CO2019012143A2 - Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso - Google Patents

Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso

Info

Publication number
CO2019012143A2
CO2019012143A2 CONC2019/0012143A CO2019012143A CO2019012143A2 CO 2019012143 A2 CO2019012143 A2 CO 2019012143A2 CO 2019012143 A CO2019012143 A CO 2019012143A CO 2019012143 A2 CO2019012143 A2 CO 2019012143A2
Authority
CO
Colombia
Prior art keywords
methods
programmed death
death receptor
combination
stable formulations
Prior art date
Application number
CONC2019/0012143A
Other languages
English (en)
Spanish (es)
Inventor
Soumendu Bhattacharya
Arnab De
Chakravarthy Nachu Narasimhan
Manoj K Sharma
Xiaoyu Yang
Rubi Burlage
Jason K Cheung
Original Assignee
Merck Sharp & Dohme
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 Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of CO2019012143A2 publication Critical patent/CO2019012143A2/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • 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)
CONC2019/0012143A 2017-05-02 2019-10-30 Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso CO2019012143A2 (es)

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
CO2019012143A2 true CO2019012143A2 (es) 2020-01-17

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2019/0012143A CO2019012143A2 (es) 2017-05-02 2019-10-30 Formulaciones estables de anticuerpos anti-ctla4 solos y en combinación con anticuerpos contra el receptor de muerte programada 1 (pd-1) y métodos para su uso

Country Status (17)

Country Link
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)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
UA129862C2 (uk) * 2017-05-02 2025-08-27 Мерк Шарп Енд Доум Елелсі Склад для лікування злоякісної пухлини або хронічної інфекції
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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KR100996801B1 (ko) * 2005-03-08 2010-11-25 파마시아 앤드 업존 캄파니 엘엘씨 항-MAdCAM 항체 조성물
EP2418278A3 (en) * 2005-05-09 2012-07-04 Ono Pharmaceutical Co., Ltd. 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
EP2442798A4 (en) * 2009-06-18 2013-03-13 Wyeth Llc LYOPHILIZED FORMULATIONS FOR SMALL-SCALE MODULAR IMMUNOPHARMACEUTICAL AGENTS
IN2012DN00863A (enExample) * 2009-07-31 2015-07-10 Medarex Inc
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
KR20250004095A (ko) * 2015-04-17 2025-01-07 브리스톨-마이어스 스큅 컴퍼니 항-pd-1 항체 및 또 다른 항체의 조합물을 포함하는 조성물
US9995753B2 (en) * 2015-09-25 2018-06-12 Merck Sharp & Dohme Corp. Anti-pembrolizumab antibodies
UA129862C2 (uk) * 2017-05-02 2025-08-27 Мерк Шарп Енд Доум Елелсі Склад для лікування злоякісної пухлини або хронічної інфекції

Also Published As

Publication number Publication date
JP2020518598A (ja) 2020-06-25
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
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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