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WO2009041613A1 - 抗体定常領域改変体 - Google Patents

抗体定常領域改変体 Download PDF

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Publication number
WO2009041613A1
WO2009041613A1 PCT/JP2008/067483 JP2008067483W WO2009041613A1 WO 2009041613 A1 WO2009041613 A1 WO 2009041613A1 JP 2008067483 W JP2008067483 W JP 2008067483W WO 2009041613 A1 WO2009041613 A1 WO 2009041613A1
Authority
WO
WIPO (PCT)
Prior art keywords
constant region
antibody constant
succeeded
stability
finding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2008/067483
Other languages
English (en)
French (fr)
Inventor
Tomoyuki Igawa
Hirotake Shiraiwa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chugai Pharmaceutical Co Ltd
Original Assignee
Chugai Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40511493&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009041613(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to HK11100811.4A priority Critical patent/HK1146728B/xx
Priority to PL15200628T priority patent/PL3059246T3/pl
Priority to KR1020167032250A priority patent/KR101922788B1/ko
Priority to KR1020207015247A priority patent/KR102225009B1/ko
Priority to EP15200628.4A priority patent/EP3059246B1/en
Priority to AU2008304748A priority patent/AU2008304748C1/en
Priority to KR1020217040531A priority patent/KR102467302B1/ko
Priority to EP08834649.9A priority patent/EP2194066B1/en
Priority to CA2700394A priority patent/CA2700394C/en
Priority to CN2008801185811A priority patent/CN101874041B/zh
Priority to MX2010003450A priority patent/MX2010003450A/es
Priority to RU2010116278/10A priority patent/RU2526512C2/ru
Priority to EP18181757.8A priority patent/EP3415529B1/en
Priority to KR1020107008918A priority patent/KR101680906B1/ko
Priority to KR1020217006046A priority patent/KR102339457B1/ko
Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Priority to ES08834649.9T priority patent/ES2566957T3/es
Priority to MX2013009569A priority patent/MX342551B/es
Priority to PH1/2018/501459A priority patent/PH12018501459B1/en
Priority to EP20198500.9A priority patent/EP3789400A1/en
Priority to BRPI0817273-0A priority patent/BRPI0817273B1/pt
Priority to KR1020187033614A priority patent/KR102119108B1/ko
Priority to US12/680,082 priority patent/US9688762B2/en
Priority to DK08834649.9T priority patent/DK2194066T3/en
Priority to PH1/2021/552811A priority patent/PH12021552811A1/en
Priority to JP2009534420A priority patent/JP5484060B2/ja
Publication of WO2009041613A1 publication Critical patent/WO2009041613A1/ja
Priority to IL204537A priority patent/IL204537A0/en
Anticipated expiration legal-status Critical
Priority to ZA2010/02422A priority patent/ZA201002422B/en
Priority to PH12014502106A priority patent/PH12014502106B1/en
Priority to US15/614,842 priority patent/US11332533B2/en
Priority to US17/720,937 priority patent/US20220251225A1/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

　本発明者らは、抗体の定常領域において、酸性条件下での安定性、ヒンジ領域のジスルフィドに由来するヘテロジェニティー、H鎖C末端に由来するヘテロジェニティー、高濃度製剤における安定性を改善させることに成功した。さらに新しいT-cellエピトープペプチドの出現を最小限にしつつ、Fcγレセプターに結合を低下させた新規な定常領域配列を見出すことに成功した。これにより、物性（安定性および均一性）、免疫原性、安全性、且つ、薬物動態を改善させた抗体定常領域を見出すことに成功した。
PCT/JP2008/067483 2007-09-26 2008-09-26 抗体定常領域改変体 Ceased WO2009041613A1 (ja)

Priority Applications (30)

