RU2565809C2 - Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами - Google Patents

Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами Download PDF

Info

Publication number
RU2565809C2
RU2565809C2 RU2011142184/10A RU2011142184A RU2565809C2 RU 2565809 C2 RU2565809 C2 RU 2565809C2 RU 2011142184/10 A RU2011142184/10 A RU 2011142184/10A RU 2011142184 A RU2011142184 A RU 2011142184A RU 2565809 C2 RU2565809 C2 RU 2565809C2
Authority
RU
Russia
Prior art keywords
sequence
seq
antibody
tocilizumab
variable region
Prior art date
Application number
RU2011142184/10A
Other languages
English (en)
Russian (ru)
Other versions
RU2011142184A (ru
Inventor
Томоюки ИГАВА
Синя ИСИИ
Ацухико МАЕДА
Мика САКУРАИ
Тецуо КОДЗИМА
Тацухико ТАТИБАНА
Хиротаке СИРАИВА
Хироюки ЦУНОДА
Йосинобу ХИГУТИ
Тифуми МОРИЯМА
Акира ХАЯСАКА
Original Assignee
Чугаи Сейяку Кабусики Кайся
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
Application filed by Чугаи Сейяку Кабусики Кайся filed Critical Чугаи Сейяку Кабусики Кайся
Publication of RU2011142184A publication Critical patent/RU2011142184A/ru
Application granted granted Critical
Publication of RU2565809C2 publication Critical patent/RU2565809C2/ru

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/72—Increased effector function due to an Fc-modification
    • 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
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
RU2011142184/10A 2009-03-19 2010-03-19 Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами RU2565809C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2009069095 2009-03-19
JP2009-069095 2009-03-19
PCT/JP2010/001977 WO2010106812A1 (en) 2009-03-19 2010-03-19 Pharmaceutical formulation containing improved antibody molecules

Publications (2)

Publication Number Publication Date
RU2011142184A RU2011142184A (ru) 2013-04-27
RU2565809C2 true RU2565809C2 (ru) 2015-10-20

Family

ID=42739479

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2011142184/10A RU2565809C2 (ru) 2009-03-19 2010-03-19 Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами

Country Status (8)

Country Link
JP (2) JP4885308B2 (ja)
KR (1) KR101468271B1 (ja)
AR (1) AR075908A1 (ja)
AU (1) AU2010225951B2 (ja)
RU (1) RU2565809C2 (ja)
SG (3) SG10201703707YA (ja)
TW (1) TWI440470B (ja)
WO (1) WO2010106812A1 (ja)

