AU2018368466B2 - VEGFR-Fc fusion protein formulations - Google Patents

VEGFR-Fc fusion protein formulations Download PDF

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Publication number
AU2018368466B2
AU2018368466B2 AU2018368466A AU2018368466A AU2018368466B2 AU 2018368466 B2 AU2018368466 B2 AU 2018368466B2 AU 2018368466 A AU2018368466 A AU 2018368466A AU 2018368466 A AU2018368466 A AU 2018368466A AU 2018368466 B2 AU2018368466 B2 AU 2018368466B2
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Australia
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formulation
val
ser
thr
lys
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AU2018368466A1 (en
Inventor
William J. Callahan
Robert Matthew FESINMEYER
Rahul Rajan KAUSHIK
Sai Chakradhar PADALA
Yael Wexler-Cohen
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Amgen Inc
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Amgen Inc
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Priority to AU2024205240A priority Critical patent/AU2024205240A1/en
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Classifications

    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1858—Platelet-derived growth factor [PDGF]
    • A61K38/1866—Vascular endothelial growth factor [VEGF]
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/26—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • 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
    • 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
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Vascular Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
AU2018368466A 2017-11-17 2018-11-16 VEGFR-Fc fusion protein formulations Active AU2018368466B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024205240A AU2024205240A1 (en) 2017-11-17 2024-07-31 VEGFR-Fc fusion protein formulations

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024205240A Division AU2024205240A1 (en) 2017-11-17 2024-07-31 VEGFR-Fc fusion protein formulations

Publications (2)

Publication Number Publication Date
AU2018368466A1 AU2018368466A1 (en) 2020-06-18
AU2018368466B2 true AU2018368466B2 (en) 2024-06-20

Family

ID=65041879

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2018368466A Active AU2018368466B2 (en) 2017-11-17 2018-11-16 VEGFR-Fc fusion protein formulations
AU2024205240A Pending AU2024205240A1 (en) 2017-11-17 2024-07-31 VEGFR-Fc fusion protein formulations

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024205240A Pending AU2024205240A1 (en) 2017-11-17 2024-07-31 VEGFR-Fc fusion protein formulations

Country Status (8)

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

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2020005170A (es) 2017-11-17 2020-10-16 Amgen Inc Formulaciones de proteinas de fusion vegfr-fc.
AU2019212622B2 (en) 2018-01-26 2024-05-23 The Regents Of The University Of 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
EP3761953A1 (en) 2018-03-08 2021-01-13 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2020055123A1 (ko) 2018-09-10 2020-03-19 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
WO2021050687A1 (en) * 2019-09-10 2021-03-18 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
BR112022010113A2 (pt) 2019-11-25 2022-09-06 Univ California Inibidores de vegf de longa ação para neovascularização intraocular
CA3190325A1 (en) * 2020-07-31 2022-02-03 Celltrion Inc. Stable pharmaceutical preparation
US20240166718A1 (en) * 2021-02-17 2024-05-23 Arecor Limited Aqueous composition of an engineered protein construct comprising an fc domain
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
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
US12240888B1 (en) 2024-04-29 2025-03-04 QILU Pharmaceutical, Co., Ltd. Composition comprising aflibercept and a variant thereof, and related methods and uses
JP2026054929A (ja) 2024-09-17 2026-03-30 キオクシア株式会社 メモリシステムおよび制御方法

