DK2970486T3 - Modulering af t-celler med bispecifikke antistoffer og fc-fusioner - Google Patents

Modulering af t-celler med bispecifikke antistoffer og fc-fusioner Download PDF

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DK2970486T3
DK2970486T3 DK14723938.8T DK14723938T DK2970486T3 DK 2970486 T3 DK2970486 T3 DK 2970486T3 DK 14723938 T DK14723938 T DK 14723938T DK 2970486 T3 DK2970486 T3 DK 2970486T3
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Seung Chu
Dilki Wickramarachichi
Matthew J Bernett
John Desjarlais
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Xencor Inc
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Claims (42)

1. Sammensætning, der omfatter et bispecifikt antistof, hvor det bispecifikke antistof omfatter: (a) en første monomer, der omfatter: (i) et første konstant tungkædeområde, der omfatter en første variant af Fc-domænet; (ii) en anti-CD25-del; og (b) en anden monomer, der omfatter: (i) et andet konstant tungkædeområde, der omfatter en anden variant af Fc-domænet; (ii) et element valgt fra gruppen bestående af: en anti-CD4-del, en anti-CD8-del, en anti-CCR4-del, en anti-GITR-del og en anti-PD-l-del, hvor den første variant af Fc-domænet har en anden aminosyresekvens end den anden variant af Fc-domænet, til anvendelse ved undertrykkelse af T-celler.
2. Sammensætning til anvendelse ifølge krav 1, hvor T-cellerne er regulatoriske T-celler og den anden monomer omfatter anti-CD4-delen, eventuelt hvor anti-CD25-delen er en anti-CD25 scFV-sekvens, der er kovalent bundet til den første tungkædesekvens.
3. Sammensætning til anvendelse ifølge krav 1, hvor T-cellerne er cytotoksiske T-celler, og hvor den anden monomer omfatter anti-CD8-delen, eventuelt hvor anti-CD8-delen omfatter hele eller en del af et antigenbindingsområde af et antistof valgt fra gruppen bestående af MCD8, 3B5, Ski, OKT-8 og DK-25.
4. Sammensætning til anvendelse ifølge krav 1-3, hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 33, eller hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 34, eller hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 35.
5. Sammensætning til anvendelse ifølge krav 1-3, hvor den første og/eller den anden variant af Fc-domænet omfatter en aminosyrevariant valgt fra gruppen bestående af: 236R, 239D, 239E, 243L, M252Y, V259I, 267D, 267E, 298A, V308F, 328F, 328R, 330L, 332D, 332E, M428L, N434A, N434S, 236R/328R, 239D/332E, M428L, 236R/328F, V259I/V308F, 267E/328F, M428L/N434S, Y436I/M428L, Y436V/M428L, Y436I/N434S, Y436V/N434S, 239D/332E/330L, M252Y/S254T/T256E, V259I/V308F/M428L og E233P/L234V/L235A/G236deES267K, hvor nummerering er ifølge EU-indeks som i Kabat.
6. Sammensætning til anvendelse ifølge krav 1-3, hvor det bispecifikke antistof omfatter en sekvens valgt fra sekvenserne vist i Figur 30-31.
