JP7876454B2 - 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

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JP7876454B2
JP7876454B2 JP2022563971A JP2022563971A JP7876454B2 JP 7876454 B2 JP7876454 B2 JP 7876454B2 JP 2022563971 A JP2022563971 A JP 2022563971A JP 2022563971 A JP2022563971 A JP 2022563971A JP 7876454 B2 JP7876454 B2 JP 7876454B2
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approximately
cancer
complex
weeks
pharmaceutical composition
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JP2023523218A5 (enExample
JP2023523218A (ja
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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
    • 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
    • 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
    • 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
    • A61K9/16—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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • 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 Active JP7876454B2 (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)

Publications (3)

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JP2023523218A JP2023523218A (ja) 2023-06-02
JP2023523218A5 JP2023523218A5 (enExample) 2024-04-30
JP7876454B2 true JP7876454B2 (ja) 2026-06-19

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US (1) US20210330747A1 (enExample)
EP (1) EP4138782A1 (enExample)
JP (1) JP7876454B2 (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)

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CN114080412B (zh) 2019-06-28 2023-08-25 国立大学法人东京大学 蛋白质内包高分子胶束
JP2024540570A (ja) * 2021-11-18 2024-10-31 山▲東▼先声生物制▲薬▼有限公司 Ｉｌ－１５突然変異体融合タンパク質医薬組成物
WO2024173571A1 (en) * 2023-02-14 2024-08-22 Amcyte Pharma, Inc. Interleukin formulations for in vivo use
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
WO2026126081A1 (en) * 2024-12-11 2026-06-18 Kashiv Biosciences, Llc A stable pharmaceutical composition of fusion protein

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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

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WO2007001677A2 (en) 2005-05-17 2007-01-04 University Of Connecticut Compositions and methods for immunomodulation in an organism
EP2366787B1 (en) 2006-01-13 2019-12-11 The Government Of The U.S.A, As Represented By The Secretary, Dept. Of Health And Human Services Codon optimized IL-15 and IL-15R-Alpha genes for expression in mammalian cells
EP2388266B1 (en) 2007-05-11 2014-04-23 Altor BioScience Corporation Fusion molecules and IL-15 variants
SG2013054218A (en) * 2008-01-15 2014-10-30 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
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JP2022530130A (ja) * 2019-04-26 2022-06-27 ルビウス セラピューティクス， インコーポレイテッド 除核赤血球細胞を含む緩衝組成物

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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

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Publication number Publication date
CA3178895A1 (en) 2021-10-28
WO2021214658A1 (en) 2021-10-28
CN115443127A (zh) 2022-12-06
KR20230004655A (ko) 2023-01-06
AR122428A1 (es) 2022-09-07
TW202214290A (zh) 2022-04-16
EP4138782A1 (en) 2023-03-01
US20210330747A1 (en) 2021-10-28
JP2023523218A (ja) 2023-06-02
BR112022020973A2 (pt) 2022-12-06
MX2022013352A (es) 2022-11-30
IL297326A (en) 2022-12-01
AU2021260989A1 (en) 2022-11-17
CO2022014867A2 (es) 2022-10-31

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