KR102594028B1 - 항-pd-1 항체 조성물 - Google Patents

항-pd-1 항체 조성물 Download PDF

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KR102594028B1
KR102594028B1 KR1020207028149A KR20207028149A KR102594028B1 KR 102594028 B1 KR102594028 B1 KR 102594028B1 KR 1020207028149 A KR1020207028149 A KR 1020207028149A KR 20207028149 A KR20207028149 A KR 20207028149A KR 102594028 B1 KR102594028 B1 KR 102594028B1
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antibody
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amino acid
pharmaceutical composition
acid sequence
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KR20200128115A (ko
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시예드 살림 아메드
브라이언 마크 발타조르
안잘리 프라모드 메타
티하미 쿠레시
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화이자 인코포레이티드
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    • 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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/26—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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]

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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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
KR1020207028149A 2018-03-07 2019-03-04 항-pd-1 항체 조성물 Active KR102594028B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862639587P 2018-03-07 2018-03-07
US62/639,587 2018-03-07
US201962807912P 2019-02-20 2019-02-20
US62/807,912 2019-02-20
PCT/IB2019/051733 WO2019171253A1 (en) 2018-03-07 2019-03-04 Anti-pd-1 antibody compositions

Publications (2)

Publication Number Publication Date
KR20200128115A KR20200128115A (ko) 2020-11-11
KR102594028B1 true KR102594028B1 (ko) 2023-10-24

Family

ID=66041593

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Application Number Title Priority Date Filing Date
KR1020207028149A Active KR102594028B1 (ko) 2018-03-07 2019-03-04 항-pd-1 항체 조성물

Country Status (10)

Country Link
US (1) US20210002369A1 (https=)
EP (1) EP3761954A1 (https=)
JP (1) JP7312188B2 (https=)
KR (1) KR102594028B1 (https=)
CN (1) CN112105343B (https=)
AU (1) AU2019232625B2 (https=)
BR (1) BR112020017935A2 (https=)
IL (1) IL277095B2 (https=)
MX (1) MX2020009275A (https=)
WO (1) WO2019171253A1 (https=)

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WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
BR112022007635A2 (pt) * 2019-11-13 2022-07-12 Pfizer Formulação aquosa e estável de anticorpos
US20230054413A1 (en) * 2019-12-13 2023-02-23 Samsung Bioepis Co., Ltd. Stable anti-pd1 antibody pharmaceutical formulations
ES3063234T3 (en) 2019-12-20 2026-04-15 Formycon Ag Formulations of anti-pd1 antibodies
BR112022023989A2 (pt) 2020-05-26 2023-02-07 Boehringer Ingelheim Int Anticorpos anti-pd-1
CN113967195A (zh) * 2020-07-22 2022-01-25 三生国健药业（上海）股份有限公司 抗her2/pd1双特异性抗体冻干制剂及其制备方法
JP2024527517A (ja) * 2021-06-23 2024-07-25 フォーマイコン アーゲー 抗ｐｄ１抗体製剤
US20250270316A1 (en) * 2021-07-01 2025-08-28 Tianjin Lipogen Technology Co., Ltd Pharmaceutical combination and use thereof
US12364756B2 (en) * 2021-07-09 2025-07-22 Macrogenics, Inc. Pharmaceutical compositions of a PD-1 antibody and use of the same
WO2023031969A1 (en) * 2021-09-03 2023-03-09 Dr. Reddy’S Laboratories Limited A method of improving stability of immune check point inhibitors
US20240352126A1 (en) * 2021-09-03 2024-10-24 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of immune check point inhibitors
IL314840A (en) * 2022-03-07 2024-10-01 Mabxience Res S L Stable Antibody Formulations
AU2023413756A1 (en) * 2022-12-21 2025-07-10 Formycon Ag Formulations of anti-pd1 antibodies
WO2024171082A1 (en) 2023-02-16 2024-08-22 Sun Pharmaceutical Industries Limited Stable protein compositions of anti-pd1 antibody
WO2025036449A1 (zh) * 2023-08-16 2025-02-20 上海迈晋生物医药科技有限公司 一种包含免疫缀合物的药物组合物及其用途
SE548163C2 (en) * 2024-02-16 2026-04-13 Xbrane Biopharma Ab Stable antibody formulation comprising nivolumab, histidine, sucrose, polysorbate and methionine
WO2025174319A1 (en) * 2024-02-16 2025-08-21 Xbrane Biopharma Ab Stable antibody formulation for intravenous use comprising nivolumab, histidine, sucrose, polysorbate and methionine

