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SE2430078A1 - Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine - Google Patents

Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine

Info

Publication number
SE2430078A1
SE2430078A1 SE2430078A SE2430078A SE2430078A1 SE 2430078 A1 SE2430078 A1 SE 2430078A1 SE 2430078 A SE2430078 A SE 2430078A SE 2430078 A SE2430078 A SE 2430078A SE 2430078 A1 SE2430078 A1 SE 2430078A1
Authority
SE
Sweden
Prior art keywords
nivolumab
polysorbate
methionine
histidine
sucrose
Prior art date
Application number
SE2430078A
Inventor
Joanne Stevenson
Klas Risveden
Maria Kadow
Mark Gallagher
Patrik Stark
Per Edebrink
Original Assignee
Xbrane Biopharma Ab
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 Xbrane Biopharma Ab filed Critical Xbrane Biopharma Ab
Priority to SE2430078A priority Critical patent/SE2430078A1/en
Priority to PCT/SE2025/050130 priority patent/WO2025174319A1/en
Publication of SE2430078A1 publication Critical patent/SE2430078A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
SE2430078A 2024-02-16 2024-02-16 Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine SE2430078A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
SE2430078A SE2430078A1 (en) 2024-02-16 2024-02-16 Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine
PCT/SE2025/050130 WO2025174319A1 (en) 2024-02-16 2025-02-16 Stable antibody formulation for intravenous use comprising nivolumab, histidine, sucrose, polysorbate and methionine

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
SE2430078A SE2430078A1 (en) 2024-02-16 2024-02-16 Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine

Publications (1)

Publication Number Publication Date
SE2430078A1 true SE2430078A1 (en) 2025-08-17

Family

ID=97027972

Family Applications (1)

Application Number Title Priority Date Filing Date
SE2430078A SE2430078A1 (en) 2024-02-16 2024-02-16 Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine

Country Status (1)

Country Link
SE (1) SE2430078A1 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210002369A1 (en) * 2018-03-07 2021-01-07 Pfizer Inc. Anti-pd-1 antibody compositions
US20220233693A1 (en) * 2020-12-28 2022-07-28 Bristol-Myers Squibb Company Antibody Compositions and Methods of Use Thereof
US11633476B2 (en) * 2017-05-02 2023-04-25 Merck Sharp & Dohme Llc Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof
WO2023211868A1 (en) * 2022-04-29 2023-11-02 Merck Sharp & Dohme Llc Stable formulations of anti-ilt4 antibodies or antigen-binding fragments thererof in combination with anti-pd-1 antibodies and methods of use thereof
US20230355757A1 (en) * 2019-12-20 2023-11-09 Formycon Ag Formulations of anti-pd1 antibodies
WO2024025986A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11633476B2 (en) * 2017-05-02 2023-04-25 Merck Sharp & Dohme Llc Stable formulations of programmed death receptor 1 (PD-1) antibodies and methods of use thereof
US20210002369A1 (en) * 2018-03-07 2021-01-07 Pfizer Inc. Anti-pd-1 antibody compositions
US20230355757A1 (en) * 2019-12-20 2023-11-09 Formycon Ag Formulations of anti-pd1 antibodies
US20220233693A1 (en) * 2020-12-28 2022-07-28 Bristol-Myers Squibb Company Antibody Compositions and Methods of Use Thereof
WO2023211868A1 (en) * 2022-04-29 2023-11-02 Merck Sharp & Dohme Llc Stable formulations of anti-ilt4 antibodies or antigen-binding fragments thererof in combination with anti-pd-1 antibodies and methods of use thereof
WO2024025986A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof

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