AU2015257798C1 - Liquid formulation comprising GM-CSF neutralizing compound - Google Patents

Liquid formulation comprising GM-CSF neutralizing compound Download PDF

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Publication number
AU2015257798C1
AU2015257798C1 AU2015257798A AU2015257798A AU2015257798C1 AU 2015257798 C1 AU2015257798 C1 AU 2015257798C1 AU 2015257798 A AU2015257798 A AU 2015257798A AU 2015257798 A AU2015257798 A AU 2015257798A AU 2015257798 C1 AU2015257798 C1 AU 2015257798C1
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AU
Australia
Prior art keywords
antibody
seq
amino acid
csf
set out
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AU2015257798A
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AU2015257798B2 (en
AU2015257798A1 (en
Inventor
Willow Diluzio
Phoung NGUYEN
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Takeda Pharmaceutical Co Ltd
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Takeda Pharmaceutical Co Ltd
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Publication of AU2015257798C1 publication Critical patent/AU2015257798C1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61P17/06—Antipsoriatics
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243—Colony Stimulating Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)
AU2015257798A 2014-05-07 2015-05-04 Liquid formulation comprising GM-CSF neutralizing compound Active AU2015257798C1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP14167405.1 2014-05-07
EP14167405 2014-05-07
US201461994319P 2014-05-16 2014-05-16
US61/994,319 2014-05-16
US201462043636P 2014-08-29 2014-08-29
US62/043,636 2014-08-29
PCT/EP2015/059709 WO2015169742A1 (en) 2014-05-07 2015-05-04 Liquid formulation comprising gm-csf neutralizing compound

Publications (3)

Publication Number Publication Date
AU2015257798A1 AU2015257798A1 (en) 2016-11-17
AU2015257798B2 AU2015257798B2 (en) 2020-04-23
AU2015257798C1 true AU2015257798C1 (en) 2020-10-22

Family

ID=50721582

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015257798A Active AU2015257798C1 (en) 2014-05-07 2015-05-04 Liquid formulation comprising GM-CSF neutralizing compound

Country Status (15)

Country Link
US (1) US11173208B2 (enExample)
EP (1) EP3139960B1 (enExample)
JP (1) JP6769879B2 (enExample)
KR (1) KR102385802B1 (enExample)
CN (1) CN106659785B (enExample)
AR (1) AR100268A1 (enExample)
AU (1) AU2015257798C1 (enExample)
BR (1) BR112016025126B1 (enExample)
EA (1) EA201691883A1 (enExample)
ES (1) ES2974895T3 (enExample)
MX (1) MX387451B (enExample)
PH (1) PH12016502100A1 (enExample)
TW (1) TWI682788B (enExample)
WO (1) WO2015169742A1 (enExample)
ZA (1) ZA201607097B (enExample)

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JOP20190255A1 (ar) 2017-04-28 2019-10-27 Amgen Inc صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها
CN107167613B (zh) * 2017-06-22 2018-10-02 深圳清华大学研究院 用于等离子体金芯片的蛋白点样缓冲液
EP3860567A4 (en) * 2018-10-01 2022-07-06 Amgen Inc. METHOD OF REDUCING AGGREGATION OF BISPECIFIC ANTIBODIES
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
BR112022007776A2 (pt) * 2019-10-25 2022-07-05 Amgen Inc Composições e métodos para minimizar a perda de proteína em baixas concentrações de proteína
CN115697406A (zh) * 2020-05-29 2023-02-03 美国安进公司 抗体配制品及其用途
AU2021392308A1 (en) * 2020-12-04 2023-06-22 CSL Innovation Pty Ltd Methods for treating inflammatory skin conditions
AU2021408085A1 (en) * 2020-12-21 2023-06-22 CSL Innovation Pty Ltd Methods for treating or preventing acute respiratory distress syndrome
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
CN117615788A (zh) * 2021-05-12 2024-02-27 安奈普泰斯生物有限公司 抗体组合物
EP4626406A1 (en) * 2022-12-01 2025-10-08 I-Mab Biopharma (Hangzhou) Co., Ltd. Liquid pharmaceutical formulation of anti-gm-csf antibody and uses thereof
WO2025217676A1 (en) * 2024-04-15 2025-10-23 CSL Innovation Pty Ltd Protein formulations and uses thereof

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US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof
WO2009038760A2 (en) * 2007-09-18 2009-03-26 Amgen Inc. Human gm-csf antigen binding proteins
WO2014068026A1 (en) * 2012-10-31 2014-05-08 Amgen Research (Munich) Gmbh Liquid formulation comprising gm-csf neutralizing compound

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US20010014326A1 (en) * 1995-07-27 2001-08-16 Genentech, Inc. Protein formulation
US20030138417A1 (en) * 2001-11-08 2003-07-24 Kaisheva Elizabet A. Stable liquid pharmaceutical formulation of IgG antibodies
EP1947178A1 (en) * 2005-10-26 2008-07-23 Evec Incorporated Human monoclonal antibody binding to human gm-csf and antigen-binding site thereof
WO2009038760A2 (en) * 2007-09-18 2009-03-26 Amgen Inc. Human gm-csf antigen binding proteins
WO2014068026A1 (en) * 2012-10-31 2014-05-08 Amgen Research (Munich) Gmbh Liquid formulation comprising gm-csf neutralizing compound

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Also Published As

Publication number Publication date
CN106659785B (zh) 2021-04-30
ES2974895T3 (es) 2024-07-02
CA2946230A1 (en) 2015-11-12
BR112016025126A8 (pt) 2022-08-09
US11173208B2 (en) 2021-11-16
TWI682788B (zh) 2020-01-21
MX2016014411A (es) 2017-04-06
EP3139960A1 (en) 2017-03-15
PH12016502100A1 (en) 2017-02-06
US20170252436A1 (en) 2017-09-07
BR112016025126A2 (pt) 2018-02-20
MX387451B (es) 2025-03-18
TW201622702A (zh) 2016-07-01
EA201691883A1 (ru) 2017-05-31
AU2015257798B2 (en) 2020-04-23
AR100268A1 (es) 2016-09-21
AU2015257798A1 (en) 2016-11-17
CN106659785A (zh) 2017-05-10
EP3139960B1 (en) 2024-01-17
JP6769879B2 (ja) 2020-10-14
KR102385802B1 (ko) 2022-04-13
BR112016025126B1 (pt) 2024-02-15
WO2015169742A1 (en) 2015-11-12
KR20160149210A (ko) 2016-12-27
JP2017514868A (ja) 2017-06-08
ZA201607097B (en) 2024-11-27

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DA2 Applications for amendment section 104

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DA3 Amendments made section 104

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Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED

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