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HRP20171912T1 - Dvodjelna funkcionalna komplementacija inducirana dvojnim antigenom - Google Patents

Dvodjelna funkcionalna komplementacija inducirana dvojnim antigenom Download PDF

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Publication number
HRP20171912T1
HRP20171912T1 HRP20171912TT HRP20171912T HRP20171912T1 HR P20171912 T1 HRP20171912 T1 HR P20171912T1 HR P20171912T T HRP20171912T T HR P20171912TT HR P20171912 T HRP20171912 T HR P20171912T HR P20171912 T1 HRP20171912 T1 HR P20171912T1
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Croatia
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domain
antigen
antibody
antigens
fragment
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HRP20171912TT
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Gernot Stuhler
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Julius-Maximilians-Universität Würzburg
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Application filed by Julius-Maximilians-Universität Würzburg filed Critical Julius-Maximilians-Universität Würzburg
Publication of HRP20171912T1 publication Critical patent/HRP20171912T1/hr

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Claims (23)

1. Skup polipeptida, naznačen time što sadrži: prvi polipeptid P1, koji sadrži (i) ciljajući ostatak T1, gdje se navedeni ciljajući ostatak T1 specifično veže na antigen A1, i (ii) fragment F1 funkcionalne domene F, gdje ni navedeni fragment F1 sam po sebi niti navedeni polipeptid P1 sam po sebi nije funkcionalan s obzirom na funkciju navedene domene F, i drugi polipeptid P2, koji sadrži (i) ciljajući ostatak T2, gdje se navedeni ciljajući ostatak T2 specifično veže na antigen A2, i (ii) fragment F2 navedene funkcionalne domene F, gdje ni navedeni fragment F2 sam po sebi niti navedeni polipeptid P2 sam po sebi nije funkcionalan s obzirom na funkciju navedene domene F, gdje navedeni antigen A1 je različit od navedenog antigena A2, gdje navedeni polipeptid P1 i navedeni polipeptid P2 nisu povezani između sebe u odsutnosti stanice koja ima i antigen A1 i antigen A2 na svojoj površini, gdje, prilikom dimeriziranja navedenog fragmenta F1 navedenog polipeptida P1 s navedenim fragmentom F2 navedenog polipeptida P2 nastali dimer je funkcionalan s obzirom na funkciju navedene domene F, i gdje navedeni fragment F1 sadrži VL domenu protutijela, a navedeni fragment F2 sadrži VH domenu istog protutijela; ili gdje navedeni fragment F1 sadrži VH domenu protutijela, a navedeni fragment F2 sadrži VL domenu istog protutijela.
2. Skup polipeptida u skladu s patentnim zahtjevom 1, naznačen time što stanica koja nosi i antigen A1 i antigen A2 na svojoj površini potiče dimeriziranje fragmenta F1 navedenog polipeptida P1 s fragmentom F2 navedenog polipeptida P2, dok stanica koja ne nosi ni antigen A1 niti antigen A2 na svojoj površini ne potiče dimeriziranje fragmenta F1 navedenog polipeptida P1 s fragmentom F2 navedenog polipeptida P2.
3. Skup polipeptida u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeni polipeptidi P1 i P2 imaju, u odsutnosti navedenog supstrata ili stanice, između sebe konstantu disocijacije KD u rasponu od 10–8 M do 10–2 M, u rasponu od 10–7 M do 10–3 M ili u rasponu od 10–6 M do 10–3 M; i /ili navedeni polipeptidi P1 i P2 imaju, u prisutnosti navedenog supstrata ili stanice, između sebe konstantu disocijacije KD ispod 10–6 M, ispod 10–7 M ispod 10–8 M ili ispod 10–9 M.
4. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je navedeni antigen A1 i/ili navedeni antigen A2 antigen eksprimiran na površini stanica tumora ili na površini stanica preteča stanica tumora.
5. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što se kombinaciju antigena A1 i antigena A2 samo može naći na stanicama raka, no ne i na stanicama koji nisu stanice raka.
6. Skup polipeptida u skladu s patentnim zahtjevom 5, naznačen time što je kombinacija antigena A1 i antigena A2 specifična za stanice raka kod određenog tipa raka.
7. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je navedeni antigen A1 MHC antigen koji je alelna varijanta koju se bira iz skupine koju čine: HLA-A2, HLA-Cw6, HLA-A1, HLA-A3, HLA-A25, HLA-B7, HLA-B8, HLA-B35, HLA-B44, HLA-Cw3, HLA-Cw4, i HLA-Cw7; i/ili navedeni antigen A2 je antigen specifičan za određeni tip stanica ili staničnu liniju koja se bira iz skupine koju čine: CD45; CD34; CD33; CD138; CD15; CD1a; CD2; CD3; CD4; CD5; CD8; CD20; CD23; CD31; CD43; CD56; CD57; CD68; CD79a; CD146; surfaktantni proteini; synaptofizin; CD56; CD57; nikotinski acetilkolinski receptor; kinaza specifična za mišiće MUSK; naponski kalcijski kanal (P/Q-tipa); naponski kalijski kanal (VGKC); receptor N-metil-d-aspartata (NMDA); TSH; amfifizin; HepPar-1; gangliozid GQ1B, GD3 ili GM1; i glikophorin-A.
8. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što se bilo koji od navedenih antigena A1 i A2 bira iz skupine koju čine: HLA-A2; HLA-Cw6; EpCAM; CD20; CD33; CD38; CD45; Her2; EGFR; CD138; CEA; CD19; PSMA; E-kadherin; Ca-125; Her-2/neu; protein tekućine velike ciste; BCA-225; CA 19-9; CD117; CD30; epitelijalni antigen BER-EP4, membrana epitela antigen i antigen vezan uz epitel MOC-31; receptor čimbenika rasta epiderme HER1; receptor čimbenika rasta iz trombocita PDGFRα; marker povezan s melanomom/Mart 1/Melan-A; CD133; TAG 72; akvaporin-2 i klonotipno protutijelo na površini B-stanice.
9. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što (i) jedan od navedenih antigena A1 i A2 je EpCAM, a drugi je EGFR, HER2/neu, CD10, VEGF-R ili MDR; (ii) jedan od navedenih antigena A1 i A2 je MCSP, a drugi je melanoferrin ili EpCAM; (iii) jedan od navedenih antigena A1 i A2 je CA125, a drugi je CD227 (iv) jedan od navedenih antigena A1 i A2 je CD56, a drugi je CD140b ili GD3 gangliozid; (v) jedan od navedenih antigena A1 i A2 je EGFR, a drugi je HER2; (vi) jedan od navedenih antigena A1 i A2 je PSMA, a drugi je HER2; (vii) jedan od navedenih antigena A1 i A2 je sijalil Lewis, a drugi je EGFR; (viii) jedan od navedenih antigena A1 i A2 je CD44, a drugi je ESA, CD24, CD133, MDR ili CD117; (ix) jedan od navedenih antigena A1 i A2 je CD34, a drugi je CD19, CD79a, CD2, CD7, HLA-DR, CD13, CD117, CD33 ili CD15; (x) jedan od navedenih antigena A1 i A2 je CD33, a drugi je CD19, CD79a, CD2, CD7, HLA-DR, CD13, CD117 ili CD15; (xi) jedan od navedenih antigena A1 i A2 je MUC1, a drugi je CD10, CEA ili CD57; (xii) jedan od navedenih antigena A1 i A2 je CD38, a drugi je CD138; (xiii) jedan od navedenih antigena A1 i A2 je CD 24, a drugi je CD29 ili CD49f; (xiv) jedan od navedenih antigena A1 i A2 je karboanhidraza IX, a drugi je akvaporin-2; (xv) jedan od navedenih antigena A1 i A2 je HLA-A2, a drugi je EpCAM; (xvi) jedan od navedenih antigena A1 i A2 je HLA-A2, a drugi je CD45; (xvii) jedan od navedenih antigena A1 i A2 je HLA-A2, a drugi je EGFR; (xviii) jedan od navedenih antigena A1 i A2 je HLA-A2, a drugi je Her2; (xix) jedan od navedenih antigena A1 i A2 je HLA-A2, a drugi je CEA; (xx) jedan od navedenih antigena A1 i A2 je EpCAM, a drugi je CEA; (xxi) jedan od navedenih antigena A1 i A2 je CD45 ili CD38, a drugi je CD138; (xxii) jedan od navedenih antigena A1 i A2 je EGFR, a drugi je CEA; (xxiii) jedan od navedenih antigena A1 i A2 je Her2, a drugi je CEA; ili (xxiv) jedan od navedenih antigena A1 i A2 je CD19, a drugi je klonotipno protutijelo na površini B-stanice.
10. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što navedeni ciljajući ostatak T1 i/ili T2 sadrži imunoglobulinski modul; ili gdje navedeni ciljajući ostatak T1 i/ili T2 sadrži aptamer ili prirodni ligand navedenog antigena A1 odnosno antigena A2.
