CL2019003143A1 - 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.

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Publication number
CL2019003143A1
CL2019003143A1 CL2019003143A CL2019003143A CL2019003143A1 CL 2019003143 A1 CL2019003143 A1 CL 2019003143A1 CL 2019003143 A CL2019003143 A CL 2019003143A CL 2019003143 A CL2019003143 A CL 2019003143A CL 2019003143 A1 CL2019003143 A1 CL 2019003143A1
Authority
CL
Chile
Prior art keywords
methods
antigen
combination
stable formulations
programmed death
Prior art date
Application number
CL2019003143A
Other languages
English (en)
Inventor
Chakravarthy Nachu Narasimhan
Soumendu Battacharya
Arnab De
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 CL2019003143A1 publication Critical patent/CL2019003143A1/es

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Classifications

    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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 [IG], 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

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)

Abstract

LA INVENCIÓN SE REFIERE A FORMULACIONES ESTABLES QUE COMPRENDEN ANTICUERPOS O FRAGMENTOS DE FIJACIÓN AL ANTÍGENO DE ESTOS QUE SE FIJAN AL ANTÍGENO 4 ASOCIADO AL LINFOCITO T CITOTÓXICO (CTLA4), OPCIONALMENTE QUE ADEMÁS CONTIENEN UN ANTICUERPO ANTI-RECEPTOR DE MUERTE PROGRAMADA HUMANO 1 (PD-1) O FRAGMENTO DE FIJACIÓN AL ANTÍGENO DE ESTE. ADEMÁS SE PROPORCIONAN MÉTODOS PARA EL TRATAMIENTO DE DIVERSOS TIPOS DE CÁNCER E INFECCIONES CRÓNICAS CON LAS FORMULACIONES DE LA INVENCIÓN.
CL2019003143A 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. CL2019003143A1 (es)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
CL2019003143A1 true CL2019003143A1 (es) 2020-03-20

Family

ID=64016829

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2019003143A CL2019003143A1 (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 (es)
EP (1) EP3618866A4 (es)
JP (2) JP2020518598A (es)
KR (1) KR102624564B1 (es)
CN (1) CN110678199B (es)
AU (1) AU2018263837B2 (es)
BR (1) BR112019022695A2 (es)
CA (1) CA3060695A1 (es)
CL (1) CL2019003143A1 (es)
CO (1) CO2019012143A2 (es)
EA (1) EA201992526A1 (es)
MA (1) MA50501A (es)
MX (1) MX2019013034A (es)
SG (1) SG11201910134SA (es)
TN (1) TN2019000294A1 (es)
UA (1) UA129862C2 (es)
WO (1) WO2018204343A1 (es)

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JP7503056B6 (ja) 2018-11-07 2024-07-16 メルク・シャープ・アンド・ドーム・エルエルシー 抗ｌａｇ３抗体および抗ｐｄ－１抗体の共－製剤
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JP2023515675A (ja) * 2020-03-05 2023-04-13 メルク・シャープ・アンド・ドーム・エルエルシー Ｐｄ－１アンタゴニスト、ｃｔｌａ４アンタゴニストおよびレンバチニブまたはその薬学的に許容される塩の組合せを用いる癌を治療する方法
JP2023525898A (ja) * 2020-05-19 2023-06-19 エフ． ホフマン－ラ ロシュ アーゲー 非経口タンパク質溶液における可視粒子の形成を防止するためのキレート剤の使用
CA3185091A1 (en) * 2020-07-08 2022-01-13 Yuan Cheng Stabilized formulations containing anti-ctla-4 antibodies
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Also Published As

Publication number Publication date
US20250074985A1 (en) 2025-03-06
UA129862C2 (uk) 2025-08-27
MA50501A (fr) 2020-09-09
EP3618866A4 (en) 2021-07-14
US20200262922A1 (en) 2020-08-20
CO2019012143A2 (es) 2020-01-17
CN110678199A (zh) 2020-01-10
JP7653465B2 (ja) 2025-03-28
KR20190142393A (ko) 2019-12-26
SG11201910134SA (en) 2019-11-28
AU2018263837A1 (en) 2019-12-05
KR102624564B1 (ko) 2024-01-12
CN110678199B (zh) 2025-02-28
AU2018263837B2 (en) 2025-02-20
MX2019013034A (es) 2020-02-05
TN2019000294A1 (en) 2021-05-07
BR112019022695A2 (pt) 2020-05-26
CA3060695A1 (en) 2018-11-08
JP2020518598A (ja) 2020-06-25
JP2023109942A (ja) 2023-08-08
WO2018204343A1 (en) 2018-11-08
EA201992526A1 (ru) 2020-03-13
EP3618866A1 (en) 2020-03-11

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