CN115443127A - 异源二聚体人白介素-15(hetil-15)的药物组合物和药物产品 - Google Patents

异源二聚体人白介素-15(hetil-15)的药物组合物和药物产品 Download PDF

Info

Publication number
CN115443127A
CN115443127A CN202180030326.7A CN202180030326A CN115443127A CN 115443127 A CN115443127 A CN 115443127A CN 202180030326 A CN202180030326 A CN 202180030326A CN 115443127 A CN115443127 A CN 115443127A
Authority
CN
China
Prior art keywords
composition
cancer
complex
buffer
pharmaceutical composition
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
CN202180030326.7A
Other languages
English (en)
Chinese (zh)
Inventor
I·菲舍尔
R·加布里埃尔
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.)
Novartis AG
Original Assignee
Novartis AG
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 Novartis AG filed Critical Novartis AG
Publication of CN115443127A publication Critical patent/CN115443127A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN202180030326.7A 2020-04-22 2021-04-20 异源二聚体人白介素-15(hetil-15)的药物组合物和药物产品 Pending CN115443127A (zh)

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 (1)

Publication Number Publication Date
CN115443127A true CN115443127A (zh) 2022-12-06

Family

ID=75639945

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180030326.7A Pending CN115443127A (zh) 2020-04-22 2021-04-20 异源二聚体人白介素-15(hetil-15)的药物组合物和药物产品

Country Status (14)

Country Link
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)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117024749A (zh) 2019-06-28 2023-11-10 国立大学法人东京大学 蛋白质内包高分子胶束
TWI857396B (zh) * 2021-11-18 2024-10-01 大陸商山東先聲生物製藥有限公司 Il-15突變體融合蛋白藥物組合物
IL322075A (en) * 2023-02-14 2025-09-01 Akron Bioproducts Llc Pharmaceutical compositions of interleukin for use in vivo
WO2025206413A1 (en) * 2024-03-28 2025-10-02 The University Of Tokyo Protein-enclosing polymeric complexes

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2958588A1 (en) * 2013-02-22 2015-12-30 CureVac AG Combination of vaccination and inhibition of the pd-1 pathway
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

Family Cites Families (12)

* 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
EP3263581B2 (en) 2005-05-17 2025-07-09 University of Connecticut Compositions and methods for immunomodulation in an organism
NZ569541A (en) 2006-01-13 2012-05-25 Us Gov Health & Human Serv Codon optimized IL-15 and IL-15R-alpha genes for expression in mammalian cells
CN101743249B (zh) 2007-05-11 2017-08-08 阿尔托生物科学有限公司 融合分子与il‑15变异体
CA2711984A1 (en) * 2008-01-15 2009-07-23 Abbott Gmbh & Co. Kg Powdered protein compositions and methods of making same
CA2727953C (en) 2008-08-22 2017-05-16 Magna Seating Inc. Disc recliner with reduced backlash
US8915886B2 (en) * 2009-10-21 2014-12-23 Owen Mumford Limited Autoinjector
US8507222B2 (en) 2010-09-21 2013-08-13 Altor Bioscience Corporation Multimeric IL-15 soluble fusion molecules and methods of making and using same
ES2811974T3 (es) * 2014-07-29 2021-03-15 Novartis Ag Regímenes de aumento escalonado de la dosis del heterodímero de il-15 e il-15ralfa para tratar afecciones
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
EP3810171B1 (en) * 2018-06-22 2025-07-09 Cugene Inc. Novel interleukin-15 (1l-15) fusion proteins and uses thereof
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2958588A1 (en) * 2013-02-22 2015-12-30 CureVac AG Combination of vaccination and inhibition of the pd-1 pathway
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
陈维益: "英汉医学辞典", 30 April 2009, 上海科学技术出版社, pages: 884 - 885 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

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

Similar Documents

Publication Publication Date Title
CN115443127A (zh) 异源二聚体人白介素-15(hetil-15)的药物组合物和药物产品
AU2010204552B2 (en) New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein
KR102109053B1 (ko) 안정한 수성 항체 제제
JP7263312B2 (ja) Ｉｌ－１５タンパク質複合体医薬組成物およびその使用
JP2025163108A (ja) 抗ＩＬ－２３ｐ１９抗体製剤
EP1688146B1 (en) Preparing aldesleukin for pharmaceutical use
US20250041394A1 (en) Immunostimulatory mrna compositions and uses thereof
JP2023145622A (ja) ＣＨＯ細胞で発現されたｈｅｔ ＩＬ－１５
AU2025200146A1 (en) Formulations
KR20230117341A (ko) 다기능성 및 다가 인터류킨-tgf-베타 수용체 융합 폴리펩티드
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
CN115581766A (zh) 一种结合PD-L1/TGFβ双功能抗体融合蛋白液体制剂
GB2415904A (en) Interleukin-2 composition
US20140271538A1 (en) Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor for the Prevention of Neutropenia in Pediatric Patients
KR20240024929A (ko) 고농도 동결건조 생물제제 약물 제품의 재구성 시간을 감소시키기 위한 수크로스, 만니톨 및 글리신의 용도
HK40114150A (zh) 免疫刺激性mrna组合物及其用途
NL1028208C1 (nl) Bereiding van aldesleukine voor farmaceutisch gebruik.
BR122024001697A2 (pt) Complexo de polipeptídeo, heterodímero de il-15/il-15ralfa isolado produzido em uma célula não humana, composição farmacêutica, célula não humana, uso dos mesmos, e métodos para produzir células que expressam heterodímero de il-15/il-15alfa bem como para produzir o dito heterodímero
PL196430B1 (pl) Sposób wytwarzania interleukiny-2 do zastosowania farmaceutycznego, kompozycja zawierająca interleukinę-2 i dodecylosiarczan sodu, liofilizowana kompozycja farmaceutyczna, wodna kompozycja farmaceutyczna, zestaw środków farmaceutycznych, zastosowanie mikroagregatów interleukiny-2 i dodecylosiarczanu sodu, zastosowanie kompozycji zawierającej interleukinę-2 oraz dodecylosiarczan sodu, zastosowanie wybranego środka farmaceutycznego, zastosowanie mikroagregatów interleukiny-2 i dodecylosiarczanusodowego oraz drugiego środka farmaceutycznego

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