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EA201992526A1 - Стабильные составы анти-ctla4 антител, отдельно и в комбинации с антителами против рецептора 1 программируемой смерти (pd-1), и способы их применения - Google Patents

Стабильные составы анти-ctla4 антител, отдельно и в комбинации с антителами против рецептора 1 программируемой смерти (pd-1), и способы их применения

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Publication number
EA201992526A1
EA201992526A1 EA201992526A EA201992526A EA201992526A1 EA 201992526 A1 EA201992526 A1 EA 201992526A1 EA 201992526 A EA201992526 A EA 201992526A EA 201992526 A EA201992526 A EA 201992526A EA 201992526 A1 EA201992526 A1 EA 201992526A1
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EA
Eurasian Patent Office
Prior art keywords
methods
antibodies
death receptor
stabilities
separately
Prior art date
Application number
EA201992526A
Other languages
English (en)
Inventor
Суменду Бхаттачарья
Арнаб Де
Чакраварти Начу Нарасимхан
Манодж К. Шарма
Сяоюй Ян
Руби Берлейдж
Джейсон К. Чеунг
Original Assignee
Мерк Шарп И Доум Корп.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Мерк Шарп И Доум Корп. filed Critical Мерк Шарп И Доум Корп.
Publication of EA201992526A1 publication Critical patent/EA201992526A1/ru

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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
    • 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
    • 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
    • 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (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)

Abstract

Изобретение относится к стабильным составам, содержащим антитела или их антигенсвязывающие фрагменты, которые связываются с ассоциированным с цитотоксическими Т-лимфоцитами антигеном 4 (CTLA4), необязательно дополнительно содержащим антитело против рецептора 1 программируемой смерти (PD-1) или его антигенсвязывающий фрагмент. Настоящее изобретение относится также к способам лечения различных злокачественных опухолей и хронических инфекций с использованием составов по изобретению.
EA201992526A 2017-05-02 2018-05-01 Стабильные составы анти-ctla4 антител, отдельно и в комбинации с антителами против рецептора 1 программируемой смерти (pd-1), и способы их применения EA201992526A1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762500268P 2017-05-02 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

Publications (1)

Publication Number Publication Date
EA201992526A1 true EA201992526A1 (ru) 2020-03-13

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201992526A EA201992526A1 (ru) 2017-05-02 2018-05-01 Стабильные составы анти-ctla4 антител, отдельно и в комбинации с антителами против рецептора 1 программируемой смерти (pd-1), и способы их применения

Country Status (16)

Country Link
US (1) US20200262922A1 (ru)
EP (1) EP3618866A4 (ru)
JP (2) JP2020518598A (ru)
KR (1) KR102624564B1 (ru)
CN (1) CN110678199A (ru)
AU (1) AU2018263837A1 (ru)
BR (1) BR112019022695A2 (ru)
CA (1) CA3060695A1 (ru)
CL (1) CL2019003143A1 (ru)
CO (1) CO2019012143A2 (ru)
EA (1) EA201992526A1 (ru)
MA (1) MA50501A (ru)
MX (1) MX2019013034A (ru)
SG (1) SG11201910134SA (ru)
TN (1) TN2019000294A1 (ru)
WO (1) WO2018204343A1 (ru)

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KR20100054780A (ko) 2007-06-18 2010-05-25 엔.브이.오가논 사람 프로그램된 사멸 수용체 ｐｄ-1에 대한 항체
LT3551660T (lt) 2016-12-07 2023-12-27 Agenus Inc. Antikūnai prieš ctla-4 ir jų naudojimo būdai
RU2019138507A (ru) 2017-05-02 2021-06-02 Мерк Шарп И Доум Корп. Составы антител против lag3 и совместные составы антител против lag3 и антител против pd-1
JOP20190260A1 (ar) * 2017-05-02 2019-10-31 Merck Sharp & Dohme صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها
AU2019222517A1 (en) * 2018-02-13 2020-08-13 Merck Sharp & Dohme Llc Methods for treating cancer with anti PD-1 antibodies and anti CTLA4 antibodies
US20210380694A1 (en) * 2018-11-07 2021-12-09 Merck Sharp & Dohme Corp. Stable formulations of programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2020162203A1 (ja) * 2019-02-08 2020-08-13 国立大学法人東京工業大学 ホモジニアス免疫測定法に適した酵素変異体
US20240115701A1 (en) * 2019-09-23 2024-04-11 Merck Sharp & Dohme Corp. Methods and compositions comprising an anti-ctla4 monoclonal antibody with reduced host cell proteins and increased polysorbate-80 stability
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
US20220031843A1 (en) * 2020-07-08 2022-02-03 Regeneron Pharmaceuticals, Inc. Stabilized Formulations Containing Anti-CTLA-4 Antibodies
TW202235108A (zh) * 2020-11-10 2022-09-16 法商賽諾菲公司 Ｃｅａｃａｍ５抗體－藥物接合物配製物
US12110330B2 (en) 2021-01-29 2024-10-08 Merck Sharp & Dohme Llc Compositions of programmed death receptor 1 (PD-1) antibodies and methods of obtaining the compositions thereof
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
WO2024025989A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and rhuph20 or variants or fragments 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

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Publication number Priority date Publication date Assignee Title
CN103861102A (zh) * 2005-03-08 2014-06-18 辉瑞产品公司 抗ctla-4 抗体组合物
NZ563193A (en) * 2005-05-09 2010-05-28 Ono Pharmaceutical Co Human monoclonal antibodies to programmed death 1(PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics
MX2011013722A (es) * 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
CN105296433B (zh) * 2014-08-01 2018-02-09 中山康方生物医药有限公司 一种ctla4抗体、其药物组合物及其用途
EA201792273A1 (ru) * 2015-04-17 2018-04-30 Бристол-Маерс Сквибб Компани Композиции, содержащие комбинацию анти-pd-1 антитела и другого антитела
US9995753B2 (en) * 2015-09-25 2018-06-12 Merck Sharp & Dohme Corp. Anti-pembrolizumab antibodies

Also Published As

Publication number Publication date
MX2019013034A (es) 2020-02-05
BR112019022695A2 (pt) 2020-05-26
CN110678199A (zh) 2020-01-10
EP3618866A1 (en) 2020-03-11
US20200262922A1 (en) 2020-08-20
CO2019012143A2 (es) 2020-01-17
EP3618866A4 (en) 2021-07-14
JP2023109942A (ja) 2023-08-08
SG11201910134SA (en) 2019-11-28
JP2020518598A (ja) 2020-06-25
MA50501A (fr) 2020-09-09
KR20190142393A (ko) 2019-12-26
KR102624564B1 (ko) 2024-01-12
CA3060695A1 (en) 2018-11-08
AU2018263837A1 (en) 2019-12-05
CL2019003143A1 (es) 2020-03-20
TN2019000294A1 (en) 2021-05-07
WO2018204343A1 (en) 2018-11-08

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