Application Number Priority Date Filing Date Title
JP2009534420A JP5484060B2 (ja) 2007-09-26 2008-09-26 抗体定常領域改変体
ES08834649.9T ES2566957T3 (es) 2007-09-26 2008-09-26 Región constante de anticuerpo modificado
KR1020167032250A KR101922788B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
KR1020207015247A KR102225009B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
EP15200628.4A EP3059246B1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
AU2008304748A AU2008304748C1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
KR1020217040531A KR102467302B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
EP08834649.9A EP2194066B1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
CA2700394A CA2700394C (en) 2007-09-26 2008-09-26 Modified antibody constant region
CN2008801185811A CN101874041B (zh) 2007-09-26 2008-09-26 抗体恒定区修饰体
PH1/2018/501459A PH12018501459B1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
RU2010116278/10A RU2526512C2 (ru) 2007-09-26 2008-09-26 Модифицированная константная область антитела
EP18181757.8A EP3415529B1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
KR1020107008918A KR101680906B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
KR1020217006046A KR102339457B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
HK11100811.4A HK1146728B (en) 2007-09-26 2008-09-26 Modified antibody constant region
MX2013009569A MX342551B (es) 2007-09-26 2008-09-26 Region constante de anticuerpo modificada.
PL15200628T PL3059246T3 (pl) 2007-09-26 2008-09-26 Zmodyfikowany region stały przeciwciała
MX2010003450A MX2010003450A (es) 2007-09-26 2008-09-26 Region constante de anticuerpo modificada.
EP20198500.9A EP3789400A1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
BRPI0817273-0A BRPI0817273B1 (pt) 2007-09-26 2008-09-26 Região constante de anticorpo humano com heterogeneidade cterminal reduzida e com amidação suprimida do aminoácido c-terminal, bem como anticorpos e composição farmacêutica
KR1020187033614A KR102119108B1 (ko) 2007-09-26 2008-09-26 항체 정상영역 개변체
US12/680,082 US9688762B2 (en) 2007-09-26 2008-09-26 Modified antibody constant region
DK08834649.9T DK2194066T3 (en) 2007-09-26 2008-09-26 Modified constant region of an antibody
PH1/2021/552811A PH12021552811A1 (en) 2007-09-26 2008-09-26 Modified antibody constant region
IL204537A IL204537A0 (en) 2007-09-26 2010-03-16 Modified antibody constant region
ZA2010/02422A ZA201002422B (en) 2007-09-26 2010-04-07 Modified antibody constant region
PH12014502106A PH12014502106B1 (en) 2007-09-26 2014-09-22 Modified antibody constant region
US15/614,842 US11332533B2 (en) 2007-09-26 2017-06-06 Modified antibody constant region
US17/720,937 US20220251225A1 (en) 2007-09-26 2022-04-14 Modified antibody constant region

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007-250147 2007-09-26
JP2007250147 2007-09-26

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/680,082 A-371-Of-International US9688762B2 (en) 2007-09-26 2008-09-26 Modified antibody constant region
US15/614,842 Division US11332533B2 (en) 2007-09-26 2017-06-06 Modified antibody constant region

Publications (1)

Publication Number Publication Date
WO2009041613A1 true WO2009041613A1 (ja) 2009-04-02

Family

ID=40511493

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/067483 Ceased WO2009041613A1 (ja) 2007-09-26 2008-09-26 抗体定常領域改変体

Country Status (22)

Country Link
US (3) US9688762B2 (ja)
EP (4) EP2194066B1 (ja)
JP (9) JP5484060B2 (ja)
KR (6) KR102467302B1 (ja)
CN (1) CN101874041B (ja)
AR (4) AR068563A1 (ja)
AU (1) AU2008304748C1 (ja)
CA (5) CA3066453C (ja)
CL (1) CL2008002886A1 (ja)
DK (2) DK3059246T3 (ja)
ES (2) ES2566957T3 (ja)
IL (1) IL204537A0 (ja)
MX (2) MX342551B (ja)
MY (3) MY193526A (ja)
PE (1) PE20090711A1 (ja)
PH (3) PH12021552811A1 (ja)
PL (1) PL3059246T3 (ja)
RU (2) RU2526512C2 (ja)
SG (2) SG193868A1 (ja)
TW (2) TWI563002B (ja)
WO (1) WO2009041613A1 (ja)
ZA (1) ZA201002422B (ja)

