WO2016127887A1 - 一种药用glp-1r抗体融合蛋白的稳定溶液制剂 - Google Patents

一种药用glp-1r抗体融合蛋白的稳定溶液制剂 Download PDF

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Publication number
WO2016127887A1
WO2016127887A1 PCT/CN2016/073279 CN2016073279W WO2016127887A1 WO 2016127887 A1 WO2016127887 A1 WO 2016127887A1 CN 2016073279 W CN2016073279 W CN 2016073279W WO 2016127887 A1 WO2016127887 A1 WO 2016127887A1
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WIPO (PCT)
Prior art keywords
glp
fusion protein
stable solution
antibody fusion
solution formulation
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.)
Ceased
Application number
PCT/CN2016/073279
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English (en)
French (fr)
Chinese (zh)
Inventor
张�成
章华
范克索
郭勇
景书谦
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.)
Gmax Biopharm LLC
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Gmax Biopharm LLC
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 Gmax Biopharm LLC filed Critical Gmax Biopharm LLC
Priority to CA2975633A priority Critical patent/CA2975633C/en
Priority to JP2017560858A priority patent/JP6731953B2/ja
Priority to US15/547,727 priority patent/US10485870B2/en
Priority to DK16748688.5T priority patent/DK3257524T3/da
Priority to AU2016218759A priority patent/AU2016218759B2/en
Priority to KR1020177023260A priority patent/KR102568272B1/ko
Priority to ES16748688T priority patent/ES2833099T3/es
Priority to EP16748688.5A priority patent/EP3257524B1/en
Priority to PL16748688T priority patent/PL3257524T3/pl
Publication of WO2016127887A1 publication Critical patent/WO2016127887A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • A61K47/50—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
    • A61K47/6835—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—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 the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • 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
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • 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
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • C07K14/575—Hormones
    • C07K14/605—Glucagons
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors

Definitions

  • pH can affect the solubility and stability of the GLP-1R antibody fusion protein and is the most critical parameter in the formulation of the preparation.
  • a stable solution formulation of a pharmaceutically acceptable GLP-1R fusion protein was prepared according to Table 1:

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Toxicology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
PCT/CN2016/073279 2015-02-11 2016-02-03 一种药用glp-1r抗体融合蛋白的稳定溶液制剂 Ceased WO2016127887A1 (zh)

Priority Applications (9)

Application Number Priority Date Filing Date Title
CA2975633A CA2975633C (en) 2015-02-11 2016-02-03 Stable pharmaceutical solution formulation of glp-1r antibody fusion protein
JP2017560858A JP6731953B2 (ja) 2015-02-11 2016-02-03 Ｇｌｐ−１ｒ抗体融合タンパク質の安定な医薬溶液製剤
US15/547,727 US10485870B2 (en) 2015-02-11 2016-02-03 Stable pharmaceutical solution formulation of GLP-1R antibody fusion protein
DK16748688.5T DK3257524T3 (da) 2015-02-11 2016-02-03 Stabiliseret opløsningspræparat af farmaceutisk glp-1r-antistoffusionsprotein
AU2016218759A AU2016218759B2 (en) 2015-02-11 2016-02-03 Stabilized solution preparation of pharmaceutical GLP-1R antibody fusion protein
KR1020177023260A KR102568272B1 (ko) 2015-02-11 2016-02-03 Ｇｌｐ-1ｒ 항체 융합 단백질의 안정한 약제학적 용액 제형
ES16748688T ES2833099T3 (es) 2015-02-11 2016-02-03 Preparación de disolución estabilizada de una proteína de fusión de un anticuerpo de GLP-1R farmacéutica
EP16748688.5A EP3257524B1 (en) 2015-02-11 2016-02-03 Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein
PL16748688T PL3257524T3 (pl) 2015-02-11 2016-02-03 Stabilny preparat farmaceutyczny w postaci roztworu białka fuzyjnego przeciwciała przeciwko glp-1r

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201510071304 2015-02-11
CN201510071304.1 2015-02-11

Publications (1)

Publication Number Publication Date
WO2016127887A1 true WO2016127887A1 (zh) 2016-08-18

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PCT/CN2016/073279 Ceased WO2016127887A1 (zh) 2015-02-11 2016-02-03 一种药用glp-1r抗体融合蛋白的稳定溶液制剂

Country Status (11)

Country Link
US (1) US10485870B2 (enExample)
EP (1) EP3257524B1 (enExample)
JP (1) JP6731953B2 (enExample)
KR (1) KR102568272B1 (enExample)
CN (2) CN121927035A (enExample)
AU (1) AU2016218759B2 (enExample)
DK (1) DK3257524T3 (enExample)
ES (1) ES2833099T3 (enExample)
PL (1) PL3257524T3 (enExample)
PT (1) PT3257524T (enExample)
WO (1) WO2016127887A1 (enExample)

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WO2019060653A1 (en) 2017-09-22 2019-03-28 Regeneron Pharmaceuticals, Inc. GLP-1 RECEPTOR AGONISTS (GLUCAGON-LIKE PEPTIDE 1) AND USES THEREOF
WO2024064842A1 (en) 2022-09-21 2024-03-28 Regeneron Pharmaceuticals, Inc. Methods of treating obesity, diabetes, and liver dysfunction
WO2026152012A1 (en) 2025-01-10 2026-07-16 Regeneron Pharmaceuticals, Inc. Glp1r agonist-tethered gdf8 antibody conjugates and uses thereof

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WO2026021575A1 (zh) * 2024-07-26 2026-01-29 鸿运华宁（杭州）生物医药有限公司 一种gipr抗体融合蛋白质的药用稳定溶液制剂及其应用

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CN102961745A (zh) * 2012-09-27 2013-03-13 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019060653A1 (en) 2017-09-22 2019-03-28 Regeneron Pharmaceuticals, Inc. GLP-1 RECEPTOR AGONISTS (GLUCAGON-LIKE PEPTIDE 1) AND USES THEREOF
US11045522B2 (en) 2017-09-22 2021-06-29 Regeneren Pharmaceuticals, Inc. Glucagon-like peptide 1 receptor agonists and uses thereof
US11779633B2 (en) 2017-09-22 2023-10-10 Regeneron Pharmaceuticals, Inc. Glucagon-like peptide 1 receptor agonists and uses thereof
US12090193B2 (en) 2017-09-22 2024-09-17 Regeneron Pharmaceuticals, Inc. Glucagon-like peptide 1 receptor agonists and uses thereof
WO2024064842A1 (en) 2022-09-21 2024-03-28 Regeneron Pharmaceuticals, Inc. Methods of treating obesity, diabetes, and liver dysfunction
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CN105854000A (zh) 2016-08-17
ES2833099T3 (es) 2021-06-14
JP2018508571A (ja) 2018-03-29
PT3257524T (pt) 2020-11-27
US10485870B2 (en) 2019-11-26
AU2016218759B2 (en) 2021-11-25
CA2975633A1 (en) 2016-08-18
JP6731953B2 (ja) 2020-07-29
EP3257524A4 (en) 2018-09-05
US20180000934A1 (en) 2018-01-04
KR102568272B1 (ko) 2023-08-21
EP3257524B1 (en) 2020-08-26
KR20170113585A (ko) 2017-10-12
DK3257524T3 (da) 2020-11-23
PL3257524T3 (pl) 2021-03-08
AU2016218759A1 (en) 2017-09-21
CN121927035A (zh) 2026-04-28
EP3257524A1 (en) 2017-12-20

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