7. Sammensætning til anvendelse ifølge krav 1, hvor den første monomer omfatter en sekvens ifølge sekvensen betegnet 11209 - OKT4A_HOLO_scFv_Anti-TAC_HlLl_scFv_GDQ-Fc(216)_IgGl_pI_ISO(-)/pI_ISO(+RR)_IgGl, Tungkæde 2 (Tungkæde 2 (Anti-TAC_HlLl_scFv_GDQ-Fc(216)_IgGl_pI_ISO(+RR)) i Figur 30, eventuelt hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 11209 - OKT4A_HOLO_scFv_Anti-TAC_H 1 Ll_scFv_GDQ-Fc(216)_IgG 1_ pI_ISO(-)/pI_ISO(+RR)_IgGl, Tungkæde 1 (OKT4A_HOLO_scFv_GDQ-Fc(216) _IgGl_pI_ISO(-)) i Figur 30, eller hvor den første monomer omfatter en sekvens ifølge sekvensen betegnet 12143 - OKT4A_H0F0_scFv_Anti-TAC_H 1 Ll_scFv_-Fc(216)_IgGl_pI_ISO(-)/pI__ISO(+RR)_C220S/FcKO, Tungkæde 2 (Anti-TAC_H 1 Fl_scFv_Fc(216)_IgGl_pI_ISO(+RR)_G236R/L328R) i Figur 30, eventuelt hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 12143 -OKT4A_HOFO_scFv_Anti-TAC_HlFl_scFv_-Fc(216)_IgGl_pI_ISO(-)/pI_ISO(+RR)_C220S/FcKO, Tungkæde 1 (OKT4A_HOFO_scFv_Fc(216)_IgGl_pI_ISO(-)_G236R/F328R) i Figur 30, eller hvor den første monomer omfatter en sekvens ifølge sekvensen betegnet 13531 - OKT4A_HlFl_Fab-Anti- TAC_H1.8Ll_scFv_Fc(216)_IgGl_pl_ISO(-)-pl_ISO(+RR)_C220S_IgGl_G236R/L328R, Tungkæde 2 (Anti-TAC_H1.8Fl_scFv_Fc(216)_IgGl_pl_ISO(+RR)_G236R/F328R) i Figur 30, eventuelt hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 13531 -OKT4A_HlFl_Fab-Anti-TAC_H1.8Fl_scFv_Fc(216)_ IgGl_pl_ISO (-)-pl_ISO(+RR)_C220S_IgGl_G236R/F328R, Tungkæde 1 (OKT4A_Hl_IgGl_pl_ISO(-)_G236R/F328R) i Figur 30, eventuelt hvor den anden monomer endvidere omfatter en sekvens ifølge sekvensen betegnet 13531 - OKT4A_HlFl_Fab-Anti-TAC_H 1.8Ll_scFv_Fc(216)_IgGl_pl_ISO (-)-pl_ISO(+RR)_C220S_IgGl_G236R/L328R, Fetkæde (0KT4A_L1) i Figur 30.
8. Sammensætning til anvendelse ifølge krav 1, hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 11209 - OKT4A_H0L0_scFv_Anti-TAC_HlLl_scFv_GDQ-Fc(216)_IgGl_pl_ISO(-)/pl_ISO(+RR)_IgGl, Tungkæde 1 (OKT4A_HOFO_scFv_GDQ- Fc(216)_IgGl_pl_ISO(-)) i Figur 30, eller hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 12143 - OKT4A_HOLO_scFv_Anti-TAC_HlLl_scFv_-Fc(216)_IgGl_pl_ISO(-)/pl_ISO(+RR)_C220S/FcKO, Tungkæde 1 (OKT4A_HOLO_scFv_Fc(216)_IgGl_pl_ISO(-)_G236R/L328R) i Figur 30, eller hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 13531 - OKT4A_HlLl_Fab-Anti-TAC_H1.8Ll_scFv_Fc(216)_IgGl_pl_ISO(-)- pI_lSO(+RR)_C220S_IgGl_G236R/L328R, Tungkæde 1 (OKT4A-Hl_IgGl_pl_ISO(-)_G236R/L328R) i Figur 30.
9. Heterodimerisk protein, hvor det heterodimeriske protein omfatter: (a) en første monomer, der omfatter: (i) et første konstant tungkædeområde, der omfatter en første variant af Fc-domænet; (ii) et IL-2-protein og (b) en anden monomer, der omfatter: (i) et andet konstant tungkædeområde, der omfatter en anden variant af Fc-domænet; (ii) et element valgt fra gruppen bestående af: en anti-CD4-del, en anti-CD8-del, en anti-CTLA4-del, en anti-CCR4-del, en anti-PD-l-del og en anti-GITR-del hvor den første variant af Fc-domænet har en anden aminosyresekvens end den anden variant af Fc-domænet, til anvendelse ved stimulering af T-celler.
10. Heterodimerisk protein til anvendelse ifølge krav 9, hvor T-celleme er regulatoriske T-celler og den anden monomer omfatter anti-CD4-delen, eventuelt hvor den anden monomer endvidere omfatter: (a) det andet konstante tungkædeområde, der endvidere omfatter et variabelt tungkædedomæne, og (b) en letkædesekvens, hvor det variable tungkædedomæne og letkædesekvensen sammen danner anti-CD4-delen.
11. Heterodimerisk protein til anvendelse ifølge krav 9, hvor T-celleme er cytotoksiske T-celler og den anden monomer omfatter anti-CD8-delen, eventuelt hvor anti-CD8-delen omfatter hele eller en del af et antigenbindingsområde af et antistof valgt fra gmppen bestående af MCD8, 3B5, Ski, OKT-8 og DK-25.
