CN110678199B - 单独的和与程序性死亡受体1(pd-1)抗体组合的抗ctla4抗体的稳定制剂及其使用方法 - Google Patents

单独的和与程序性死亡受体1(pd-1)抗体组合的抗ctla4抗体的稳定制剂及其使用方法 Download PDF

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CN110678199B
CN110678199B CN201880029175.1A CN201880029175A CN110678199B CN 110678199 B CN110678199 B CN 110678199B CN 201880029175 A CN201880029175 A CN 201880029175A CN 110678199 B CN110678199 B CN 110678199B
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antibody
formulation
seq
ctla
antigen
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CN110678199A (zh
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S·巴塔查亚
A·德
C·N·纳拉西曼
M·K·沙玛
杨孝育
R·布拉格
J·K·张
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Merck Sharp & Dohme BV
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Merck Sharp & Dohme LLC
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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
    • A61K9/08—Solutions
    • 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 [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
    • 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
    • A61K9/14—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
    • 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)
CN201880029175.1A 2017-05-02 2018-05-01 单独的和与程序性死亡受体1(pd-1)抗体组合的抗ctla4抗体的稳定制剂及其使用方法 Active CN110678199B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
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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CN110678199A CN110678199A (zh) 2020-01-10
CN110678199B true CN110678199B (zh) 2025-02-28

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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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CN110913906A (zh) 2017-05-02 2020-03-24 默沙东公司 抗lag3抗体的制剂和抗lag3抗体与抗pd-1抗体的共制剂
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CN119792515A (zh) * 2018-02-13 2025-04-11 默沙东有限责任公司 用抗pd-1抗体和抗ctla-4抗体治疗癌症的方法
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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
JP7849358B2 (ja) * 2020-11-10 2026-04-21 サノフイ Ｃｅａｃａｍ５抗体－薬物コンジュゲート製剤
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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
AU2018263837B2 (en) 2025-02-20
MX2019013034A (es) 2020-02-05
TN2019000294A1 (en) 2021-05-07
BR112019022695A2 (pt) 2020-05-26
CL2019003143A1 (es) 2020-03-20
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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