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HRP20231134T1 - Humanizirana i afinitetno zrela protutijela na fcrh5 i postupci za uporabu - Google Patents

Humanizirana i afinitetno zrela protutijela na fcrh5 i postupci za uporabu Download PDF

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Publication number
HRP20231134T1
HRP20231134T1 HRP20231134TT HRP20231134T HRP20231134T1 HR P20231134 T1 HRP20231134 T1 HR P20231134T1 HR P20231134T T HRP20231134T T HR P20231134TT HR P20231134 T HRP20231134 T HR P20231134T HR P20231134 T1 HRP20231134 T1 HR P20231134T1
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HR
Croatia
Prior art keywords
fcrh5
antibody
binding
seq
amino acid
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HRP20231134TT
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English (en)
Inventor
Isidro Hotzel
Teemu T. Juntilla
Ji Li
Justin Scheer
Danielle Dicara
Diego ELLERMAN
Christoph Spiess
Paul Carter
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F. Hoffmann - La Roche Ag
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Application filed by F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20231134T1 publication Critical patent/HRP20231134T1/hr

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    • 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
    • C07K16/2803—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
    • C07K16/283—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 Fc-receptors, e.g. CD16, CD32, CD64
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
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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
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    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
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    • C07K16/2827—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 B7 molecules, e.g. CD80, CD86
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Claims (43)

1. Anti-Fc receptor kao 5 (FcRH5) protutijelo ili njegov FcRH5-vezujući fragment protutijela, pri čemu anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela sadrži vezujuću domenu, naznačeni time, da ona sadrže: (a) varijabilnu domenu teškog lanca (VH) koja sadrži aminokiselinski slijed SEQ ID NO: 104 i varijabilnu domenu lakog lanca (VL) koja sadrži aminokiselinski slijed SEQ ID NO: 105; (b) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 106 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 107; (c) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 84 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 85; (d) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 86 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 87; (e) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 88 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 89; (f) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 90 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 91; (g) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 92 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 93; (h) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 96 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 97; (i) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 98 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 99; ili (j) varijabilnu domenu VH koja sadrži aminokiselinski slijed SEQ ID NO: 100 i varijabilnu domenu VL koja sadrži aminokiselinski slijed SEQ ID NO: 101.
2. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 1, naznačeni time, da se anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela veže na epitop u Ig-sličnoj domeni 9 od FcRH5.
3. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 2, naznačeni time, da epitop sadrži dio aminokiselina 745-850 od SEQ ID NO: 114.
4. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeni time, da anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela sadrži mutaciju na mjestu aglikozilacije.
5. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 4, naznačeni time, da mutacija na mjestu aglikozilacije je supstitucijska mutacija u aminokiselinskom ostatku N297, D265 i/ili P329 prema EU numeriranju.
6. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 4 ili 5, naznačeni time, da mutacija na mjestu aglikozilacije je supstitucijska mutacija odabrana iz skupine koju čine N297G, N297A, D265A i P329G.
7. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 6, naznačeni time, da supstitucijska mutacija je N297G supstitucijska mutacija.
8. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, naznačeni time, da anti-FcRH5 protutijelo je monoklonsko, humanizirano ili kimerno protutijelo.
9. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 8, naznačeni time, da anti-FcRH5 protutijelo je humanizirano protutijelo.
10. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 9, naznačeni time, da anti-FcRH5 protutijelo je protutijelo pune duljine.
11. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 10, naznačeni time, da anti-FcRH5 protutijelo ili njegov fragment protutijela koji se veže na FcRH5 je multispecifično protutijelo.
12. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 11, naznačeni time, da multispecifično protutijelo je bispecifično protutijelo koje sadrži drugu vezujuću domenu koja veže klaster diferencijacije 3 (CD3).
13. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 12, naznačeni time, da druga vezujuća domena sadrži sljedećih šest HVR-ova: (a) HVR-H1 koja sadrži aminokiselinski slijed SEQ ID NO: 115; (b) HVR-H2 koja sadrži aminokiselinski slijed SEQ ID NO: 116; (c) HVR-H3 koja sadrži aminokiselinski slijed SEQ ID NO: 117; (d) HVR-L1 koja sadrži aminokiselinski slijed SEQ ID NO: 118; (e) HVR-L2 koja sadrži aminokiselinski slijed SEQ ID NO: 119; i (f) HVR-L3 koja sadrži aminokiselinski slijed SEQ ID NO: 120, ili te time, da druga vezujuća domena sadrži sljedećih šest HVR-ova: (a) HVR-H1 koja sadrži aminokiselinski slijed SEQ ID NO: 115; (b) HVR-H2 koja sadrži aminokiselinski slijed SEQ ID NO: 116; (c) HVR-H3 koja sadrži aminokiselinski slijed SEQ ID NO: 121; (d) HVR-L1 koja sadrži aminokiselinski slijed SEQ ID NO: 118; (e) HVR-L2 koja sadrži aminokiselinski slijed SEQ ID NO: 119; i (f) HVR-L3 koja sadrži aminokiselinski slijed SEQ ID NO: 123.
14. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 12, naznačeni time, da druga vezujuća domena sadrži: (a) VH domenu koja sadrži aminokiselinski slijed SEQ ID NO: 133, i (b) VL domenu koja sadrži aminokiselinski slijed SEQ ID NO: 134.
15. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 12, naznačeni time, da druga vezujuća domena sadrži: (a) VH domenu koja sadrži aminokiselinski slijed SEQ ID NO: 137, i (b) VL domenu koja sadrži aminokiselinski slijed SEQ ID NO: 138.
16. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 12, naznačeni time, da druga vezujuća domena sadrži: (a) VH domenu koja sadrži aminokiselinski slijed SEQ ID NO: 153, i (b) VL domenu koja sadrži aminokiselinski slijed SEQ ID NO: 154.
17. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 12, naznačeni time, da druga vezujuća domena sadrži: (a) VH domenu koja sadrži aminokiselinski slijed SEQ ID NO: 172, i (b) VL domenu koja sadrži aminokiselinski slijed SEQ ID NO: 173.
18. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 9 i 11 do 17, naznačeni time, da je FcRH5-vezujući fragment protutijela odabran iz skupine koju čine bis-Fab, Fab, Fab'-SH, Fv, scFv, i (Fab')2 fragmenti.
19. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 12 do 17, naznačeni time, da anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela sadrži jednu ili više konstantnih domena teškog lanca, pri čemu su jedna ili više konstantnih domena teškog lanca odabrane između prve CH2 domene (CH21), prve CH3 domene (CH31), druge CH2 domene (CH22) i druge CH3 domene (CH32).
20. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 19, naznačeni time, da je najmanje jedna od jedne ili više konstantnih domena teškog lanca uparena s drugačijom konstantnom domenom teškog lanca.
21. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 20, naznačeni time, da svaka od CH31 i CH32 sadrži izbočinu (P1) ili šupljinu (C1), pri čemu se P1 ili C1 u CH31 može postaviti u C1 odnosno P1 u CH32.
22. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 21, naznačeni time, da se CH31 i CH32 susreću na granici između P1 i C1.
23. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema patentnom zahtjevu 21 ili 22, naznačeni time, da P1sadrži supstitucijsku mutaciju T366W prema EU numeriranju.
24. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 21 do 23, naznačeni time, da C1 sadrži supstitucijske mutacije T366S, L368A i Y407V prema EU numeriranju.
25. Jedna ili više izoliranih nukleinskih kiselina, naznačene time, da kodiraju anti-FcRH5 protutijelo ili FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 24.
26. Jedan ili više vektora, naznačeni time, da sadrže jednu ili više izoliranih nukleinskih kiselina prema patentnom zahtjevu 25.
27. Imunokonjugat, naznačen time, da sadrži anti-FcRH5 protutijelo ili FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 24 i citotoksično sredstvo.
