HRP20190939T1 - Monoklonska antitijela za upotrebu u dijagnozi i terapiji raka i autoimunih bolesti - Google Patents

Monoklonska antitijela za upotrebu u dijagnozi i terapiji raka i autoimunih bolesti Download PDF

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HRP20190939T1
HRP20190939T1 HRP20190939TT HRP20190939T HRP20190939T1 HR P20190939 T1 HRP20190939 T1 HR P20190939T1 HR P20190939T T HRP20190939T T HR P20190939TT HR P20190939 T HRP20190939 T HR P20190939T HR P20190939 T1 HRP20190939 T1 HR P20190939T1
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Croatia
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antibody
seq
heavy chain
light chain
tumor
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HRP20190939TT
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Jeffrey Molldrem
Anna Sergeeva
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Board Of Regents, The University Of Texas System
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Publication of HRP20190939T1 publication Critical patent/HRP20190939T1/hr

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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 the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A—HUMAN NECESSITIES
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    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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 the non-active ingredient being a modifying agent
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    • A61K47/6835—Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6871—Medicinal 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 the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting an enzyme
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    • A61K49/0013—Luminescence
    • A61K49/0017—Fluorescence in vivo
    • A61K49/005—Fluorescence in vivo characterised by the carrier molecule carrying the fluorescent agent
    • A61K49/0058—Antibodies
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P35/04—Antineoplastic agents specific for metastasis
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    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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
    • C07K16/2833—Immunoglobulins [IGs], 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 MHC-molecules, e.g. HLA-molecules
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [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
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    • C07K16/30—Immunoglobulins [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
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    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; 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
    • G01N33/57488—Immunoassay; 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
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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Claims (17)

