CN115916242A - 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

Info

Publication number
CN115916242A
CN115916242A CN202180042991.8A CN202180042991A CN115916242A CN 115916242 A CN115916242 A CN 115916242A CN 202180042991 A CN202180042991 A CN 202180042991A CN 115916242 A CN115916242 A CN 115916242A
Authority
CN
China
Prior art keywords
composition
polypeptide
certain embodiments
aqueous solution
nacl
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
CN202180042991.8A
Other languages
English (en)
Chinese (zh)
Inventor
T·A·蔡丹
M·卡拉里亚
F·O·格布米塔
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.)
Alkermes Inc
Original Assignee
Alkermes Inc
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 Alkermes Inc filed Critical Alkermes Inc
Publication of CN115916242A publication Critical patent/CN115916242A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2013IL-2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/54Interleukins [IL]
    • C07K14/55IL-2
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/715Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • C07K14/7155Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons for interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CN202180042991.8A 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 CN115916242A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063022853P 2020-05-11 2020-05-11
US63/022,853 2020-05-11
PCT/US2021/031611 WO2021231316A1 (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
CN115916242A true CN115916242A (zh) 2023-04-04

Family

ID=78524918

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180042991.8A Pending CN115916242A (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) US20210371486A1 (https=)
EP (1) EP4149515A4 (https=)
JP (1) JP2023525565A (https=)
KR (1) KR20230009446A (https=)
CN (1) CN115916242A (https=)
AU (1) AU2021270745A1 (https=)
BR (1) BR112022022764A2 (https=)
CA (1) CA3172871A1 (https=)
IL (1) IL298065A (https=)
MX (1) MX2022014164A (https=)
TW (1) TW202207970A (https=)
WO (1) WO2021231316A1 (https=)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63122628A (ja) * 1986-10-27 1988-05-26 シタス コーポレイション 組換えインターフェロン−2の医薬組成物及び配合方法
CN1437466A (zh) * 1999-12-30 2003-08-20 希龙公司 白细胞介素-2经肺部的输递方法
JP2006137678A (ja) * 2004-11-10 2006-06-01 Shionogi & Co Ltd インターロイキン−2組成物
US20160175458A1 (en) * 2014-12-19 2016-06-23 Alkermes, Inc. Single chain fc fusion proteins
US20180318293A1 (en) * 2014-08-18 2018-11-08 Alkermes Pharma Ireland Limited Aripiprazole prodrug composition
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
WO2021074689A1 (en) * 2019-10-18 2021-04-22 Alkermes Pharma Ireland Limited Immunomodulatory il-2 agents in combination with immune checkpoint inhibitors
CN115335394A (zh) * 2020-01-24 2022-11-11 奥克梅斯制药爱尔兰有限公司 纯化方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1816356A (zh) * 2003-05-14 2006-08-09 免疫原公司 药物缀合物组合物
US9156897B2 (en) * 2012-06-08 2015-10-13 Alkermes, Inc. Fusion polypeptides comprising an active protein linked to a mucin-domain polypeptide
US20210038684A1 (en) * 2019-06-11 2021-02-11 Alkermes Pharma Ireland Limited Compositions and Methods for Cancer Immunotherapy

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63122628A (ja) * 1986-10-27 1988-05-26 シタス コーポレイション 組換えインターフェロン−2の医薬組成物及び配合方法
CN1437466A (zh) * 1999-12-30 2003-08-20 希龙公司 白细胞介素-2经肺部的输递方法
JP2006137678A (ja) * 2004-11-10 2006-06-01 Shionogi & Co Ltd インターロイキン−2組成物
US20180318293A1 (en) * 2014-08-18 2018-11-08 Alkermes Pharma Ireland Limited Aripiprazole prodrug composition
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
WO2021074689A1 (en) * 2019-10-18 2021-04-22 Alkermes Pharma Ireland Limited Immunomodulatory il-2 agents in combination with immune checkpoint inhibitors
CN114555110A (zh) * 2019-10-18 2022-05-27 奥克梅斯制药爱尔兰有限公司 与免疫检查点抑制剂组合的免疫调节性il-2剂
CN115335394A (zh) * 2020-01-24 2022-11-11 奥克梅斯制药爱尔兰有限公司 纯化方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
LOPES, J.E. ET AL.: ""Chain A, Interleukin-2, Interleukin-2 receptor subunit alpha PDB:6VWU_A"", 《GENPEPT》, 29 April 2020 (2020-04-29), pages 1 - 2 *
贺端明等: ""标本放置时间对白细胞介素-6水平稳定性的影响"", 《检验医学与临床》, vol. 13, no. 1, 31 January 2016 (2016-01-31), pages 100 - 102 *

Also Published As

Publication number Publication date
KR20230009446A (ko) 2023-01-17
CA3172871A1 (en) 2021-11-18
EP4149515A4 (en) 2023-12-06
BR112022022764A2 (pt) 2023-01-17
JP2023525565A (ja) 2023-06-16
IL298065A (en) 2023-01-01
MX2022014164A (es) 2023-02-22
TW202207970A (zh) 2022-03-01
AU2021270745A1 (en) 2022-12-15
WO2021231316A1 (en) 2021-11-18
US20210371486A1 (en) 2021-12-02
EP4149515A1 (en) 2023-03-22

Similar Documents

Publication Publication Date Title
CN102614134B (zh) Vegf拮抗剂制剂
RU2550271C2 (ru) Иммуногенная композиция для лечения или профилактики clostridium difficile, способ ее получения и способ индукции иммунного ответа к c. difficile
AU2020392890A1 (en) Bicyclic peptide ligands specific for EphA2 and uses thereof
KR102720834B1 (ko) Il-15 단백질 복합체 약학 조성물 및 이의 용도
KR20080071192A (ko) 면역글로불린 융합 단백질 제형
KR20190066014A (ko) 실온 안정성 동결건조된 단백질
CN112516090B (zh) 抗体偶联药物的药物组合、冷冻干燥剂及制备方法、用途
RS55772B1 (sr) Stabilizacija fsh
JP2023539476A (ja) アネキシンa1のn末端ペプチド製剤及び方法
MD3419595T2 (ro) Formulare de gonadotropină lichidă stabilă
TW200303756A (en) Lyophilised preparation comprising immunocytokines
EP3060256B1 (en) A novel stable formulation
CN115916242A (zh) Il-2融合多肽组合物以及其制备和使用方法
JP2023526024A (ja) Il-2融合ポリペプチド組成物ならびにその作製及び使用方法
CN116077646A (zh) 一种抗冠状病毒s蛋白的抗体制剂及其制备方法和用途
KR20240099278A (ko) 에프룩시페르민의 제약 조성물
JP2022110121A (ja) サポシンc薬学的組成物および癌を治療する方法
CN117257936B (zh) 一种阿达木单抗组合物
CN117257936A (zh) 一种阿达木单抗组合物
US20250367264A1 (en) Glp-1 analogue compositions and preparation method
WO2025191149A1 (en) Pharmaceutical composition comprising dual gip and glp-1 receptor agonist
TW202241513A (zh) 一種包含抗體融合蛋白的醫藥組成物及其用途

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination