AU2018246252A1 - Formulations comprising PD-1 binding proteins and methods of making thereof - Google Patents

Formulations comprising PD-1 binding proteins and methods of making thereof Download PDF

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Publication number
AU2018246252A1
AU2018246252A1 AU2018246252A AU2018246252A AU2018246252A1 AU 2018246252 A1 AU2018246252 A1 AU 2018246252A1 AU 2018246252 A AU2018246252 A AU 2018246252A AU 2018246252 A AU2018246252 A AU 2018246252A AU 2018246252 A1 AU2018246252 A1 AU 2018246252A1
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AU
Australia
Prior art keywords
antibody
seq
pharmaceutical formulation
antigen
amino acid
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.)
Abandoned
Application number
AU2018246252A
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English (en)
Inventor
Douglas Banks
Xiao-Ping Dai
Willard R. Foss
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.)
Celgene Corp
Original Assignee
Celgene Corp
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63678296&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018246252(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Celgene Corp filed Critical Celgene Corp
Publication of AU2018246252A1 publication Critical patent/AU2018246252A1/en
Abandoned legal-status Critical Current

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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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • 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
    • C07K16/2809Immunoglobulins [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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • 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]
    • 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
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
AU2018246252A 2017-03-29 2018-03-28 Formulations comprising PD-1 binding proteins and methods of making thereof Abandoned AU2018246252A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762478524P 2017-03-29 2017-03-29
US62/478,524 2017-03-29
PCT/US2018/024787 WO2018183459A1 (en) 2017-03-29 2018-03-28 Formulations comprising pd-1 binding proteins and methods of making thereof

Publications (1)

Publication Number Publication Date
AU2018246252A1 true AU2018246252A1 (en) 2019-09-19

Family

ID=63678296

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018246252A Abandoned AU2018246252A1 (en) 2017-03-29 2018-03-28 Formulations comprising PD-1 binding proteins and methods of making thereof

Country Status (16)

Country Link
US (1) US20180289802A1 (https=)
EP (1) EP3601338A4 (https=)
JP (1) JP2020512359A (https=)
KR (1) KR20190141658A (https=)
CN (1) CN110678482A (https=)
AU (1) AU2018246252A1 (https=)
BR (1) BR112019018996A2 (https=)
CA (1) CA3055984A1 (https=)
CL (1) CL2019002605A1 (https=)
CO (1) CO2019010230A2 (https=)
EA (1) EA201991912A1 (https=)
EC (1) ECSP19076344A (https=)
IL (1) IL268884A (https=)
MX (1) MX2019010999A (https=)
SG (1) SG11201907948TA (https=)
WO (1) WO2018183459A1 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX383464B (es) 2015-07-13 2025-03-14 Cytomx Therapeutics Inc Anticuerpos anti-pd-1, anticuerpos anti-pd-1 activables, y métodos de uso de los mismos.
BR112018006237A2 (pt) 2015-09-29 2018-10-09 Celgene Corp proteínas de ligação a pd-1 e métodos de uso das mesmas
MX2019002867A (es) 2016-09-19 2019-11-12 Celgene Corp Metodos de tratamiento de trastornos inmunologicos usando proteinas de union a pd-1.
JP2019534859A (ja) 2016-09-19 2019-12-05 セルジーン コーポレイション Pd−1結合タンパク質を使用して白斑を治療する方法
TWI890481B (zh) 2018-02-09 2025-07-11 日商小野藥品工業股份有限公司 雙特異性抗體
TWI871300B (zh) * 2019-01-28 2025-02-01 美商安進公司 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
US20230143066A1 (en) * 2020-04-17 2023-05-11 Ono Pharmaceutical Co., Ltd. Method for removing color from drug substance of protein preparation
CR20220596A (es) 2020-05-26 2023-01-23 Boehringer Ingelheim Int Anticuerpos anti-pd-1
JP2023535384A (ja) * 2020-07-31 2023-08-17 江蘇恒瑞医薬股▲ふん▼有限公司 抗pd-1抗体医薬組成物及びその用途
EP4008345A1 (en) * 2020-12-03 2022-06-08 Hexal AG Novel formulations for antibodies
WO2023006055A1 (en) * 2021-07-29 2023-02-02 Shanghai Junshi Biosciences Co., Ltd. Anti-pd-1 antibody pharmaceutical composition and use thereof
CN117088981B (zh) * 2023-08-15 2024-09-10 福建医科大学附属协和医院 抗b7-h3的单链抗体

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040241745A1 (en) * 2001-07-31 2004-12-02 Tasuku Honjo Substance specific to pd-1
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
JP5676849B2 (ja) * 2006-10-20 2015-02-25 中外製薬株式会社 抗hb−egf抗体を有効成分として含む癌治療剤
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
EP2604279A1 (en) * 2008-03-27 2013-06-19 ZymoGenetics, Inc. Compositions and methods for inhibiting PDGFRBETA and VEGF-A
NO2344540T3 (https=) * 2008-10-02 2018-04-28
TW201134488A (en) * 2010-03-11 2011-10-16 Ucb Pharma Sa PD-1 antibodies
MY175472A (en) * 2013-09-27 2020-06-29 Genentech Inc Anti-pdl1 antibody formulations
CN106029697B (zh) * 2013-12-20 2021-06-04 英特维特国际股份有限公司 具有经修饰的ch2-ch3序列的犬抗体
WO2015103139A1 (en) * 2013-12-31 2015-07-09 Development Center For Biotechnology Anti-vegf antibodies and use thereof
TWI681969B (zh) * 2014-01-23 2020-01-11 美商再生元醫藥公司 針對pd-1的人類抗體
TWI595006B (zh) * 2014-12-09 2017-08-11 禮納特神經系統科學公司 抗pd-1抗體類和使用彼等之方法
KR20250004095A (ko) * 2015-04-17 2025-01-07 브리스톨-마이어스 스큅 컴퍼니 항-pd-1 항체 및 또 다른 항체의 조합물을 포함하는 조성물
BR112018006237A2 (pt) * 2015-09-29 2018-10-09 Celgene Corp proteínas de ligação a pd-1 e métodos de uso das mesmas
MX2019002867A (es) * 2016-09-19 2019-11-12 Celgene Corp Metodos de tratamiento de trastornos inmunologicos usando proteinas de union a pd-1.
JP2019534859A (ja) * 2016-09-19 2019-12-05 セルジーン コーポレイション Pd−1結合タンパク質を使用して白斑を治療する方法

Also Published As

Publication number Publication date
IL268884A (en) 2019-10-31
CA3055984A1 (en) 2018-10-04
BR112019018996A2 (pt) 2020-04-14
MX2019010999A (es) 2020-02-05
EA201991912A1 (ru) 2020-03-10
ECSP19076344A (es) 2019-10-31
SG11201907948TA (en) 2019-09-27
CL2019002605A1 (es) 2020-05-29
CN110678482A (zh) 2020-01-10
US20180289802A1 (en) 2018-10-11
EP3601338A4 (en) 2020-12-16
JP2020512359A (ja) 2020-04-23
KR20190141658A (ko) 2019-12-24
CO2019010230A2 (es) 2020-01-17
WO2018183459A1 (en) 2018-10-04
EP3601338A1 (en) 2020-02-05

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Legal Events

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MK1 Application lapsed section 142(2)(a) - no request for examination in relevant period