CN115867307A - Il-2融合多肽组合物以及其制备和使用方法 - Google Patents

Il-2融合多肽组合物以及其制备和使用方法 Download PDF

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Publication number
CN115867307A
CN115867307A CN202180040284.5A CN202180040284A CN115867307A CN 115867307 A CN115867307 A CN 115867307A CN 202180040284 A CN202180040284 A CN 202180040284A CN 115867307 A CN115867307 A CN 115867307A
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CN
China
Prior art keywords
composition
polypeptide
certain embodiments
aqueous solution
composition comprises
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
CN202180040284.5A
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English (en)
Chinese (zh)
Inventor
F·O·格布米塔
T·A·蔡丹
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Alkermes Inc
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Alkermes Inc
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Filing date
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Publication of CN115867307A publication Critical patent/CN115867307A/zh
Pending 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/20—Interleukins [IL]
    • A61K38/2013—IL-2
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/54—Interleukins [IL]
    • C07K14/55—IL-2
    • 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
    • C07K14/715—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7155—Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/70—Fusion polypeptide containing domain for protein-protein interaction
    • C07K2319/74—Fusion polypeptide containing domain for protein-protein interaction containing a fusion for binding to a cell surface receptor
    • C07K2319/75—Fusion polypeptide containing domain for protein-protein interaction containing a fusion for binding to a cell surface receptor containing a fusion for activation of a cell surface receptor, e.g. thrombopoeitin, NPY and other peptide hormones

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
CN202180040284.5A 2020-05-11 2021-05-10 Il-2融合多肽组合物以及其制备和使用方法 Pending CN115867307A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063022860P 2020-05-11 2020-05-11
US63/022,860 2020-05-11
PCT/US2021/031616 WO2021231319A1 (en) 2020-05-11 2021-05-10 Il-2 fusion polypeptide compositions and methods of making and using the same

Publications (1)

Publication Number Publication Date
CN115867307A true CN115867307A (zh) 2023-03-28

Family

ID=78524880

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180040284.5A Pending CN115867307A (zh) 2020-05-11 2021-05-10 Il-2融合多肽组合物以及其制备和使用方法

Country Status (12)

Country Link
US (1) US20210395325A1 (cg-RX-API-DMAC10.html)
EP (1) EP4149514A4 (cg-RX-API-DMAC10.html)
JP (1) JP2023526024A (cg-RX-API-DMAC10.html)
KR (1) KR20230008759A (cg-RX-API-DMAC10.html)
CN (1) CN115867307A (cg-RX-API-DMAC10.html)
AU (1) AU2021269585A1 (cg-RX-API-DMAC10.html)
BR (1) BR112022022869A2 (cg-RX-API-DMAC10.html)
CA (1) CA3172874A1 (cg-RX-API-DMAC10.html)
IL (1) IL298064A (cg-RX-API-DMAC10.html)
MX (1) MX2022014163A (cg-RX-API-DMAC10.html)
TW (1) TW202207971A (cg-RX-API-DMAC10.html)
WO (1) WO2021231319A1 (cg-RX-API-DMAC10.html)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130336924A1 (en) * 2012-06-08 2013-12-19 Alkermes, Inc. Ligands Modified by Circular Permutation as Agonists and Antagonists
WO2015148444A1 (en) * 2014-03-24 2015-10-01 Biogen Ma Inc. Lyophilized factor ix formulations
US20160175458A1 (en) * 2014-12-19 2016-06-23 Alkermes, Inc. Single chain fc fusion proteins
CN109963581A (zh) * 2017-07-25 2019-07-02 江苏恒瑞医药股份有限公司 一种il-15蛋白复合物药物组合物及其用途

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA48763A (fr) * 2017-05-05 2020-04-08 Amgen Inc Composition pharmaceutique comprenant des constructions d'anticorps bispécifiques pour un stockage et une administration améliorés
WO2021074689A1 (en) * 2019-10-18 2021-04-22 Alkermes Pharma Ireland Limited Immunomodulatory il-2 agents in combination with immune checkpoint inhibitors

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130336924A1 (en) * 2012-06-08 2013-12-19 Alkermes, Inc. Ligands Modified by Circular Permutation as Agonists and Antagonists
WO2015148444A1 (en) * 2014-03-24 2015-10-01 Biogen Ma Inc. Lyophilized factor ix formulations
US20160175458A1 (en) * 2014-12-19 2016-06-23 Alkermes, Inc. Single chain fc fusion proteins
CN109963581A (zh) * 2017-07-25 2019-07-02 江苏恒瑞医药股份有限公司 一种il-15蛋白复合物药物组合物及其用途

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CYNTHIA A. CHALLENER: "For Lyophilization, Excipients Really Do Matter", BIOPHARM INTERNATIONAL, vol. 30, no. 1, 1 January 2017 (2017-01-01) *

Also Published As

Publication number Publication date
EP4149514A1 (en) 2023-03-22
WO2021231319A1 (en) 2021-11-18
JP2023526024A (ja) 2023-06-20
AU2021269585A1 (en) 2022-12-15
BR112022022869A2 (pt) 2023-01-31
KR20230008759A (ko) 2023-01-16
US20210395325A1 (en) 2021-12-23
CA3172874A1 (en) 2021-11-18
MX2022014163A (es) 2023-02-22
EP4149514A4 (en) 2024-06-26
TW202207971A (zh) 2022-03-01
IL298064A (en) 2023-01-01

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