AU2019265005B2 - High concentration VEGF receptor fusion protein containing formulations - Google Patents

High concentration VEGF receptor fusion protein containing formulations Download PDF

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Publication number
AU2019265005B2
AU2019265005B2 AU2019265005A AU2019265005A AU2019265005B2 AU 2019265005 B2 AU2019265005 B2 AU 2019265005B2 AU 2019265005 A AU2019265005 A AU 2019265005A AU 2019265005 A AU2019265005 A AU 2019265005A AU 2019265005 B2 AU2019265005 B2 AU 2019265005B2
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AU
Australia
Prior art keywords
formulation
fusion protein
vegf receptor
receptor fusion
histidine
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AU2019265005A
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AU2019265005A1 (en
Inventor
Kenneth S. Graham
Saurabh Wadhwa
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of AU2019265005A1 publication Critical patent/AU2019265005A1/en
Priority to AU2024100037A priority Critical patent/AU2024100037B4/en
Application granted granted Critical
Publication of AU2019265005B2 publication Critical patent/AU2019265005B2/en
Priority to AU2025204229A priority patent/AU2025204229A1/en
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    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • 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
    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
AU2019265005A 2018-05-10 2019-05-10 High concentration VEGF receptor fusion protein containing formulations Active AU2019265005B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2024100037A AU2024100037B4 (en) 2018-05-10 2024-09-20 High concentration VEGF receptor fusion protein containing formulations
AU2025204229A AU2025204229A1 (en) 2018-05-10 2025-06-05 High Concentration VEGF Receptor Fusion Protein Containing Formulations

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201862669506P 2018-05-10 2018-05-10
US62/669,506 2018-05-10
US201862752127P 2018-10-29 2018-10-29
US62/752,127 2018-10-29
US201862769876P 2018-11-20 2018-11-20
US62/769,876 2018-11-20
US201962813882P 2019-03-05 2019-03-05
US62/813,882 2019-03-05
PCT/US2019/031879 WO2019217927A1 (en) 2018-05-10 2019-05-10 High concentration vegf receptor fusion protein containing formulations

Related Child Applications (2)

Application Number Title Priority Date Filing Date
AU2024100037A Division AU2024100037B4 (en) 2018-05-10 2024-09-20 High concentration VEGF receptor fusion protein containing formulations
AU2025204229A Division AU2025204229A1 (en) 2018-05-10 2025-06-05 High Concentration VEGF Receptor Fusion Protein Containing Formulations

Publications (2)

Publication Number Publication Date
AU2019265005A1 AU2019265005A1 (en) 2020-12-17
AU2019265005B2 true AU2019265005B2 (en) 2025-03-13

Family

ID=66669104

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2019265005A Active AU2019265005B2 (en) 2018-05-10 2019-05-10 High concentration VEGF receptor fusion protein containing formulations
AU2024100037A Active AU2024100037B4 (en) 2018-05-10 2024-09-20 High concentration VEGF receptor fusion protein containing formulations
AU2025204229A Pending AU2025204229A1 (en) 2018-05-10 2025-06-05 High Concentration VEGF Receptor Fusion Protein Containing Formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2024100037A Active AU2024100037B4 (en) 2018-05-10 2024-09-20 High concentration VEGF receptor fusion protein containing formulations
AU2025204229A Pending AU2025204229A1 (en) 2018-05-10 2025-06-05 High Concentration VEGF Receptor Fusion Protein Containing Formulations

Country Status (28)

Country Link
US (4) US11103552B2 (https=)
EP (3) EP3790532A1 (https=)
JP (3) JP7235770B2 (https=)
KR (1) KR20210021299A (https=)
CN (5) CN121570417A (https=)
AU (3) AU2019265005B2 (https=)
BR (1) BR112020022610A2 (https=)
CA (2) CA3099551C (https=)
CL (3) CL2020002872A1 (https=)
CO (1) CO2020014427A2 (https=)
DK (1) DK4364724T3 (https=)
ES (1) ES3056525T3 (https=)
FI (1) FI4364724T3 (https=)
HR (1) HRP20260001T1 (https=)
IL (2) IL318714A (https=)
JO (1) JOP20200275A1 (https=)
LT (1) LT4364724T (https=)
MA (1) MA52570A (https=)
MX (3) MX421310B (https=)
MY (1) MY204232A (https=)
NZ (1) NZ770284A (https=)
PH (1) PH12020551839A1 (https=)
PL (1) PL4364724T3 (https=)
PT (1) PT4364724T (https=)
RS (1) RS67656B1 (https=)
SG (1) SG11202010684YA (https=)
SI (1) SI4364724T1 (https=)
WO (1) WO2019217927A1 (https=)

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