JP7366353B2 - 抗インドキシル硫酸の単離されたモノクローナル抗体及び/又はその抗原結合断片の組成物及びその用途 - Google Patents
抗インドキシル硫酸の単離されたモノクローナル抗体及び/又はその抗原結合断片の組成物及びその用途 Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
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- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5308—Immunoassay; Biospecific binding assay; Materials therefor for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6806—Determination of free amino acids
- G01N33/6812—Assays for specific amino acids
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/34—Genitourinary disorders
- G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
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Description
ISの特異的結合用の組成物
ISの検出や定量及び臨床診断用の免疫測定法
IS除去用のデバイス組成物
被験者におけるISの除去又は低減用の薬物組成物
単離された抗IS mAbの可変領域のポリヌクレオチド及びポリペプチド配列
5/6腎摘除(5/6 Nx)ラットの慢性腎不全疾患(CKD)のモデル及び治療
実施例
実施例1:抗原性IS複合体の調製
実施例2:ハイブリドーマ技術による抗IS mAbの生成
実施例3:競合的ELISAによるmAb特異性のテスト
実施例4:抗ISのmAbの2つ単一クローンの特徴付け
実施例5:生物試料におけるISの検出
1.Meyer, T. W., and T. H. Hostetter.2007.Uremia.N. Engl.J. Med.357:1316-1325.
2.Vanholder, R., R. De Smet, and N. Lameire.2001.Protein-bound uremic solutes: the forgotten toxins.Kidney Int.Suppl.78:S266-270.
3.Lee, C.-T., C.-C. Kuo, Y.-M. Chen, C.-Y. Hsu, W.-C. Lee, Y.-C. Tsai, H.-Y. Ng, L.-C. Kuo, T. T.-Y. Chiou, Y.-K. Yang, B.-C. Cheng, and J.-B. Chen.2010.Factors associated with blood concentrations of indoxyl sulfate and p-cresol in patients undergoing peritoneal dialysis.Perit.Dial.Int.J. Int.Soc.Perit.Dial.30:456-463.
4.Wu, I.-W., K.-H. Hsu, C.-C. Lee, C.-Y. Sun, H.-J. Hsu, C.-J. Tsai, C.-Y. Tzen, Y.-C. Wang, C.-Y. Lin, and M.-S. Wu.2011. p-Cresyl sulphate and indoxyl sulphate predict progression of chronic kidney disease.Nephrol.Dial.Transpl.Assoc.-Eur.Ren.Assoc.26:938-947.
5.Schulman, G., T. Berl, G. J. Beck, G. Remuzzi, E. Ritz, K. Arita, A. Kato, and M. Shimizu.2015.Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD.J. Am.Soc.Nephrol.JASN 26:1732-1746.
6.Yamaguchi, J., T. Tanaka, and R. Inagi.2017.Effect of AST-120 in Chronic Kidney Disease Treatment:Still a Controversy Nephron 135:201-206.
7.Lin, C.-N., I.-W. Wu, Y.-F. Huang, S.-Y. Peng, Y.-C. Huang, and H.-C. Ning.2018.Measuring serum total and free indoxyl sulfate and p-cresyl sulfate in chronic kidney disease using UPLC-MS/MS.J. Food Drug Anal.
8.Al Za’abi, M., B. Ali, and M. Al Toubi.2013.HPLC-fluorescence method for measurement of the uremic toxin indoxyl sulfate in plasma.J. Chromatogr.Sci.51:40-43.
9.Hoshi, H., K. Kikuchi, Y. Itoh, and A. Konagai.2015.Indoxyl sulfate measurement method.US20150355171A1.
10.Taki, K., S. Nakamura, M. Miglinas, A. Enomoto, and T. Niwa.2006.Accumulation of indoxyl sulfate in OAT1/3-positive tubular cells in kidneys of patients with chronic renal failure.J. Ren.Nutr.Off.J. Counc.Ren.Nutr.Natl.Kidney Found.16:199-203.
11.Ito, S., M. Osaka, T. Edamatsu, Y. Itoh, and M. Yoshida.2016.Crucial Role of the Aryl Hydrocarbon Receptor (AhR) in Indoxyl Sulfate-Induced Vascular Inflammation.J. Atheroscler.Thromb.23:960-975.
12.Essono, S., Y. Frobert, J. Grassi, C. Creminon, and D. Boquet.2003.A general method allowing the design of oligonucleotide primers to amplify the variable regions from immunoglobulin cDNA.J. Immunol.Methods 279:251-266.
13.McCafferty, J., A. D. Griffiths, G. Winter, and D. J. Chiswell.1990.Phage antibodies: filamentous phage displaying antibody variable domains.Nature 348:552-554.
14.Dai, C., L. P. Kiss, and Y. Liu.2008.Animal Models of Kidney Diseases.In Sourcebook of Models for Biomedical Research P. M. Conn, ed. Humana Press, Totowa, NJ.657-664.
15.Yang, H.-C., Y. Zuo, and A. B. Fogo.2010.Models of chronic kidney disease.Drug Discov.Today Dis.Models 7:13-19.
Nangaku, M. 2004.Mechanisms of tubulointerstitial injury in the kidney: final common pathways to end-stage renal failure.Intern.Med.Tokyo Jpn.43:9-17.
17.Miwa, A., M. Yoshioka, A. Shirahata, and Z. Tamura.1977.Preparation of specific antibodies to catecholamines and L-3,4-dihydroxyphenylalanine.I. Preparation of the conjugates.Chem.Pharm.Bull.(Tokyo) 25:1904-1910.
