JP5726085B2 - 治療用タンパク質製剤 - Google Patents

治療用タンパク質製剤 Download PDF

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JP5726085B2
JP5726085B2 JP2011537608A JP2011537608A JP5726085B2 JP 5726085 B2 JP5726085 B2 JP 5726085B2 JP 2011537608 A JP2011537608 A JP 2011537608A JP 2011537608 A JP2011537608 A JP 2011537608A JP 5726085 B2 JP5726085 B2 JP 5726085B2
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antibody
amino acid
antibodies
acid sequence
asp
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Japanese (ja)
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JP2012509344A5 (enExample
JP2012509344A (ja
Inventor
ブルース カバコフ，
ブルース カバコフ，
ダレン ネルソン，
ダレン ネルソン，
ジュン オヤン，
ジュン オヤン，
トレヴァー， エリ スウォーツ，
トレヴァー， エリ スウォーツ，
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Genentech Inc
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Genentech Inc
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    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6807—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug or compound being a sugar, nucleoside, nucleotide, nucleic acid, e.g. RNA antisense
    • A61K47/6809—Antibiotics, e.g. antitumor antibiotics anthracyclins, adriamycin, doxorubicin or daunomycin
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6869—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from a cell of the reproductive system: ovaria, uterus, testes, prostate
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P37/04—Immunostimulants
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
    • 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
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • 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
    • C07K2317/90—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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Reproductive Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gynecology & Obstetrics (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2011537608A 2008-11-20 2009-11-19 治療用タンパク質製剤 Active JP5726085B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11654108P 2008-11-20 2008-11-20
US61/116,541 2008-11-20
PCT/US2009/065084 WO2010059787A1 (en) 2008-11-20 2009-11-19 Therapeutic protein formulations

Publications (3)

Publication Number Publication Date
JP2012509344A JP2012509344A (ja) 2012-04-19
JP2012509344A5 JP2012509344A5 (enExample) 2015-04-02
JP5726085B2 true JP5726085B2 (ja) 2015-05-27

Family

ID=41683048

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011537608A Active JP5726085B2 (ja) 2008-11-20 2009-11-19 治療用タンパク質製剤

Country Status (12)

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US (2) US20120027772A1 (enExample)
EP (1) EP2358393A1 (enExample)
JP (1) JP5726085B2 (enExample)
KR (1) KR101676887B1 (enExample)
CN (2) CN102281901A (enExample)
AU (1) AU2009316592B2 (enExample)
BR (1) BRPI0921947A2 (enExample)
CA (1) CA2737045C (enExample)
HK (1) HK1244426A1 (enExample)
IL (1) IL211670A (enExample)
MX (1) MX2011004748A (enExample)
WO (1) WO2010059787A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2009003938A (es) 2006-10-27 2009-04-24 Genentech Inc Anticuerpos e inmunoconjugados y sus usos.
BR112012031727B1 (pt) * 2010-06-15 2022-03-29 Genmab A/S Conjugado de droga-anticorpo, composição farmacêutica, e, uso do conjugado de droga- anticorpo
EP2399604A1 (en) * 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
MX354988B (es) 2011-10-25 2018-03-28 Prothena Biosciences Ltd Formulaciones de anticuerpo y metodos.
JP2017516860A (ja) * 2014-05-27 2017-06-22 ナビゲン，インコーポレーテッド Ａｒｆ６阻害剤並びにそれらの合成方法及び使用
WO2017055388A2 (en) * 2015-10-02 2017-04-06 F. Hoffmann-La Roche Ag Bispecific t cell activating antigen binding molecules
KR102667951B1 (ko) 2017-04-03 2024-05-22 에프. 호프만-라 로슈 아게 Steap-1에 결합하는 항체
CN116898955A (zh) * 2017-09-22 2023-10-20 旭化成制药株式会社 稳定性优异的含有特立帕肽的液态药物组合物
TWI841554B (zh) 2018-03-21 2024-05-11 丹麥商珍美寶股份有限公司 以鉑為主之劑與抗組織因子抗體－藥物共軛物的組合治療癌症之方法
MX2020010320A (es) * 2018-04-02 2021-01-08 Amgen Inc Composiciones de erenumab y usos de las mismas.
IL278522B2 (en) 2018-05-07 2025-10-01 Genmab As Methods for treating cancer with a combination of anti-PD-1 antibody and always an anti-tissue factor antibody drug
TWI844571B (zh) 2018-10-30 2024-06-11 丹麥商珍美寶股份有限公司 使用抗血管內皮生長因子（ｖｅｇｆ）抗體與抗組織因子（ｔｆ）抗體－藥物共軛體之組合以治療癌症之方法
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001054732A1 (en) * 2000-01-27 2001-08-02 Genetics Institute, Llc. Antibodies against ctla4 (cd152), conjugates comprising same, and uses thereof
EP1314437B1 (en) * 2000-08-11 2014-06-25 Chugai Seiyaku Kabushiki Kaisha Stabilized antibody-containing preparations
JP5052736B2 (ja) * 2001-05-30 2012-10-17 中外製薬株式会社 タンパク質製剤
US20030113316A1 (en) * 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies
JP2003128575A (ja) * 2001-10-25 2003-05-08 Mochida Pharmaceut Co Ltd 脳腫瘍治療剤
NZ534542A (en) * 2002-02-14 2006-08-31 Chugai Pharmaceutical Co Ltd Antibody-containing solutions in which the formation of degradation products and insoluble particles during storage and freeze/thaw cycles is inhibited by adding a sugar and surfactant respectively
EP1558645B1 (en) * 2002-11-08 2011-07-27 Ablynx N.V. Stabilized single domain antibodies in pharmaceutical composition adapted for inhalation
NZ550816A (en) * 2004-04-22 2009-12-24 Agensys Inc Antibodies and molecules derived therefrom that bind to STEAP-1 proteins
BRPI0516284A (pt) * 2004-09-23 2008-09-02 Genentech Inc anticorpo construìdo com cisteìna, método de selecionar anticorpos, compostos conjugados de droga-anticorpo, composição farmacêutica, método para matar ou inibir a proliferação de células de tumor, métodos de inibir a proliferação celular e o crescimento de células de tumor, artigo manufaturado e método para produzir um composto
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
MX2009003938A (es) * 2006-10-27 2009-04-24 Genentech Inc Anticuerpos e inmunoconjugados y sus usos.

Also Published As

Publication number Publication date
CN102281901A (zh) 2011-12-14
AU2009316592A1 (en) 2010-05-27
KR101676887B1 (ko) 2016-11-16
CA2737045A1 (en) 2010-05-27
MX2011004748A (es) 2011-05-25
BRPI0921947A2 (pt) 2018-10-16
IL211670A0 (en) 2011-06-30
CN107184976A (zh) 2017-09-22
EP2358393A1 (en) 2011-08-24
CA2737045C (en) 2017-11-14
WO2010059787A1 (en) 2010-05-27
AU2009316592B2 (en) 2016-01-07
HK1244426A1 (zh) 2018-08-10
IL211670A (en) 2016-12-29
JP2012509344A (ja) 2012-04-19
US20160068607A1 (en) 2016-03-10
US20120027772A1 (en) 2012-02-02
KR20110089141A (ko) 2011-08-04

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