Families Citing this family (36)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2568436T3 (es) 2006-03-31 2016-04-29 Chugai Seiyaku Kabushiki Kaisha Procedimiento para controlar la farmacocinética en sangre de anticuerpos
EP3689912A1 (en) 2007-09-26 2020-08-05 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in cdr
EP4238993A3 (en) 2008-04-11 2023-11-29 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly
TWI440469B (zh) 2008-09-26 2014-06-11 Chugai Pharmaceutical Co Ltd Improved antibody molecules
JO3417B1 (ar) * 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
CN102844332B (zh) 2010-03-11 2015-08-19 瑞纳神经科学公司 呈pH依赖性抗原结合的抗体
MX2013005024A (es) * 2010-11-08 2013-11-21 Chugai Pharmaceutical Co Ltd Anticuerpo anti-il-6 receptor administrado subcutaneamente.
SG190727A1 (en) 2010-11-30 2013-07-31 Chugai Pharmaceutical Co Ltd Antigen-binding molecule capable of binding to plurality of antigen molecules repeatedly
WO2012093704A1 (ja) * 2011-01-07 2012-07-12 中外製薬株式会社 抗体の物性を改善させる方法
WO2012132067A1 (ja) * 2011-03-30 2012-10-04 中外製薬株式会社 抗原結合分子の血漿中滞留性と免疫原性を改変する方法
KR102147548B1 (ko) * 2011-02-25 2020-08-24 추가이 세이야쿠 가부시키가이샤 ＦｃγＲＩＩｂ 특이적 Ｆｃ 항체
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
JP6322411B2 (ja) 2011-09-30 2018-05-09 中外製薬株式会社 複数の生理活性を有する抗原の消失を促進する抗原結合分子
TWI589299B (zh) 2011-10-11 2017-07-01 再生元醫藥公司 用於治療類風濕性關節炎之組成物及其使用方法
US9943594B2 (en) 2011-10-11 2018-04-17 Sanofi Biotechnology Methods for the treatment of rheumatoid arthritis
EP3517550A1 (en) 2011-11-30 2019-07-31 Chugai Seiyaku Kabushiki Kaisha Drug containing carrier into cell for forming immune complex
WO2014163101A1 (ja) 2013-04-02 2014-10-09 中外製薬株式会社 Ｆｃ領域改変体
EP3082861A1 (en) * 2013-12-20 2016-10-26 DioGenix Inc. Methods for evaluating neurological disease
US10654933B2 (en) * 2013-12-27 2020-05-19 Chugai Seiyaku Kabushiki Kaisha Method for purifying antibody having low isoelectric point
TW202339800A (zh) 2015-02-27 2023-10-16 日商中外製藥股份有限公司 Il-6受體抗體用於製備醫藥組成物的用途
CN107614683B (zh) * 2015-05-22 2020-12-22 安斯泰来制药株式会社 新型抗人NGF抗体Fab片段
SG11201805123XA (en) 2015-12-18 2018-07-30 Astellas Pharma Inc Pharmaceutical composition comprising anti-human tslp receptor antibody
BR112019005328A2 (pt) * 2016-09-27 2019-06-18 Fresenius Kabi Deutschland Gmbh composição farmacêutica líquida
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
US11851486B2 (en) 2017-05-02 2023-12-26 National Center Of Neurology And Psychiatry Method for predicting and evaluating therapeutic effect in diseases related to IL-6 and neutrophils
US11692037B2 (en) 2017-10-20 2023-07-04 Hyogo College Of Medicine Anti-IL-6 receptor antibody-containing medicinal composition for preventing post-surgical adhesion
CN109350740B (zh) * 2017-11-30 2023-06-20 百奥泰生物制药股份有限公司 一种治疗il-6相关疾病的人源化抗体的液体制剂
EP3747469A4 (en) 2018-01-31 2022-03-23 Motokazu Kato THERAPEUTIC AGENT FOR ASTHMA CONTAINING AN IL-6 INHIBITOR
MA53481A (fr) 2018-08-29 2021-07-07 Regeneron Pharma Méthodes et compositions pour le traitement de sujets ayant une polyarthrite rhumatoïde
JP2022519828A (ja) 2019-01-31 2022-03-25 サノフィ・バイオテクノロジー 若年性特発性関節炎を治療するための抗ｉｌ－６受容体抗体
TW202102540A (zh) 2019-03-29 2021-01-16 日商中外製藥股份有限公司 包含抗il-6受體抗體之bbb功能低下之抑制劑
JPWO2020213665A1 (ja) 2019-04-17 2020-10-22
US20230210991A1 (en) 2020-05-29 2023-07-06 Chugai Seiyaku Kabushiki Kaisha Antibody-containing formulation
KR20220028972A (ko) * 2020-08-31 2022-03-08 (주)셀트리온 안정한 약제학적 제제
IL305793A (en) 2021-03-12 2023-11-01 Hoffmann La Roche A pharmaceutical preparation for the treatment or prevention of myasthenia gravis

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004075913A1 (ja) * 2003-02-28 2004-09-10 Chugai Seiyaku Kabushiki Kaisha タンパク質含有安定化製剤
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤
RU2318829C2 (ru) * 2001-11-14 2008-03-10 Сентокор, Инк. Антитела против il-6, композиции, способы и применение

