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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (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 (enExample)
EP (1) EP3761954A1 (enExample)
JP (1) JP7312188B2 (enExample)
KR (1) KR102594028B1 (enExample)
CN (1) CN112105343B (enExample)
AU (1) AU2019232625B2 (enExample)
BR (1) BR112020017935A2 (enExample)
IL (1) IL277095B2 (enExample)
MX (1) MX2020009275A (enExample)
WO (1) WO2019171253A1 (enExample)

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EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
PE20212185A1 (es) 2019-02-18 2021-11-11 Lilly Co Eli Formulacion de anticuerpos terapeuticos
AU2020385048A1 (en) * 2019-11-13 2022-06-02 Pfizer Inc. Stable aqueous anti-TFPI antibody formulation
TW202138006A (zh) * 2019-12-13 2021-10-16 韓商三星Ｂｉｏｅｐｉｓ股份有限公司 穩定之抗-pd1抗體醫藥調配物
US20230355757A1 (en) 2019-12-20 2023-11-09 Formycon Ag Formulations of anti-pd1 antibodies
WO2021152175A1 (en) * 2020-01-31 2021-08-05 Sanofi Pulmonary delivery of antibodies
CA3181776A1 (en) 2020-05-26 2021-12-02 Boehringer Ingelheim International Gmbh Anti-pd-1 antibodies
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
CN114652824A (zh) * 2020-12-23 2022-06-24 上海药明生物技术有限公司 抗egfr和pd-1双特异性抗体制剂与保存方法
US20240287185A1 (en) 2021-06-23 2024-08-29 Formycon Ag Formulations of anti-pd1 antibodies
CN117881419A (zh) * 2021-07-01 2024-04-12 天津立博美华基因科技有限责任公司 药物组合及其用途
CA3224640A1 (en) * 2021-07-09 2023-01-12 Krishnan SAMPATHKUMAR Pharmaceutical compositions of a pd-1 antibody and use of the same
JP2024532462A (ja) * 2021-09-03 2024-09-05 ドクター レディズ ラボラトリーズ リミテッド 免疫チェックポイント阻害剤の安定性を改善する方法
CN118076380A (zh) * 2021-09-03 2024-05-24 雷迪博士实验室有限公司 免疫检查点抑制剂的药物配制物
MX2024009994A (es) * 2022-03-07 2024-08-22 Mabxience Res S L Formulaciones estables para anticuerpos.
US20260207493A1 (en) * 2022-12-21 2026-07-23 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
TW202508641A (zh) * 2023-08-16 2025-03-01 大陸商上海邁晉生物醫藥科技有限公司 一種包含免疫綴合物的醫藥組成物及其用途
WO2025174319A1 (en) * 2024-02-16 2025-08-21 Xbrane Biopharma Ab Stable antibody formulation for intravenous use comprising nivolumab, histidine, sucrose, polysorbate and methionine
SE548163C2 (en) * 2024-02-16 2026-04-13 Xbrane Biopharma Ab Stable antibody formulation 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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CA2602316A1 (en) * 2005-03-23 2006-09-28 Pfizer Products Inc. Anti-ctla4 antibody and indolinone combination therapy for treatment of cancer
EP3530736A3 (en) 2005-05-09 2019-11-06 ONO Pharmaceutical Co., Ltd. Human monoclonal antibodies to programmed death 1 (pd-1) and methods for treating cancer using anti-pd-1 antibodies alone or in combination with other immunotherapeutics
PT2170959E (pt) 2007-06-18 2014-01-07 Merck Sharp & Dohme Anticorpos para o receptor humano de morte programada pd-1
EA201500417A1 (ru) 2008-08-25 2015-11-30 Эмплиммьюн, Инк. Композиции антагонистов pd-1 и способы применения
MX2012012927A (es) * 2010-05-06 2013-05-01 Novartis Ag Composiciones y metodos de uso para anticuerpos multivalentes terapeuticos de proteina relacionada con lipoproteina de baja densidad 6 (lrp6).
BR112013025845A2 (pt) * 2011-04-07 2018-09-04 Glaxosmithkline Llc formulações com viscosidade reduzida
DK3049441T3 (da) * 2013-09-27 2020-02-03 Hoffmann La Roche Anti-PDL1-antistofformuleringer
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
WO2016120753A1 (en) * 2015-01-28 2016-08-04 Pfizer Inc. Stable aqueous anti- vascular endothelial growth factor (vegf) antibody formulation
EP3357508A4 (en) * 2015-09-28 2019-04-24 Suzhou Suncadia Biopharmaceuticals Co., Ltd. STABLE PHARMACEUTICAL ANTI-PD-1 ANTIBODY PREPARATION AND APPLICATION THEREOF IN MEDICINE
WO2017055966A1 (en) * 2015-10-01 2017-04-06 Pfizer Inc. Low viscosity antibody compositions
SG11201909941QA (en) * 2017-05-02 2019-11-28 Merck Sharp & Dohme Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
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Also Published As

Publication number Publication date
JP2021517129A (ja) 2021-07-15
BR112020017935A2 (pt) 2021-02-09
AU2019232625A1 (en) 2020-09-17
CA3093036A1 (en) 2019-09-12
IL277095B1 (en) 2025-06-01
EP3761954A1 (en) 2021-01-13
CN112105343B (zh) 2024-07-30
RU2020129226A3 (enExample) 2022-04-07
KR20200128115A (ko) 2020-11-11
US20210002369A1 (en) 2021-01-07
CN112105343A (zh) 2020-12-18
KR102594028B1 (ko) 2023-10-24
JP7312188B2 (ja) 2023-07-20
WO2019171253A8 (en) 2020-10-01
IL277095A (en) 2020-10-29
WO2019171253A1 (en) 2019-09-12
IL277095B2 (en) 2025-10-01
RU2020129226A (ru) 2022-04-07
MX2020009275A (es) 2021-01-08

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