28. Pripravak, naznačen time, da sadrži anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 24, te nadalje sadrži farmaceutski prihvatljivu pomoćnu tvar ili razrjeđivač.
29. Pripravak prema patentnom zahtjevu 28, naznačen time, da pripravak nadalje sadrži antagonist vezivanja osi PD-1 ili dodatno terapeutsko sredstvo.
30. Pripravak prema patentnom zahtjevu 29, naznačen time, da je antagonist vezivanja osi PD-1 odabran iz skupine koju čine antagonist vezanja PD-L1, antagonist vezanja PD-1 i antagonist vezanja PD-L2.
31. Pripravak prema patentnom zahtjevu 30, naznačen time, da antagonist vezivanja osi PD-1 je antagonist vezanja PD-L1, pri čemu je izborno antagonist vezanja PD-L1 odabran iz skupine koju čine MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab) i MSB0010718C (avelumab), i pri čemu izborno antagonist vezanja PD-L1 je MPDL3280A (atezolizumab).
32. Pripravak prema patentnom zahtjevu 30, naznačen time, da je antagonist vezivanja osi PD-1 antagonist vezanja PD-1, pri čemu je izborno antagonist vezanja PD-1 odabran iz skupine koju čine MDX 1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 i REGN2810.
33. Pripravak prema patentnom zahtjevu 30, naznačen time, da je antagonist vezivanja osi PD-1 antagonist vezanja PD-L2, pri čemu izborno antagonist vezanja PD-L2 je protutijelo ili imunoadhezin.
34. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 24, naznačeni time, da su za uporabu u liječenju ili odgađanju progresije FcRH5-pozitivnog raka kod ispitanika kojemu je to potrebno.
35. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela prema bilo kojem od patentnih zahtjeva 1 do 24, naznačeni time, da su za uporabu u poboljšanju imunološke funkcije kod ispitanika koji ima FcRH5-pozitivan rak.
36. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 34 ili 35, naznačeni time, da FcRH5-pozitivan rak je B-stanični rak.
37. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema bilo kojem od patentnih zahtjeva 34 do 36, naznačeni time, da se anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela treba primijeniti na ispitaniku u dozi od oko 0,01 mg/kg/tjedno do oko 50 mg/kg/tjedno.
38. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema bilo kojem od patentnih zahtjeva 34 do 37, naznačeni time, da se anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela treba primijeniti na ispitaniku s antagonistom vezivanja osi PD-1 i/ili dodatnim terapeutskim sredstvom.
39. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 38, naznačeni time, da se antagonist vezivanja osi PD-1 i/ili dodatno terapeutsko sredstvo treba primijeniti prije, istovremeno ili uzastopno nakon primjene anti-FcRH5 protutijela ili njegovog FcRH5-vezujućeg fragmenta protutijela.
40. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 38 ili 39, naznačeni time, da je antagonist vezivanja osi PD-1 odabran iz skupine koju čine antagonist vezanja PD-L1, antagonist vezanja PD-1 i antagonist vezanja PD-L2.
41. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 40, naznačeni time, da antagonist vezivanja osi PD-1 je antagonist vezanja PD-L1, pri čemu je izborno antagonist vezanja PD-L1 odabran iz skupine koju čine MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab), i MSB0010718C (avelumab), pri čemu izborno antagonist vezanja PD-L1 je MPDL3280A (atezolizumab).
42. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 40, naznačeni time, da antagonist vezivanja osi PD-1 je antagonist vezanja PD-1, pri čemu je izborno antagonist vezanja PD-1 odabran iz skupine koju čine MDX 1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 i REGN2810.
43. Anti-FcRH5 protutijelo ili njegov FcRH5-vezujući fragment protutijela za uporabu prema patentnom zahtjevu 40, naznačeni time, da antagonist vezivanja osi PD-1 je antagonist vezanja PD-L2, pri čemu izborno antagonist vezanja PD-L2 je protutijelo ili imunoadhezin.
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