DK2365987T3 - Isoformspecifikke anti-HER4-antistoffer - Google Patents

Isoformspecifikke anti-HER4-antistoffer Download PDF

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Publication number
DK2365987T3
DK2365987T3 DK09760430.0T DK09760430T DK2365987T3 DK 2365987 T3 DK2365987 T3 DK 2365987T3 DK 09760430 T DK09760430 T DK 09760430T DK 2365987 T3 DK2365987 T3 DK 2365987T3
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Denmark
Prior art keywords
antibody
her4
isoform
antibodies
cells
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DK09760430.0T
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English (en)
Inventor
Mark X Sliwkowski
Klaus Elenius
Maija Hollmen
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Genentech Inc
Univ Turku
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Publication of DK2365987T3 publication Critical patent/DK2365987T3/da

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • G01N33/57492Immunoassay; 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 localized on the membrane of tumor or cancer cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • 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
    • 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
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/77Internalization into the cell
    • 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
    • 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
    • G01N2333/705Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/71Assays involving receptors, cell surface antigens or cell surface determinants for growth factors; for growth regulators

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Hospice & Palliative Care (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (16)

1. Isoleret anti-HER4-antistof, som specifikt binder til HER4 JM-a-isoformen, hvilket antistof ikke har nogen væsentlig krydsreaktivitet med HER4 JM-b-isoformen, hvor antistoffet konkurrerer for at binde sig til JM-a-isoformen med anti-HER4-antistoffet mAb 1479 produceret af hybridom-cellelinjen deponeret hos ATCC med accessionsnr. PTA-9655.
2. Antistof ifølge krav 1, hvor antistoffet binder til den samme epitop som den epitop, som det monoklonale antistof mAb 1479 produceret af hybridom-cellelinjen deponeret hos ATCC med accessionsnr. PTA-9655 binder til.
3. Antistof ifølge krav 1 eller 2, hvor antistoffet omfatter et fragment fra det monoklonale antistof mAb 1479 produceret af hybridom-cellelinjen deponeret hos ATCC med accessionsnr. PTA-9655, hvor fragmentet omfatter alle tre af de hypervariable VH1-, VH2- og VH3-regioner og alle tre af de hypervariable VLI-, VL2- og VL3-regioner af mAb 1479.
4. Antistof ifølge krav 3, hvor fragmentet fra det monoklonale antistof mAb 1479 omfatter de variable regioner af mAb 1479 med let og tung kæde.
5. Antistof ifølge et af de foregående krav, hvor omfanget af krydsreaktivitet med HER4 JM-b er mindre end a) 10 % b) 5 % c) 2 % eller d) 1% som fastlagt ved fluorescens-aktiveret cellesorteringsanalyse (FACS) eller radioimmunoudfældning (RIA).
6. Antistof ifølge et af de foregående krav, hvor antistoffet binder til HER4 JM-a-isoformen med affinitet repræsenteret af en Kd på 10'8 M, eller med højere affinitet.
7. Antistof ifølge et af de foregående krav, hvor antistoffet er et kimærisk, humant eller humaniseret antistof.
8. Antistof ifølge krav 4, hvor antistoffet er monoklonalt antistof mAb 1479 produceret af hybridom-cellelinjen deponeret hos ATCC med accessionsnr. PTA-9655 eller humaniseret form deraf.
9. Antistof ifølge et af de foregående krav, hvor antistoffet er bundet til et cy-totoksisk middel.
10. Antistof ifølge et af kravene 1-9, hvor antistoffet har mindre kardiotoksici-tet end et anti-HER4-antistof, som genkender HER4 JM-b-isoformen.
11. Antistof ifølge et af de foregående krav til anvendelse ved en fremgangsmåde til behandling af brystcancer hos en patient, hvis cancer ekspri-merer HER4 JM-a-isoformen, hvor fremgangsmåden omfatter at indgive en terapeutisk virksom mængde af antistoffet i patienten.
12. Antistof til anvendelse ifølge krav 11, hvor fremgangsmåden til behandling af cancer hos en patient omfatter de følgende trin: a) at udvælge en patient, hvis cancerceller eksprimerer eller overeksprimerer HER4 JM-a-isoformen; og b) at indgive en terapeutisk virksom mængde af antistoffet i patienten.
13. Antistof til anvendelse ifølge krav 12, hvor ekspressionen af HER4 JM-a-isoformen ved fremgangsmåden påvises ved påvisning af forekomsten af et JM-a isoform-polypeptid, forekomsten af et JM-a isoform-polynukleotid eller forekomsten af fraspaltet HER4-ektodomæne.
14. Antistof til anvendelse ifølge krav 13, hvor forekomsten af fraspaltet HER4-ektodomæne påvises ved fremgangsmåden, omfattende at bringe et antistof ifølge et af kravene 1 til 10 i kontakt med en prøve fra en tumor i patienten og at påvise bindingen af antistoffet til fraspaltet HER4-ektodomæne.
15. Antistof til anvendelse ifølge krav 14, hvor patientens cancerceller eksprimerer HER4 JM-a-isoformen på niveauer, som er mindst: a) 10 %; b) 20 %; eller c) 30 % højere end ekspressionsniveauer i ikke-cancerceller af den samme celletype eller i ikke-cancerceller grænsende op til cancercellerne.
16. Fremgangsmåde til påvisning af forekomsten af fraspaltet HER4-ekto-domæne i en prøve af celler omfattende at bringe cellerne i kontakt med et antistof ifølge et af kravene 1 til 10 og at påvise bindingen af antistoffet til fraspaltet HER4-ektodomæne.
DK09760430.0T 2008-11-25 2009-11-24 Isoformspecifikke anti-HER4-antistoffer DK2365987T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11790308P 2008-11-25 2008-11-25
PCT/US2009/065712 WO2010068437A1 (en) 2008-11-25 2009-11-24 Isoform specific anti-her4 antibodies

