CN111201036A - 包含抗α(V)β(6)抗体的药物组合物和剂量方案 - Google Patents

包含抗α(V)β(6)抗体的药物组合物和剂量方案 Download PDF

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Publication number
CN111201036A
CN111201036A CN201880065802.7A CN201880065802A CN111201036A CN 111201036 A CN111201036 A CN 111201036A CN 201880065802 A CN201880065802 A CN 201880065802A CN 111201036 A CN111201036 A CN 111201036A
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China
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seq
amino acid
concentration
αvβ6
acid sequence
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Pending
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CN201880065802.7A
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English (en)
Chinese (zh)
Inventor
T.B.埃斯蒂
G.戈文丹
S.萨鲁贾
K.格普塔
M.麦格拉思
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Biogen MA Inc
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Biogen MA Inc
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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
    • 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
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2842—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
    • 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
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • 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
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201880065802.7A 2017-08-22 2018-08-22 包含抗α(V)β(6)抗体的药物组合物和剂量方案 Pending CN111201036A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762548772P 2017-08-22 2017-08-22
US62/548,772 2017-08-22
PCT/US2018/047502 WO2019040608A1 (en) 2017-08-22 2018-08-22 PHARMACEUTICAL COMPOSITIONS AND DOSAGE SCHEMES CONTAINING ANTI-ALPHA (V) BETA ANTIBODIES (6)

Publications (1)

Publication Number Publication Date
CN111201036A true CN111201036A (zh) 2020-05-26

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Application Number Title Priority Date Filing Date
CN201880065802.7A Pending CN111201036A (zh) 2017-08-22 2018-08-22 包含抗α(V)β(6)抗体的药物组合物和剂量方案

Country Status (11)

Country Link
US (1) US20210363259A1 (enExample)
EP (1) EP3672632A1 (enExample)
JP (1) JP2020531521A (enExample)
KR (1) KR20200044066A (enExample)
CN (1) CN111201036A (enExample)
AU (1) AU2018322475A1 (enExample)
BR (1) BR112020003498A2 (enExample)
CA (1) CA3073286A1 (enExample)
MA (1) MA49948A (enExample)
MX (1) MX2020001851A (enExample)
WO (1) WO2019040608A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7551750B2 (ja) * 2019-12-05 2024-09-17 シージェン インコーポレイテッド 抗αｖβ６抗体及び抗体薬物コンジュゲート

Citations (14)

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US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US20060194280A1 (en) * 2004-10-22 2006-08-31 Amgen Inc. Methods for refolding of recombinant antibodies
CN101262884A (zh) * 2005-01-28 2008-09-10 艾兰制药国际有限公司 抗Aβ抗体制剂
CN101287841A (zh) * 2005-07-08 2008-10-15 拜奥根Idec马萨诸塞公司 抗－αvβ6抗体及其用途
US20090028853A1 (en) * 2006-10-19 2009-01-29 The Regents Of The University Of California, A California Corporation TREATMENT AND PREVENTION OF CHRONIC ASTHMA USING ANTAGONISTS OF INTEGRIN ALPHAvBETA6
CN101426817A (zh) * 2006-04-21 2009-05-06 诺华有限公司 拮抗性抗-cd4o抗体药物组合物
CN101600457A (zh) * 2007-01-09 2009-12-09 惠氏公司 抗il-13抗体调配物和其用途
CN101883588A (zh) * 2007-12-27 2010-11-10 中外制药株式会社 含高浓度抗体的溶液制剂
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
CN103037899A (zh) * 2010-02-26 2013-04-10 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
CN103501825A (zh) * 2011-05-02 2014-01-08 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
US20150164874A1 (en) * 2011-05-25 2015-06-18 Intermune, Inc. Pirfenidone and anti-fibrotic therapy in selected patients
CN105705139A (zh) * 2013-09-11 2016-06-22 阿尔西亚治疗有限公司 包含水溶性有机染料的液体蛋白质制剂
WO2017095848A1 (en) * 2015-11-30 2017-06-08 Medimmune, Llc Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents

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Publication number Priority date Publication date Assignee Title
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
US20060194280A1 (en) * 2004-10-22 2006-08-31 Amgen Inc. Methods for refolding of recombinant antibodies
CN101262884A (zh) * 2005-01-28 2008-09-10 艾兰制药国际有限公司 抗Aβ抗体制剂
CN103768009A (zh) * 2005-01-28 2014-05-07 杨森阿尔茨海默氏症免疫治疗公司 抗Aβ抗体制剂
CN104072614A (zh) * 2005-07-08 2014-10-01 拜奥根Idec马萨诸塞公司 抗-αvβ6 抗体及其用途
CN101287841A (zh) * 2005-07-08 2008-10-15 拜奥根Idec马萨诸塞公司 抗－αvβ6抗体及其用途
CN101426817A (zh) * 2006-04-21 2009-05-06 诺华有限公司 拮抗性抗-cd4o抗体药物组合物
US20090028853A1 (en) * 2006-10-19 2009-01-29 The Regents Of The University Of California, A California Corporation TREATMENT AND PREVENTION OF CHRONIC ASTHMA USING ANTAGONISTS OF INTEGRIN ALPHAvBETA6
CN101600457A (zh) * 2007-01-09 2009-12-09 惠氏公司 抗il-13抗体调配物和其用途
CN101883588A (zh) * 2007-12-27 2010-11-10 中外制药株式会社 含高浓度抗体的溶液制剂
CN103037899A (zh) * 2010-02-26 2013-04-10 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
CN103501825A (zh) * 2011-05-02 2014-01-08 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
US20150164874A1 (en) * 2011-05-25 2015-06-18 Intermune, Inc. Pirfenidone and anti-fibrotic therapy in selected patients
CN105705139A (zh) * 2013-09-11 2016-06-22 阿尔西亚治疗有限公司 包含水溶性有机染料的液体蛋白质制剂
WO2017095848A1 (en) * 2015-11-30 2017-06-08 Medimmune, Llc Optimized ratios of amino acids and sugars as amorphous stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents

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US20210363259A1 (en) 2021-11-25
AU2018322475A1 (en) 2020-03-05
WO2019040608A1 (en) 2019-02-28
KR20200044066A (ko) 2020-04-28
CA3073286A1 (en) 2019-02-28
BR112020003498A2 (pt) 2020-08-25
EP3672632A1 (en) 2020-07-01
JP2020531521A (ja) 2020-11-05
MX2020001851A (es) 2020-08-20
MA49948A (fr) 2020-07-01

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