DK2376535T3 - Anti-pd-l1-antistoffer og deres anvendelse til at fremme t cellefunktion - Google Patents

Anti-pd-l1-antistoffer og deres anvendelse til at fremme t cellefunktion Download PDF

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DK2376535T3
DK2376535T3 DK09764997.4T DK09764997T DK2376535T3 DK 2376535 T3 DK2376535 T3 DK 2376535T3 DK 09764997 T DK09764997 T DK 09764997T DK 2376535 T3 DK2376535 T3 DK 2376535T3
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antibody
cells
sequence
hvr
cell
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DK09764997.4T
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Bryan Irving
Jeanne Cheung
Henry Chiu
Sophie M Lehar
Sanjeev Mariathasan
Yan Wu
Heather Maecker
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Hoffmann La Roche
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Claims (17)

1. Isoleret anti-PD-Ll-antistof eller antigen-bindende fragment deraf omfattende en tung kæde og en let kæde variabel regionsekvens, hvor: (a) den tunge kæde omfatter en HVR-H1, HVR-H2 og HVR-H3, hvor yderligere: (i) HVR-H 1-sekvensen er GFTFSDSWIH (SEQ ID NO: 15); (ii) HVR-H2-sekvensen er AWISPYGGSTYYADSVKG (SEQ ID NO: 16); (iii) HVR-H3-sekvensen er RHWPGGFDY (SEQ ID NO:3); og (b) den lette kæde omfatter en HVR-L1, FIVR-L2 og HVR-L3, hvor yderligere: (iv) HVR-Ll-sekvensen er RASQDVSTAVA (SEQ ID NO: 17); (v) HVR-L2-sekvensen er SASFLYS (SEQ ID NO: 18); (vi) HVR-L3-sekvensen er QQYLYHPAT (SEQ ID NO: 19).
2. Antistoffet eller antistoffragment deraf ifølge krav 1 yderligere omfattende: (a) variabel region tung kæde framework-sekvenser sidestillet mellem HVR'erne ifølge formlen: (HC-FR1)-(HVR-H1)-(HC-FR2)-(HVR-H2)-(HC-FR3)-(HVR-H3)-(HC-FR4), og (b) variabel region let kæde framework-sekvenser sidestillet mellem HVR'erne ifølge formlen: (LC-FR1)-(HVR-L1)-(LC-FR2)-(HVR-L2)-(LC-FR3)-(HVR-L3)-(LC-FR4).
3. Antistoffet eller antistoffragment deraf ifølge krav 1 eller 2, hvor framework-sekvenserne er afledt fra humane konsensus-framework-sekvenser, hvor de variable region tung kæde framework-sekvenser er VH-undergruppe III konsensus-framework og/eller hvor de variable region let kæde framework-sekvenser er VL kappa I konsensus-framework-sekvenser.
4. Antistoffet eller antistoffragment deraf ifølge krav 2 eller 3, hvor én eller flere af framework-sekvenserne er følgende: HC-FR1 er EVQLVESGGGLVQPGGSLRLSCAAS (SEQ ID NO:4); HC-FR2 er WVRQAPGKGLEWV (SEQ ID NO: 5); HC-FR3 er RFTISADTSKNTAYLQMNSLRAEDTAVYYCAR (SEQ ID NO:6); HC-FR4 er WGQGTLVTVSA (SEQ ID NO:7); og/eller hvor én eller flere af framework-sekvenserne er følgende: LC-FR1 er DIQMTQSPSSLSASVGDRVTITC (SEQ ID NO: 11); LC-FR2 er WYQQKPGKAPKLLIY (SEQ ID NO: 12); LC-FR3 er GVPSRFSGSGSGTDFTLTISSI,QPEDFATYYC (SEQ ID NO: 13); LC-FR4 er FGQGTKVEIKR (SEQ ID NO: 14).
5. Antistoffet eller antistoffragment deraf ifølge krav 4 yderligere omfattende en human konstant region eller yderligere omfattende en murin konstant region.
6. Antistoffet eller antistoffragment deraf ifølge krav 5, hvor den humane konstante region er valgt fra gruppen bestående af IgGl, IgG2, IgG3 og IgG4 eller hvor den humane konstante region er IgGl og hvor den murine konstante region er valgt fra gruppen bestående af IgGl, IgG2A, IgG2B og IgG3 eller hvor den murine konstante region er IgG2A.
7. Antistoffet eller antistoffragment deraf ifølge et hvilket som helst af kravene 1 til 6, hvor antistoffet eller antistoffragment har reduceret eller minimal effektorfunktion.
8. Antistoffet eller antistoffragment deraf ifølge krav 7, hvor den minimale effektorfunktion resulterer fra en effektor-løs-Fc-mutation.
9. Antistoffet eller antistoffragment deraf ifølge krav 7 eller 8, hvor effektor-løs-Fc-mutationen er N297A og/eller er D265A/N297A.
10. Antistoffet eller antistoffragment deraf ifølge et hvilket som helst af kravene 7 til 9, hvor den minimale effektor-funktion resulterer fra aglycosylering.
11. Antistoffet eller antistoffragment deraf ifølge krav 1, yderligere omfattende en VH- og VL-frameworkregion afledt fra en human konsensus-sekvens, hvor VH framework-sekvensen er afledt fra en Kabat-undergruppe I, II, eller III sekvens, hvor VH-framework-sekvensen fortrinsvis er en Kabat-undergruppe III konsensus-framework sekvens og hvor VL-framework-sekvensen er afledt fra en Kabat kappa I, II, III or IV-undergruppe sekvens, hvor VL-framework-sekvensen fortrinsvis er en Kabat kappa I konsensus-framework-sekvens.
12. Isoleret anti-PD-Ll-antistof eller antigen-bindende fragment deraf ifølge et hvilket som helst af kravene 1 til 11 omfattende en tung kæde og let kæde variabel regionsekvens, hvor: (a) den tunge kæde omfatter sekvensen: EVQLVESGGGLVQPGGSLRLS CAASGFTFSDSWIHWVRQAPGKGLEWVAWISPYGGSTYYADSVKGRFTI SADTSKNTAYLQMNSLRAEDTAVYYCARRHWPGGFDYWGQGTLVTVS A (SEQ ID NO:20); og (b) den lette kæde omfatter sekvensen: DIQMTQSPSSLSASVGDRVTITC RASQDVSTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSGSGTDFTL TISSLQPEDFATYYCQQYLYH PATFGQGTKVEIKR (SEQ ID NO:21).
13. Sammensætning omfattende anti-PD-Ll-antistoffet eller antigen-bindende fragment deraf ifølge et hvilket som helst af kravene 1 til 12 og mindst én farmaceutisk-acceptabel bærer.
14. Isoleret nukleinsyre der koder for antistoffet eller antigen-bindende fragment deraf ifølge et hvilket som helst af kravene 1 til 12.
15. Vektor omfattende nukleinsyren ifølge krav 14.
16. Værtscelle omfattende vektoren ifølge krav 15.
17. Fremgangsmåde til fremstilling af et anti-PD-Ll-antistof eller antigenbindende fragment deraf omfattende dyrkning af værtscellen ifølge krav 16 under betingelser der er egnede for ekspressionen af vektoren der koder for anti-PD-Ll-antistoffet eller antigen-bindende fragment deraf, og genvinde antistoffet eller antigen-bindende fragment.
DK09764997.4T 2008-12-09 2009-12-08 Anti-pd-l1-antistoffer og deres anvendelse til at fremme t cellefunktion DK2376535T3 (da)

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