JP2023513833A - ヒト抗tslp抗体の製剤及びそれを使用する方法 - Google Patents

ヒト抗tslp抗体の製剤及びそれを使用する方法 Download PDF

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JP2023513833A
JP2023513833A JP2022549318A JP2022549318A JP2023513833A JP 2023513833 A JP2023513833 A JP 2023513833A JP 2022549318 A JP2022549318 A JP 2022549318A JP 2022549318 A JP2022549318 A JP 2022549318A JP 2023513833 A JP2023513833 A JP 2023513833A
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antibody
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JP2023513833A5 (enExample
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ローレン ロシェン,
ジェニファー リトウスキ,
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Amgen Inc
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Amgen Inc
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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
    • C07K16/24—Immunoglobulins [IG], 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 [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
    • C07K16/244—Interleukins [IL]
    • C07K16/246—IL-2
    • 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
    • A61K47/08—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
    • A61K47/16—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
    • A61K47/22—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
    • A61K47/06—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pulmonology (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2022549318A 2020-02-18 2021-02-18 ヒト抗tslp抗体の製剤及びそれを使用する方法 Pending JP2023513833A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062978201P 2020-02-18 2020-02-18
US62/978,201 2020-02-18
PCT/US2021/018561 WO2021168100A1 (en) 2020-02-18 2021-02-18 Formulations of human anti-tslp antibodies and methods of using the same

Related Child Applications (1)

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JP2026042471A Division JP2026131038A (ja) 2020-02-18 2026-03-16 ヒト抗tslp抗体の製剤及びそれを使用する方法

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JP2023513833A true JP2023513833A (ja) 2023-04-03
JP2023513833A5 JP2023513833A5 (enExample) 2024-02-27

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US (1) US20230081261A1 (enExample)
EP (1) EP4106811A1 (enExample)
JP (1) JP2023513833A (enExample)
KR (1) KR20220143699A (enExample)
CN (1) CN115151276A (enExample)
AR (1) AR121368A1 (enExample)
AU (1) AU2021221998A1 (enExample)
CA (1) CA3167975A1 (enExample)
CL (1) CL2022002251A1 (enExample)
CO (1) CO2022013251A2 (enExample)
CR (1) CR20220465A (enExample)
IL (1) IL295511A (enExample)
JO (1) JOP20220193A1 (enExample)
MX (1) MX2022010120A (enExample)
PE (1) PE20230115A1 (enExample)
PH (1) PH12022552132A1 (enExample)
TW (1) TW202144004A (enExample)
UY (1) UY39089A (enExample)
WO (1) WO2021168100A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4145105A1 (de) * 2021-09-06 2023-03-08 Anacyte Laboratories GmbH Lösung für die asservierung von zellen
CN118215681A (zh) * 2021-09-18 2024-06-18 江苏康宁杰瑞生物制药有限公司 包含pd-l1抗原结合片段的组合物及其用途
CN116251181B (zh) * 2021-12-02 2023-09-22 北京东方百泰生物科技股份有限公司 一种抗tslp单克隆抗体的注射制剂
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
TW202426485A (zh) * 2022-10-26 2024-07-01 美商安進公司 抗tslp抗體組成物及其用途
WO2024146630A1 (zh) * 2023-01-06 2024-07-11 江苏恒瑞医药股份有限公司 一种tslp抗体治疗哮喘的方法
WO2024238877A1 (en) * 2023-05-18 2024-11-21 Medimmune, Llc Treatment of corticosteroid dependent asthma with anti-tslp antibody

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018191479A1 (en) * 2017-04-12 2018-10-18 Amgen Inc. Treatment of asthma with anti-tslp antibody
WO2018200533A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
ES2246502T3 (es) 1990-08-29 2006-02-16 Genpharm International, Inc. Animales no humanos transgenicos capaces de producir anticuerpos heterologos.
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
US8359965B2 (en) 2007-09-17 2013-01-29 Oxford J Craig Apparatus and method for broad spectrum radiation attenuation
TW201018482A (en) 2008-08-08 2010-05-16 Glaxo Wellcome Mfg Pte Ltd Novel treatment
EP3594356A1 (en) 2009-11-04 2020-01-15 Merck Sharp & Dohme Corp. Engineered anti-tslp antibody
SI2523688T1 (en) * 2010-01-15 2018-03-30 Kirin-Amgen, Inc. Formulation of antibodies and therapeutic regimes
AR082163A1 (es) 2010-07-15 2012-11-14 Hoffmann La Roche Anticuerpos especificamente ligantes del tslpr humano y metodos de utilizacion de los mismos
AT510032B1 (de) 2010-11-30 2012-01-15 Steiner Erwin Ing Montageeinrichtung für fassadenelemente
US9100245B1 (en) 2012-02-08 2015-08-04 Amazon Technologies, Inc. Identifying protected media files
US9306926B2 (en) 2013-03-15 2016-04-05 Brian A. Truong User authentication using unique hidden identifiers
CN107428828A (zh) 2015-03-11 2017-12-01 葛兰素史密斯克莱知识产权发展有限公司 Tslp结合蛋白
EA038332B1 (ru) 2015-09-09 2021-08-10 Новартис Аг Молекулы, связывающиеся с тимусным стромальным лимфопоэтином (tslp), и способы применения таких молекул
CA3066399A1 (en) 2017-06-08 2018-12-13 Amgen Inc. Torque driven drug delivery device
IL319987A (en) 2017-11-10 2025-06-01 Amgen Inc Plungers for drug delivery devices
WO2019178151A1 (en) 2018-03-13 2019-09-19 Amgen Inc. Methods for the preparation of trypsin-resistant polypeptides for mass spectrometric analysis
MA53913A (fr) 2018-10-15 2022-01-19 Amgen Inc Procédé d'assemblage de plate-forme pour dispositif d'administration de médicament
JP7719714B2 (ja) 2018-10-15 2025-08-06 アムジエン・インコーポレーテツド ダンピング機構を有する薬物送達装置

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018191479A1 (en) * 2017-04-12 2018-10-18 Amgen Inc. Treatment of asthma with anti-tslp antibody
WO2018200533A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CLIN. THER., vol. 43, no. 1, JPN6026032195, December 2020 (2020-12-01), pages 142 - 155, ISSN: 0005917587 *
DRUG DELIV. SYS., vol. 28(5), JPN6024021999, 2013, pages 412 - 423, ISSN: 0005731203 *

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Publication number Publication date
CR20220465A (es) 2023-03-30
KR20220143699A (ko) 2022-10-25
PH12022552132A1 (en) 2024-01-29
MX2022010120A (es) 2022-09-05
PE20230115A1 (es) 2023-01-27
AR121368A1 (es) 2022-06-01
CA3167975A1 (en) 2021-08-26
EP4106811A1 (en) 2022-12-28
UY39089A (es) 2021-08-31
AU2021221998A1 (en) 2022-09-15
WO2021168100A1 (en) 2021-08-26
IL295511A (en) 2022-10-01
CL2022002251A1 (es) 2023-04-14
CN115151276A (zh) 2022-10-04
CO2022013251A2 (es) 2022-12-20
JOP20220193A1 (ar) 2023-01-30
BR112022016456A2 (pt) 2022-10-04
US20230081261A1 (en) 2023-03-16
TW202144004A (zh) 2021-12-01

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