JP7438396B2 - インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤 - Google Patents

インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤 Download PDF

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JP7438396B2
JP7438396B2 JP2022561419A JP2022561419A JP7438396B2 JP 7438396 B2 JP7438396 B2 JP 7438396B2 JP 2022561419 A JP2022561419 A JP 2022561419A JP 2022561419 A JP2022561419 A JP 2022561419A JP 7438396 B2 JP7438396 B2 JP 7438396B2
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recombinant protein
dosage unit
body weight
human patient
regimen comprises
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JP2023512337A (ja
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カミッラ バッチ
テレーザ ヘンメル
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フィロジェン ソチエタ ペル アツィオーニ
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    • 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
    • C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • 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]
    • A61K38/208—IL-12
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6843—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a material from animals or humans
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/54—Interleukins [IL]
    • C07K14/5434—IL-12
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/626—Diabody or triabody
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
JP2022561419A 2020-04-14 2021-04-13 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤 Active JP7438396B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023199561A JP2024028756A (ja) 2020-04-14 2023-11-27 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20169469 2020-04-14
EP20169469.2 2020-04-14
PCT/EP2021/059570 WO2021209452A1 (en) 2020-04-14 2021-04-13 Dosage units and regimen, uses, methods or formulations of compositions comprising a recombinant protein comprising interleukin-12 and an antibody binding the extra-domain b of fibronectin

Related Child Applications (1)

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JP2023199561A Division JP2024028756A (ja) 2020-04-14 2023-11-27 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤

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JP2023512337A JP2023512337A (ja) 2023-03-24
JP7438396B2 true JP7438396B2 (ja) 2024-02-26

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JP2022561419A Active JP7438396B2 (ja) 2020-04-14 2021-04-13 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤
JP2023199561A Pending JP2024028756A (ja) 2020-04-14 2023-11-27 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤

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JP2023199561A Pending JP2024028756A (ja) 2020-04-14 2023-11-27 インターロイキン－１２とフィブロネクチンのエクストラドメインｂに結合する抗体とを含む組換えタンパク質を含む組成物の投与単位およびレジメン、使用、方法または製剤

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US (1) US20230312726A1 (https=)
EP (1) EP4135751B1 (https=)
JP (2) JP7438396B2 (https=)
AU (1) AU2021257594B2 (https=)
WO (1) WO2021209452A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2023206004B2 (en) * 2022-01-04 2025-04-17 Philogen S.P.A. Combination of an immunocytokine comprising il-12 and a kinase inhibitor
WO2025061801A1 (en) 2023-09-19 2025-03-27 Philochem Ag Therapeutic combination of an anti-edb fibronectin domain antibody il2 or il12 fusion protein and a lutetium-177 radioconjugate

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008543278A (ja) 2005-05-11 2008-12-04 フィロゲン エスピーエー フィブロネクチンｅｄ−ｂに対する抗体ｌ１９とインターロイキン１２との融合タンパク質
JP2009536170A (ja) 2006-05-08 2009-10-08 フィロジェン・エッセペア 治療用の抗体標的指向サイトカイン
WO2018011404A1 (en) 2016-07-15 2018-01-18 Philogen S.P.A Antibody compositions
WO2019154986A1 (en) 2018-02-09 2019-08-15 Philogen S.P.A. Edb targeting il-12 compositions
WO2019201894A1 (en) 2018-04-16 2019-10-24 Merck Patent Gmbh Additives for protein formulations to improve thermal stability

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3749370B1 (de) 2018-02-07 2025-05-07 Smawa GmbH Pharmazeutische formulierungen, verfahren zum herstellen einer pharmazeutischen formulierung sowie ein arzneimittel umfassend eine solche

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008543278A (ja) 2005-05-11 2008-12-04 フィロゲン エスピーエー フィブロネクチンｅｄ−ｂに対する抗体ｌ１９とインターロイキン１２との融合タンパク質
JP2009536170A (ja) 2006-05-08 2009-10-08 フィロジェン・エッセペア 治療用の抗体標的指向サイトカイン
WO2018011404A1 (en) 2016-07-15 2018-01-18 Philogen S.P.A Antibody compositions
WO2019154986A1 (en) 2018-02-09 2019-08-15 Philogen S.P.A. Edb targeting il-12 compositions
WO2019201894A1 (en) 2018-04-16 2019-10-24 Merck Patent Gmbh Additives for protein formulations to improve thermal stability

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS，2005年05月13日，VOL:60, NR:3,，PAGE(S):335 - 348
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS，ELSEVIER，2007年01月05日，VOL:65, NR:2,，PAGE(S):131 - 148
JOURNAL OF BIOTECHNOLOGY，2019年02月，VOL:291，PAGE(S):17 - 25

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Publication number Publication date
EP4135751C0 (en) 2024-07-31
EP4135751B1 (en) 2024-07-31
WO2021209452A1 (en) 2021-10-21
JP2023512337A (ja) 2023-03-24
EP4135751A1 (en) 2023-02-22
AU2021257594A1 (en) 2022-12-15
JP2024028756A (ja) 2024-03-05
AU2021257594B2 (en) 2024-02-15
US20230312726A1 (en) 2023-10-05
CA3175357A1 (en) 2021-10-21

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