CA3011638C - Liquid formulation of a vegf antagonist - Google Patents
Liquid formulation of a vegf antagonist Download PDFInfo
- Publication number
- CA3011638C CA3011638C CA3011638A CA3011638A CA3011638C CA 3011638 C CA3011638 C CA 3011638C CA 3011638 A CA3011638 A CA 3011638A CA 3011638 A CA3011638 A CA 3011638A CA 3011638 C CA3011638 C CA 3011638C
- Authority
- CA
- Canada
- Prior art keywords
- histidine
- aflibercept
- concentration
- polysorbate
- vegf
- 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.)
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Public Health (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
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- Zoology (AREA)
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- Dermatology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (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)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| EP16152767.6 | 2016-01-26 | ||
| EP16152767 | 2016-01-26 | ||
| EP16199497.5 | 2016-11-18 | ||
| EP16199497 | 2016-11-18 | ||
| PCT/EP2017/051662 WO2017129685A1 (en) | 2016-01-26 | 2017-01-26 | Liquid formulation of a vegf antagonist |
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| CA3011638A1 CA3011638A1 (en) | 2017-08-03 |
| CA3011638C true CA3011638C (en) | 2023-01-10 |
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| CA3011638A Active CA3011638C (en) | 2016-01-26 | 2017-01-26 | Liquid formulation of a vegf antagonist |
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| EP (1) | EP3407868A1 (enExample) |
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| CA (1) | CA3011638C (enExample) |
| WO (1) | WO2017129685A1 (enExample) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2432155C3 (ru) | 2006-06-16 | 2017-11-17 | Ридженерон Фармасьютикалз, Инк. | Составы антагониста vegf, подходящие для интравитреального введения |
| KR101808234B1 (ko) | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| EP3518971A4 (en) * | 2016-09-28 | 2020-05-13 | Board Of Regents, The University Of Texas System | Antibody and protein therapeutic formulations and uses thereof |
| EP3541365A1 (en) * | 2016-11-21 | 2019-09-25 | Just Biotherapeutics, Inc. | Aflibercept formulations and uses thereof |
| US10918754B2 (en) | 2017-03-27 | 2021-02-16 | Regeneron Pharmaceuticals, Inc. | Sterilisation method |
| WO2019020777A1 (en) | 2017-07-26 | 2019-01-31 | Formycon Ag | LIQUID FORMULATION OF A VEGF ANTAGONIST |
| EP3684332A1 (en) | 2017-09-18 | 2020-07-29 | Amgen Inc. | Vegfr-fc fusion protein formulations |
| MA50908A (fr) * | 2017-11-17 | 2020-09-23 | Amgen Inc | Formulations de protéines de fusion vegfr-fc |
| CN111356471A (zh) | 2017-11-20 | 2020-06-30 | 济世发展生物药业有限公司 | 包含赖氨酸盐作为张力调节剂的阿柏西普制剂及其用途 |
| KR20210021299A (ko) | 2018-05-10 | 2021-02-25 | 리제너론 파아마슈티컬스, 인크. | 고농도 vegf 수용체 융합 단백질 함유 제제 |
| BR112020026348A2 (pt) * | 2018-08-30 | 2021-03-30 | Regeneron Pharmaceuticals, Inc. | Método para avaliar a estequiometria e distribuição de tamanho de complexos de proteínas, para selecionar um medicamento de proteína principal e para caracterizar complexos de proteínas, e, composição farmacêutica |
| KR20200029374A (ko) * | 2018-09-10 | 2020-03-18 | 삼성바이오에피스 주식회사 | 단백질을 포함하는 액상 조성물 |
| WO2020087003A1 (en) | 2018-10-26 | 2020-04-30 | Amgen Inc. | Formulations comprising a tris buffer and a protein |
| IL281717B2 (en) * | 2018-10-29 | 2025-07-01 | Hoffmann La Roche | Antibody formulation |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| KR20230152810A (ko) | 2019-12-06 | 2023-11-03 | 리제너론 파아마슈티컬스, 인크. | 항-vegf 단백질 조성물 및 이를 생산하는 방법 |
| KR20220149690A (ko) * | 2020-03-04 | 2022-11-08 | 상하이 헨리우스 바이오테크, 인크. | 베바시주맙을 포함하는 약물 조제용 제제 |
| JP2023525034A (ja) | 2020-05-08 | 2023-06-14 | 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 | Vegfトラップおよびミニトラップならびに眼障害およびがんの治療方法 |
| 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 |
| WO2025217334A1 (en) * | 2024-04-09 | 2025-10-16 | Regeneron Pharmaceuticals, Inc. | Low concentration vegf receptor fusion protein containing formulations |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US6124449A (en) | 1990-06-11 | 2000-09-26 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands and inhibitors |