Family Cites Families (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI1478394T1 (sl) 2002-02-27 2008-12-31 Immunex Corp STABILIZIRAN TNFR-Fc SESTAVEK Z ARGININOM
MXPA05010555A (es) 2003-04-04 2006-03-09 Genentech Inc Formulaciones de proteina y anticuerpo de alta concentracion.
US7303748B2 (en) 2005-02-02 2007-12-04 Regeneron Pharmaceuticals, Inc. Method of treating eye injury with local administration of a VEGF inhibitor
ES2633574T3 (es) 2005-03-25 2017-09-22 Regeneron Pharmaceuticals, Inc. Formulaciones de antagonistas de VEGF
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
US8216575B2 (en) 2006-03-31 2012-07-10 Chengdu Kanghong Biotechnologies Co., Ltd. Inhibition of neovascularization with a soluble chimeric protein comprising VEGF FLT-1 and KDR domains
CA2654510C (en) 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
CN103816115B (zh) 2010-08-31 2017-06-27 成都康弘生物科技有限公司 一种含有抑制血管增生的融合蛋白的药物组合物及用途
ES2985784T3 (es) 2011-11-18 2024-11-07 Regeneron Pharma Micropartículas de proteínas recubiertas con polímeros para formulaciones de liberación prolongada para su uso en el humor vítreo del ojo para tratar trastornos oculares vasculares
JP6313712B2 (ja) 2011-12-21 2018-04-18 アムジエン・インコーポレーテツド 新生児Ｆｃ受容体への結合を強化された変異型Ｆｃポリペプチド
CN103212075B (zh) 2012-01-19 2017-06-27 成都康弘生物科技有限公司 一种含有vegf拮抗剂的滴眼液
US20130323242A1 (en) * 2012-06-01 2013-12-05 Ophthotech Corp. Compositions comprising an anti-pdgf aptamer and a vegf antagonist
AU2013267310A1 (en) 2012-06-01 2014-12-11 Ophthotech Corporation Compositions comprising an anti-PDGF aptamer and a VEGF antagonist
UA115789C2 (uk) * 2012-09-05 2017-12-26 Трейкон Фармасутікалз, Інк. Композиція антитіла до cd105 та її застосування
WO2014078627A1 (en) 2012-11-19 2014-05-22 Merck Sharp & Dohme Corp. Liquid formulations for tnfr:fc fusion proteins
CA2926853C (en) 2013-10-18 2022-04-26 Regeneron Pharmaceuticals, Inc. Methods and compositions comprising a combination of a vegf antagonist and an anti-ctla-4 antibody
CN105435222B (zh) 2014-09-25 2018-05-29 信达生物制药(苏州)有限公司 重组融合蛋白制剂
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
EP3362041B1 (en) 2015-10-16 2026-04-08 Regeneron Pharmaceuticals, Inc. Stable protein compositions
ES2981791T3 (es) 2015-12-16 2024-10-10 Regeneron Pharma Composiciones y métodos para fabricar micropartículas de proteína
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist
EP3436473A4 (en) 2016-03-29 2019-10-23 Navya Biologicals Pvt. Ltd. METHOD FOR PURIFYING FC FUSION PROTEINS
KR101685532B1 (ko) 2016-04-26 2016-12-13 한국프라임제약주식회사 혈관내피성장인자 수용체 융합단백질
EP3518971A4 (en) 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System ANTIBODIES AND THERAPEUTIC PROTEIN FORMULATIONS AND USES THEREOF
PT3528787T (pt) 2016-10-21 2026-03-11 Amgen Inc Formulações farmacêuticas e métodos para produzir as mesmas
JP7116059B2 (ja) 2016-11-21 2022-08-09 ジャスト－エヴォテック バイオロジックス、インコーポレイテッド アフリベルセプト製剤及びその使用
CR20190291A (es) 2016-12-23 2019-11-05 Serum Institute Of India Pvt Ltd Métodos mejorados para estimular la productividad de anticuerpos en el cultivo de células de mamiferos y reducir la agregación durante los procesos de formulación post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos
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
US20200255496A1 (en) 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
CN107595765A (zh) 2017-09-22 2018-01-19 沈阳兴齐眼药股份有限公司 一种眼用缓释药物递送系统及其制备方法
MX2020005170A (es) 2017-11-17 2020-10-16 Amgen Inc Formulaciones de proteinas de fusion vegfr-fc.
MY202872A (en) 2017-11-20 2024-05-28 Just Evotec Biologics Inc Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
WO2019124946A1 (ko) 2017-12-22 2019-06-27 삼성바이오에피스 주식회사 Vegf 길항제를 포함하는 액상 조성물
EP3761953A1 (en) * 2018-03-08 2021-01-13 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
US11426446B2 (en) 2018-03-08 2022-08-30 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
WO2020055123A1 (ko) 2018-09-10 2020-03-19 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
US20210353713A1 (en) 2018-10-26 2021-11-18 Amgen Inc. Formulations comprising a tris buffer and a protein
EP3923907B1 (en) 2019-02-13 2024-09-25 Novaliq GmbH Compositions and methods for the treatment of ocular neovascularization
GB201911461D0 (en) 2019-08-09 2019-09-25 Arecor Ltd Novel composition
WO2021050687A1 (en) 2019-09-10 2021-03-18 Coherus Biosciences, Inc. Stable aqueous formulations of aflibercept

Also Published As

Publication number Publication date
EP3709971A2 (en) 2020-09-23
JP7536640B2 (ja) 2024-08-20
WO2019099921A3 (en) 2019-06-27
US12156900B2 (en) 2024-12-03
JP2021503485A (ja) 2021-02-12
CA3082899A1 (en) 2019-05-23
JP2024160287A (ja) 2024-11-13
MX2020005170A (es) 2020-10-16
US20250082726A1 (en) 2025-03-13
AU2024205240A1 (en) 2024-08-22
MX2025004779A (es) 2025-05-02
AU2018368466A1 (en) 2020-06-18
MA50908A (fr) 2020-09-23
US20200338164A1 (en) 2020-10-29
WO2019099921A2 (en) 2019-05-23

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