JP7420827B2 - 抗ｉｌ－３６ｒ抗体製剤 - Google Patents

抗ｉｌ－３６ｒ抗体製剤 Download PDF

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JP7420827B2
JP7420827B2 JP2021552832A JP2021552832A JP7420827B2 JP 7420827 B2 JP7420827 B2 JP 7420827B2 JP 2021552832 A JP2021552832 A JP 2021552832A JP 2021552832 A JP2021552832 A JP 2021552832A JP 7420827 B2 JP7420827 B2 JP 7420827B2
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antibody
seq
amino acid
acid sequence
formulation
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JP2022524502A (ja
Inventor
デンキンガー，サンドラ・ニコル
シュタイナー，アンナ・マリア
カタヤマ，デリック・スペンサー
メーラ，ラジニ・プラサード
プレッサー，インゴ・ミヒャエル
シン，ラヴィジャ
ライト，サラ・ケイ
Original Assignee
ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング
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    • 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
    • A61K47/08—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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K16/2866—Immunoglobulins [IGs], 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
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
JP2021552832A 2019-03-08 2020-03-05 抗ｉｌ－３６ｒ抗体製剤 Active JP7420827B2 (ja)

Priority Applications (1)

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JP2023193220A JP2024020372A (ja) 2019-03-08 2023-11-13 抗ｉｌ－３６ｒ抗体製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962815405P 2019-03-08 2019-03-08
US62/815,405 2019-03-08
PCT/US2020/021059 WO2020185479A1 (en) 2019-03-08 2020-03-05 Anti-il-36r antibody formulations

Related Child Applications (1)

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JP2023193220A Division JP2024020372A (ja) 2019-03-08 2023-11-13 抗ｉｌ－３６ｒ抗体製剤

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JP2022524502A JP2022524502A (ja) 2022-05-06
JP7420827B2 true JP7420827B2 (ja) 2024-01-23

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JP2021552832A Active JP7420827B2 (ja) 2019-03-08 2020-03-05 抗ｉｌ－３６ｒ抗体製剤
JP2023193220A Pending JP2024020372A (ja) 2019-03-08 2023-11-13 抗ｉｌ－３６ｒ抗体製剤

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US (2) US11730812B2 (enExample)
EP (1) EP3934617A1 (enExample)
JP (2) JP7420827B2 (enExample)
KR (1) KR20210137520A (enExample)
CN (1) CN113543772A (enExample)
AU (1) AU2020238676B2 (enExample)
BR (1) BR112021016198A2 (enExample)
CA (1) CA3132917A1 (enExample)
CL (1) CL2021002331A1 (enExample)
EA (1) EA202192405A1 (enExample)
IL (1) IL286100B2 (enExample)
MX (1) MX2021010783A (enExample)
PH (1) PH12021552150A1 (enExample)
TW (1) TW202100141A (enExample)
WO (1) WO2020185479A1 (enExample)

Families Citing this family (8)

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ES2914243T3 (es) 2015-04-15 2022-06-08 Anaptysbio Inc Anticuerpos dirigidos contra el receptor de la interleuquina 36 (IL-36R)
CA3090421A1 (en) * 2018-03-14 2019-09-19 Boehringer Ingelheim International Gmbh Use of anti-il-36r antibodies for treatment of inflammatory bowel disease
CA3132917A1 (en) 2019-03-08 2020-09-17 Boehringer Ingelheim International Gmbh Anti-il-36r antibody formulations
KR20230038774A (ko) * 2020-07-17 2023-03-21 베링거 인겔하임 인터내셔날 게엠베하 호중성 피부병의 치료를 위한 항-il-36r 항체
CN112094349B (zh) * 2020-11-04 2021-02-09 上海华奥泰生物药业股份有限公司 靶向于白介素36r的抗体及其制备方法和应用
WO2022166977A1 (zh) * 2021-02-08 2022-08-11 上海普铭生物科技有限公司 抗人il-36r抗体及其应用
EP4301409A1 (en) 2021-03-04 2024-01-10 Boehringer Ingelheim International GmbH Methods for the treatment of gpp
CA3218343A1 (en) * 2021-05-12 2022-11-17 Anaptysbio, Inc. Antibody composition

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JP2007524602A (ja) 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
US20120121580A1 (en) 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
JP2015500633A (ja) 2011-11-16 2015-01-08 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗ｉｌ−３６ｒ抗体
JP2018512157A (ja) 2015-04-15 2018-05-17 アナプティスバイオ インコーポレイティッド インターロイキン３６受容体（ｉｌ−３６ｒ）に対する抗体

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JP2002504907A (ja) 1997-06-13 2002-02-12 ジェネンテク，インコーポレイテッド 抗体製剤
JP2007524602A (ja) 2003-04-04 2007-08-30 ジェネンテック・インコーポレーテッド 高濃度抗体及びタンパク質製剤
US20120121580A1 (en) 2009-07-28 2012-05-17 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
JP2015500633A (ja) 2011-11-16 2015-01-08 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 抗ｉｌ−３６ｒ抗体
JP2018512157A (ja) 2015-04-15 2018-05-17 アナプティスバイオ インコーポレイティッド インターロイキン３６受容体（ｉｌ−３６ｒ）に対する抗体

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IL286100B1 (en) 2024-08-01
JP2024020372A (ja) 2024-02-14
MX2021010783A (es) 2021-09-30
EA202192405A1 (ru) 2022-01-13
IL286100A (en) 2021-10-31
US20200282053A1 (en) 2020-09-10
IL286100B2 (en) 2024-12-01
WO2020185479A1 (en) 2020-09-17
CA3132917A1 (en) 2020-09-17
KR20210137520A (ko) 2021-11-17
PH12021552150A1 (en) 2022-08-15
JP2022524502A (ja) 2022-05-06
TW202100141A (zh) 2021-01-01
US11730812B2 (en) 2023-08-22
EP3934617A1 (en) 2022-01-12
AU2020238676B2 (en) 2025-04-17
BR112021016198A2 (pt) 2021-11-03
CN113543772A (zh) 2021-10-22
AU2020238676A1 (en) 2021-09-16
CL2021002331A1 (es) 2022-06-17
US20230372480A1 (en) 2023-11-23

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