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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (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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WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
US20230035617A1 (en) * 2019-11-13 2023-02-02 Pfizer Inc. Stable aqueous anti-tfpi antibody formulation
US20230054413A1 (en) * 2019-12-13 2023-02-23 Samsung Bioepis Co., Ltd. Stable anti-pd1 antibody pharmaceutical formulations
SI4076385T1 (sl) 2019-12-20 2026-04-30 Formycon Ag Formulacije protiteles anti-pd1
JP2023512286A (ja) * 2020-01-31 2023-03-24 サノフイ 抗体の肺送達
CR20220596A (es) 2020-05-26 2023-01-23 Boehringer Ingelheim Int Anticuerpos 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
WO2023274275A1 (zh) * 2021-07-01 2023-01-05 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
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
WO2023031969A1 (en) * 2021-09-03 2023-03-09 Dr. Reddy’S Laboratories Limited A method of improving stability of immune check point inhibitors
IL314840A (en) * 2022-03-07 2024-10-01 Mabxience Res S L Stable Antibody Formulations
EP4637818A1 (en) 2022-12-21 2025-10-29 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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US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
ES2569409T3 (es) * 2005-03-08 2016-05-10 Pfizer Products Inc. Composiciones de anticuerpo anti-CTLA-4
MX2007011767A (es) * 2005-03-23 2007-10-18 Pfizer Prod Inc Terapia de combinacion de anticuerpo anti-ctla4 e indolinona para el tratamiento del cancer.
DK2439273T3 (da) 2005-05-09 2019-06-03 Ono Pharmaceutical Co Humane monoklonale antistoffer til programmeret død-1(pd-1) og fremgangsmåder til behandling af cancer ved anvendelse af anti-pd-1- antistoffer alene eller i kombination med andre immunterapeutika
BR122017025062B8 (pt) 2007-06-18 2021-07-27 Merck Sharp & Dohme anticorpo monoclonal ou fragmento de anticorpo para o receptor de morte programada humano pd-1, polinucleotídeo e composição compreendendo o referido anticorpo ou fragmento
AU2009288730B2 (en) 2008-08-25 2013-06-20 Amplimmune, Inc. Compositions of PD-1 antagonists and methods of use
PH12012502193A1 (en) * 2010-05-06 2021-08-09 Novartis Ag Compositions and methods of use for therapeutic low density lipoprotein - related protein 6 (lrp6) multivalent antibodies
EA201391489A1 (ru) * 2011-04-07 2014-02-28 ГЛЭКСОСМИТКЛАЙН ЭлЭлСи Композиции со сниженной вязкостью
MY175472A (en) * 2013-09-27 2020-06-29 Genentech Inc Anti-pdl1 antibody formulations
AR099812A1 (es) * 2014-03-21 2016-08-17 Abbvie Inc Anticuerpos y conjugados de anticuerpo y fármaco anti-egfr
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
MX2017009759A (es) * 2015-01-28 2017-10-27 Pfizer Formulacion de anticuerpo del anti-factor de crecimiento endotelial vascular (vegf) acuosa estable.
CN106999591B (zh) * 2015-09-28 2021-02-23 苏州盛迪亚生物医药有限公司 一种抗pd-1抗体制剂及其在医药上的应用
WO2017055966A1 (en) * 2015-10-01 2017-04-06 Pfizer Inc. Low viscosity antibody compositions
KR102770786B1 (ko) * 2017-05-02 2025-02-20 머크 샤프 앤드 돔 엘엘씨 항-tigit 항체 단독의, 및 프로그램화된 사멸 수용체 1 (pd-1) 항체와 조합된 항-tigit 항체의 안정한 제제 및 그의 사용 방법
US10646569B2 (en) * 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity

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

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