Cited By (110)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010064697A1 (ja) * 2008-12-05 2010-06-10 中外製薬株式会社 抗nr10抗体、およびその利用
WO2010106812A1 (en) * 2009-03-19 2010-09-23 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical formulation containing improved antibody molecules
WO2010107108A1 (ja) * 2009-03-19 2010-09-23 中外製薬株式会社 関節リウマチ治療剤
WO2010107109A1 (ja) * 2009-03-19 2010-09-23 中外製薬株式会社 抗体定常領域改変体
WO2010107110A1 (ja) * 2009-03-19 2010-09-23 中外製薬株式会社 抗体定常領域改変体
WO2010131733A1 (ja) 2009-05-15 2010-11-18 中外製薬株式会社 抗axl抗体
WO2011037158A1 (ja) 2009-09-24 2011-03-31 中外製薬株式会社 抗体定常領域改変体
WO2011055550A1 (ja) 2009-11-05 2011-05-12 国立大学法人大阪大学 自己免疫疾患又はアレルギー治療剤とそのスクリーニング方法
WO2011090088A1 (ja) 2010-01-20 2011-07-28 中外製薬株式会社 安定化抗体含有溶液製剤
WO2011092989A1 (ja) 2010-01-29 2011-08-04 東レ株式会社 ポリ乳酸系樹脂シート
JPWO2010064697A1 (ja) * 2008-12-05 2012-05-10 中外製薬株式会社 抗ｎｒ１０抗体、およびその利用
WO2012067176A1 (ja) 2010-11-17 2012-05-24 中外製薬株式会社 血液凝固第viii因子の機能を代替する機能を有する多重特異性抗原結合分子
WO2012073985A1 (ja) * 2010-11-30 2012-06-07 中外製薬株式会社 細胞傷害誘導治療剤
WO2012115241A1 (ja) 2011-02-25 2012-08-30 中外製薬株式会社 FcγRIIb特異的Fc抗体
WO2013002362A1 (ja) 2011-06-30 2013-01-03 中外製薬株式会社 ヘテロ二量化ポリペプチド
WO2013012022A1 (ja) 2011-07-19 2013-01-24 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤
US8431127B2 (en) 2007-12-05 2013-04-30 Chugai Seiyaku Kabushiki Kaisha Method for treating pruritus comprising administering an NR10 antagonist
JPWO2011108714A1 (ja) * 2010-03-04 2013-06-27 中外製薬株式会社 抗体定常領域改変体
WO2013100120A1 (ja) 2011-12-28 2013-07-04 中外製薬株式会社 ヒト化抗Epiregulin抗体および当該抗体を有効成分として含む癌治療剤
WO2013118858A1 (ja) 2012-02-09 2013-08-15 中外製薬株式会社 抗体のFc領域改変体
US8562991B2 (en) 2008-09-26 2013-10-22 Chugai Seiyaku Kabushiki Kaisha Antibody molecules that bind to IL-6 receptor
JP2013539361A (ja) * 2010-07-29 2013-10-24 ゼンコア インコーポレイテッド 改変された等電点を有する抗体
WO2013187495A1 (ja) 2012-06-14 2013-12-19 中外製薬株式会社 改変されたFc領域を含む抗原結合分子
WO2014030750A1 (ja) 2012-08-24 2014-02-27 中外製薬株式会社 マウスFcγRII特異的Fc抗体
WO2014030728A1 (ja) 2012-08-24 2014-02-27 中外製薬株式会社 FcγRIIb特異的Fc領域改変体
WO2014104165A1 (ja) 2012-12-27 2014-07-03 中外製薬株式会社 ヘテロ二量化ポリペプチド
WO2014163101A1 (ja) 2013-04-02 2014-10-09 中外製薬株式会社 Ｆｃ領域改変体
WO2014208482A1 (ja) 2013-06-24 2014-12-31 中外製薬株式会社 ヒト化抗Ｅｐｉｒｅｇｕｌｉｎ抗体を有効成分として含む腺癌以外の非小細胞肺癌の治療剤
JP2015500002A (ja) * 2011-10-10 2015-01-05 ゼンコア インコーポレイテッド 抗体を精製する方法
JP2015502373A (ja) * 2011-12-19 2015-01-22 シンイミューン ゲーエムベーハー 二重特異性抗体分子
US8945558B2 (en) 2005-10-21 2015-02-03 Chugai Seiyaku Kabushiki Kaisha Methods for treating myocardial infarction comprising administering an IL-6 inhibitor
WO2015046467A1 (ja) 2013-09-27 2015-04-02 中外製薬株式会社 ポリペプチド異種多量体の製造方法
US9028821B2 (en) 2006-06-08 2015-05-12 Chugai Seiyaku Kabushiki Kaisha Method of treating an inflammatory disease comprising administering an NR 10 antibody antagonist
