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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AU2015257798A1 (en
AU2015257798B2 (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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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243Colony Stimulating Factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (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 (16)

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)
CA (1) CA2946230A1 (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
SG11202102995PA (en) * 2018-10-01 2021-04-29 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
EP4048310A4 (en) * 2019-10-25 2024-03-13 Amgen Inc. COMPOSITIONS AND METHODS FOR MINIMIZING PROTEIN LOSS AT LOW PROTEIN CONCENTRATIONS
CA3183934A1 (en) * 2020-05-29 2021-12-02 Amgen Inc. Antibody formulations and uses thereof
JP2023551549A (ja) * 2020-12-04 2023-12-08 シーエスエル イノベーション プロプライアタリー リミティド 炎症性皮膚状態を治療する方法
KR102375269B1 (ko) * 2021-01-27 2022-03-17 한미약품 주식회사 단백질 액상 제제 및 이의 제조방법
CA3218343A1 (en) * 2021-05-12 2022-11-17 Anaptysbio, Inc. Antibody composition
JP2025539457A (ja) * 2022-12-01 2025-12-05 アイ-エムエービー バイオファーマ (ハンジョウ) カンパニー リミテッド 抗gm-csf抗体の液体医薬品製剤及びその用途

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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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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
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Also Published As

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

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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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