CA2889307C - Liquid formulation comprising gm-csf neutralizing compound - Google Patents

Liquid formulation comprising gm-csf neutralizing compound Download PDF

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Publication number
CA2889307C
CA2889307C CA2889307A CA2889307A CA2889307C CA 2889307 C CA2889307 C CA 2889307C CA 2889307 A CA2889307 A CA 2889307A CA 2889307 A CA2889307 A CA 2889307A CA 2889307 C CA2889307 C CA 2889307C
Authority
CA
Canada
Prior art keywords
antibody
seq
amino acid
set out
csf
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2889307A
Other languages
English (en)
French (fr)
Other versions
CA2889307A1 (en
Inventor
Thomas Urbig
Thomas Boehm
Wolfram Steinhilber
Michael MOLHOJ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda GmbH
Amgen Research Munich GmbH
Original Assignee
Takeda GmbH
Amgen Research Munich GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takeda GmbH, Amgen Research Munich GmbH filed Critical Takeda GmbH
Publication of CA2889307A1 publication Critical patent/CA2889307A1/en
Application granted granted Critical
Publication of CA2889307C publication Critical patent/CA2889307C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • A61P37/02Immunomodulators
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243Colony Stimulating Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies

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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Pulmonology (AREA)
  • Endocrinology (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (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)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2889307A 2012-10-31 2013-10-31 Liquid formulation comprising gm-csf neutralizing compound Active CA2889307C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261720892P 2012-10-31 2012-10-31
US61/720,892 2012-10-31
EP12199191 2012-12-21
EP12199191.3 2012-12-21
PCT/EP2013/072761 WO2014068026A1 (en) 2012-10-31 2013-10-31 Liquid formulation comprising gm-csf neutralizing compound

Publications (2)

Publication Number Publication Date
CA2889307A1 CA2889307A1 (en) 2014-05-08
CA2889307C true CA2889307C (en) 2021-11-23

Family

ID=47504727

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2889307A Active CA2889307C (en) 2012-10-31 2013-10-31 Liquid formulation comprising gm-csf neutralizing compound

Country Status (14)

Country Link
US (2) US9919051B2 (https=)
EP (2) EP2914290B1 (https=)
JP (1) JP6346189B2 (https=)
KR (1) KR102106914B1 (https=)
CN (1) CN104768580B (https=)
AR (1) AR093297A1 (https=)
AU (1) AU2013340845B2 (https=)
BR (1) BR112015009259B8 (https=)
CA (1) CA2889307C (https=)
EA (1) EA032829B1 (https=)
MX (1) MX363807B (https=)
PH (1) PH12015500864B1 (https=)
TW (1) TWI639440B (https=)
WO (1) WO2014068026A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10745475B2 (en) 2013-08-30 2020-08-18 Takeda Gmbh Antibodies neutralizing GM-CSF for use in the treatment of rheumatoid arthritis or as analgesics
KR102385802B1 (ko) * 2014-05-07 2022-04-13 다케다 야쿠힝 고교 가부시키가이샤 Gm-csf 중화 화합물을 포함하는 액체 제제
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PT2946765T (pt) 2014-05-23 2016-11-10 Ares Trading Sa Composição farmacêutica líquida
SG11201901789WA (en) * 2016-09-19 2019-03-28 I Mab Anti-gm-csf antibodies and uses thereof
BR112019018022A2 (pt) * 2017-03-01 2020-06-02 Medimmune Limited Formulações de anticorpos monoclonais
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
WO2021011404A1 (en) * 2019-07-12 2021-01-21 Contrafect Corporation Therapeutic protein formulations comprising antibodies and uses thereof

