HRP20161630T1 - Citotoksični imunoglobulin - Google Patents

Citotoksični imunoglobulin Download PDF

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Publication number
HRP20161630T1
HRP20161630T1 HRP20161630TT HRP20161630T HRP20161630T1 HR P20161630 T1 HRP20161630 T1 HR P20161630T1 HR P20161630T T HRP20161630T T HR P20161630TT HR P20161630 T HRP20161630 T HR P20161630T HR P20161630 T1 HRP20161630 T1 HR P20161630T1
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Croatia
Prior art keywords
modular
antibody
modular antibody
pharmaceutical composition
antibody according
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HRP20161630TT
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English (en)
Inventor
Gottfried Himmler
Geert Mudde
Anton Bauer
Gerda Redl
Florian Rueker
Gordana Wozniak-Knopp
Maximilian Woisetschlaeger
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F-Star Biotechnologische Forschungs- Und Entwicklungsges.M.B.H
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Publication of HRP20161630T1 publication Critical patent/HRP20161630T1/hr

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    • 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
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/005Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies constructed by phage libraries
    • 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
    • C07K16/2863Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • 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
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • 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
    • C07K2317/70Immunoglobulins 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
    • C07K2317/73Inducing 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
    • C07K2317/70Immunoglobulins 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
    • C07K2317/734Complement-dependent cytotoxicity [CDC]
    • 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
    • C07K2317/90Immunoglobulins 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

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Virology (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (20)

1. Citotoksično modularno antitijelo sa molekulskom masom do 60kD, specifično se vezuje za humani Her2 sa afinitetom vezivanja Kd <10-8 M, gdje antitijelo sadrži fragment teškog lanca humanog IgG1 koji sadrži CH2 domenu i CH3 domenu i gdje antitijelo sadrži vezujuće mjesto koje se specifično vezuje za Her2 koji je projektiran u strukturnoj regiji petlje CH3 domena i sadrži amino-kiselinske sekvence sa identifikacijskim brojevima sekvenci (SEQ ID NO) 191, 241 i 370, gdje SEQ ID NO: 191 je sadržana unutar AB petlje, SEQ ID NO: 241 je sadržana unutar CD petlje, i SEQ ID NO: 370 je sadržana unutar EF petlje strukturne regije petlje.
2. Modularno antitijelo prema patentnom zahtjevu 1, koje ima najmanje jedno od – stanično posredovana citotoksičnost zavisna od antitijela (ADCC), stanična fagocitoza zavisna od antitijela (ADCP), citotoksičnost zavisna od komplementa (CDC) ili apoptotična aktivnost.
3. Modularno antitijelo prema patentnom zahtjevu 2, koje ima apoptotičnu aktivnost.
4. Modularno antitijelo prema patentnim zahtjevima 1 do 3, gdje je spomenuto antitijelo antigen-vezujući Fc.
5. Modularno antitijelo prema patentnom zahtjevu 4, gdje je spomenuto antitijelo antigen-vezujući IgG1 Fc.
6. Kombinirano modularno antitijelo koje sadrži modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 5, dalje kombinirano sa jednim ili više modificiranih modularnih antitijela ili sa nemodificiranim modularnim antitijelima ili njihovim dijelovima.
7. Kombinirano modularno antitijelo prema patentnom zahtjevu 6, koje je potpun molekula antitijela.
8. Modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 7, gdje je modularno antitijelo fuzioni protein u kome je domena modularnog antitijela fuzionirana za jedan ili više drugih proteina.
9. Modularno antitijelo prema patentnom zahtjevu 8, gdje je protein fuzioniran za modularno antitijelo odabran iz grupe koja se sastoji od drugih modularnih antitijela, imunoglobulina, laganada, proteina skele (“scaffold”), enzima, i toksina.
10. Modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 9 za primjenu u terapiji.
11. Modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 10, za primjenu u liječenju pacijenta koji boluje od solidnog tumora, čiji tumor eksprimira receptor erbB klase, gdje receptor je Her2.
12. Modularno antitijelo za primjenu prema patentnim zahtjevima 10 ili 11, gdje je modularno antitijelo administrirano u kombinaciji sa jednim ili više drugih terapijskih agenasa.
13. Modularno antitijelo za primjenu prema patentnim zahtjevima 10 ili 11, gdje je modularno antitijelo administrirano istovremeno sa jednim ili više terapijskih režima.
14. Farmaceutska kompozicija koja sadrži modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 9.
15. Farmaceutska kompozicija prema patentnom zahtjevu 14, koja sadrži modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 9 i jedan ili više dodatnih terapijskih aktivnih agenasa.
16. Farmaceutska kompozicija prema patentnom zahtjevu 14 ili 15, gdje farmaceutska kompozicija dalje sadrži farmaceutski prihvatljiv nosač, ekscipijens ili stabilizator.
17. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 14 do 16, gdje farmaceutska kompozicija je liofilizovana formulacija, ili vodena otopina.
18. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 14 do 16, gdje je farmaceutska kompozicija za oralnu, subkutanu, intravensku, intranazalnu, intraotičku, transdermalnu, mukoznu, topikalnu, intraperitonealnu, intramuskularnu, intrapulmonarnu, vaginalnu, parenteralnu, rektalnu, ili intraokularnu administraciju.
19. Molekul nukleinske kiseline sadrži sekvencu koja kodira modularno antitijelo prema bilo kojem od patentnih zahtjeva 1 do 7 i kontrolne sekvence u operabilnom spoju, gdje je domaćin transformiran ili transfektiran sa spomenutim sekvencama sposoban da proizvode kodirano modularno antitijelo.
20. Vektor koji sadrži molekulu nukleinske kiseline iz patentnog zahtjeva 19.
HRP20161630TT 2008-05-02 2016-12-05 Citotoksični imunoglobulin HRP20161630T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08450068A EP2113255A1 (en) 2008-05-02 2008-05-02 Cytotoxic immunoglobulin
EP13167714.8A EP2630970B1 (en) 2008-05-02 2009-03-03 Cytotoxic immunoglobulin

Publications (1)

Publication Number Publication Date
HRP20161630T1 true HRP20161630T1 (hr) 2017-02-10

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ID=39745473

Family Applications (3)

Application Number Title Priority Date Filing Date
HRP20140760AT HRP20140760T1 (hr) 2008-05-02 2014-08-11 Citotoksiäśni imunoglobulin
HRP20161630TT HRP20161630T1 (hr) 2008-05-02 2016-12-05 Citotoksični imunoglobulin
HRP20181267TT HRP20181267T1 (hr) 2008-05-02 2018-08-03 Citotoksični imunoglobulin

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HRP20140760AT HRP20140760T1 (hr) 2008-05-02 2014-08-11 Citotoksiäśni imunoglobulin

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20181267TT HRP20181267T1 (hr) 2008-05-02 2018-08-03 Citotoksični imunoglobulin

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US (4) US8859738B2 (hr)
EP (4) EP2113255A1 (hr)
JP (2) JP5693447B2 (hr)
CN (2) CN102083464B (hr)
CA (1) CA2721614C (hr)
CY (1) CY1119508T1 (hr)
DK (3) DK2274012T3 (hr)
ES (3) ES2609359T3 (hr)
HR (3) HRP20140760T1 (hr)
HU (2) HUE039975T2 (hr)
LT (2) LT2630970T (hr)
PL (3) PL2630970T3 (hr)
PT (1) PT2630970T (hr)
SI (2) SI2274012T1 (hr)
WO (1) WO2009132876A1 (hr)

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