| US5731424A (en) | 1990-06-11 | 1998-03-24 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands and inhibitors |
| US5731144A (en) | 1990-06-11 | 1998-03-24 | Nexstar Pharmaceuticals, Inc. | High affinity TGFβ nucleic acid ligands |
| US6582959B2 (en) | 1991-03-29 | 2003-06-24 | Genentech, Inc. | Antibodies to vascular endothelial cell growth factor |
| ATE348110T1 (de) | 1992-10-28 | 2007-01-15 | Genentech Inc | Hvegf rezeptor als vegf antagonist |
| IL117645A (en) | 1995-03-30 | 2005-08-31 | Genentech Inc | Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration |
| JP4531132B2 (ja) | 1995-06-02 | 2010-08-25 | ギリード・サイエンシズ・インコーポレーテッド | 増殖因子に対する高親和性オリゴヌクレオチドリガンド |
| SI1695985T1 (sl) | 1997-04-07 | 2011-06-30 | Genentech Inc | Postopki za tvorbo humaniziranih protiteles z naključno mutagenezo |
| WO1998045331A2 (en) | 1997-04-07 | 1998-10-15 | Genentech, Inc. | Anti-vegf antibodies |
| US20020032315A1 (en) | 1997-08-06 | 2002-03-14 | Manuel Baca | Anti-vegf antibodies |
| US6703020B1 (en) | 1999-04-28 | 2004-03-09 | Board Of Regents, The University Of Texas System | Antibody conjugate methods for selectively inhibiting VEGF |
| CA2376379C (en) | 1999-06-08 | 2007-08-07 | Regeneron Pharmaceuticals, Inc. | Modified chimeric polypeptides with improved pharmacokinetic properties |
| WO2005044853A2 (en) | 2003-11-01 | 2005-05-19 | Genentech, Inc. | Anti-vegf antibodies |
| CN102614134B (zh) * | 2005-03-25 | 2016-09-07 | 瑞泽恩制药公司 | Vegf拮抗剂制剂 |
| RU2432155C3 (ru) * | 2006-06-16 | 2017-11-17 | Ридженерон Фармасьютикалз, Инк. | Составы антагониста vegf, подходящие для интравитреального введения |
| EP3219294A1 (en) * | 2006-06-20 | 2017-09-20 | Ben-Gurion University of The Negev Research and Development Authority | Amphiphilic peptides and hydrogel matrices thereof for bone repair |
| KR102095257B1 (ko) | 2008-06-25 | 2020-04-01 | 노바르티스 아게 | Vegf를 억제하는 안정하고 가용성인 항체 |
| WO2010060748A1 (en) | 2008-11-03 | 2010-06-03 | Molecular Partners Ag | Binding proteins inhibiting the vegf-a receptor interaction |
| AR081361A1 (es) | 2010-04-30 | 2012-08-29 | Molecular Partners Ag | Proteinas de union modificadas que inhiben la interaccion de receptor del factor de crecimiento endotelial vascular de glicoproteina a vegf-a |
| US20130323242A1 (en) * | 2012-06-01 | 2013-12-05 | Ophthotech Corp. | Compositions comprising an anti-pdgf aptamer and a vegf antagonist |
| KR20150033620A (ko) * | 2012-06-01 | 2015-04-01 | 옵쏘테크 코포레이션 | 항-pdgf 압타머 및 vegf 길항제를 포함하는 조성물 |
| JP2015528454A (ja) * | 2012-08-28 | 2015-09-28 | ノバルティス アーゲー | 眼血管増殖性疾患の処置におけるvegfアンタゴニストの使用 |
| EP3010525A1 (en) * | 2013-06-20 | 2016-04-27 | Novartis AG | Use of a vegf antagonist in treating choroidal neovascularisation |
| ES2875878T3 (es) | 2013-11-18 | 2021-11-11 | Formycon Ag | Composición farmacéutica de un anticuerpo anti-VEGF |
| WO2015173260A1 (en) | 2014-05-12 | 2015-11-19 | Formycon Ag | Pre-filled plastic syringe containing a vegf antagonist |
| KR101808234B1 (ko) * | 2015-06-23 | 2017-12-12 | (주)알테오젠 | IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제 |
| EP3377151A1 (en) | 2015-11-18 | 2018-09-26 | Formycon AG | Pre-filled plastic syringe containing a vegf antagonist |
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2017
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- 2017-01-26 AU AU2017213103A patent/AU2017213103B2/en active Active
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2020
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2023
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| AU2017213103B2 (en) | 2022-08-11 |
| US20200237862A1 (en) | 2020-07-30 |
| CA3011638A1 (en) | 2017-08-03 |
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| AU2017213103A1 (en) | 2018-07-26 |
| US20230248806A1 (en) | 2023-08-10 |
| US10576128B2 (en) | 2020-03-03 |
| EP3407868A1 (en) | 2018-12-05 |
| JP2019504882A (ja) | 2019-02-21 |
| US20190030123A1 (en) | 2019-01-31 |
| JP6953433B2 (ja) | 2021-10-27 |
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