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 (OSRAM)
EP (1) EP3761954A1 (OSRAM)
JP (1) JP7312188B2 (OSRAM)
KR (1) KR102594028B1 (OSRAM)
CN (1) CN112105343B (OSRAM)
AU (1) AU2019232625B2 (OSRAM)
BR (1) BR112020017935A2 (OSRAM)
IL (1) IL277095B2 (OSRAM)
MX (1) MX2020009275A (OSRAM)
WO (1) WO2019171253A1 (OSRAM)

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US20200087390A1 (en) 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
SG11202108627SA (en) 2019-02-18 2021-09-29 Lilly Co Eli Therapeutic antibody formulation
CA3160806A1 (en) * 2019-11-13 2021-05-20 Pfizer Inc. Stable aqueous formulation containing anti-tfpi antibody _______
EP4074338A4 (en) * 2019-12-13 2024-03-06 Samsung Bioepis Co., Ltd. PHARMACEUTICAL PREPARATION OF STABLE ANTI-PD-1 ANTIBODY
US20230355757A1 (en) 2019-12-20 2023-11-09 Formycon Ag Formulations of anti-pd1 antibodies
CN115397394A (zh) * 2020-01-31 2022-11-25 赛诺菲 抗体的肺部递送
MA59827B1 (fr) 2020-05-26 2024-10-31 Boehringer Ingelheim International Gmbh Anticorps 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
EP4359001A1 (en) 2021-06-23 2024-05-01 Formycon AG Formulations of anti-pd1 antibodies
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
PE20240797A1 (es) * 2021-07-09 2024-04-18 Macrogenics Inc Composiciones farmaceuticas de un anticuerpo contra pd-1 y uso de las mismas
EP4395816A4 (en) * 2021-09-03 2025-07-30 Dr Reddys Laboratories Ltd PHARMACEUTICAL FORMULATION OF IMMUNE CHECKPOINT INHIBITORS
EP4395815A4 (en) * 2021-09-03 2025-07-30 Dr Reddys Laboratories Ltd METHOD FOR IMPROVING THE STABILITY OF IMMUNE CHECKPOINT INHIBITORS
AU2023229902A1 (en) * 2022-03-07 2024-08-29 Mabxience Research, S.L. Stable formulations for antibodies
EP4637818A1 (en) 2022-12-21 2025-10-29 Formycon AG Formulations of anti-pd1 antibodies
IL322410A (en) 2023-02-16 2025-09-01 Sun Pharmaceutical Ind Ltd Stable protein complexes containing an antibody against PD1
KR20260054696A (ko) * 2023-08-16 2026-04-22 상하이 맙젠 바이오텍 리미티드 면역접합체를 포함하는 약학적 조성물 및 이의 용도
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)

* Cited by examiner, † Cited by third party
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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
LT2620450T (lt) * 2005-03-08 2019-02-11 Pfizer Products Inc. Anti-ctla-4 antikūnų kompozicijos
CN101146553A (zh) * 2005-03-23 2008-03-19 辉瑞产品公司 用于治疗癌症的抗-ctla4抗体和吲哚酮组合治疗
PL2161336T5 (pl) 2005-05-09 2017-10-31 Ono Pharmaceutical Co Ludzkie przeciwciała monoklonalne przeciwko białku Programmed Death 1 (PD-1) oraz sposoby leczenia raka z zastosowaniem samych przeciwciał anty-PD-1 lub w połączeniu z innymi środkami immunoterapeutycznymi
KR101586617B1 (ko) 2007-06-18 2016-01-20 머크 샤프 앤 도메 비.브이. 사람 프로그램된 사멸 수용체 ｐｄ-1에 대한 항체
ES2545609T3 (es) 2008-08-25 2015-09-14 Amplimmune, Inc. Composiciones de antagonistas de PD-1 y métodos de uso
EA201291181A1 (ru) * 2010-05-06 2013-05-30 Новартис Аг Композиции и способы применения терапевтических поливалентных антител против белка, родственного рецептору липопротеинов низкой плотности 6 (lrp6)
SG193964A1 (en) 2011-04-07 2013-11-29 Glaxosmithkline Llc Formulations with reduced viscosity
DK3049441T3 (da) * 2013-09-27 2020-02-03 Hoffmann La Roche Anti-PDL1-antistofformuleringer
TW202214691A (zh) * 2014-03-21 2022-04-16 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
AU2016210918A1 (en) * 2015-01-28 2017-07-13 Pfizer Inc., Stable aqueous anti- vascular endothelial growth factor (VEGF) antibody formulation
MX395336B (es) * 2015-09-28 2025-03-25 Suzhou Suncadia Biopharmaceuticals Co Ltd Preparacion farmaceutica de anticuerpo anti-pd-1 estable y aplicacion del mismo en medicina.
WO2017055966A1 (en) * 2015-10-01 2017-04-06 Pfizer Inc. Low viscosity antibody compositions
CA3061050A1 (en) * 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2018211517A1 (en) * 2017-05-16 2018-11-22 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
US20210002369A1 (en) 2021-01-07
JP2021517129A (ja) 2021-07-15
RU2020129226A (ru) 2022-04-07
IL277095B2 (en) 2025-10-01
WO2019171253A1 (en) 2019-09-12
CA3093036A1 (en) 2019-09-12
RU2020129226A3 (OSRAM) 2022-04-07
CN112105343A (zh) 2020-12-18
KR102594028B1 (ko) 2023-10-24
AU2019232625A1 (en) 2020-09-17
KR20200128115A (ko) 2020-11-11
BR112020017935A2 (pt) 2021-02-09
WO2019171253A8 (en) 2020-10-01
IL277095A (en) 2020-10-29
EP3761954A1 (en) 2021-01-13
JP7312188B2 (ja) 2023-07-20
CN112105343B (zh) 2024-07-30
IL277095B1 (en) 2025-06-01
MX2020009275A (es) 2021-01-08

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Legal Events

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