HRP20230282T3 - Monoklonska antitijela protiv klaudina-18 za liječenje raka - Google Patents

Monoklonska antitijela protiv klaudina-18 za liječenje raka

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Publication number
HRP20230282T3
HRP20230282T3 HRP20230282TT HRP20230282T HRP20230282T3 HR P20230282 T3 HRP20230282 T3 HR P20230282T3 HR P20230282T T HRP20230282T T HR P20230282TT HR P20230282 T HRP20230282 T HR P20230282T HR P20230282 T3 HRP20230282 T3 HR P20230282T3
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Croatia
Prior art keywords
antibody
pharmaceutical preparation
dsm
use according
cells
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HRP20230282TT
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English (en)
Inventor
Ugur Sahin
Özlem TÜRECI
Gunda Brandenburg
Dirk Usener
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Astellas Pharma Inc.
Tron - Translationale Onkologie An Der Universitätsmedizin Der Johannes Gutenberg- Universität Mainz Gemeinnützige Gmbh
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Application filed by Astellas Pharma Inc., Tron - Translationale Onkologie An Der Universitätsmedizin Der Johannes Gutenberg- Universität Mainz Gemeinnützige Gmbh filed Critical Astellas Pharma Inc.
Publication of HRP20230282T3 publication Critical patent/HRP20230282T3/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
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • 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
    • C07K16/18Immunoglobulins [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
    • C07K16/3046Stomach, Intestines
    • 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
    • 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
    • C07K2317/70Immunoglobulins 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]

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

Claims (18)

1. Postupak za detektiranje metastatskih stanica raka želuca, koji obuhvaća dovođenje u kontakt uzorka dobivenog iz Krukenbergovog tumora ili uzorka dobivenog iz limfnih čvorova, i kontrolnog uzorka, sa antitijelom koje se specifično veže za klaudin-18 spojene varijante 2 (CLD18A2), pod uvjetima koji omogućavaju formiranje kompleksa između antitijela ili njegovog antigen-vezujućeg dijela i CLD18A2, naznačen time, što povećana količina formiranja kompleksa u uzorku ukazuje na metastatske stanice u uzorku.
2. Postupak prema patentnom zahtjevu 1, naznačen time, što metastatske stanice raka predstavljaju stanice Krukenbergovog tumora.
3. Farmaceutski pripravak koji sadrži antitijelo i/ili konjugat koji sadrži navedeno antitijelo povezano sa terapijskim sredstvom i farmaceutski prihvatljiv nosač, za uporabu u postupku za liječenje metastaze raka želuca, naznačen time, što navedeno antitijelo ima sposobnost vezanja za CLD18A2 i posredovanja u ubijanju stanica koje eksprimiraju CLD18A2 induciranjem lize posredovane citotoksičnosti ovisnom od komplementa (CDC) ili induciranjem lize posredovane staničnom citotoksičnosti ovisnom od antitijela (ADCC) i/ili inhibicijom proliferacije stanica koje eksprimiraju CLD18A2.
4. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 3, naznačen time, što se navedeno antitijelo veže za klaudin-18 spojene varijante 1 (CLD18A1) i CLD18A2.
5. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 3, naznačen time, što se navedeno antitijelo veže za CLD18A2, ali ne i za CLD18A1.
6. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-5, naznačen time, što se navedeno ubijanje stanica i/ili inhibicija proliferacije induciraju vezanjem navedenog antitijela za CLD18A2 koji eksprimiraju navedene stanice.
7. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-6, naznačen time, što se navedeno ubijanje stanica i/ili inhibicija proliferacije ne induciraju vezanjem navedenog antitijela za CLD18A1 koji eksprimiraju navedene stanice.
8. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-7, naznačen time, što navedeno antitijelo ne inducira CDC-posredovanu lizu navedenih stanica.
9. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-8, naznačen time, što se navedena ADCC-posredovana liza odvija u prisustvu efektorskih stanica odabranih iz grupe koja se sastoji od monocita, mononuklearnih stanica, NK stanica i PMN stanica.
10. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-9, naznačen time, što je navedeno antitijelo monoklonsko, kimerno ili humanizirano antitijelo, ili antigen-vezujući fragment antitijela.
11. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-10, naznačen time, što je navedeno antitijelo odabrano iz grupe koja se sastoji od IgG1, IgG2, IgG2a i IgG2b, IgG3, IgG4, IgM, IgA1, IgA2, sekretornog IgA, IgD, i IgE antitijela.
12. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-11, naznačen time, što CLD18A2 ima aminokiselinsku sekvencu prema SEQ ID NO: 2.
13. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 4-12, naznačen time, što CLD18A1 ima aminokiselinsku sekvencu prema SEQ ID NO: 8.
14. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-13, naznačen time, što je navedeno antitijelo specifično za stanice raka želuca.
15. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-14, naznačen time, što se navedeni CLD18A2 eksprimira na površini navedenih stanica.
16. Farmaceutski pripravak koji sadrži antitijelo koje se veže za CLD18A2 i/ili konjugat koji sadrži navedeno antitijelo povezano sa terapijskim sredstvom, i farmaceutski prihvatljiv nosač, za uporabu u postupku za liječenje metastaze raka želuca, naznačen time, što navedeno antitijelo proizvodi klon deponiran pod pristupnim br. DSM ACC2737, DSM ACC2738, DSM ACC2739, DSM ACC2740, DSM ACC2741, DSM ACC2742, DSM ACC2743, DSM ACC2745, DSM ACC2746, DSM ACC2747, DSM ACC2748, DSM ACC2808, DSM ACC2809 ili DSM ACC2810.
17. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-16, naznačen time, što je navedeno terapijsko sredstvo toksin, radioizotop, lijek ili citotoksično sredstvo.
18. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 3-17, naznačen time, što je navedena metastaza raka želuca metastaza u limfnim čvorovima.
HRP20230282TT 2007-05-29 2008-05-27 Monoklonska antitijela protiv klaudina-18 za liječenje raka HRP20230282T3 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US93209907P 2007-05-29 2007-05-29
EP07010622A EP1997832A1 (en) 2007-05-29 2007-05-29 Monoclonal antibodies against Claudin-18 for treatment of cancer
EP18168460.6A EP3401334B1 (en) 2007-05-29 2008-05-27 Monoclonal antibodies against claudin-18 for treatment of cancer

Publications (1)

Publication Number Publication Date
HRP20230282T3 true HRP20230282T3 (hr) 2023-05-12

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Country Status (24)

Country Link
US (1) US8425902B2 (hr)
EP (4) EP1997832A1 (hr)
JP (3) JP5816431B2 (hr)
KR (3) KR101693365B1 (hr)
CN (2) CN101687929B (hr)
BR (1) BRPI0811907A2 (hr)
CA (1) CA2687206C (hr)
DK (1) DK3401334T5 (hr)
ES (2) ES2940775T3 (hr)
FI (1) FI3401334T3 (hr)
HR (1) HRP20230282T3 (hr)
HU (1) HUE061795T2 (hr)
IL (3) IL201666A (hr)
LT (1) LT3401334T (hr)
MX (1) MX2009012906A (hr)
NZ (1) NZ581365A (hr)
PL (1) PL3401334T3 (hr)
PT (1) PT3401334T (hr)
RS (1) RS64065B1 (hr)
RU (2) RU2682285C2 (hr)
SG (1) SG183773A1 (hr)
SI (1) SI3401334T1 (hr)
WO (1) WO2008145338A2 (hr)
ZA (1) ZA200907675B (hr)

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