Publications (1)

Publication Number Publication Date
DK2365987T3 true DK2365987T3 (da) 2015-01-12

Family

ID=42021645

Family Applications (1)

Application Number Title Priority Date Filing Date
DK09760430.0T DK2365987T3 (da) 2008-11-25 2009-11-24 Isoformspecifikke anti-HER4-antistoffer

Country Status (15)

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US (2) US20110293614A1 (da)
EP (1) EP2365987B1 (da)
JP (1) JP5894436B2 (da)
KR (1) KR101789338B1 (da)
CN (2) CN109608545A (da)
AU (1) AU2009324939B2 (da)
BR (1) BRPI0916092A2 (da)
CA (1) CA2744512C (da)
DK (1) DK2365987T3 (da)
ES (1) ES2528929T3 (da)
IL (1) IL212900A0 (da)
MX (1) MX2011005382A (da)
PL (1) PL2365987T3 (da)
SI (1) SI2365987T1 (da)
WO (1) WO2010068437A1 (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2365987T3 (pl) 2008-11-25 2015-04-30 Genentech Inc Przeciwciała anty-HER4 swoiste dla określonej izoformy
US10083108B1 (en) * 2017-12-18 2018-09-25 Clover Network, Inc. Automated stack-based computerized application crawler
CN112753956A (zh) * 2021-01-20 2021-05-07 重庆周师兄餐饮文化有限公司 一种腰片的加工方法
CN113999228B (zh) * 2021-11-08 2022-11-04 南京卓康医药科技有限公司 一种他达拉非的合成方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5208020A (en) 1989-10-25 1993-05-04 Immunogen Inc. Cytotoxic agents comprising maytansinoids and their therapeutic use
CA2149329C (en) 1992-11-13 2008-07-15 Darrell R. Anderson Therapeutic application of chimeric and radiolabeled antibodies to human b lymphocyte restricted differentiation antigen for treatment of b cell lymphoma
CA2103323A1 (en) 1992-11-24 1994-05-25 Gregory D. Plowman Her4 human receptor tyrosine kinase
US5811098A (en) * 1992-11-24 1998-09-22 Bristol-Myers Squibb Company Antibodies to HER4, human receptor tyrosine kinase
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
IL127891A0 (en) 1996-07-12 1999-10-28 Genentech Inc Chimeric heteromultimeter adhesins
US6121415A (en) 1997-07-09 2000-09-19 Genentech, Inc. ErbB4 receptor-specific neuregolin related ligands and uses therefor
AU9805398A (en) * 1997-10-15 1999-05-03 Children's Medical Center Corporation Novel human egf receptors and use thereof
US20020119148A1 (en) 2000-09-01 2002-08-29 Gerritsen Mary E. ErbB4 antagonists
PL2365987T3 (pl) 2008-11-25 2015-04-30 Genentech Inc Przeciwciała anty-HER4 swoiste dla określonej izoformy

Also Published As

Publication number Publication date
CA2744512C (en) 2018-05-15
CN102725310A (zh) 2012-10-10
IL212900A0 (en) 2011-07-31
AU2009324939A1 (en) 2010-06-17
KR101789338B1 (ko) 2017-10-23
US9963517B2 (en) 2018-05-08
PL2365987T3 (pl) 2015-04-30
SI2365987T1 (sl) 2015-03-31
JP5894436B2 (ja) 2016-03-30
MX2011005382A (es) 2011-07-20
JP2012509896A (ja) 2012-04-26
US20110293614A1 (en) 2011-12-01
US20160075798A1 (en) 2016-03-17
WO2010068437A1 (en) 2010-06-17
EP2365987B1 (en) 2014-11-12
AU2009324939B2 (en) 2015-07-09
KR20110098756A (ko) 2011-09-01
CN109608545A (zh) 2019-04-12
BRPI0916092A2 (pt) 2015-11-17
CA2744512A1 (en) 2010-06-17
ES2528929T3 (es) 2015-02-13
EP2365987A1 (en) 2011-09-21

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