HRP20191590T1 - Protutijela za bubrežni antigen 1 i njihov fragment koji veže antigen - Google Patents

Protutijela za bubrežni antigen 1 i njihov fragment koji veže antigen Download PDF

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HRP20191590T1
HRP20191590T1 HRP20191590T HRP20191590T1 HR P20191590 T1 HRP20191590 T1 HR P20191590T1 HR P20191590 T HRP20191590 T HR P20191590T HR P20191590 T1 HRP20191590 T1 HR P20191590T1
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Croatia
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antigen
binding fragment
variable region
humanized antibody
seq
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Gilles Bernard Tremblay
Anna N Moraitis
Traian Sulea
Mario Filion
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Adc Therapeutics Sa
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Publication of HRP20191590T1 publication Critical patent/HRP20191590T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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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
    • C07K16/30—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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    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/06—Tripeptides
    • A—HUMAN NECESSITIES
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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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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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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    • C07K16/30—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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Claims (15)

1. Humanizirano protutijelo ili njegov fragment koji veže antigen, naznačeno time, da je sposobno za specifično vezanje na antigen 1 povezan s bubregom (KAAG1- engl. "Kidney associated antigen 1") i posjeduje varijabilno područje teškog lanca koje obuhvaća CDRH1 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:5, CDRH2 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:6 i CDRH3 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:7, te varijabilno područje lakog lanca koje obuhvaća CDRL1 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:8, CDRL2 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:9 i CDRL3 aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:10, pri čemu protutijelo ili njegov fragment koji veže antigen obuhvaća područja ljudskog okvira i opcionalno jednu ili više ponavljajućih mutacija u varijabilnom području lakog lanca i/ili varijabilnom području teškog lanca, gdje su jedna ili više ponavljajućih mutacija u području okvira i odgovaraju okviru aminokiselina koje se mogu pronaći u aminokiselinskoj sekvenci od varijabilnog područja teškog lanca kako je prikazano u SEQ ID NO:2 i/ili u aminokiselinskoj sekvenci varijabilnog područja lakog lanca kako je prikazano u SEQ ID NO:4 od matičnog mišjeg protutijela.
2. Humanizirano protutijelo ili njegov fragment koji veže antigen prema zahtjevu 1, naznačeno time, da ponavljajuće mutacije u varijabilnom području teškog lanca su Ile na poziciji 2 i Lys na poziciji 73.
3. Humanizirano protutijelo ili njegov fragment koji veže antigen prema zahtjevu 2, naznačeno time, da sadrži dodatne ponavljajuće mutacije u varijabilnom području teškog lanca, pri čemu navedene dodatne ponavljajuće mutacije su Ile na poziciji 48, Ala na poziciji 67, Leu na poziciji 69 i Val na poziciji 71.
4. Humanizirano protutijelo ili njegov fragment koji veže antigen prema zahtjevu 3, naznačeno time, da sadrži dodatne ponavljajuće mutacije u varijabilnom području teškog lanca, pri čemu navedene dodatne ponavljajuće mutacije su Lys na poziciji 38 i Lys na poziciji 66.
5. Humanizirano protutijelo ili njegov fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 4, naznačeno time, da ponavljajuće mutacije u varijabilnom području lakog lanca su Val na poziciji 2 i Lys na poziciji 45.
6. Humanizirano protutijelo ili njegov fragment koji veže antigen, naznačeno time, da je sposobno za specifično vezanje na antigen 1 povezan s bubregom (KAAG1), pri čemu humanizirano protutijelo ili njegov fragment koji veže antigen posjeduje varijabilno područje teškog lanca koje ima aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:35, SEQ ID NO:36 ili SEQ ID NO:37, te varijabilno područje lakog lanca koje ima aminokiselinsku sekvencu kako je prikazano u SEQ ID NO:30, SEQ ID NO:31 ili SEQ ID NO:32.
7. Humanizirano protutijelo ili njegov fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 6, naznačeno time, da je protutijelo ili njegov fragment koji veže antigen, konjugirano s terapeutskim dijelom skupine, citotoksičnim sredstvom ili s dijelom skupine koji se može detektirati.
8. Nukleinska kiselina, naznačena time, da ona kodira varijabilno područje lakog lanca i varijabilno područje teškog lanca od protutijela ili njegovog fragmenta koji veže antigen u skladu s bilo kojim od zahtjeva 1 do 6.
9. Vektor, naznačen time, da obuhvaća nukleinsku kiselinu prema zahtjevu 8.
10. Izolirana stanica, naznačena time, da obuhvaća: (a) nukleinsku kiselinu koja kodira varijabilno područje lakog lanca humaniziranog protutijela ili njegovog fragmenta koji veže antigen u skladu s bilo kojim od zahtjeva 1 do 6 i nukleinsku kiselinu koja kodira varijabilno područje teškog lanca humaniziranog protutijela ili njegovog fragmenta koji veže antigen u skladu s bilo kojim od zahtjeva 1 do 6, pri čemu je svaka nukleinska kiselina na zasebnom vektoru ili na istom vektoru; ili (b) humanizirano protutijelo ili njegov fragment koji veže antigen, u skladu s bilo kojim od zahtjeva 1 do 7.
11. Pripravak ili farmaceutski pripravak, naznačen time, da sadrži humanizirano protutijelo ili njegov fragment koji veže antigen u skladu s bilo kojim od zahtjeva 1 do 7, pri čemu navedeni pripravak dodatno sadrži nosač, te time, da navedeni farmaceutski pripravak nadalje sadrži farmaceutski prihvatljiv nosač.
12. Garnitura, naznačena time, da obuhvaća humanizirano protutijelo ili njegov fragment koji veže antigen u skladu s bilo kojim od zahtjeva 1 do 7.
13. Humanizirano protutijelo ili njegov fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 7, ili pripravak ili farmaceutski pripravak u skladu sa zahtjevom 11, naznačen time, da se upotrebljava u liječenju, detekciji ili dijagnostici raka koji obuhvaća stanice koje eksprimiraju KAAG1 ili varijantu KAAG1.
14. Humanizirano protutijelo ili njegov fragment koji veže antigen ili pripravak ili farmaceutski pripravak za uporabu prema zahtjevu 13, naznačen time, da je rak odabran iz skupine koja se sastoji od sljedećih: rak jajnika, rak kože, rak bubrega, kolorektalni rak, sarkom, leukemija, rak mozga, rak tiroidne žlijezde, rak dojke, rak prostate, rak jednjaka, rak mjehura, rak pluća i rak glave i vrata i/ili time, da je rak metastatski.
15. DNK-rekombinantni postupak za pripravu humaniziranog protutijela ili njegovog fragmenta koji veže antigen prema bilo kojem od zahtjeva 1 do 6, naznačen time, da obuhvaća kultiviranje izolirane stanice kako je definirano u dijelu (a) zahtjeva 10, te se tako proizvede protutijelo ili njegov fragment koji veže antigen.
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