AU2021237761B2 - Liquid formulation of GM-CSF for inhalation - Google Patents

Liquid formulation of GM-CSF for inhalation

Info

Publication number
AU2021237761B2
AU2021237761B2 AU2021237761A AU2021237761A AU2021237761B2 AU 2021237761 B2 AU2021237761 B2 AU 2021237761B2 AU 2021237761 A AU2021237761 A AU 2021237761A AU 2021237761 A AU2021237761 A AU 2021237761A AU 2021237761 B2 AU2021237761 B2 AU 2021237761B2
Authority
AU
Australia
Prior art keywords
csf
liquid formulation
rhgm
concentration
formulation according
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.)
Active
Application number
AU2021237761A
Other languages
English (en)
Other versions
AU2021237761A1 (en
Inventor
Lars Skriver
Alan Watts
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.)
Drugrecure AS
Original Assignee
Drugrecure AS
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 Drugrecure AS filed Critical Drugrecure AS
Publication of AU2021237761A1 publication Critical patent/AU2021237761A1/en
Application granted granted Critical
Publication of AU2021237761B2 publication Critical patent/AU2021237761B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K38/193Colony stimulating factors [CSF]
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/04Drugs for disorders of the respiratory system for throat disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2021237761A 2020-03-17 2021-03-17 Liquid formulation of GM-CSF for inhalation Active AU2021237761B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062990810P 2020-03-17 2020-03-17
US62/990,810 2020-03-17
EP20164648 2020-03-20
EP20164648.6 2020-03-20
PCT/EP2021/056851 WO2021185921A1 (en) 2020-03-17 2021-03-17 Liquid formulation of gm-csf for inhalation

Publications (2)

Publication Number Publication Date
AU2021237761A1 AU2021237761A1 (en) 2022-09-22
AU2021237761B2 true AU2021237761B2 (en) 2026-02-05

Family

ID=74871418

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021237761A Active AU2021237761B2 (en) 2020-03-17 2021-03-17 Liquid formulation of GM-CSF for inhalation

Country Status (12)

Country Link
US (1) US20230201307A1 (enExample)
EP (1) EP4121000A1 (enExample)
JP (2) JP7631358B2 (enExample)
KR (1) KR102874958B1 (enExample)
CN (1) CN115297844A (enExample)
AU (1) AU2021237761B2 (enExample)
BR (1) BR112022018501A2 (enExample)
CA (1) CA3168421A1 (enExample)
IL (1) IL295406A (enExample)
MX (1) MX2022011498A (enExample)
WO (1) WO2021185921A1 (enExample)
ZA (1) ZA202209002B (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120324338A (zh) * 2025-06-10 2025-07-18 厦门特宝生物工程股份有限公司 一种重组人粒细胞巨噬细胞刺激因子注射用液体制剂

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1739793A (zh) * 2005-09-16 2006-03-01 深圳市孚沃德生物技术有限公司 一种人粒细胞巨噬细胞集落刺激因子喷雾剂及其制备方法
WO2007009208A1 (en) * 2005-06-02 2007-01-25 Cangene Corporation Poly(ethylene glocol) modified human gm-csf with increased biological activity
EP1941901A1 (en) * 2005-09-27 2008-07-09 Genescience Pharmaceuticals Co. Ltd. An exterior-applied formulation and its preparation methods and uses
WO2012021088A1 (en) * 2010-08-13 2012-02-16 Closed Joint Stock Company "Biocad" A novel conjugate of granulocyte colony-stimulating factor (g-csf) with polyethylene glycol
WO2020002650A1 (en) * 2018-06-29 2020-01-02 Targovax Asa A formulation

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020141970A1 (en) 2001-03-05 2002-10-03 Pettit Dean K. Stable aqueous solutions of granulocyte macrophage colony-stimulating factor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007009208A1 (en) * 2005-06-02 2007-01-25 Cangene Corporation Poly(ethylene glocol) modified human gm-csf with increased biological activity
CN1739793A (zh) * 2005-09-16 2006-03-01 深圳市孚沃德生物技术有限公司 一种人粒细胞巨噬细胞集落刺激因子喷雾剂及其制备方法
EP1941901A1 (en) * 2005-09-27 2008-07-09 Genescience Pharmaceuticals Co. Ltd. An exterior-applied formulation and its preparation methods and uses
WO2012021088A1 (en) * 2010-08-13 2012-02-16 Closed Joint Stock Company "Biocad" A novel conjugate of granulocyte colony-stimulating factor (g-csf) with polyethylene glycol
WO2020002650A1 (en) * 2018-06-29 2020-01-02 Targovax Asa A formulation

Also Published As

Publication number Publication date
JP2025090573A (ja) 2025-06-17
WO2021185921A1 (en) 2021-09-23
JP7631358B2 (ja) 2025-02-18
BR112022018501A2 (pt) 2022-10-25
US20230201307A1 (en) 2023-06-29
CA3168421A1 (en) 2021-09-23
NZ791835A (en) 2025-10-31
CN115297844A (zh) 2022-11-04
KR102874958B1 (ko) 2025-10-21
KR20220154214A (ko) 2022-11-21
JP2023517480A (ja) 2023-04-26
IL295406A (en) 2022-10-01
MX2022011498A (es) 2022-10-07
EP4121000A1 (en) 2023-01-25
ZA202209002B (en) 2025-11-26
AU2021237761A1 (en) 2022-09-22

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