MX2017016907A - Formulacion liquida estable de proteina de fusion con dominio fc de inmunoglobulina g (igg). - Google Patents

Formulacion liquida estable de proteina de fusion con dominio fc de inmunoglobulina g (igg).

Info

Publication number
MX2017016907A
MX2017016907A MX2017016907A MX2017016907A MX2017016907A MX 2017016907 A MX2017016907 A MX 2017016907A MX 2017016907 A MX2017016907 A MX 2017016907A MX 2017016907 A MX2017016907 A MX 2017016907A MX 2017016907 A MX2017016907 A MX 2017016907A
Authority
MX
Mexico
Prior art keywords
domain
igg
protein
liquid formulation
fusion protein
Prior art date
Application number
MX2017016907A
Other languages
English (en)
Inventor
Hye Shin Chung
Soon Jae Park
Young Kim Jun
Original Assignee
Alteogen Inc
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 Alteogen Inc filed Critical Alteogen Inc
Publication of MX2017016907A publication Critical patent/MX2017016907A/es

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Classifications

    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • 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
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6845—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a cytokine, e.g. growth factors, VEGF, TNF, a lymphokine or an interferon
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material 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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (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)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención está relacionada a una formulación líquida estable de una proteína de fusión que tiene un dominio Fc de una inmunoglobulina G humana (IgG) (en particular, una proteína en la cual un dominio Fc de una inmunoglobulina G humana (IgG) y un dominio extracelular soluble de un receptor del factor de crecimiento endotelial vascular (VEGF) están fusionados (por ejemplo, aflibercept)); además, la presente invención está relacionada a una composición para estabilizar una proteína en la cual un dominio Fc de una IgG y un dominio extracelular soluble de un receptor del VEGF están fusionados, y a un método para estabilizar una proteína en la cual un dominio Fc de una IgG y un dominio extracelular soluble de un receptor del VEGF están fusionados; la presente invención mejora los efectos terapéuticos de varias enfermedades oftálmicas (por ejemplo, oclusión de vena retinal, edema macular diabético, neovascularización coroidal y degeneración macular húmeda relacionada con la edad, etc.) causadas por la angiogénesis anormal, mientras que se persigue la estabilización de la bioactividad a través de una formulación líquida estable adecuada para inyección intravítrea de una proteína de fusión anti-VEGF-Fc que incluye aflibercept.
MX2017016907A 2015-06-23 2016-06-23 Formulacion liquida estable de proteina de fusion con dominio fc de inmunoglobulina g (igg). MX2017016907A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20150089186 2015-06-23
KR1020160078234A KR101808234B1 (ko) 2015-06-23 2016-06-22 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
PCT/KR2016/006679 WO2016208989A1 (en) 2015-06-23 2016-06-23 A stable liquid formulation of fusion protein with igg fc domain

Publications (1)

Publication Number Publication Date
MX2017016907A true MX2017016907A (es) 2018-04-18

Family

ID=57810344

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2017016907A MX2017016907A (es) 2015-06-23 2016-06-23 Formulacion liquida estable de proteina de fusion con dominio fc de inmunoglobulina g (igg).

Country Status (11)

Country Link
US (1) US9982032B2 (es)
EP (2) EP3313373A4 (es)
JP (1) JP6541875B2 (es)
KR (3) KR101808234B1 (es)
CN (2) CN114159386A (es)
AU (1) AU2016283557B9 (es)
BR (1) BR112017027945A2 (es)
CA (1) CA2990582C (es)
MX (1) MX2017016907A (es)
RU (1) RU2688679C1 (es)
WO (1) WO2016208989A1 (es)

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EP3407868A1 (en) * 2016-01-26 2018-12-05 Formycon AG Liquid formulation of a vegf antagonist
US11135266B2 (en) 2016-11-21 2021-10-05 Just-Evotec Biologics, Inc. Aflibercept formulations and uses thereof
KR101861163B1 (ko) * 2017-04-26 2018-05-25 삼천당제약주식회사 안과용 약학 조성물
WO2019020777A1 (en) * 2017-07-26 2019-01-31 Formycon Ag LIQUID FORMULATION OF A VEGF ANTAGONIST
WO2019055902A1 (en) 2017-09-18 2019-03-21 Amgen Inc. FUSION PROTEIN FORMULATIONS VEGFR-FC
US20200338164A1 (en) * 2017-11-17 2020-10-29 Amgen Inc. Vegfr-fc fusion protein formulations
WO2019099965A1 (en) * 2017-11-20 2019-05-23 Just Biotherapeutics, Inc. Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
KR20230021164A (ko) * 2017-12-22 2023-02-13 삼성바이오에피스 주식회사 Vegf 길항제를 포함하는 액상 조성물
WO2019173767A1 (en) * 2018-03-08 2019-09-12 Coherus Biosciences Inc. Stable aqueous formulations of aflibercept
US11426446B2 (en) 2018-03-08 2022-08-30 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
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Also Published As

Publication number Publication date
KR20170000356A (ko) 2017-01-02
AU2016283557B2 (en) 2020-04-09
KR20220130053A (ko) 2022-09-26
CN114159386A (zh) 2022-03-11
US20160376342A1 (en) 2016-12-29
AU2016283557A1 (en) 2017-12-14
EP3313373A1 (en) 2018-05-02
JP2018517773A (ja) 2018-07-05
CA2990582C (en) 2020-06-09
JP6541875B2 (ja) 2019-07-17
BR112017027945A2 (pt) 2018-08-28
KR101808234B1 (ko) 2017-12-12
EP3313373A4 (en) 2019-03-20
RU2688679C1 (ru) 2019-05-22
CA2990582A1 (en) 2016-12-29
US9982032B2 (en) 2018-05-29
KR20170138387A (ko) 2017-12-15
WO2016208989A1 (en) 2016-12-29
AU2016283557B9 (en) 2020-10-15
CN107889457A (zh) 2018-04-06
CN107889457B (zh) 2021-11-12
EP3824879A1 (en) 2021-05-26

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