Citations (3)

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WO2006096491A2 (en) 2005-03-08 2006-09-14 Pharmacia & Upjohn Company Llc Anti-ctla-4 antibody compositions
US20160159905A1 (en) 2014-12-09 2016-06-09 Rinat Neuroscience Corp. Anti-pd-1 antibodies and methods of use thereof
WO2016120753A1 (en) * 2015-01-28 2016-08-04 Pfizer Inc. Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
KR20070104673A (ko) * 2005-03-23 2007-10-26 화이자 프로덕츠 인코포레이티드 암의 치료를 위한 항－ｃｔｌａ４ 항체와 인돌리논병용요법
RU2494107C2 (ru) 2005-05-09 2013-09-27 Оно Фармасьютикал Ко., Лтд. Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами
HRP20131167T1 (hr) 2007-06-18 2014-01-03 Merck Sharp & Dohme B.V. Antitijela za humani receptor programirane smrti pd-1
CN102203132A (zh) 2008-08-25 2011-09-28 安普利穆尼股份有限公司 Pd-1拮抗剂的组合物和使用方法
KR20130066631A (ko) * 2010-05-06 2013-06-20 노파르티스 아게 치료적 저밀도 지단백질-관련 단백질 ６ （ｌｒｐ６） 다가 항체에 대한 조성물 및 사용 방법
CA2832560A1 (en) * 2011-04-07 2012-10-18 Glaxosmithkline Llc Formulations with reduced viscosity
MX375378B (es) * 2013-09-27 2025-03-06 Genentech Inc Formulaciones de anticuerpos anti-pdl1.
TWI731535B (zh) * 2014-03-21 2021-06-21 美商艾伯維有限公司 抗-egfr抗體及抗體藥物結合物
TW201617368A (zh) * 2014-09-05 2016-05-16 史坦森特瑞斯公司 新穎抗ｍｆｉ２抗體及使用方法
CA2999079A1 (en) * 2015-09-28 2017-04-06 Jiangsu Hengrui Medicine Co., Ltd. Stable anti-pd-1 antibody pharmaceutical preparation and application thereof in medicine
WO2017055966A1 (en) 2015-10-01 2017-04-06 Pfizer Inc. Low viscosity antibody compositions
JP7402693B2 (ja) * 2017-05-02 2023-12-21 メルク・シャープ・アンド・ドーム・エルエルシー 単独のおよびプログラム死受容体１（ｐｄ－１）抗体と組み合わされた抗ｔｉｇｉｔ抗体の安定な製剤、ならびにその使用方法
CA3063324A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity

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Publication number Priority date Publication date Assignee Title
WO2006096491A2 (en) 2005-03-08 2006-09-14 Pharmacia & Upjohn Company Llc Anti-ctla-4 antibody compositions
US20160159905A1 (en) 2014-12-09 2016-06-09 Rinat Neuroscience Corp. Anti-pd-1 antibodies and methods of use thereof
WO2016120753A1 (en) * 2015-01-28 2016-08-04 Pfizer Inc. Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation

Also Published As

Publication number Publication date
RU2020129226A (ru) 2022-04-07
WO2019171253A8 (en) 2020-10-01
AU2019232625A1 (en) 2020-09-17
CN112105343B (zh) 2024-07-30
WO2019171253A1 (en) 2019-09-12
CN112105343A (zh) 2020-12-18
EP3761954A1 (en) 2021-01-13
CA3093036A1 (en) 2019-09-12
BR112020017935A2 (pt) 2021-02-09
KR20200128115A (ko) 2020-11-11
RU2020129226A3 (https=) 2022-04-07
JP2021517129A (ja) 2021-07-15
IL277095B1 (en) 2025-06-01
JP7312188B2 (ja) 2023-07-20
MX2020009275A (es) 2021-01-08
IL277095B2 (en) 2025-10-01
AU2019232625B2 (en) 2025-12-11
IL277095A (en) 2020-10-29
US20210002369A1 (en) 2021-01-07

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