IL277095B2 - Preparations containing anti-PD-1 antibody - Google Patents

Preparations containing anti-PD-1 antibody

Info

Publication number
IL277095B2
IL277095B2 IL277095A IL27709520A IL277095B2 IL 277095 B2 IL277095 B2 IL 277095B2 IL 277095 A IL277095 A IL 277095A IL 27709520 A IL27709520 A IL 27709520A IL 277095 B2 IL277095 B2 IL 277095B2
Authority
IL
Israel
Prior art keywords
pharmaceutical composition
seq
amino acid
acid sequence
sequence shown
Prior art date
Application number
IL277095A
Other languages
English (en)
Hebrew (he)
Other versions
IL277095B1 (en
IL277095A (en
Original Assignee
Pfizer
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 Pfizer filed Critical Pfizer
Publication of IL277095A publication Critical patent/IL277095A/en
Publication of IL277095B1 publication Critical patent/IL277095B1/en
Publication of IL277095B2 publication Critical patent/IL277095B2/en

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
    • A61K47/26Carbohydrates, 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • 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
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • 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]

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)
  • 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)
IL277095A 2018-03-07 2019-03-03 Preparations containing anti-PD-1 antibody IL277095B2 (en)

Applications Claiming Priority (3)

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

Publications (3)

Publication Number Publication Date
IL277095A IL277095A (en) 2020-10-29
IL277095B1 IL277095B1 (en) 2025-06-01
IL277095B2 true IL277095B2 (en) 2025-10-01

Family

ID=66041593

Family Applications (1)

Application Number Title Priority Date Filing Date
IL277095A IL277095B2 (en) 2018-03-07 2019-03-03 Preparations containing anti-PD-1 antibody

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=)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015048520A1 (en) * 2013-09-27 2015-04-02 Genentech, Inc. Anti-pdl1 antibody formulations
US20160159905A1 (en) * 2014-12-09 2016-06-09 Rinat Neuroscience Corp. Anti-pd-1 antibodies and methods of use thereof

Family Cites Families (15)

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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
EP1871806A2 (en) 2005-03-08 2008-01-02 Pharmacia & Upjohn Company LLC ANTI-MAdCAM ANTIBODY COMPOSITIONS
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
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
US10894083B2 (en) * 2015-01-28 2021-01-19 Pfizer Inc. Stable aqueous anti-vascular endothelial growth factor (VEGF) antibody formulation
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

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
WO2015048520A1 (en) * 2013-09-27 2015-04-02 Genentech, Inc. Anti-pdl1 antibody formulations
US20160159905A1 (en) * 2014-12-09 2016-06-09 Rinat Neuroscience Corp. Anti-pd-1 antibodies and methods of use thereof

Also Published As

Publication number Publication date
RU2020129226A (ru) 2022-04-07
KR102594028B1 (ko) 2023-10-24
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
AU2019232625B2 (en) 2025-12-11
IL277095A (en) 2020-10-29
US20210002369A1 (en) 2021-01-07

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