AU2019232625B2 - Anti-PD-1 antibody compositions - Google Patents

Anti-PD-1 antibody compositions

Info

Publication number
AU2019232625B2
AU2019232625B2 AU2019232625A AU2019232625A AU2019232625B2 AU 2019232625 B2 AU2019232625 B2 AU 2019232625B2 AU 2019232625 A AU2019232625 A AU 2019232625A AU 2019232625 A AU2019232625 A AU 2019232625A AU 2019232625 B2 AU2019232625 B2 AU 2019232625B2
Authority
AU
Australia
Prior art keywords
antibody
seq
pharmaceutical composition
amino acid
acid sequence
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2019232625A
Other languages
English (en)
Other versions
AU2019232625A1 (en
Inventor
Syed Saleem Ahmed
Bryan Mark BALTHAZOR
Anjali Pramod MEHTA
Tihami QURESHI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pfizer Inc
Original Assignee
Pfizer Inc
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 Inc filed Critical Pfizer Inc
Publication of AU2019232625A1 publication Critical patent/AU2019232625A1/en
Application granted granted Critical
Publication of AU2019232625B2 publication Critical patent/AU2019232625B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/26—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
    • 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
    • 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
    • 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]

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)
AU2019232625A 2018-03-07 2019-03-04 Anti-PD-1 antibody compositions Active AU2019232625B2 (en)

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
AU2019232625A1 AU2019232625A1 (en) 2020-09-17
AU2019232625B2 true AU2019232625B2 (en) 2025-12-11

Family

ID=66041593

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2019232625A Active AU2019232625B2 (en) 2018-03-07 2019-03-04 Anti-PD-1 antibody compositions

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 (1)

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US20160159905A1 (en) * 2014-12-09 2016-06-09 Rinat Neuroscience Corp. Anti-pd-1 antibodies and methods of use thereof

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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
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
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
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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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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
IL277095B2 (en) 2025-10-01
IL277095A (en) 2020-10-29
US20210002369A1 (en) 2021-01-07

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