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HRP20201517T1 - Anti-cd3 protutijela, anti-cd123 protutijela i bispecifična protutijela koja se specifično vežu na cd3 i/ili cd123 - Google Patents

Anti-cd3 protutijela, anti-cd123 protutijela i bispecifična protutijela koja se specifično vežu na cd3 i/ili cd123 Download PDF

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HRP20201517T1
HRP20201517T1 HRP20201517TT HRP20201517T HRP20201517T1 HR P20201517 T1 HRP20201517 T1 HR P20201517T1 HR P20201517T T HRP20201517T T HR P20201517TT HR P20201517 T HRP20201517 T HR P20201517T HR P20201517 T1 HRP20201517 T1 HR P20201517T1
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seq
sequence
immunoglobulin
polypeptide
light chain
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HRP20201517TT
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Jana ALBRECHT
Cédric BARRIERE
Christian Beil
Jochen Beninga
Chantal Carrez
Stéphane GUERIF
Katja Kroll
Christian Lange
Cendrine Lemoine
Wulf-Dirk LEUSCHNER
Ercole Rao
Marion Schneider
Marie-Cécile WETZEL
Peter Wonerow
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Sanofi
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Claims (21)

1. Vezujući protein sličan protutijelu koji se veže na CD3 i na barem jedan daljnji ciljani antigen koji je CD123, koji sadrži dva polipeptidna lanca koji tvore dva antigenska mjesta vezanja, pri čemu prvi polipeptid ima strukturu predstavljenu formulom [I]: VD1-L1-VD2-L2-CL [I] i drugi polipeptid ima strukturu predstavljenu formulom [II]: VD3-L3-VD4-L4-CH1 [II] naznačen time što: VD1 je varijabilna domena teškog ili lakog lanca prvog imunoglobulina; VD2 je varijabilna domena teškog ili lakog lanca drugog imunoglobulina; VD3 je varijabilna domena teškog ili lakog lanca navedenog drugog imunoglobulina; VD4 je varijabilna domena teškog ili lakog lanca navedenog prvog imunoglobulina; CL je konstantna domena lakog lanca imunoglobulina; CH1 je CH1 konstantna domena teškog lanca imunoglobulina; L1, L2, L3, i L4 su aminokiselinske poveznice; i pri čemu prvi i drugi polipeptid tvore unakrsni par laki lanac-teški lanac, i pri čemu su VD1 i VD2 obje ili varijabilne domene lakih lanaca, ili varijabilne domene teških lanaca, i VD3 i VD4 obje su varijabilne domene teških lanaca ako su VD1 i VD2 varijabilne domene lakih lanaca, ili VD3 i VD4 su obje varijabilne domene lakih lanaca ako su VD1 i VD2 varijabilne domene teških lanaca; pri čemu je navedeni prvi ili drugi imunoglobulin anti-CD3 protutijelo koje sadrži varijabilnu domenu teškog lanca koja sadrži CDR1-H od sekvence SEQ ID NO: 6, CDR2-H od sekvence SEQ ID NO: 7, i CDR3-H od sekvence SEQ ID NO: 8, i varijabilnu domenu lakog lanca koja sadrži CDR1-L od sekvence SEQ ID NO: 142, CDR2-L od sekvence 'KVS', i CDR3-L od sekvence SEQ ID NO: 11; i pri čemu je drugi od navedenog prvog ili drugog imunoglobulina anti-CD123 protutijelo koje sadrži varijabilnu domenu teškog lanca koja sadrži CDR1-H od sekvence SEQ ID NO: 381, CDR2-H od sekvence SEQ ID NO: 384, i CDR3-H od sekvence SEQ ID NO: 382, i varijabilnu domenu lakog lanca koja sadrži CDR1-L od sekvence SEQ ID NO: 378, CDR2-L od sekvence 'WAS', i CDR3-L od sekvence SEQ ID NO: 379.
2. Vezujući protein sličan protutijelu prema patentnom zahtjevu 1, naznačen time što polipeptid s formulom [II] nadalje sadrži Fc domenu.
3. Vezujući protein sličan protutijelu prema patentnom zahtjevu 1 ili 2, naznačen time što sadrži dva polipeptidna lanca koji tvore dva mjesta vezanja antigena, pri čemu jedan polipeptidni lanac ima strukturu predstavljenu formulom [I]: VD1-L1-VD2-L2-CL [I] i jedan polipeptidni lanac ima strukturu predstavljenu formulom [III]: VD3-L3-VD4-L4-CH1-Fc [III] pri čemu: VD1 je varijabilna domena teškog ili lakog lanca prvog imunoglobulina; VD2 je varijabilna domena teškog ili lakog lanca drugog imunoglobulina; VD3 je varijabilna domena teškog ili lakog lanca navedenog drugog imunoglobulina; VD4 je varijabilna domena teškog ili lakog lanca navedenog prvog imunoglobulina; CL je konstantna domena lakog lanca imunoglobulina; CH1 je CH1 konstantna domena teškog lanca imunoglobulina; Fc je zglobna regija imunoglobulina i CH2, CH3 imunoglobulinske konstantne domene teškog lanca imunoglobulina; L1, L2, L3, i L4 su aminokiselinske poveznice; i pri čemu polipeptid s formulom I i polipeptid s formulom III tvore unakrsni par laki lanac-teški lanac.
4. Vezujući protein sličan protutijelu prema patentnom zahtjevu 2 ili 3, naznačen time što polipeptid s formulom [I] nadalje sadrži Fc domenu (Fc2).
5. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 2 do 4, naznačen time što sadrži polipeptidna lanca koji tvore dva mjesta vezanja antigena, pri čemu jedan polipeptidni lanac ima strukturu predstavljenu formulom [IV]: VD1-L1-VD2-L2-CL-L5-Fc2 [IV] i jedan polipeptidni lanac ima strukturu predstavljenu formulom [III]: VD3-L3-VD4-L4-CH1-Fc [III] pri čemu: VD1 je varijabilna domena teškog ili lakog lanca prvog imunoglobulina; VD2 je varijabilna domena teškog ili lakog lanca drugog imunoglobulina; VD3 je varijabilna domena teškog ili lakog lanca navedenog drugog imunoglobulina; VD4 je varijabilna domena teškog ili lakog lanca navedenog prvog imunoglobulina; CL je konstantna domena lakog lanca imunoglobulina; CH1 je CH1 konstantna domena teškog lanca imunoglobulina; Fc je zglobna regija imunoglobulina i CH2, CH3 imunoglobulinske konstantne domene teškog lanca imunoglobulina; Fc2 je zglobna regija imunoglobulina i CH2, CH3 imunoglobulinske konstantne domene teškog lanca imunoglobulina; L1, L2, L3, L4 i L5 su aminokiselinske poveznice; pri čemu polipeptid s formulom [IV] i polipeptid s formulom [III] tvore unakrsni par laki lanac-teški lanac.
6. Vezujući protein sličan protutijelu prema patentnom zahtjevu 2 ili 3, naznačen time što sadrži treći polipeptidni lanac koji obuhvaća Fc domenu (Fc3).
7. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 2, 3, ili 6, naznačen time što sadrži tri polipeptidna lanca koji tvore dva mjesta vezanja antigena, pri čemu prvi polipeptid ima strukturu predstavljenu formulom [I]: VD1-L1-VD2-L2-CL [I] drugi polipeptid ima strukturu predstavljenu formulom [III]: VD3-L3-VD4-L4-CH1-Fc [III] treći polipeptid Fc3 koji je zglobna regija imunoglobulina i CH2, CH3 imunoglobulinske konstantne domene teškog lanca imunoglobulina; pri čemu VD1 je varijabilna domena teškog ili lakog lanca prvog imunoglobulina; VD2 je varijabilna domena teškog ili lakog lanca drugog imunoglobulina; VD3 je varijabilna domena teškog ili lakog lanca navedenog drugog imunoglobulina; VD4 je varijabilna domena teškog ili lakog lanca navedenog prvog imunoglobulina; CL je konstantna domena lakog lanca imunoglobulina; CH1 je CH1, konstantna domena teškog lanca imunoglobulina; Fc je zglobna regija imunoglobulina i CH2, CH3 imunoglobulinske konstantne domene teškog lanca imunoglobulina; L1, L2, L3, i L4 su aminokiselinske poveznice; i pri čemu polipeptid s formulom [I] i polipeptid s formulom [III] tvore unakrsni par laki lanac-teški lanac; i pri čemu polipeptid s formulom [III] heterodimerizira s trećim polipeptidom kroz njegovu Fc domenu.
8. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time što su VD1 i VD2 varijabilne domene lakog lanca, a VD3 i VD4 su varijabilne domene teškog lanca.
9. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time što VD1 sadrži CDR1-L od sekvence SEQ ID NO: 378, CDR2-L od sekvence 'WAS', i CDR3-L od sekvence SEQ ID NO: 379; VD2 sadrži CDR4-L od sekvence SEQ ID NO: 142, CDR5-L od sekvence 'KVS', i CDR6-L od sekvence SEQ ID NO: 11; VD3 sadrži CDR1-H od sekvence SEQ ID NO: 6, CDR2-H od sekvence SEQ ID NO: 7, i CDR3-H od sekvence SEQ ID NO: 8; i VD4 sadrži CDR4-H od sekvence SEQ ID NO: 381, CDR5-H od sekvence SEQ ID NO: 384, i CDR6-H od sekvence SEQ ID NO: 382.
10. Vezujući protein sličan protutijelu prema patentnom zahtjevu 9, naznačen time što vezujući protein sličan protutijelu sadrži VD1 koji sadrži sekvencu aminokiseline SEQ ID NO: 385 ili sekvencu koja je najmanje 85% identična s njom, VD2 koji sadrži sekvencu aminokiseline SEQ ID NO: 141 ili sekvencu koja je najmanje 85% identična s njom, VD3 koji sadrži sekvencu aminokiseline SEQ ID NO: 138 ili sekvencu koja je najmanje 85% identična s njom, i VD4 koji sadrži sekvencu aminokiseline SEQ ID NO: 383 ili sekvencu koja je najmanje 85% identična s njom.
11. Vezujući protein sličan protutijelu prema patentnom zahtjevu 10, naznačen time što sadrži poveznicu L1 od sekvence SEQ ID NO: 389, L2 od sekvence SEQ ID NO: 389, L3 i L4 se sastoji od 0 aminokiselina, i CH1 od sekvence SEQ ID NO: 313.
12. Vezujući protein sličan protutijelu prema patentnom zahtjevu 11, naznačen time što nadalje sadrži poveznicu L5 koja se sastoji od 0 aminokiselina, Fc od sekvence SEQ ID NO: 394, ili Fc2 od sekvence SEQ ID NO: 392.
13. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1, 2, 4, ili 6-12, naznačen time što sadrži: a) jedan polipeptid prema formuli [I] koji sadrži sekvencu aminokiseline SEQ ID NO: 388 koja obuhvaća VD1 od sekvence SEQ ID NO: 385, L1 od sekvence SEQ ID NO: 389, VD2 od sekvence SEQ ID NO: 141, L2 od sekvence SEQ ID NO: 389, i CL od sekvence SEQ ID NO: 310, ili sekvencu koja je najmanje 85% identična sa SEQ ID NO: 388 koja obuhvaća CDR1-L od sekvence SEQ ID NO: 378, CDR2-L od sekvence 'WAS', CDR3-L od sekvence SEQ ID NO: 379, CDR4-L od sekvenci SEQ ID NO: 142, CDR5-L od sekvence 'KVS', i CDR6-L od sekvence SEQ ID NO: 11; i b) jedan polipeptid prema formuli [II] koji sadrži sekvencu aminokiseline SEQ ID NO: 390 koja obuhvaća VD3 od sekvence SEQ ID NO: 138, L3 je 0 aminokiselina, VD4 od sekvence SEQ ID NO: 383, L4 je 0 aminokiselina, i CH1 od sekvence SEQ ID NO: 313, ili sekvencu koja je najmanje 85% identična sa SEQ ID NO: 390 koja obuhvaća CDR1-H od sekvence SEQ ID NO: 381, CDR2-H od sekvence SEQ ID NO: 384, CDR3-H od sekvence SEQ ID NO: 382, i CDR4-H od sekvence SEQ ID NO: 6, CDR5-H od sekvence SEQ ID NO: 7, i CDR6-H od sekvence SEQ ID NO: 8; i pri čemu polipeptid s formulom [I] i polipeptid s formulom [II] tvore unakrsni par laki lanac-teški lanac.
14. Vezujući protein sličan protutijelu prema patentnom zahtjevu 13, naznačen time što sadrži jedan polipeptid prema formuli [I] koji sadrži sekvencu aminokiseline SEQ ID NO: 388 i jedan polipeptid prema formuli [II] koji sadrži sekvencu aminokiseline SEQ ID NO: 390.
15. Vezujući protein sličan protutijelu prema patentnom zahtjevu 5, naznačen time što sadrži: a) jedan polipeptid prema formuli [IV] koji sadrži sekvencu aminokiseline SEQ ID NO: 391 koja obuhvaća VD1 od sekvence SEQ ID NO: 385, L1 od sekvence SEQ ID NO: 389, VD2 od sekvence SEQ ID NO: 141, L2 od sekvence SEQ ID NO: 389, CL od sekvence SEQ ID NO: 310, L5 koji obuhvaća 0 aminokiselina, i Fc2 od sekvence SEQ ID NO: 392, ili sekvencu koja je najmanje 85% identična sa SEQ ID NO: 391 koja obuhvaća CDR1-L od sekvence SEQ ID NO: 378, CDR2-L od sekvence 'WAS', CDR3-L od sekvence SEQ ID NO: 379, CDR4-L od sekvence SEQ ID NO: 142, CDR5-L od sekvence 'KVS', i CDR6-L od sekvence SEQ ID NO: 11; i b) jedan polipeptid prema formuli [III] koji sadrži sekvencu aminokiseline SEQ ID NO: 393 koja obuhvaća VD3 od sekvence SEQ ID NO: 138, L3 je 0 aminokiselina, VD4 od sekvence SEQ ID NO: 383, L4 je 0 aminokiselina, CH1 od sekvence SEQ ID NO: 313, i Fc od sekvence SEQ ID NO: 394, ili sekvencu koja je najmanje 85% identična sa SEQ ID NO: 393 koja obuhvaća CDR1-H od sekvence SEQ ID NO: 381, CDR2-H od sekvence SEQ ID NO: 384, CDR3-H od sekvence SEQ ID NO: 382, CDR4-H od sekvenci SEQ ID NO: 6, CDR5-H od sekvence SEQ ID NO: 7, i CDR6-H od sekvence SEQ ID NO: 8; i pri čemu polipeptid s formulom [IV] i polipeptid s formulom [III] tvore unakrsni par laki lanac-teški lanac.
16. Vezujući protein sličan protutijelu prema patentnom zahtjevu 15, naznačen time što sadrži jedan polipeptid prema formuli [IV] koji sadrži sekvencu aminokiseline SEQ ID NO: 391 i jedan polipeptid prema formuli [III] koji sadrži sekvencu aminokiseline SEQ ID NO: 393.
17. Vezujući protein sličan protutijelu naznačen time što sadrži jedan polipeptid koji sadrži sekvencu aminokiseline SEQ ID NO:391 i jedan polipeptid koji sadrži sekvencu aminokiseline SEQ ID NO:393, pri čemu polipeptid koji sadrži sekvencu aminokiseline SEQ ID NO:391 i polipeptid koji sadrži sekvencu aminokiseline SEQ ID NO:393 tvore unakrsni par laki lanac-teški lanac.
18. Farmaceutski pripravak naznačen time što sadrži vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1 do 17, i farmaceutski prihvatljiv nosač.
19. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1 do 17, ili farmaceutski pripravak prema patentnom zahtjevu 18 naznačen time što je za uporabu kao lijek.
20. Vezujući protein sličan protutijelu prema bilo kojem od patentnih zahtjeva 1 do 17, ili farmaceutski pripravak prema patentnom zahtjevu 18, naznačen time što je za uporabu za liječenje raka.
21. Vezujući protein sličan protutijelu ili farmaceutski pripravak za uporabu prema zahtjevu 20, naznačen time što je rak je hematološki rak.
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