WO2015068847A1 (ja) 2013-11-11 2015-05-14 中外製薬株式会社 改変された抗体可変領域を含む抗原結合分子
WO2015099165A1 (ja) 2013-12-27 2015-07-02 中外製薬株式会社 等電点の低い抗体の精製方法
US9096651B2 (en) 2007-09-26 2015-08-04 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in CDR
WO2015187779A1 (en) 2014-06-03 2015-12-10 Xbiotech, Inc. Compositions and methods for treating and preventing staphylococcus aureus infections
US9260516B2 (en) 2006-04-07 2016-02-16 Osaka University Method for promoting muscle regeneration by administering an antibody to the IL-6 receptor
WO2016098357A1 (en) 2014-12-19 2016-06-23 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies, polypeptides containing variant fc regions, and methods of use
US9399680B2 (en) 2007-12-05 2016-07-26 Chugai Seiyaku Kabushiki Kaisha Nucleic acids encoding anti-NR10 antibodies
US9539322B2 (en) 2010-05-28 2017-01-10 National University Corporation Hokkaido University Method of enhancing an antitumor T cell response by administering an anti-IL-6 receptor antibody
US9605080B2 (en) 2014-11-21 2017-03-28 Bristol-Myers Squibb Company Antibodies against CD73
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WO2017104783A1 (en) 2015-12-18 2017-06-22 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies, polypeptides containing variant fc regions, and methods of use
US9688762B2 (en) 2007-09-26 2017-06-27 Chugai Sciyaku Kabushiki Kaisha Modified antibody constant region
US9725514B2 (en) 2007-01-23 2017-08-08 Shinshu University Chronic rejection inhibitor
WO2017217525A1 (en) 2016-06-17 2017-12-21 Chugai Seiyaku Kabushiki Kaisha Anti-myostatin antibodies and methods of use
US9868948B2 (en) 2008-04-11 2018-01-16 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly
US9975966B2 (en) 2014-09-26 2018-05-22 Chugai Seiyaku Kabushiki Kaisha Cytotoxicity-inducing theraputic agent
US10011858B2 (en) 2005-03-31 2018-07-03 Chugai Seiyaku Kabushiki Kaisha Methods for producing polypeptides by regulating polypeptide association
JP2018529758A (ja) * 2015-08-07 2018-10-11 イマジナブ・インコーポレーテッド 標的分子に対する抗原結合コンストラクト
WO2019077092A1 (en) 2017-10-20 2019-04-25 F. Hoffmann-La Roche Ag METHOD FOR GENERATING MULTISPECIFIC ANTIBODIES FROM MONOSPECIFIC ANTIBODIES
WO2019086362A1 (en) 2017-10-30 2019-05-09 F. Hoffmann-La Roche Ag Method for in vivo generation of multispecific antibodies from monospecific antibodies
WO2019225568A1 (ja) 2018-05-21 2019-11-28 中外製薬株式会社 ガラス容器に封入された凍結乾燥製剤
US10544227B2 (en) 2015-04-14 2020-01-28 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising IL-31 antagonist as active ingredient
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