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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English (en)
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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 AU2015257798A1 publication Critical patent/AU2015257798A1/en
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Application granted granted Critical
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Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED reassignment TAKEDA PHARMACEUTICAL COMPANY LIMITED Request for Assignment Assignors: TAKEDA GMBH
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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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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 (https=)
EP (1) EP3139960B1 (https=)
JP (1) JP6769879B2 (https=)
KR (1) KR102385802B1 (https=)
CN (1) CN106659785B (https=)
AR (1) AR100268A1 (https=)
AU (1) AU2015257798C1 (https=)
BR (1) BR112016025126B1 (https=)
EA (1) EA201691883A1 (https=)
ES (1) ES2974895T3 (https=)
MX (1) MX387451B (https=)
PH (1) PH12016502100A1 (https=)
TW (1) TWI682788B (https=)
WO (1) WO2015169742A1 (https=)
ZA (1) ZA201607097B (https=)

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SI4190355T1 (sl) 2017-04-28 2025-02-28 Amgen Inc. Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe
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
WO2020072306A1 (en) * 2018-10-01 2020-04-09 Amgen Inc. Methods for reducing aggregation of bispecific antibodies
US11684655B2 (en) 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
KR20220099585A (ko) * 2019-10-25 2022-07-13 암젠 인크 낮은 단백질 농도에서 단백질 손실을 최소화하기 위한 조성물 및 방법
US20240374720A1 (en) * 2020-05-29 2024-11-14 Amgen Inc. Antibody formulations and uses thereof
AU2021392308A1 (en) * 2020-12-04 2023-06-22 CSL Innovation Pty Ltd Methods for treating inflammatory skin conditions
CA3198776A1 (en) * 2020-12-21 2022-06-30 Catherine Mary Owczarek 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
JP2024518536A (ja) * 2021-05-12 2024-05-01 アナプティスバイオ インコーポレイティッド 抗体組成物
CN119095584A (zh) * 2022-12-01 2024-12-06 天境生物科技(杭州)有限公司 抗gm-csf抗体的液体药物配制品及其用途
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
US11173208B2 (en) 2021-11-16
AU2015257798B2 (en) 2020-04-23
EP3139960A1 (en) 2017-03-15
JP2017514868A (ja) 2017-06-08
MX387451B (es) 2025-03-18
US20170252436A1 (en) 2017-09-07
JP6769879B2 (ja) 2020-10-14
BR112016025126A2 (pt) 2018-02-20
AU2015257798A1 (en) 2016-11-17
CA2946230A1 (en) 2015-11-12
CN106659785B (zh) 2021-04-30
MX2016014411A (es) 2017-04-06
AR100268A1 (es) 2016-09-21
ZA201607097B (en) 2024-11-27
WO2015169742A1 (en) 2015-11-12
KR20160149210A (ko) 2016-12-27
ES2974895T3 (es) 2024-07-02
BR112016025126B1 (pt) 2024-02-15
EP3139960B1 (en) 2024-01-17
EA201691883A1 (ru) 2017-05-31
BR112016025126A8 (pt) 2022-08-09
TWI682788B (zh) 2020-01-21
PH12016502100A1 (en) 2017-02-06
TW201622702A (zh) 2016-07-01
CN106659785A (zh) 2017-05-10
KR102385802B1 (ko) 2022-04-13

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DA2 Applications for amendment section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT(S) FILED 29 JUN 2020

DA3 Amendments made section 104

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Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED

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