12. Heterodimerisk protein til anvendelse ifølge krav 9-11, hvor den første og den anden variant af Fe-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 33, eller hvor den første og den anden variant af Fe-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 34, eller hvor den første og den anden variant af Fe-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 35.
13. Heterodimerisk protein til anvendelse ifølge krav 9-11, hvor den første og/eller den anden variant af Fe-domænet omfatter en aminosyrevariant valgt fra gruppen bestående af: 236R, 239D, 239E, 243L, M252Y, V259I, 267D, 267E, 298A, V308F, 328F, 328R, 330L, 332D, 332E, M428L, N434A, N434S, 236R/328R, 239D/332E, M428L, 236R/328F, V259I/V308F, 267E/328F, M428L/N434S, Y436I/M428L, Y436V/M428L, Y436I/N434S, Y436V/N434S, 239D/332E/330L, M252Y/S254T/T256E, V259I/V308F/M428L og E233P/L234V/L235A/G236del/S267K, hvor nummerering er ifølge EU-indeks som i Kabat.
14. Heterodimerisk protein til anvendelse ifølge krav 9-11, hvor det bispecifikke antistof omfatter en sekvens valgt fra de sekvenser, der vises i Figur 30-31.
15. Heterodimerisk protein til anvendelse ifølge krav 9, hvor den første monomer omfatter en sekvens ifølge sekvensen betegnet 13027 - hIL2_OKT4A_HlLl_IgGl_pl_ISC>(-/+RR)_C220S_G236R/L328R, Tungkæde 1 (hIL2_IgGl_pl_ISO(-)_C220S/G236R/L328R) i Figur 30.
16. Heterodimerisk protein til anvendelse ifølge krav 9 eller 15, hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 13027 - hIL2_OKT4A_HlLl_IgGl_pl_ISO(-/+RR)_C220S_G236R/L328R, Tungkæde 2 (OKT4A_Hl_IgGl_pl_ISO(+RR)_G236R/L328R) i Figur 30, eventuelt hvor den anden monomer endvidere omfatter en sekvens ifølge sekvensen betegnet 13027 -hIL2_OKT4A_HlLl_IgGl_pl_ISO(-/+RR)_ C220S_G236R/L328R, Letkæde (OKT4A_Ll) i Figur 30, eller hvor den anden monomer omfatter en sekvens ifølge sekvensen betegnet 13038 - OKT4A_HlLl_IgGl_G236R/L328R_hIL2(2), Tungkæde (OKT4A_Hl_IgGl_G236R/L328R_hIL2) i Figur 30, eventuelt hvor den anden monomer endvidere omfatter en sekvens ifølge sekvensen betegnet 13038 - OKT4A_HlLl_IgGl_G236R/L328R_hIL2(2), Letkæde (0KT4A_L1) i Figur 30.
17. Sammensætning, der omfatter et heterodimerisk antistof, hvilket heterodimerisk antistof omfatter: (a) en første monomer, der omfatter: (i) et første antigen-bindingsdomæne, der er et anti-CD25-domæne; (ii) en første tungkædesekvens, der omfatter en første variant af Fe-domænet sammenlignet med et humant Fc-domæne; og (b) en anden monomer, der omfatter: (i) et andet antigen-bindingsdomæne, der binder til et element valgt fra gruppen bestående af: CD4, CD8, CCR4, GITR og PD-1, (ii) en anden tungkædesekvens, der omfatter en anden variant af Fe-domænet sammenlignet med et humant Fc-domæne; hvor den første og den anden variant af Fc-domænet har forskellige aminosyresekvenser.
18. Sammensætning ifølge krav 17, hvor det andet antigen-bindingsdomæne binder til CD4.
19. Sammensætning ifølge krav 17-18, hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 33, eller hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 34 eller 35, eller hvor den første og den anden variant af Fc-domænet omfatter en aminosyrevariant valgt fra gruppen bestående af: L368D/K370S og S364K; L368D/K370S og S364K/E357L; L368D/K370S og S364K/E357Q; T411E/K360E/Q362E og D401K; L368E/K370S og S364K; K370S og S364K/E357Q; og K370S og S364K/E357Q, hvor nummerering er ifølge EU-indeks som i Kabat.
