BR112017027945A2 - formulação líquida estável de proteína de fusão com domínio igg fc e composição para estabilizar uma proteína - Google Patents

formulação líquida estável de proteína de fusão com domínio igg fc e composição para estabilizar uma proteína

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Publication number
BR112017027945A2
BR112017027945A2 BR112017027945-2A BR112017027945A BR112017027945A2 BR 112017027945 A2 BR112017027945 A2 BR 112017027945A2 BR 112017027945 A BR112017027945 A BR 112017027945A BR 112017027945 A2 BR112017027945 A2 BR 112017027945A2
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BR
Brazil
Prior art keywords
domain
protein
igg
liquid formulation
stable liquid
Prior art date
Application number
BR112017027945-2A
Other languages
English (en)
Inventor
Jae Park Soon
Shin Chung Hye
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.)
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Publication date
Application filed by Alteogen, Inc. filed Critical Alteogen, Inc.
Publication of BR112017027945A2 publication Critical patent/BR112017027945A2/pt

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    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (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

a presente invenção refere-se a uma formulação líquida estável de uma proteína de fusão possuindo um domínio fc de uma imunoglobulina humana g (igg) (em particular, uma proteína em que um domínio fc de uma imunoglobulina humana g (igg) e um domínio extracelular solúvel de um receptor do fator de crescimento endotelial vascular (vegf) são fundidos (por exemplo, aflibercept)). além disso, a presente invenção refere-se a uma composição para estabilizar uma proteína em que um domínio fc de uma igg e um domínio extracelular solúvel de um receptor de vegf são fundidos, e a um método para estabilizar uma proteína em que um domínio fc de uma igg e um domínio extracelular solúvel de um receptor de vegf são fundidos. a presente invenção melhora os efeitos terapêuticos sobre várias doenças oftálmicas (por exemplo, oclusão da veia da retina, edema macular diabético, neovascularização coroidal e degeneração macular relacionada com a idade úmida, etc.) causadas por angiogênese anormal, enquanto persegue a estabilização da bioatividade através de uma formulação líquida estável adequada para injeção intravítrea de uma proteína de fusão anti-vegf-fc incluindo aflibercept.
BR112017027945-2A 2015-06-23 2016-06-23 formulação líquida estável de proteína de fusão com domínio igg fc e composição para estabilizar uma proteína BR112017027945A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
KR20150089186 2015-06-23
KR10-2015-0089186 2015-06-23
KR1020160078234A KR101808234B1 (ko) 2015-06-23 2016-06-22 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
KR10-2016-0078234 2016-06-22
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
BR112017027945A2 true BR112017027945A2 (pt) 2018-08-28

Family

ID=57810344

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017027945-2A BR112017027945A2 (pt) 2015-06-23 2016-06-23 formulação líquida estável de proteína de fusão com domínio igg fc e composição para estabilizar uma proteína

Country Status (11)

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

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CN116327963A (zh) * 2016-11-21 2023-06-27 济世-伊沃泰克生物制品有限公司 一种眼科制剂及其用途
KR101861163B1 (ko) * 2017-04-26 2018-05-25 삼천당제약주식회사 안과용 약학 조성물
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Also Published As

Publication number Publication date
EP3313373A1 (en) 2018-05-02
RU2688679C1 (ru) 2019-05-22
JP6541875B2 (ja) 2019-07-17
WO2016208989A1 (en) 2016-12-29
KR20170138387A (ko) 2017-12-15
KR20170000356A (ko) 2017-01-02
CN107889457B (zh) 2021-11-12
CN107889457A (zh) 2018-04-06
JP2018517773A (ja) 2018-07-05
EP3824879A1 (en) 2021-05-26
MX2017016907A (es) 2018-04-18
US9982032B2 (en) 2018-05-29
KR101808234B1 (ko) 2017-12-12
AU2016283557B9 (en) 2020-10-15
US20160376342A1 (en) 2016-12-29
EP3313373A4 (en) 2019-03-20
CA2990582C (en) 2020-06-09
AU2016283557A1 (en) 2017-12-14
AU2016283557B2 (en) 2020-04-09
KR20220130053A (ko) 2022-09-26
CA2990582A1 (en) 2016-12-29
CN114159386A (zh) 2022-03-11

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