CA3082899A1 - Vegfr-fc fusion protein formulations - Google Patents
Vegfr-fc fusion protein formulations Download PDFInfo
- 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
- Authority
- 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
Links
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)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (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)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Ophthalmology & Optometry (AREA)
- Vascular Medicine (AREA)
- Organic Chemistry (AREA)
- Cell Biology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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 (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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7536640B2 (ja) | 2017-11-17 | 2024-08-20 | アムジエン・インコーポレーテツド | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
| FI3743091T3 (fi) | 2018-01-26 | 2025-01-03 | Univ California | Menetelmät ja koostumukset verisuoniperäisten sairauksien hoitoon käyttämällä anti-vegf vaikuttavia aineita |
| 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 |
| US11103552B2 (en) | 2018-05-10 | 2021-08-31 | Regeneron Pharmaceuticals, Inc. | High concentration VEGF receptor fusion protein containing formulations |
| 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 |
| WO2021108255A1 (en) | 2019-11-25 | 2021-06-03 | The Regents Of The University Of California | Long-acting vegf inhibitors for intraocular neovascularization |
| US20230312683A1 (en) * | 2020-07-31 | 2023-10-05 | Celltrion Inc. | Stable pharmaceutical preparation |
| MX2023009614A (es) * | 2021-02-17 | 2023-08-24 | Arecor Ltd | Composicion acuosa de una construccion de proteina modificada geneticamente que comprende un dominio fc. |
| US11723955B1 (en) | 2022-05-13 | 2023-08-15 | Allgenesis Biotherapeutics Inc. | VEGFR fusion protein pharmaceutical composition |
| TW202602913A (zh) * | 2024-04-29 | 2026-01-16 | 大陸商齊魯製藥有限公司 | 包含阿柏西普和其變體的組合物以及相關方法和應用 |
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT1946776T (pt) | 2002-02-27 | 2017-03-17 | Immunex Corp | Composição de tnfr-fc estabilizada compreendendo arginina |
| CN1798575A (zh) | 2003-04-04 | 2006-07-05 | 健泰科生物技术公司 | 高浓度抗体和蛋白制剂 |
| US7303748B2 (en) | 2005-02-02 | 2007-12-04 | Regeneron Pharmaceuticals, Inc. | Method of treating eye injury with local administration of a VEGF inhibitor |
| CN102614134B (zh) | 2005-03-25 | 2016-09-07 | 瑞泽恩制药公司 | Vegf拮抗剂制剂 |
| MX2007015476A (es) | 2005-06-14 | 2008-02-25 | Amgen Inc | Formulaciones de proteina autoamortiguadoras. |
| 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 |
| US7608261B2 (en) | 2006-06-16 | 2009-10-27 | Regeneron Pharmacuticals, 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 |
| PL3574897T3 (pl) | 2011-11-18 | 2022-05-09 | Regeneron Pharmaceuticals, Inc. | Postać użytkowa o przedłużonym uwalnianiu zawierająca mikrocząstki białka polimerowego do stosowania w ciele szklistym oka w leczeniu naczyniowych zaburzeń oczu |
| AU2012355435A1 (en) | 2011-12-21 | 2014-07-17 | Amgen Inc. | Variant Fc-polypeptides with enhanced binding to the neonatal Fc receptor |
| CN107115294B (zh) | 2012-01-19 | 2019-10-18 | 北京康弘生物医药有限公司 | 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 |
| EP2919812A4 (en) | 2012-11-19 | 2016-05-18 | Merck Sharp & Dohme | Liquid formulations for TNFR: FC fusion proteins |
| WO2015058048A1 (en) | 2013-10-18 | 2015-04-23 | 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 |