11. Skup polipeptida u skladu s patentnim zahtjevom 10, naznačen time što navedeni ciljajući ostatak T1 sadrži imunoglobulinski modul I1, naznačen time što sadrži VL domenu povezanu s VH domenom ili koji sadrži varijablnu domenu VHH ljaminog protutijela, devinog protutijela ili protutijela morskog psa; i/ili navedeni ciljajući ostatak T2 sadrži imunoglobulinski modul I2, koji sadrži VL domenu povezanu s VH domenom ili koji sadrži varijablnu domenu VHH ljaminog protutijela, devinog protutijela ili protutijela morskog psa.
12. Skup polipeptida u skladu s patentnim zahtjevom 11, naznačen time što navedeni imunoglobulinski modul I1 sadrži scFv (jednolančani varijantni fragment), Fab ili F(ab’)2 protutijela ili kompletno protutijelo; i/ili navedeni imunoglobulinski modul I2 sadrži scFv (jednolančani varijantni fragment), Fab ili F(ab’)2 protutijela ili kompletno protutijelo.
13. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 3 i 6 do 12, naznačen time što bilo koji od navedenih ciljajućihih ostataka T1 i T2 sadrži alergen ili supstrat koji se veže na klonotipno protutijelo na površini B-stanice.
14. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što je navedena funkcionalna domena F ili sadrži imunoglobulinski modul.
15. Skup polipeptida u skladu s patentnim zahtjevom 14, naznačen time što je navedena funkcionalna domena F Fv (varijantni fragment) ili scFv (jednolančani varijantni fragment) protutijela.
16. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 15, naznačen time što navedeni fragment F1 sadrži VL domenu protutijela protiv CD3, protiv His ili protiv DIG, a navedeni fragment F2 sadrži VH domenu istog protutijela, ili gdje navedeni fragment F1 sadrži VH domenu protutijela protiv CD3 protiv His ili protiv DIG, a navedeni fragment F2 sadrži VL domenu istog protutijela.
17. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 14 do 16, naznačen time što navedeni imunoglobulinski modul sadrži V domena koji se bira iz skupine koju čine: (i) V domena protutijela protiv CD3, koja sadrži VL domenu koja sadrži SEQ ID NO: 2 i/ili VH domenu koja sadrži SEQ ID NO: 1; (ii) V domena protutijela protiv CD3, koja sadrži VL domenu koja sadrži SEQ ID NO: 4 i/ili VH domenu koja sadrži SEQ ID NO: 3; (iii) V domena protutijela protiv CD3, koja sadrži VL domenu koja sadrži SEQ ID NO: 6 i/ili VH domenu koja sadrži SEQ ID NO: 5; (iv) V domena protutijela protiv CD3, koja sadrži VL domenu koja sadrži SEQ ID NO: 8 i/ili VH domenu koja sadrži SEQ ID NO: 7; (v) V domena protutijela protiv CD3, koja sadrži VL domenu koja sadrži SEQ ID NO: 10 i/ili VH domenu koja sadrži SEQ ID NO: 9; i (vi) V domena protutijela protiv His, koja sadrži VL domenu koja sadrži SEQ ID NO: 12 i/ili VH domenu koja sadrži SEQ ID NO: 11; (vii) V domena protutijela protiv DIG, koja sadrži VL domenu koja sadrži SEQ ID NO: 14 i/ili VH domenu koja sadrži SEQ ID NO: 30.
18. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 17, naznačen time što bilo koji od polipeptida P1 i P2 je ili sadrži aminokiselinski slijed koji se bira iz skupine koju čine SEQ ID NO: 114-129 i 197.
19. Skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 18, naznačen time što je namijenjen upotrebi u liječenju pacijenta koji boluje od raka i/ili tumora ili, naznačen time što je namijenjen upotrebi u postavljanju dijagnoze kod pacijenta koji boluje od raka i/ili tumora.
20. Molekula nukleinske kiseline ili skup molekula nukleinskih kiselina, naznačeni time što kodiraju skup polipeptida ili jedan od polipeptida iz skupa polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 18.
21. Molekula nukleinske kiseline ili skup molekula nukleinskih kiselina u skladu s patentnim zahtjevom 20, naznačeni time što sadrže nukleotidni slijed kao što je opisan u bilo kojem od SEQ ID NO: 135-150 i 196.
22. Farmaceutski pripravak, naznačen time što sadrži bilo skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1 do 18 ili molekulu nukleinske kiseline/skup molekula nukleinskih kiselina u skladu s patentnim zahtjevom 20 ili 21, gdje navedeni farmaceutski pripravak dodatno sadrži farmaceutski prihvatljiv nosač.
23. Komplet, naznačen time što sadrži skup polipeptida u skladu s bilo kojim od patentnih zahtjeva 1-18 ili molekulu nukleinske kiseline ili skup molekula nukleinskih kiselina u skladu s patentnim zahtjevom 20 ili 21.
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