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR9908226A (pt) * 1998-02-25 2000-10-24 Lexigen Pharm Corp Melhoramento da meia vida de circulação de proteìnas de fusão com base em anticorpo
KR101080021B1 (ko) * 2002-02-14 2011-11-04 추가이 세이야쿠 가부시키가이샤 항체함유 용액제제
AU2003286467B2 (en) * 2002-10-15 2009-10-01 Abbvie Biotherapeutics Inc. Alteration of FcRn binding affinities or serum half-lives of antibodies by mutagenesis
JP4685764B2 (ja) * 2003-04-10 2011-05-18 アボット バイオセラピューティクス コーポレイション 変異誘発による抗体のＦｃＲｎ結合親和力又は血清半減期の改変
ATE464908T1 (de) * 2004-02-11 2010-05-15 Warner Lambert Co Verfahren zur behandlung von osteoarthritis mit anti-il-6 antikörpern
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
CA2638811A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
ES2568436T3 (es) * 2006-03-31 2016-04-29 Chugai Seiyaku Kabushiki Kaisha Procedimiento para controlar la farmacocinética en sangre de anticuerpos
RS52643B (en) * 2006-06-02 2013-06-28 Regeneron Pharmaceuticals Inc. HIGH AFINITY ANTIBODIES TO THE HUMAN IL-6 RECEPTOR
EP3689912A1 (en) * 2007-09-26 2020-08-05 Chugai Seiyaku Kabushiki Kaisha Method of modifying isoelectric point of antibody via amino acid substitution in cdr
CN101939425B (zh) * 2007-09-26 2014-05-14 中外制药株式会社 抗il-6受体抗体
SG10201605394SA (en) * 2007-09-26 2016-08-30 Chugai Pharmaceutical Co Ltd Modified Antibody Constant Region
EP4238993A3 (en) * 2008-04-11 2023-11-29 Chugai Seiyaku Kabushiki Kaisha Antigen-binding molecule capable of binding to two or more antigen molecules repeatedly

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2318829C2 (ru) * 2001-11-14 2008-03-10 Сентокор, Инк. Антитела против il-6, композиции, способы и применение
WO2004075913A1 (ja) * 2003-02-28 2004-09-10 Chugai Seiyaku Kabushiki Kaisha タンパク質含有安定化製剤
WO2007074880A1 (ja) * 2005-12-28 2007-07-05 Chugai Seiyaku Kabushiki Kaisha 抗体含有安定化製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MAINI R.N. et al., "Double-Blind Randomized Controlled Clinical Trial of the Interleukin-6 Receptor Antagonist, Tocilizumab, in European Patients With Rheumatoid Arthritis Who Had an Incomplete Response to Methotrexate", Arthritis & Rheumatism (2006), 54 (9): 2817-2829 *

Also Published As

Publication number Publication date
KR20110139745A (ko) 2011-12-29
TW201100100A (en) 2011-01-01
SG10201900451SA (en) 2019-02-27
TWI440470B (zh) 2014-06-11
KR101468271B1 (ko) 2014-12-03
JP4885308B2 (ja) 2012-02-29
JP5661553B2 (ja) 2015-01-28
WO2010106812A1 (en) 2010-09-23
RU2011142184A (ru) 2013-04-27
AU2010225951A1 (en) 2011-09-22
AU2010225951B2 (en) 2014-03-13
JP2011173918A (ja) 2011-09-08
AR075908A1 (es) 2011-05-04
SG10201703707YA (en) 2017-06-29
JP2012504106A (ja) 2012-02-16
SG174428A1 (en) 2011-10-28

Similar Documents

Publication Publication Date Title
RU2565809C2 (ru) Фармацевтический состав, содержащий молекулы антител с улучшенными свойствами
US20240010738A1 (en) Antibody molecules
CN101939425B (zh) 抗il-6受体抗体
US20090238820A1 (en) ANTI-MAdCAM ANTIBODY COMPOSITIONS
AU2012200724B2 (en) Improved antibody molecules