18.Watanabe, H., T. Noguchi, Y. Miyamoto, D. Kadowaki, S. Kotani, M. Nakajima, S. Miyamura, Y. Ishima, M. Otagiri, and T. Maruyama.2012.Interaction between two sulfate-conjugated uremic toxins, p-cresyl sulfate and indoxyl sulfate, during binding with human serum albumin.Drug Metab.Dispos.Biol.Fate Chem.40:1423-1428.
Claims (14)
- 相補性決定領域(CDR)‐H1、CDR‐H2及びCDR‐H3を含む重鎖可変(VH)ドメインと、
可変領域CDR‐L1、CDR‐L2及びCDR‐L3を含む軽鎖可変(VL)ドメインと、
を備え、
ある単離されたモノクローナル抗体又はその抗原結合断片のCDRは以下のアミノ酸配列を有し、
SEQ ID NO:1のCDR‐H1、
SEQ ID NO:2のCDR‐H2、
SEQ ID NO:3のCDR‐H3、
SEQ ID NO:6のCDR‐L1、
SEQ ID NO:7のCDR‐L2、及び
SEQ ID NO:8のCDR‐L3、又は、
別の単離されたモノクローナル抗体又はその抗原結合断片のCDRは以下アミノ酸配列を有する、
SEQ ID NO:11のCDR‐H1、
SEQ ID NO:12のCDR‐H2、
SEQ ID NO:13のCDR‐H3、
SEQ ID NO:16のCDR‐L1、
SEQ ID NO:17のCDR‐L2、及び
SEQ ID NO:18のCDR‐L3、
抗インドキシル硫酸の単離されたモノクローナル抗体又はその抗原結合断片。 - 前記単離された抗体又はその抗原結合断片は、全長免疫グロブリン分子、単鎖可変断片(scFv)、可変断片(Fv)、Fab断片、Fab'断片、多特異的結合分子、又は単離された、キメラ、ヒト化、合成、組換え抗体又はその抗原結合断片の組み合わせである請求項1に記載の抗インドキシル硫酸の単離されたモノクローナル抗体又はその抗原結合断片。
- 体外表面表示システムから、前記単離されたモノクローナル抗体又はその抗原結合断片を選別する請求項1~2の何れか1項に記載の抗インドキシル硫酸の単離されたモノクローナル抗体又はその抗原結合断片。
- 前記単離された抗体又はその抗原結合断片は、化学的に修飾され又は薬学的に許容可能な担体と混合される請求項1~3の何れか1項に記載の抗インドキシル硫酸の単離されたモノクローナル抗体又はその抗原結合断片。
- 請求項1~4の何れか1項に記載の単離されたモノクローナル抗体又はその抗原結合断片を用いて、被験者から収集した未処理の生物試料におけるインドキシル硫酸を検出し又はその濃度を確定するインドキシル硫酸の検出用の免疫測定法。
- 前記生物試料は、血液、血清、血漿、腹水、尿及び生検標本を含む請求項5に記載の免疫測定法。
- 前記生物試料は、アルブミンを含む請求項5に記載の免疫測定法。
- 請求項1~4の何れか1項に記載の単離されたモノクローナル抗体又はその抗原結合断片を含み、必要とする患者のインドキシル硫酸を除去するための体外で生体液を浄化するためのシステムに使用されるための組成物。
- 前記単離されたモノクローナル抗体又はその抗原結合断片は、固相に共役される請求項8に記載の組成物。
- 請求項1~4の何れか1項に記載の単離されたモノクローナル抗体又はその抗原結合断片を含む患者におけるインドキシル硫酸の除去又は低減用の薬物組成物。
- 単離されたモノクローナル抗体又はその抗原結合断片に組み合わせられた医療用吸着剤を更に含む請求項10に記載の前記患者におけるインドキシル硫酸の除去又は低減用の薬物組成物。
- 前記医療用吸着剤は、活性炭吸着剤を含む請求項11に記載の前記患者におけるインドキシル硫酸の除去又は低減用の薬物組成物。
- 抗インドキシル硫酸の単離されたモノクローナル抗体又は抗原結合断片をコード化する単離されたポリヌクレオチド断片であって、
ある単離されたモノクローナル抗体又は抗原結合断片は、
SEQ ID NO:4に示すVHドメイン、
SEQ ID NO:9に示すVLドメインのポリペプチド配列を含み、
又は、
別の単離されたモノクローナル抗体又は抗原結合断片は、
SEQ ID NO:14に示すVHドメイン、及び
SEQ ID NO:19に示すVLドメインのポリペプチド配列を含む、単離されたポリヌクレオチド断片。 - 抗インドキシル硫酸の単離されたモノクローナル抗体又は抗原結合断片をコード化する単離されたポリヌクレオチド断片であって、
ある単離されたモノクローナル抗体又は抗原結合断片は、
SEQ ID NO:1のCDR‐H1、
SEQ ID NO:2のCDR‐H2、
SEQ ID NO:3のCDR‐H3、
SEQ ID NO:6のCDR‐L1、
SEQ ID NO:7のCDR‐L2、及び
SEQ ID NO:8のCDR‐L3、の配列を含み、又は、
別の単離されたモノクローナル抗体又はその抗原結合断片は、
のCDRのアミノ酸配列は、
SEQ ID NO:11のCDR‐H1、
SEQ ID NO:12のCDR‐H2、
SEQ ID NO:13のCDR‐H3、
SEQ ID NO:16のCDR‐L1、
SEQ ID NO:17のCDR‐L2、及び
SEQ ID NO:18のCDR‐L3、の配列を含む、
単離されたポリヌクレオチド断片。
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