CA3082899A1 - Vegfr-fc fusion protein formulations - Google Patents

Vegfr-fc fusion protein formulations Download PDF

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Publication number
CA3082899A1
CA3082899A1 CA3082899A CA3082899A CA3082899A1 CA 3082899 A1 CA3082899 A1 CA 3082899A1 CA 3082899 A CA3082899 A CA 3082899A CA 3082899 A CA3082899 A CA 3082899A CA 3082899 A1 CA3082899 A1 CA 3082899A1
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CA
Canada
Prior art keywords
formulation
formulations
trehalose
sucrose
concentration
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.)
Pending
Application number
CA3082899A
Other languages
English (en)
French (fr)
Inventor
Yael Wexler-Cohen
Rahul Rajan KAUSHIK
William J. Callahan
Sai Chakradhar PADALA
Robert Matthew FESINMEYER
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.)
Amgen Inc
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Publication of CA3082899A1 publication Critical patent/CA3082899A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1858Platelet-derived growth factor [PDGF]
    • A61K38/1866Vascular endothelial growth factor [VEGF]
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Cell Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA3082899A 2017-11-17 2018-11-16 Vegfr-fc fusion protein formulations Pending CA3082899A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762587733P 2017-11-17 2017-11-17
US62/587,733 2017-11-17
US201862618904P 2018-01-18 2018-01-18
US62/618,904 2018-01-18
PCT/US2018/061644 WO2019099921A2 (en) 2017-11-17 2018-11-16 Vegfr-fc fusion protein formulations

Publications (1)

Publication Number Publication Date
CA3082899A1 true CA3082899A1 (en) 2019-05-23

Family

ID=65041879

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3082899A Pending CA3082899A1 (en) 2017-11-17 2018-11-16 Vegfr-fc fusion protein formulations

Country Status (8)

Country Link
US (2) US12156900B2 (enExample)
EP (1) EP3709971A2 (enExample)
JP (2) JP7536640B2 (enExample)
AU (2) AU2018368466B2 (enExample)
CA (1) CA3082899A1 (enExample)
MA (1) MA50908A (enExample)
MX (2) MX2020005170A (enExample)
WO (1) WO2019099921A2 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA50908A (fr) 2017-11-17 2020-09-23 Amgen Inc Formulations de protéines de fusion vegfr-fc
ES3009668T3 (en) 2018-01-26 2025-03-31 Univ California Methods and compositions for treatment of angiogenic disorders using anti-vegf agents
US11426446B2 (en) 2018-03-08 2022-08-30 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
WO2019173767A1 (en) * 2018-03-08 2019-09-12 Coherus Biosciences Inc. Stable aqueous formulations of aflibercept
KR20210021299A (ko) 2018-05-10 2021-02-25 리제너론 파아마슈티컬스, 인크. 고농도 vegf 수용체 융합 단백질 함유 제제
KR20200029374A (ko) * 2018-09-10 2020-03-18 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
WO2021050687A1 (en) * 2019-09-10 2021-03-18 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
EP4065150A4 (en) 2019-11-25 2023-12-06 The Regents of the University of California LONG-ACTING VEGF INHIBITORS FOR INTRAVASCULAR NEOVASCULARIZATION
US20230312683A1 (en) * 2020-07-31 2023-10-05 Celltrion Inc. Stable pharmaceutical preparation
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
US12240888B1 (en) 2024-04-29 2025-03-04 QILU Pharmaceutical, Co., Ltd. Composition comprising aflibercept and a variant thereof, and related methods and uses
WO2025227916A1 (zh) * 2024-04-29 2025-11-06 齐鲁制药有限公司 包含阿柏西普和其变体的组合物以及相关方法和应用

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US11426446B2 (en) 2018-03-08 2022-08-30 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
KR20210021299A (ko) 2018-05-10 2021-02-25 리제너론 파아마슈티컬스, 인크. 고농도 vegf 수용체 융합 단백질 함유 제제
KR20200029374A (ko) 2018-09-10 2020-03-18 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
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WO2021050687A1 (en) 2019-09-10 2021-03-18 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept

Also Published As

Publication number Publication date
AU2018368466B2 (en) 2024-06-20
US12156900B2 (en) 2024-12-03
US20200338164A1 (en) 2020-10-29
US20250082726A1 (en) 2025-03-13
MA50908A (fr) 2020-09-23
AU2018368466A1 (en) 2020-06-18
MX2025004779A (es) 2025-05-02
JP2021503485A (ja) 2021-02-12
MX2020005170A (es) 2020-10-16
AU2024205240A1 (en) 2024-08-22
JP7536640B2 (ja) 2024-08-20
WO2019099921A3 (en) 2019-06-27
EP3709971A2 (en) 2020-09-23
JP2024160287A (ja) 2024-11-13
WO2019099921A2 (en) 2019-05-23

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