20. Sammensætning ifølge krav 17-19, hvor den første og/eller den anden variant af Fc-domænet endvidere omfatter en aminosyrevariant valgt fra gruppen bestående af: 236R, 239D, 239E, 243L, M252Y, V259I, 267D, 267E, 298A, V308F, 328F, 328R, 330L, 332D, 332E, M428L, N434A, N434S, 236R/328R, 239D/332E, M428L, 236R/328F, V259I/V308F, 267E/328F, M428L/N434S, Y436I/M428L, Y436V/M428L, Y436I/N434S, Y436V/N434S, 239D/332E/330L, M252Y/S254T/T256E, V259I/V308F/M428L og E233P/L234V/L235A/G236del/S267K, hvor nummerering er ifølge EU-indeks som i Kabat.
21. Sammensætning ifølge krav 17-20, hvor anti-CD25-domænet er en anti-CD25 scFv-sekvens og er kovalent bundet til den første tungkædesekvens.
22. Sammensætning ifølge krav 17-20, hvor det andet antigen-bindingsdomæne omfatter en scFv-sekvens.
23. Sammensætning ifølge krav 17-20, hvor den anden monomer endvidere omfatter: (a) den anden tungkædesekvens, der endvidere omfatter et variabelt tungkædedomæne, (b) en letkædesekvens, hvor det variable tungkædedomæne og letkædesekvensen danner det andet antigen-bindingsdomæne.
24. Sammensætning ifølge krav 17-23, hvor sammensætningen omfatter et format i overensstemmelse med et format som vist i Figur 3 eller Figur 36-37.
25. Sammensætning, der omfatter et heterodimerisk protein, hvilket heterodimerisk protein omfatter: (a) en første monomer, der omfatter: (i) et første protein, der omfatter IL-2; (ii) en første tungkædesekvens, der omfatter en første variant af Fc-domænet sammenlignet med et humant Fc-domæne; og (b) en anden monomer, der omfatter: (i) et antigen-bindingsdomæne, der binder til et element valgt fra gruppen bestående af: CD4, CD8, CTLA-4, CCR4 og PD-1, (ii) en anden tungkædesekvens, der omfatter en anden variant af Fc-domænet sammenlignet med et humant Fc-domæne; hvor den første og den anden variant af Fc-domænet har forskellige aminosyresekvenser.
26. Sammensætning ifølge krav 25, hvor den første og den anden variant af Fc-domænet omfatter et sæt aminosyresubstitutioner valgt fra gruppen bestående af de, der vises i Figur 33, 34 eller 35, eller hvor den første og den anden variant af Fc-domænet omfatter en aminosyrevariant uafhængigt valgt fra gruppen bestående af: L368D/K370S og S364K; L368D/K370S og S364K/E357L; L368D/K370S og S364K/E357Q; T411E/K360E/Q362E og D401K; L368E/K370S og S364K; K370S og S364K/E357Q; og K370S og S364K/E357Q, hvor nummerering er ifølge EU-indeks som i Kabat.
27. Sammensætning ifølge krav 25-26, hvor den første og/eller den anden variant af Fc-domænet endvidere omfatter en aminosyrevariant valgt fra gruppen bestående af: 236R, 239D, 239E, 243L, M252Y, V259I, 267D, 267E, 298A, V308F, 328F, 328R, 330L, 332D, 332E, M428L, N434A, N434S, 236R/328R, 239D/332E, M428L, 236R/328F, V259I/V308F, 267E/328F, M428L/N434S, Y436I/M428E, Y436V/M428L, Y436I/N434S, Y436V/N434S, 239D/332E/330L, M252Y/S254T/T256E, V259I/V308F/M428E og E233P/L234V/L235A/G236del/S267K, hvor nummerering er ifølge EU-indeks som i Kabat.
28. Sammensætning ifølge krav 25-27, hvor antigen-bindingsdomænet er en scFv-sekvens, der er ko valent bundet til den anden tungkædesekvens.
29. Sammensætning ifølge krav 25-27, hvor den anden monomer endvidere omfatter: (a) den anden tungkædesekvens, der endvidere omfatter et variabelt tungkædedomæne, (b) en letkædesekvens, hvor det variable tungkædedomæne og letkædesekvensen danner det andet antigen-bindingsdomæne.
30. Sammensætning, der omfatter et heterodimerisk protein ifølge krav 25 eller et heterodimerisk antistof ifølge krav 17, der omfatter en sekvens som anført i Figur 30 og 31.
31. En eller flere nukleinsyrer, der koder for et heterodimerisk antistof eller heterodimerisk protein fra sammensætningen ifølge krav 17-27.
