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MA50501A - Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation - Google Patents

Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation

Info

Publication number
MA50501A
MA50501A MA050501A MA50501A MA50501A MA 50501 A MA50501 A MA 50501A MA 050501 A MA050501 A MA 050501A MA 50501 A MA50501 A MA 50501A MA 50501 A MA50501 A MA 50501A
Authority
MA
Morocco
Prior art keywords
methods
combination
programmed death
stable formulations
ctla4 antibodies
Prior art date
Application number
MA050501A
Other languages
English (en)
Inventor
Soumendu Bhattacharya
Rubi Burlage
Jason K Cheung
Arnab De
Chakravarthy Nachu Narasimhan
Manoj K Sharma
Xiaoyu Yang
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 MA50501A publication Critical patent/MA50501A/fr

Links

Classifications

    • 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
    • A61K9/08Solutions
    • 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
    • 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
    • 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
    • A61K9/14Particulate 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
    • 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)
  • 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)
MA050501A 2017-05-02 2018-05-01 Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation MA50501A (fr)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
MA50501A true MA50501A (fr) 2020-09-09

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
MA050501A MA50501A (fr) 2017-05-02 2018-05-01 Formulations stables d'anticorps anti-ctla4 seuls et en combinaison avec des anticorps anti-récepteur de mort programmée 1 (pd-1) et leurs procédés d'utilisation

Country Status (16)

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

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (fr) * 2019-02-08 2020-08-13 国立大学法人東京工業大学 Mutant enzymatique pour méthode d'immunoessai homogène
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 (fr) * 2022-04-29 2023-11-02 Merck Sharp & Dohme Llc Formulations stables d'anticorps anti-ilt4 ou de fragments de liaison à l'antigène de ceux-ci en combinaison avec des anticorps anti-pd-1 et leurs procédés d'utilisation
WO2024025989A1 (fr) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Compositions pharmaceutiques d'anticorps de récepteur de mort programmée 1 (pd-1) et rhuph20 ou variants ou fragments de ceux-ci
WO2024025986A1 (fr) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Compositions pharmaceutiques d'anticorps de récepteur 1 de mort programmée (pd-1) et de variants de ph20 ou de fragments de ceux-ci

Family Cites Families (6)

* Cited by examiner, † Cited by third party
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
EA201992526A1 (ru) 2020-03-13
CN110678199A (zh) 2020-01-10
EP3618866A1 (fr) 2020-03-11
US20200262922A1 (en) 2020-08-20
CO2019012143A2 (es) 2020-01-17
EP3618866A4 (fr) 2021-07-14
JP2023109942A (ja) 2023-08-08
SG11201910134SA (en) 2019-11-28
JP2020518598A (ja) 2020-06-25
KR20190142393A (ko) 2019-12-26
KR102624564B1 (ko) 2024-01-12
CA3060695A1 (fr) 2018-11-08
AU2018263837A1 (en) 2019-12-05
CL2019003143A1 (es) 2020-03-20
TN2019000294A1 (en) 2021-05-07
WO2018204343A1 (fr) 2018-11-08

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