1. Humanizirano antitijelo koje vezuje VLQELNVTV (SEQ ID NO:45) pri čemu kada se vezuje za HLA-A2 receptor, spomenuto antitijelo obuhvaća varijabilno područje teškog lanca koji se sastoji od aminokiseline koja je prikazana u SEQ ID NO: 16, i varijabilno područje lakog lanca koji se sastoji iz sekvenci aminokiselina koje su prikazane u SEQ ID NOS: 19 ili 20.
2. Antitijelo prema zahtjevu 1, pri čemu antitijelo obuhvaća teški lanac koji obuhvaća varijabilno područje teškog lanca koji se sastoji iz sekvence aminokiselina koja je prikazana u SEQ ID NO: 16 i konstantno područje teškog lanca koji je konstantno područje humanog gama-1 teškog lanca, i laki lanac koji obuhvaća varijabilno područje lakog lanca koji se sastoji iz sekvenci aminokiselina koje su prikazane u SEQ ID NOS: 19 i konstantnog područja lakog lanca koji je konstantno područje humanog kapa lakog lanca.
3. Antitijelo prema zahtjevu 1, pri čemu antitijelo obuhvaća teški lanac koji obuhvaća varijabilno područje teškog lanca koji se sastoji iz sekvence aminokiselina koja je prikazana u SEQ ID NO: 16 i konstantno područje teškog lanca koji je konstantno područje humanog gama-1 teškog lanca, i laki lanac koji obuhvaća varijabilno područje lakog lanca koji se sastoji iz sekvenci aminokiselina koje su prikazane u SEQ ID NO: 20 i konstantnog područja lakog lanca koji je konstantno područje humanog kapa lakog lanca.
4. Antitijelo prema bilo kojim zahtjevima 1-3, gdje je antitijelo izolirano i pročišćeno.
5. Antitijelo prema bilo kojim zahtjevima 1-4, pri čemu je spomenuto antitijelo spojeno sa peptidom koji nije antitijelo ili segmentom polipeptida.
6. Antitijelo prema bilo kojim zahtjevima 1-5, gdje je spomenuto antitijelo povezano sa dijagnostičkim reagensom koji je izabran iz grupe koja se sastoji iz fluorofora, kromofora, boje, radioizotopa, kemiluminiscentne molekule, paramagnetskog iona, i reagensa za hvatanje spina, ili gdje je spomenuto antitijelo povezano sa terapeutskim reagensom koji je izabran iz grupe koja obuhvaća citokin, kemoterapeutik, radioterapeutik, hormon, Fc fragment antitijela, TLR agonist, molekulu koja sadrži CpG, i imunski ko-stimulatornu molekulu.
7. Ekspresijski vektor koji obuhvaća nukleinsku kiselinu koja kodira varijabilno područje teškog lanca antitijela prema zahtjevu 1 i nukleinsku kiselinu koja kodira varijabilno područje lakog lanca antitijela prema zahtjevu 1.
8. Stanica domaćina, pri čemu su nukleinska kiselina koja kodira varijabilno područje teškog lanca antitijela prema zahtjevu 1 i nukleinska kiselina koja kodira varijabilno područje lakog lanca antitijela prema zahtjevu 1 unesene u stanicu domaćina.
9. Stanica domaćina pri čemu su nukleinska kiselina koja kodira teški lanac antitijela prema zahtjevu 2 ili 3 i nukleinska kiselina koja kodira laki lanac antitijela prema zahtjevu 2 ili 3 unesene u stanicu domaćina.
10. Postupak za proizvodnju humaniziranog antitijela koji obuhvaća uzgoj u kulturi stanice domaćina prema zahtjevu 8 pod uvjetima koji podržavaju ekspresiju humaniziranog antitijela koje vezuje VLQELNVTV (SEQ ID NO: 45) kada se veže za HLA-A2 receptor.
11. Postupak za proizvodnju humaniziranog antitijela koji obuhvaća uzgoj u kulturi stanice domaćina prema zahtjevu 9 pod uvjetima koji podržavaju ekspresiju humaniziranog antitijela koje vezuje VLQELNVTV (SEQ ID NO: 45) kada se veže za HLA-A2 receptor.
12. Humanizirano antitijelo proizvedeno postupkom prema zahtjevu 10 koje vezuje VLQELNVTV (SEQ ID NO: 45) kada se veže za HLA-A2 receptor.
13. Humanizirano antitijelo proizvedeno postupkom prema zahtjevu 11 koje vezuje VLQELNVTV (SEQ ID NO: 45) kada se veže za HLA-A2 receptor.
14. Antitijelo prema zahtjevu 12 ili 13, gdje je spomenuto antitijelo vezano sa dijagnostikom koja je izabrana iz grupe koja se sastoji iz fluorofore, kromofore, boje, radioizotopa, kemiluminiscentne molekule, paramagnetskog iona, i reagensa za hvatanje iona, ili pri čemu je spomenuto antitijelo povezano sa terapeutskim reagensom koji je izabran iz grupe koja se sastoji iz citokina, kemoterapeutika, radioterapeutika, hormona, Fc fragmenta antitijela, TLR agonista, molekule koja sadrži CpG, i imunog ko-stimulatornog molekula.
15. Antitijelo prema bilo kojim zahtjevima 1-6 ili 12-14 za upotrebu u postupku liječenja subjekta koji ima rak, pri čemu spomenuti postupak obuhvaća davanje antitijela spomenutom subjektu.
16. Antitijelo za upotrebu prema zahtjevu 15, pri čemu spomenuti rak je čvrsti tumor odabran iz grupe koja se sastoji iz tumora glave & vrata, tumora mozga, tumora jednjaka, tumora grudi, tumora pluća, tumora jetre, tumora slezene, tumora želuca, tumora tankog crijeva, tumora debelog crijeva, tumora rektuma, tumora jajnika, tumora maternice, cervikalnog tumora, tumora prostate, tumora testisa i tumora kože, ili gdje je spomenuti rak rak krvi izabran iz grupe koja obuhvaća leukemiju i limfom.
17. Antitijelo za upotrebu prema zahtjevima 15 ili 16, pri čemu je spomenuti rak rekurentan ili metastatski rak.
HRP20190939TT 2012-07-10 2019-05-21 Monoklonska antitijela za upotrebu u dijagnozi i terapiji raka i autoimunih bolesti HRP20190939T1 (hr)

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US201261669967P 2012-07-10 2012-07-10
US201261702916P 2012-09-19 2012-09-19
EP16152641.3A EP3088421B1 (en) 2012-07-10 2013-07-03 Monoclonal antibodies for use in diagnosis and therapy of cancers and autoimmune disease

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US (2) US9926380B2 (hr)
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JP (1) JP6336696B2 (hr)
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AU2013288982A1 (en) 2015-01-29
CY1121743T1 (el) 2020-07-31
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