JP2023523218A - ヘテロ二量体ヒトインターロイキン－１５（ｈｅｔＩＬ－１５）の医薬組成物及び医薬製品 - Google Patents

ヘテロ二量体ヒトインターロイキン－１５（ｈｅｔＩＬ－１５）の医薬組成物及び医薬製品 Download PDF

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JP2023523218A
JP2023523218A JP2022563971A JP2022563971A JP2023523218A JP 2023523218 A JP2023523218 A JP 2023523218A JP 2022563971 A JP2022563971 A JP 2022563971A JP 2022563971 A JP2022563971 A JP 2022563971A JP 2023523218 A JP2023523218 A JP 2023523218A
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フィッシャー，インゴ
ガブリエル，リチャード
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ノバルティス アーゲー
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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
    • A61K9/08—Solutions
    • 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]
    • A61K38/2086—IL-13 to IL-16
    • 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
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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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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    • 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
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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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules

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  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2022563971A 2020-04-22 2021-04-20 ヘテロ二量体ヒトインターロイキン－１５（ｈｅｔＩＬ－１５）の医薬組成物及び医薬製品 Pending JP2023523218A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063013801P 2020-04-22 2020-04-22
US63/013,801 2020-04-22
PCT/IB2021/053254 WO2021214658A1 (en) 2020-04-22 2021-04-20 Pharmaceutical compositions and pharmaceutical products of heterodimeric human interleukin-15 (hetil-15)

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JP2023523218A true JP2023523218A (ja) 2023-06-02
JP2023523218A5 JP2023523218A5 (enExample) 2024-04-30

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US (1) US20210330747A1 (enExample)
EP (1) EP4138782A1 (enExample)
JP (1) JP2023523218A (enExample)
KR (1) KR20230004655A (enExample)
CN (1) CN115443127A (enExample)
AR (1) AR122428A1 (enExample)
AU (1) AU2021260989A1 (enExample)
BR (1) BR112022020973A2 (enExample)
CA (1) CA3178895A1 (enExample)
CO (1) CO2022014867A2 (enExample)
IL (1) IL297326A (enExample)
MX (1) MX2022013352A (enExample)
TW (1) TW202214290A (enExample)
WO (1) WO2021214658A1 (enExample)

Families Citing this family (5)

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JP7083206B2 (ja) 2019-06-28 2022-06-10 国立大学法人 東京大学 タンパク質内包高分子ミセル
EP4434998A4 (en) * 2021-11-18 2025-06-18 Shandong Simcere Biopharmaceutical Co., Ltd. PHARMACEUTICAL COMPOSITION OF IL-15 MUTANT FUSION PROTEIN
KR20250144433A (ko) * 2023-02-14 2025-10-10 아크론 바이오프로덕츠 엘엘씨 생체내 이용을 위한 인터루킨 제형물
CN117883565A (zh) * 2023-12-25 2024-04-16 中山大学 沙美特罗和pd-1抗体联用在制备治疗黑色素瘤的药物中的应用
WO2025206413A1 (en) * 2024-03-28 2025-10-02 The University Of Tokyo Protein-enclosing polymeric complexes

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016018920A1 (en) * 2014-07-29 2016-02-04 Admune Therapeutics Llc Il-15 and il-15ralpha heterodimer dose escalation regimens for treating conditions
WO2017177063A1 (en) * 2016-04-06 2017-10-12 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Use of heterodimeric il-15 in adoptive cell transfer
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
WO2019246379A1 (en) * 2018-06-22 2019-12-26 Cugene Inc. Novel interleukin-15 (1l-15) fusion proteins and uses thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6174666B1 (en) 1992-03-27 2001-01-16 The United States Of America As Represented By The Department Of Health And Human Services Method of eliminating inhibitory/instability regions from mRNA
PL1899364T5 (pl) 2005-05-17 2024-12-09 University Of Connecticut Kompozycje i sposoby immunomodulacji w organizmie
EP1984505B1 (en) 2006-01-13 2019-12-25 The Government of the U.S.A., as repr. by the Secretary, Dept. of Health & Human Services, the Nat. Inst. of Health Codon optimized il-15 and il-15r-alpha genes for expression in mammalian cells
DK2160401T3 (da) 2007-05-11 2014-10-20 Altor Bioscience Corp Fusionsmolekyler og il-15-varianter
EP2249809A1 (en) * 2008-01-15 2010-11-17 Abbott GmbH & Co. KG Powdered protein compositions and methods of making same
CN102099221B (zh) 2008-08-22 2014-01-29 麦格纳座椅公司 具有减小空转的盘形调角器
KR101746881B1 (ko) * 2009-10-21 2017-06-14 오웬 멈포드 리미티드 오토인젝터
EP2619229B1 (en) 2010-09-21 2016-04-06 Altor BioScience Corporation Multimeric il-15 soluble fusion molecules and methods of making and using same
BR122021025267B1 (pt) * 2013-02-22 2023-12-05 Curevac Ag Partes de kit e composição farmacêutica compreendendo um inibidor da via de pd-1
KR20220005028A (ko) * 2019-04-26 2022-01-12 루비우스 테라퓨틱스, 아이엔씨. 탈핵 적혈구를 포함하는 조성물

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016018920A1 (en) * 2014-07-29 2016-02-04 Admune Therapeutics Llc Il-15 and il-15ralpha heterodimer dose escalation regimens for treating conditions
WO2017177063A1 (en) * 2016-04-06 2017-10-12 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Use of heterodimeric il-15 in adoptive cell transfer
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
WO2019246379A1 (en) * 2018-06-22 2019-12-26 Cugene Inc. Novel interleukin-15 (1l-15) fusion proteins and uses thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
INT.J. PHARMTECH RES, vol. vol. 1(2), JPN6025015486, 2009, pages 299 - 303, ISSN: 0005737820 *

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IL297326A (en) 2022-12-01
AR122428A1 (es) 2022-09-07
BR112022020973A2 (pt) 2022-12-06
CN115443127A (zh) 2022-12-06
MX2022013352A (es) 2022-11-30
CA3178895A1 (en) 2021-10-28
CO2022014867A2 (es) 2022-10-31
AU2021260989A1 (en) 2022-11-17
US20210330747A1 (en) 2021-10-28
WO2021214658A1 (en) 2021-10-28
EP4138782A1 (en) 2023-03-01
TW202214290A (zh) 2022-04-16
KR20230004655A (ko) 2023-01-06

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