32. Værtscelle, der omfatter den ene eller flere nukleinsyrer ifølge krav 31.
33. Fremgangsmåde til fremstilling af en sammensætning ifølge krav 17-27, hvilken fremgangsmåde omfatter dyrkning af en værtscelle ifølge krav 32 under betingelser, hvorved sammensætningen produceres.
34. Fremgangsmåde til oprensning af et heterodimerisk protein eller bispecifikt antistof ifølge krav 17-29, hvilken fremgangsmåde omfatter: (a) tilvejebringelse af en sammensætning ifølge krav 17-29; (b) påfyldning af sammensætningen på en ionbyttersøjle og (c) opsamling af en fraktion, der indeholder det heterodimeriske protein eller bispecifikke antistof.
35. Sammensætning, der omfatter et bispecifikt antistof, hvor det bispecifikke antistof omfatter: (a) en første monomer, der omfatter: (i) et første konstant tungkædeområde, der omfatter en første variant af Fc-domænet; (ii) en anti-CD25-del og (b) en anden monomer, der omfatter: (i) et andet konstant tungkædeområde, der omfatter en anden variant af Fc-domænet; (ii) et element valgt fra gruppen bestående af: en anti-CD4-del, en anti-CD8-del, en anti-CCR4-del, en anti-GITR-del og en anti-PD-l-del, hvor den første variant af Fc-domænet har en anden aminosyresekvens end den anden variant af Fc-domænet, til anvendelse i behandling af cancer hos et individ.
36. Heterodimerisk protein, der omfatter: (a) en første monomer, der omfatter: (i) et første konstant tungkædeområde, der omfatter en første variant af Fc-domænet; (ii) et IL-2-protein og (b) en anden monomer, der omfatter: (i) et andet konstant tungkædeområde, der omfatter en anden variant af Fc-domænet; (ii) et element valgt fra gruppen bestående af: en anti-CD4-del, en anti-CD8-del, en anti-CTLA4-del, en anti-CCR4-del, en anti-PD-l-del og en anti-GITR-del, hvor den første variant af Fc-domænet har en anden aminosyresekvens end den anden variant af Fc-domænet til anvendelse i behandling af en autoimmun sygdom hos et individ.
37. Heterodimerisk protein eller sammensætning til anvendelse ifølge krav 35 eller 36, hvor den anden monomer omfatter anti-CD4-bindingsdelen.
38. Heterodimerisk protein eller sammensætning til anvendelse ifølge krav 35 eller 36, hvor anti-CD8-delen omfatter hele eller en del af et antigenbindingsområde af et antistof valgt fra gruppen bestående af MCD8, 3B5, Ski, OKT-8 og DK-25.
39. Heterodimerisk protein eller sammensætning til anvendelse ifølge krav 35-38, hvor den første og den anden variant af Fc-domænet omfatter en aminosyrevaiiant uafhængigt valgt fra varianterne opført i Figur 33, eller hvor den første og den anden variant af Fc-domænet omfatter en aminosyrevariant uafhængigt valgt fra varianterne opført i Figur 34, eller hvor den første og den anden variant af Fc-domænet omfatter en aminosyrevariant uafhængigt valgt fra gruppen bestående af: L368D/K370S og S364K; L368D/K370S og S364K/E357L; L368D/K370S og S364K/E357Q; T411E/K360E/Q362E og D401K; L368E/K370S og S364K; K370S og S364K/E357Q; og K370S og S364K/E357Q, hvor nummerering er ifølge EU-indeks som i Kabat.
40. Heterodimerisk protein eller sammensætning til anvendelse ifølge krav 35-39, hvor den første og/eller den anden variant af Fc-domænet endvidere omfatter en aminosyrevariant valgt fra gruppen bestående af: 236R, 239D, 239E, 243L, M252Y, V259I, 267D, 267E, 298A, V308F, 328F, 328R, 330L, 332D, 332E, M428L, N434A, N434S, 236R/328R, 239D/332E, M428L, 236R/328F, V259FV308F, 267E/328F, M428L/N434S, Y436FM428L, Y436V/M428L, Y436I/N434S, Y436V/N434S, 239D/332E/330L, M252Y/S254T/T256E, V259FV308F/M428L og E233P/L234V/L235A/G236del/S267K, hvor nummerering er ifølge EU-indeks som i Kabat.
41. Sammensætning ifølge krav 17, hvor den første og den anden variant af Fc-domænet er varianter af et human IgGl Fc-domæne.
42. Sammensætning ifølge krav 25, hvor den første og den anden variant af Fc-domænet er varianter af et humant IgGl Fc-domæne.
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