| WO2017066554A1 (en) | 2015-10-16 | 2017-04-20 | Regeneron Pharmaceuticals, Inc. | Stable protein compositions |
| JP7185526B2 (ja) | 2015-12-16 | 2022-12-07 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | タンパク質微粒子の組成物及び製造方法 |
| AU2017213103B2 (en) * | 2016-01-26 | 2022-08-11 | Formycon Ag | Liquid formulation of a VEGF antagonist |
| WO2017168296A1 (en) | 2016-03-29 | 2017-10-05 | Navya Biologicals Pvt. Ltd | A process for purification of fc-fusion proteins |
| KR101685532B1 (ko) | 2016-04-26 | 2016-12-13 | 한국프라임제약주식회사 | 혈관내피성장인자 수용체 융합단백질 |
| CA3038894A1 (en) | 2016-09-28 | 2018-04-05 | Board Of Regents, The University Of Texas System | Antibody and protein therapeutic formulations and uses thereof |
| AU2017345490B2 (en) | 2016-10-21 | 2022-07-07 | Amgen Inc. | Pharmaceutical formulations and methods of making the same |
| CN109937034B (zh) | 2016-11-21 | 2022-09-16 | 济世-伊沃泰克生物制品有限公司 | 阿柏西普制剂及其用途 |
| 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 |
| MA50174A (fr) | 2017-09-18 | 2020-07-29 | Amgen Inc | Formules de protéines de fusion vegfr-fc |
| 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 |
| JP7536640B2 (ja) | 2017-11-17 | 2024-08-20 | アムジエン・インコーポレーテツド | ＶＥＧＦＲ－Ｆｃ融合タンパク質製剤 |
| CA3081094A1 (en) | 2017-11-20 | 2019-05-23 | Alison J. GILLESPIE | Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof |
| KR102742284B1 (ko) | 2017-12-22 | 2024-12-16 | 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 |
| US11103552B2 (en) | 2018-05-10 | 2021-08-31 | Regeneron Pharmaceuticals, Inc. | High concentration VEGF receptor fusion protein containing formulations |
| WO2020055123A1 (ko) | 2018-09-10 | 2020-03-19 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
| WO2020087003A1 (en) | 2018-10-26 | 2020-04-30 | Amgen Inc. | Formulations comprising a tris buffer and a protein |
| CN113710228A (zh) | 2019-02-13 | 2021-11-26 | 诺瓦利克有限责任公司 | 用于治疗眼部新生血管形成的组合物和方法 |
| 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 |
-
2018
- 2018-11-16 JP JP2020527828A patent/JP7536640B2/ja active Active
- 2018-11-16 CA CA3082899A patent/CA3082899A1/en active Pending
- 2018-11-16 MA MA050908A patent/MA50908A/fr unknown
- 2018-11-16 US US16/764,463 patent/US12156900B2/en active Active
- 2018-11-16 AU AU2018368466A patent/AU2018368466B2/en active Active
- 2018-11-16 WO PCT/US2018/061644 patent/WO2019099921A2/en not_active Ceased
- 2018-11-16 MX MX2020005170A patent/MX2020005170A/es unknown
- 2018-11-16 EP EP18836718.9A patent/EP3709971A2/en active Pending
-
2020
- 2020-07-13 MX MX2025004779A patent/MX2025004779A/es unknown
-
2024
- 2024-07-31 AU AU2024205240A patent/AU2024205240A1/en active Pending
- 2024-08-06 JP JP2024129687A patent/JP2024160287A/ja active Pending
- 2024-11-25 US US18/959,137 patent/US20250082726A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3709971A2 (en) | 2020-09-23 |
| MX2025004779A (es) | 2025-05-02 |
| MA50908A (fr) | 2020-09-23 |
| US20250082726A1 (en) | 2025-03-13 |
| US20200338164A1 (en) | 2020-10-29 |
| WO2019099921A3 (en) | 2019-06-27 |
| MX2020005170A (es) | 2020-10-16 |
| JP2024160287A (ja) | 2024-11-13 |
| WO2019099921A2 (en) | 2019-05-23 |
| JP2021503485A (ja) | 2021-02-12 |
| AU2018368466A1 (en) | 2020-06-18 |
| US12156900B2 (en) | 2024-12-03 |
| AU2018368466B2 (en) | 2024-06-20 |
| AU2024205240A1 (en) | 2024-08-22 |
| JP7536640B2 (ja) | 2024-08-20 |
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