KR20230009446A - Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법 - Google Patents

Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법 Download PDF

Info

Publication number
KR20230009446A
KR20230009446A KR1020227043013A KR20227043013A KR20230009446A KR 20230009446 A KR20230009446 A KR 20230009446A KR 1020227043013 A KR1020227043013 A KR 1020227043013A KR 20227043013 A KR20227043013 A KR 20227043013A KR 20230009446 A KR20230009446 A KR 20230009446A
Authority
KR
South Korea
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.)
Withdrawn
Application number
KR1020227043013A
Other languages
English (en)
Korean (ko)
Inventor
타렉 에이. 제이단
메여 칼라리야
프란시스카 오. 그보르미타
Original Assignee
엘커메스 파마 아일랜드 리미티드
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 엘커메스 파마 아일랜드 리미티드 filed Critical 엘커메스 파마 아일랜드 리미티드
Publication of KR20230009446A publication Critical patent/KR20230009446A/ko
Withdrawn legal-status Critical Current

Links

Images

Classifications

    • 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]
    • 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
    • A61K47/12—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

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)
KR1020227043013A 2020-05-11 2021-05-10 Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법 Withdrawn KR20230009446A (ko)

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
KR20230009446A true KR20230009446A (ko) 2023-01-17

Family

ID=78524918

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227043013A Withdrawn KR20230009446A (ko) 2020-05-11 2021-05-10 Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법

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=)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1292686C (en) * 1986-10-27 1991-12-03 Ze'ev Shaked Pharmaceutical compositions of recombinant interleukin-2 and formulation process
SK11142002A3 (sk) * 1999-12-30 2004-09-08 Chiron Corporation Liečivo na podávanie interleukínu-2 a stabilizovaný lyofilizovaný alebo sprejovo sušený farmaceutický prostriedok s obsahom interleukínu-2
CN1816356A (zh) * 2003-05-14 2006-08-09 免疫原公司 药物缀合物组合物
JP2006137678A (ja) * 2004-11-10 2006-06-01 Shionogi & Co Ltd インターロイキン−２組成物
US9156897B2 (en) * 2012-06-08 2015-10-13 Alkermes, Inc. Fusion polypeptides comprising an active protein linked to a mucin-domain polypeptide
US10016415B2 (en) * 2014-08-18 2018-07-10 Alkermes Pharma Ireland Limited Aripiprazole prodrug compositions
AU2015364396B2 (en) * 2014-12-19 2018-08-09 Alkermes, Inc. Single chain Fc fusion proteins
WO2019019998A1 (zh) * 2017-07-25 2019-01-31 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
US20210038684A1 (en) * 2019-06-11 2021-02-11 Alkermes Pharma Ireland Limited Compositions and Methods for Cancer Immunotherapy
BR112022007158A2 (pt) * 2019-10-18 2022-07-05 Alkermes Pharma Ireland Ltd Agentes imunomodulatórios de il-2 em combinação com inibidores do ponto de verificação imunológico
EP4093755A4 (en) * 2020-01-24 2024-07-31 Alkermes Pharma Ireland Limited PURIFICATION PROCESSES

Also Published As

Publication number Publication date
CA3172871A1 (en) 2021-11-18
CN115916242A (zh) 2023-04-04
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
RU2550271C2 (ru) Иммуногенная композиция для лечения или профилактики clostridium difficile, способ ее получения и способ индукции иммунного ответа к c. difficile
KR102720834B1 (ko) Il-15 단백질 복합체 약학 조성물 및 이의 용도
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
EP4374874A1 (en) Pharmaceutical composition containing anti-trop2 antibody drug conjugate and use thereof
RS55772B1 (sr) Stabilizacija fsh
WO2021067775A1 (en) Anto-connexin antibody formulations
TW200303756A (en) Lyophilised preparation comprising immunocytokines
US4797388A (en) Pharmaceutical compositions with galactitol as carrier
JPH0314520A (ja) インターロイキン―１組成物
KR20230009446A (ko) Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법
CN116077646B (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
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
TWI844697B (zh) 用於穩定液體蛋白質調配物之組合物及方法
JP2005060377A (ja) インターロイキン−１１含有凍結乾燥製剤
TW202600172A (zh) 載體組合物
CN117355321A (zh) 增强性能的赋形剂以及降低生物制剂的粘度和提高生物制剂的稳定性的方法
BR122025026726A2 (pt) Composições farmacêuticas de interleucina-15 humana heterodimérica, uso e método de preparação das mesmas, bem como forma de dosagem, frasco, seringa, kit, autoinjetor e produto farmacêutico
CN111375058A (zh) 一种抗肿瘤坏死因子-α抗体注射液制剂
EA045592B1 (ru) Жидкий препарат, содержащий антитело к il-17

Legal Events

Date Code Title Description
PA0105 International application

St.27 status event code: A-0-1-A10-A15-nap-PA0105

P11-X000 Amendment of application requested

St.27 status event code: A-2-2-P10-P11-nap-X000

P13-X000 Application amended

St.27 status event code: A-2-2-P10-P13-nap-X000

PG1501 Laying open of application

St.27 status event code: A-1-1-Q10-Q12-nap-PG1501

PC1203 Withdrawal of no request for examination

St.27 status event code: N-1-6-B10-B12-nap-PC1203