JP2020518598A - 単独およびプログラム死受容体１（ｐｄ−１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法 - Google Patents

単独およびプログラム死受容体１（ｐｄ−１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法 Download PDF

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JP2020518598A
JP2020518598A JP2019559826A JP2019559826A JP2020518598A JP 2020518598 A JP2020518598 A JP 2020518598A JP 2019559826 A JP2019559826 A JP 2019559826A JP 2019559826 A JP2019559826 A JP 2019559826A JP 2020518598 A JP2020518598 A JP 2020518598A
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formulation
antibody
seq
binding fragment
ctla4
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JP2020518598A5 (enExample
Inventor
バタチャリヤ，ショーメンドウ
デ，アルナブ
ナラシンハン，チャクラヴァルティ・ナチュ
シャルマ，マノジュ・ケー
ヤン，シャオユウ
ベルラーヘ，ルビ
チャン，ジェイソン・ケー
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Merck Sharp and Dohme LLC
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Merck Sharp and Dohme LLC
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Priority to JP2023085581A priority Critical patent/JP7653465B2/ja
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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
    • A61K47/06—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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • 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
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2019559826A 2017-05-02 2018-05-01 単独およびプログラム死受容体１（ｐｄ−１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法 Ceased JP2020518598A (ja)

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JP2023085581A JP7653465B2 (ja) 2017-05-02 2023-05-24 単独およびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法

Applications Claiming Priority (3)

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US201762500268P 2017-05-02 2017-05-02
US62/500,268 2017-05-02
PCT/US2018/030420 WO2018204343A1 (en) 2017-05-02 2018-05-01 Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

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JP2023085581A Division JP7653465B2 (ja) 2017-05-02 2023-05-24 単独およびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法

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JP2020518598A5 JP2020518598A5 (enExample) 2021-04-30

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JP2023085581A Active JP7653465B2 (ja) 2017-05-02 2023-05-24 単独およびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法

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US (2) US20200262922A1 (enExample)
EP (1) EP3618866A4 (enExample)
JP (2) JP2020518598A (enExample)
KR (1) KR102624564B1 (enExample)
CN (1) CN110678199B (enExample)
AU (1) AU2018263837B2 (enExample)
BR (1) BR112019022695A2 (enExample)
CA (1) CA3060695A1 (enExample)
CL (1) CL2019003143A1 (enExample)
CO (1) CO2019012143A2 (enExample)
EA (1) EA201992526A1 (enExample)
MA (1) MA50501A (enExample)
MX (1) MX2019013034A (enExample)
SG (1) SG11201910134SA (enExample)
TN (1) TN2019000294A1 (enExample)
UA (1) UA129862C2 (enExample)
WO (1) WO2018204343A1 (enExample)

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JP2023109942A (ja) * 2017-05-02 2023-08-08 メルク・シャープ・アンド・ドーム・エルエルシー 単独およびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法

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EP2535354B1 (en) 2007-06-18 2017-01-11 Merck Sharp & Dohme B.V. Antibodies to human programmed death receptor pd-1
IL266918B2 (en) 2016-12-07 2024-03-01 Agenus Inc Anti-ctla-4 antibodies and methods of use thereof
MA50661A (fr) * 2017-05-02 2020-08-05 Merck Sharp & Dohme Formulations stables d'anticorps anti-tigit seuls et en association avec des anticorps du récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation
WO2018204374A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations of anti-lag3 antibodies and co-formulations of anti-lag3 antibodies and anti-pd-1 antibodies
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
MA51844A (fr) * 2018-02-13 2021-05-19 Merck Sharp & Dohme Méthodes de traitement du cancer avec des anticorps anti pd-1 et des anticorps anti ctla4
EP3876978A4 (en) * 2018-11-07 2022-09-28 Merck Sharp & Dohme Corp. STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF
KR20210089215A (ko) 2018-11-07 2021-07-15 머크 샤프 앤드 돔 코포레이션 항-lag3 항체 및 항-pd-1 항체의 공동-제제
US12188063B2 (en) * 2019-02-08 2025-01-07 Institute Of Science Tokyo Enzymatic mutant suitable for homogeneous immunoassay method
CA3132198A1 (en) * 2019-03-13 2020-09-17 Merck Sharp & Dohme Corp. Anti-cancer combination therapies comprising ctla-4 and pd-1 blocking agents
MX2021012967A (es) * 2019-04-23 2022-01-18 Sanofi Sa Anticuerpos y formulaciones de anti-cd38.
KR20220069043A (ko) * 2019-09-23 2022-05-26 머크 샤프 앤드 돔 코포레이션 감소된 숙주 세포 단백질 및 증가된 폴리소르베이트-80 안정성을 갖는 항-ctla4 모노클로날 항체를 포함하는 방법 및 조성물
US20230118596A1 (en) * 2020-03-05 2023-04-20 Merck Sharp & Dohme Llc Methods for treating cancer using a combination of a pd-1 antagonist, a ctla4 antagonist, and lenvatinib or a pharmaceutically accpetable salt thereof
AU2021305093A1 (en) * 2020-07-08 2023-03-09 Regeneron Pharmaceuticals, Inc. Stabilized formulations containing anti-CTLA-4 antibodies
CN116635077A (zh) * 2020-11-10 2023-08-22 赛诺菲 Ceacam5抗体-药物缀合物制剂
AR124712A1 (es) 2021-01-29 2023-04-26 Merck Sharp & Dohme Composiciones de anticuerpos del receptor de muerte programada 1 (pd-1) y métodos para obtener las composiciones de los mismos
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
CA3263055A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc PHARMACEUTICAL COMPOSITIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) AND RHUPH20 ANTIBODIES OR VARIANTS OR FRAGMENTS THEREOF

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Publication number Priority date Publication date Assignee Title
JP2023109942A (ja) * 2017-05-02 2023-08-08 メルク・シャープ・アンド・ドーム・エルエルシー 単独およびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｃｔｌａ４抗体の安定な製剤、ならびにその使用方法

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Publication number Publication date
US20250074985A1 (en) 2025-03-06
EP3618866A1 (en) 2020-03-11
EP3618866A4 (en) 2021-07-14
JP2023109942A (ja) 2023-08-08
MX2019013034A (es) 2020-02-05
WO2018204343A1 (en) 2018-11-08
CO2019012143A2 (es) 2020-01-17
KR20190142393A (ko) 2019-12-26
SG11201910134SA (en) 2019-11-28
CN110678199A (zh) 2020-01-10
CL2019003143A1 (es) 2020-03-20
CA3060695A1 (en) 2018-11-08
UA129862C2 (uk) 2025-08-27
US20200262922A1 (en) 2020-08-20
MA50501A (fr) 2020-09-09
JP7653465B2 (ja) 2025-03-28
TN2019000294A1 (en) 2021-05-07
BR112019022695A2 (pt) 2020-05-26
CN110678199B (zh) 2025-02-28
KR102624564B1 (ko) 2024-01-12
AU2018263837A1 (en) 2019-12-05
AU2018263837B2 (en) 2025-02-20
EA201992526A1 (ru) 2020-03-13

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