JP2023553538A - 抗ｃｓｆ１および抗ｃｓｆ１ｒ抗体の高濃度製剤 - Google Patents

抗ｃｓｆ１および抗ｃｓｆ１ｒ抗体の高濃度製剤 Download PDF

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Publication number
JP2023553538A
JP2023553538A JP2023560246A JP2023560246A JP2023553538A JP 2023553538 A JP2023553538 A JP 2023553538A JP 2023560246 A JP2023560246 A JP 2023560246A JP 2023560246 A JP2023560246 A JP 2023560246A JP 2023553538 A JP2023553538 A JP 2023553538A
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Japan
Prior art keywords
pharmaceutical composition
aqueous pharmaceutical
composition according
arginine
antibody
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JP2023560246A
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Japanese (ja)
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JP2023553538A5 (https=
Inventor
チュン－チアン スー，
レーマン アラニ，
Original Assignee
エーマックス バイオ， インコーポレイテッド
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Application filed by エーマックス バイオ， インコーポレイテッド filed Critical エーマックス バイオ， インコーポレイテッド
Publication of JP2023553538A publication Critical patent/JP2023553538A/ja
Publication of JP2023553538A5 publication Critical patent/JP2023553538A5/ja
Pending legal-status Critical Current

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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
    • A61K9/14—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
    • 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
    • A61K47/06—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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/243—Colony Stimulating Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • 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)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
JP2023560246A 2020-12-14 2021-12-13 抗ｃｓｆ１および抗ｃｓｆ１ｒ抗体の高濃度製剤 Pending JP2023553538A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202063125277P 2020-12-14 2020-12-14
US63/125,277 2020-12-14
US202163186684P 2021-05-10 2021-05-10
US63/186,684 2021-05-10
PCT/US2021/063086 WO2022132636A1 (en) 2020-12-14 2021-12-13 High concentration formulations of anti-csf1 and anti-csf1r antibodies

Publications (2)

Publication Number Publication Date
JP2023553538A true JP2023553538A (ja) 2023-12-21
JP2023553538A5 JP2023553538A5 (https=) 2024-12-12

Family

ID=81942250

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JP2023560246A Pending JP2023553538A (ja) 2020-12-14 2021-12-13 抗ｃｓｆ１および抗ｃｓｆ１ｒ抗体の高濃度製剤

Country Status (4)

Country Link
US (3) US11419822B2 (https=)
EP (1) EP4065161A4 (https=)
JP (1) JP2023553538A (https=)
WO (1) WO2022132636A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022132636A1 (en) 2020-12-14 2022-06-23 AmMax Bio, Inc. High concentration formulations of anti-csf1 and anti-csf1r antibodies
JP2024518536A (ja) * 2021-05-12 2024-05-01 アナプティスバイオ インコーポレイティッド 抗体組成物
WO2023019262A1 (en) * 2021-08-12 2023-02-16 AmMax Bio, Inc. Targeted delivery of anti-csf1r antibodies

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010536378A (ja) * 2007-08-21 2010-12-02 アムジエン・インコーポレーテツド ヒトｃ−ｆｍｓ抗原結合性タンパク質
JP2013515754A (ja) * 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤
JP2017520562A (ja) * 2014-06-23 2017-07-27 ファイヴ プライム セラピューティクス インク コロニー刺激因子１受容体（ｃｓｆ１ｒ）に結合する抗体で疾患を治療する方法
JP2018501254A (ja) * 2014-12-22 2018-01-18 ファイヴ プライム セラピューティクス インク Ｐｖｎｓを治療するための抗ｃｓｆ１ｒ抗体
WO2020242950A1 (en) * 2019-05-24 2020-12-03 Elixiron Immunotherapeutics (hong Kong) Limited Anti-csf1r antibodies, il10 fusion proteins, and uses thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
EP2458990B1 (en) 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
WO2022132636A1 (en) 2020-12-14 2022-06-23 AmMax Bio, Inc. High concentration formulations of anti-csf1 and anti-csf1r antibodies

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010536378A (ja) * 2007-08-21 2010-12-02 アムジエン・インコーポレーテツド ヒトｃ−ｆｍｓ抗原結合性タンパク質
JP2013515754A (ja) * 2009-12-29 2013-05-09 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト 新規な抗体製剤
JP2017520562A (ja) * 2014-06-23 2017-07-27 ファイヴ プライム セラピューティクス インク コロニー刺激因子１受容体（ｃｓｆ１ｒ）に結合する抗体で疾患を治療する方法
JP2018501254A (ja) * 2014-12-22 2018-01-18 ファイヴ プライム セラピューティクス インク Ｐｖｎｓを治療するための抗ｃｓｆ１ｒ抗体
WO2020242950A1 (en) * 2019-05-24 2020-12-03 Elixiron Immunotherapeutics (hong Kong) Limited Anti-csf1r antibodies, il10 fusion proteins, and uses thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
EUR. J. PHARM. BIOPHARM., vol. 78, JPN6024010936, 2011, pages 208 - 212, ISSN: 0005772851 *

Also Published As

Publication number Publication date
US12178915B2 (en) 2024-12-31
US20220370364A1 (en) 2022-11-24
EP4065161A1 (en) 2022-10-05
WO2022132636A1 (en) 2022-06-23
EP4065161A4 (en) 2025-07-30
US20220183979A1 (en) 2022-06-16
US20250073170A1 (en) 2025-03-06
US11419822B2 (en) 2022-08-23

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