DK3054298T3 - Fremgangsmåde til detektering af tumor i bugspytkirtlen - Google Patents

Fremgangsmåde til detektering af tumor i bugspytkirtlen Download PDF

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Publication number
DK3054298T3
DK3054298T3 DK14850747.8T DK14850747T DK3054298T3 DK 3054298 T3 DK3054298 T3 DK 3054298T3 DK 14850747 T DK14850747 T DK 14850747T DK 3054298 T3 DK3054298 T3 DK 3054298T3
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Prior art keywords
apoa2
protein
antibody
atq
terminus
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DK14850747.8T
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English (en)
Inventor
Mitsuaki SANADA
Michimoto Kobayashi
Aiko Takayama
Yoshiyuki SASAJIMA
Giman Jung
Tesshi Yamada
Kazufumi Honda
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Toray Industries
Nat Cancer Ct
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Publication of DK3054298T3 publication Critical patent/DK3054298T3/da

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57407Specifically defined cancers
    • G01N33/57438Specifically defined cancers of liver, pancreas or kidney
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/303Liver or Pancreas
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57488Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds identifable in body fluids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • G01N33/6857Antibody fragments
    • 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
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/775Apolipopeptides

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Hospice & Palliative Care (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (8)

1. Fremgangsmåde til detektering af kræft i bugspytkirtlen eller godartet tumor i bugspytkirtlen ved at måle mængderne af apolipoprotein A2 (APOA2)-proteinvarianter i en kropsvæskeprøve fra en forsøgsperson, idet fremgangsmåden til detektering omfatter: (A) et første trin til måling af mængden af APOA2-ATQ-protein i prøven under anvendelse af et anti-APOA2-ATQ-terminus antistof der specifikt binder til en C-terminal region af APOA2-ATQ-proteinet omfattende aminosyresekvensen repræsenteret ved SEQ ID NO: 1, og et anti-APOA2-ATQ ikke-terminus antistof der binder til aminosyresekvensen bortset fra den C-terminale region; (B) et andet trin til måling af mængden af APOA2-AT-protein i prøven under anvendelse af et anti-APOA2-AT-terminus antistof der specifikt binder til en C-terminal region af APOA2-AT-proteinet omfattende aminosyresekvensen repræsenteret ved SEQ ID NO: 2 og et anti-APOA2-AT ikke-terminus antistof der binder til aminosyresekvensen bortset fra den C-terminal region; og (C) et tredje trin til indlæsning, til en forud indstillet diskriminant, af målingsværdien af mængden af APOA2-ATQ-protein opnået i det første trin og målingsværdien af mængden af APOA2-AT-protein opnået i det andet trin og til at bestemme om forsøgspersonen har kræft i bugspytkirtlen eller en godartet tumor i bugspytkirtlen, når den resulterende diskriminantværdi hos forsøgspersonen er statistisk signifikant anderledes sammenlignet med diskriminantværdien hos en normal person, hvor APOA2-ATQ-proteinet er fuldlængde APOA2-proteinet og APOA2-AT proteinet er APOA2-proteinet, som mangler den C-terminale glutaminrest.
2. Fremgangsmåde til detektering ifølge krav 1, hvor de C-terminale regioner af APOA2-ATQ-proteinet og APOA2-AT-proteinet hver består af en sekvens omfattende 6 eller flere fortløbende aminosyrer inklusiv C terminuset.
3. Fremgangsmåde til detektering ifølge krav 1 eller 2, hvor diskriminanten er en hvilken som helst valgt fra gruppen bestående af en logistisk regression ekspression, en ekspression udarbejdet ved analyse med en supportvektormaskine, en ekspression udarbejdet ved analyse af et nervenetværk og en ekspression udarbejdet ved diskriminantanalyse.
4. Fremgangsmåde til detektering ifølge krav 3, hvor den logistiske regression ekspression omfatter, som en variable, måleværdien af APOA2-ATQ-proteinet, måleværdien af APOA2-AT-proteinet, og/eller produktet af måleværdien af APOA2-ATQ-proteinet og måleværdien af APOA2-AT-proteinet.
5. Fremgangsmåde ifølge krav 4, hvor diskriminantværdien af forsøgspersonen opnået fra den logistiske regression ekspression er 2/3 eller lavere end diskriminantværdien hos en normal person.
6. Fremgangsmåde til detektering ifølge et hvilket som helst af kravene 1 til 5, yderligere omfattende et fjerde trin til måling af mængden af bugspytkirtel kræftmarkør CA19-9 eller DU-PAN-2 i en kropsvæskeprøve fra forsøgspersonen bestemt til at have kræft i bugspytkirtlen eller en godartet tumor i bugspytkirtlen i det tredje trin, og til at bestemme at forsøgspersonen har kræft i bugspytkirtlen, når måleværdien overstiger en forudbestemt referenceværdi og til at bestemme at forsøgspersonen har en godartet tumor i bugspytkirtlen, når måleværdien er lig med eller mindre end referenceværdien.
7. Fremgangsmåde til detektering ifølge et hvilket som helst af kravene 1 til 6, hvor kropsvæskeprøven er blod, plasma eller serum.
8. Fremgangsmåde til detektering ifølge et hvilket som helst af kravene 1 til 7, hvor kræften i bugspytkirtlen er tidlig kræft i bugspytkirtlen.
DK14850747.8T 2013-10-01 2014-09-30 Fremgangsmåde til detektering af tumor i bugspytkirtlen DK3054298T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2013206682 2013-10-01
JP2014166188 2014-08-18
PCT/JP2014/076035 WO2015050107A1 (ja) 2013-10-01 2014-09-30 膵腫瘍の検出方法、抗体及び膵腫瘍検出用キット

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US (1) US20160245815A1 (da)
EP (1) EP3054298B1 (da)
JP (1) JP6519056B2 (da)
KR (1) KR102235380B1 (da)
CN (1) CN105637366B (da)
BR (1) BR112016007037B1 (da)
CA (3) CA3189270A1 (da)
DK (1) DK3054298T3 (da)
RU (1) RU2693006C2 (da)
WO (1) WO2015050107A1 (da)

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Publication number Publication date
EP3054298B1 (en) 2019-02-20
CA2925099C (en) 2023-04-04
CA3189270A1 (en) 2015-04-09
KR102235380B1 (ko) 2021-04-01
BR112016007037A2 (pt) 2017-12-12
CA2925099A1 (en) 2015-04-09
JPWO2015050107A1 (ja) 2017-03-09
RU2016116773A3 (da) 2018-07-23
RU2693006C2 (ru) 2019-07-01
EP3054298A1 (en) 2016-08-10
RU2016116773A (ru) 2017-11-14
US20160245815A1 (en) 2016-08-25
CN105637366A (zh) 2016-06-01
JP6519056B2 (ja) 2019-05-29
WO2015050107A1 (ja) 2015-04-09
EP3054298A4 (en) 2017-08-02
CN105637366B (zh) 2018-05-29
CA3189276A1 (en) 2015-04-09
KR20160065876A (ko) 2016-06-09
BR112016007037B1 (pt) 2023-12-26

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