Family Cites Families (47)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2916711A1 (de) 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
EP0158487B1 (en) 1984-04-09 1991-08-28 Takeda Chemical Industries, Ltd. Stable composition of interleukin-2
GB8624899D0 (en) 1986-10-17 1986-11-19 Sandoz Ltd Monoclonal antibodies
JP3101690B2 (ja) 1987-03-18 2000-10-23 エス・ビィ・2・インコーポレイテッド 変性抗体の、または変性抗体に関する改良
US5070013A (en) 1988-05-31 1991-12-03 Schering Corporation Immunochemical assay for human granulocyte-macrophage colony stimulating factor
GB8903593D0 (en) 1989-02-16 1989-04-05 Pafra Ltd Storage of materials
WO1994009149A1 (en) 1990-08-10 1994-04-28 Amrad Corporation Limited Monoclonal antibody
CA2060741A1 (en) 1991-02-11 1992-08-12 Robert S. Greenfield Gm-csf inhibiting oligopeptides
US5580856A (en) 1994-07-15 1996-12-03 Prestrelski; Steven J. Formulation of a reconstituted protein, and method and kit for the production thereof
US6309636B1 (en) 1995-09-14 2001-10-30 Cancer Research Institute Of Contra Costa Recombinant peptides derived from the Mc3 anti-BA46 antibody, methods of use thereof, and methods of humanizing antibody peptides
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
GB9722131D0 (en) 1997-10-20 1997-12-17 Medical Res Council Method
US7112324B1 (en) 1998-04-21 2006-09-26 Micromet Ag CD 19×CD3 specific polypeptides and uses thereof
US7101551B2 (en) 2000-02-14 2006-09-05 Mitsubishi Pharma Corporation Remedies for hepatitis C
MXPA04000747A (es) * 2001-07-25 2004-07-08 Protein Desing Labs Inc Formulacion farmaceutica liofilizada estable de anticuerpos igg.
JP2006500905A (ja) 2002-02-13 2006-01-12 ルードヴィッヒ インスティテュート フォー キャンサー リサーチ ヒト化gm−csf抗体
SI1478394T1 (sl) 2002-02-27 2008-12-31 Immunex Corp STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM
US9415102B2 (en) * 2002-09-06 2016-08-16 Alexion Pharmaceuticals, Inc. High concentration formulations of anti-C5 antibodies
AU2005249360B2 (en) * 2004-04-12 2011-07-21 Medimmune, Llc Anti-IL-9 antibody formulations and uses thereof
ATE435238T1 (de) 2004-05-05 2009-07-15 Micromet Ag Herstellung eines einkettigen fv antikörperfragments
GB0417487D0 (en) 2004-08-05 2004-09-08 Novartis Ag Organic compound
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
US20060177436A1 (en) 2004-12-16 2006-08-10 Genentech, Inc. Methods for Treating Autoimmune Disorders
GT200600031A (es) * 2005-01-28 2006-08-29 Formulacion anticuerpo anti a beta
BRPI0608281B8 (pt) * 2005-04-18 2021-05-25 Amgen Res Munich Gmbh anticorpo monoclonal humano ou seu fragmento, seu uso no tratamento de doenças inflamatórias, bem como composição farmacêutica que o compreende
RU2447085C2 (ru) 2005-05-18 2012-04-10 МорфоСис АГ Анти-gm-csf антитела и их применение
JP4736037B2 (ja) 2005-10-26 2011-07-27 株式会社イーベック ヒトgm−csfに結合するヒトのモノクローナル抗体並びにその抗原結合部分
CA2638811A1 (en) 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
US7741450B2 (en) 2006-02-08 2010-06-22 Morphotek Inc. Antibodies to GM-CSF
MX2008012291A (es) 2006-03-27 2009-01-12 Medimmune Ltd Miembro que enlaza al receptor gm-csf.
EP2101780B1 (en) * 2006-11-21 2013-10-09 Kalobios Pharmaceuticals, Inc. Methods of treating chronic inflammatory diseases using a gm-csf antagonist
EP2170268A2 (en) * 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
TW200918553A (en) 2007-09-18 2009-05-01 Amgen Inc Human GM-CSF antigen binding proteins
CN104072613A (zh) 2007-11-13 2014-10-01 Evec股份有限公司 与hGM-CSF结合的单克隆抗体及包含它的药物组合物
WO2009134805A2 (en) 2008-04-28 2009-11-05 Kalobios Pharmaceuticals, Inc. Antibodies to granulocyte-macrophage colony-stimulating factor
CA2717987C (en) 2008-04-29 2018-11-13 Micromet Ag Inhibitors of gm-csf and il-17 for therapy
CA2747206C (en) 2008-12-22 2018-04-24 The University Of Melbourne Pain treatment
US20120116059A1 (en) 2009-05-05 2012-05-10 Morphosys Ag Treatment For M Treatment For Multiple Sclerosis
EP2458990B1 (en) * 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
BR112012013148A2 (pt) * 2009-12-29 2017-03-21 F Hoffmann - La Roche Ag formulação farmacêutica e uso
EP3409289B1 (en) * 2010-02-26 2020-09-30 Novo Nordisk A/S Stable antibody containing compositions
EP2399604A1 (en) * 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
MA37946B1 (fr) * 2012-09-20 2018-09-28 Morphosys Ag Utilisation d’un anticorps anti-gm-csf pour le traitement de la polyarthrite rhumatoïde
WO2014068029A1 (en) * 2012-10-31 2014-05-08 Takeda Gmbh Lyophilized formulation comprising gm-csf neutralizing compound

Also Published As

Publication number Publication date
PH12015500864A1 (en) 2015-06-22
US10758621B2 (en) 2020-09-01
AU2013340845B2 (en) 2018-02-22
AU2013340845A1 (en) 2015-03-26
EP3744344A1 (en) 2020-12-02
KR20150075083A (ko) 2015-07-02
PH12015500864B1 (en) 2015-06-22
KR102106914B1 (ko) 2020-05-08
EA032829B1 (ru) 2019-07-31
EP2914290B1 (en) 2020-04-01
AR093297A1 (es) 2015-05-27
WO2014068026A1 (en) 2014-05-08
US9919051B2 (en) 2018-03-20
MX363807B (es) 2019-04-03
CN104768580A (zh) 2015-07-08
BR112015009259B1 (pt) 2022-05-17
BR112015009259A2 (https=) 2017-08-22
BR112015009259B8 (pt) 2022-08-23
EP2914290A1 (en) 2015-09-09
JP2015536931A (ja) 2015-12-24
TW201438735A (zh) 2014-10-16
CN104768580B (zh) 2018-11-02
JP6346189B2 (ja) 2018-06-20
MX2015005237A (es) 2015-10-29
US20180207278A1 (en) 2018-07-26
TWI639440B (zh) 2018-11-01
EA201590509A1 (ru) 2015-10-30
US20150314001A1 (en) 2015-11-05
HK1214761A1 (en) 2016-08-05
CA2889307A1 (en) 2014-05-08

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