78(6):707-714.
|
|
|
| [53] |
Zhang X, Imel E A, Ruppe M D , et al. Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia. J Clin Pharmacol, 2016,56(2):176-185.
|
|
|
| [54] |
Lamb Y N . Burosumab:first global approval. Drugs, 2018,78(6):707-714.
|
|
|
| [55] |
Carpenter T O, Whyte M P, Imel E A , et al. Burosumab therapy in children with X-Linked hypophosphatemia. N Engl J Med, 2018,378(21):1987-1998.
|
|
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