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DK3174557T3 - ROR1(NTRKR1)-specifikke kimære antigenreceptorer til cancerimmunterapi - Google Patents

ROR1(NTRKR1)-specifikke kimære antigenreceptorer til cancerimmunterapi Download PDF

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DK3174557T3
DK3174557T3 DK15744216.1T DK15744216T DK3174557T3 DK 3174557 T3 DK3174557 T3 DK 3174557T3 DK 15744216 T DK15744216 T DK 15744216T DK 3174557 T3 DK3174557 T3 DK 3174557T3
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Cecile Schiffer-Mannioui
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Cellectis
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Claims (31)

1. R0R1 (NTRKR1 )-specifik kimær antigenreceptor (CAR) med en af polypep-tidstrukturerne valgt blandt V3, V5 og V1 som illustreret i figur 4, hvilken struktur omfatter et ekstracellulært ligandbindingsdomæne, der omfatter VH og VL fra et monoklonalt anti-ROR1-antistof, et hængsel, et CD8a-transmembrando-mæne og et cytoplasmisk domæne indbefattende et CD3-zetasignalerende domæne og et co-stimulerende domæne fra 4-1BB; hvor det ekstracellulære ligandbindingsdomæne omfatter: - en variabel tung, VH, kæde omfattende CDRer fra det monoklonale museantistof H10 med SEQ ID NO: 54 (CDR-H1), SEQ ID NO: 55 (CDR-H2) og SEQ ID NO:56 (CDR-H3), og - en variabel let, VL, kæde omfattende CDRer fra det monoklonale museantistof H10 med SEQ ID NO: 59 (CDR-L1), SEQ ID NO: 60 (CDR-L2) og SEQ ID NO:61 (CDR-L3); eller - en variabel tung, VH, kæde omfattende CDRer fra det monoklonale museantistof D10 med SEQ ID NO: 28 (CDR-H1), SEQ ID NO: 29 (CDR-H2) og SEQ ID NO: 30 (CDR-H3), og - en variabel let, VL, kæde omfattende CDRer fra det monoklonale museantistof D10 med SEQ ID NO: 33 (CDR-L1), SEQ ID NO: 34 (CDR-L2) og SEQ ID NO: 35 (CDR-L3).
2. ROR1 (NTRKRI)-specifik kimær antigenreceptor (CAR) ifølge krav 1, hvor CD8a-transmembrandomænet har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 6.
3. ROR1 (NTRKRI)-specifik kimær antigenreceptor (CAR) ifølge krav 1 eller 2, hvor hængslet er valgt blandt CD8a-hængsel, lgG1-hængsel og FcyRllla-hængsel.
4. ROR1 (NTRKRI)-specifik kimær antigenreceptor (CAR) ifølge krav 1 eller 2, hvor hængslet har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet, for strukturerne V3, V5 og V1, med SEQ ID NO: 4 (CD8a), SEQ ID NO: 5 (lgG1) og SEQ ID NO: 3 (FcyRllla).
5. ROR1-specifik CAR ifølge et af kravene 1 til 3 med polypeptidstrukturen V3 omfattende et CD8a-hængsel, der har mindst 80% sekvensidentitet med ami-nosyresekvensen ifølge SEQ ID NO: 4, og et CD8a-transmembrandomæne, der har mindst 80% sekvensidentitet med aminosyresekvensen ifølge SEQ ID NO: 6.
6. ROR1-specifik CAR ifølge et af kravene 1 til 3 med polypeptidstrukturen V5 omfattende et lgG1-hængsel, der har mindst 80% identitet med aminosyresekvensen ifølge SEQ ID NO: 5, og et CD8a-transmembrandomæne, der har mindst 80% identitet med aminosyresekvensen ifølge SEQ ID NO: 6.
7. ROR1-specifik CAR ifølge et af kravene 1 til 3 med polypeptidstrukturen V1 omfattende et FcyRllla-hængsel, der har mindst 80% sekvensidentitet med aminosyresekvensen ifølge SEQ ID NO: 3, og et CD8a-transmembrando-mæne, der har mindst 80% sekvensidentitet med aminosyresekvensen ifølge SEQ ID NO: 6.
8. ROR1-specifik kimær antigenreceptor ifølge et af kravene 1 til 7, hvor det ekstracellulære ligandbindingsdomæne omfatter VH- og VL-kæder, der hver især har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 53 (H10-VH) og SEQ ID NO: 58 (H10-VL).
9. ROR1-specifik kimær antigenreceptor ifølge et af kravene 1 til 7, hvor det ekstracellulære ligandbindingsdomæne omfatter VH- og VL-kæder, der hver især har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 27 (D10-VH) og SEQ ID NO: 32 (D10-VL).
10. ROR1-specifik kimær antigenreceptor ifølge et af kravene 1 til 9, hvor det ekstracellulære ligandbindingsdomæne omfatter VH- og VL-kæder fra H10-eller D1 O-antistoffer, der er blevet humaniseret.
11. R0R1 -specifik kimær antigen receptor ifølge krav 10, hvor det ekstracellu-lære ligandbindingsdomæne omfatter VH- og VL-kæder, hvor - en VH-kæde har et polypeptid, der kodes af SEQ ID NO: 57, og - en VL-kæde har et polypeptid, der kodes af SEQ ID NO: 62.
12. ROR1-specifik kimær antigen receptor ifølge krav 10, hvor det ekstracellu-lære ligandbindingsdomæne omfatter: - en VH-kæde med et polypeptid, der kodes af SEQ ID NO: 31, og - en VL-kæde med et polypeptid, der kodes af SEQ ID NO: 36.
13. ROR1-specifik kimær antigenreceptor ifølge krav 1, hvor CAR-polypepti-det har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 117 (H10v3-CAR-sekvens).
14. ROR1-specifik kimær antigenreceptor ifølge krav 1, hvor CAR-polypepti-det har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 93 (D10v3-CAR-sekvens).
15. ROR1-specifik kimær antigenreceptor ifølge krav 1, hvor CAR-polypepti-det har mindst 80%, fortrinsvis mindst 90%, mere foretrukket mindst 95% og endnu mere foretrukket mindst 99% sekvensidentitet med SEQ ID NO: 95 (D10v5-CAR-sekvens).
16. ROR1-specifik CAR ifølge et af kravene 1 til 15, hvor det co-stimulerende domæne fra 4-1BB har mindst 80 % identitet med SEQ ID NO: 8.
17. ROR1-specifik CAR ifølge et af kravene 1 til 16, hvor CD3 zeta-signale-ringsdomænet har mindst 80% identitet med SEQ ID NO: 9.
18. ROR1-specifik CAR ifølge et af kravene 1 til 17, endvidere omfattende et signalpeptid.
19. ROR1-specifik kimær antigenreceptor ifølge krav 1, hvor nævnte CAR har aminosyresekvensen med SEQ ID NO: 117 (H10v3-CAR-sekvens), SEQ ID NO: 93 (D10v3-CAR-sekvens) eller SEQ ID NO: 95 (D10v5-CAR-sekvens).
20. Polynukleotid, der koder for en kimær antigenreceptor ifølge et af kravene 1 til 18.
21. Ekspressionsvektor omfattende et polynukleotid ifølge krav 20.
22. Ændret immuncelle, der ved celleoverflademembranen udtrykker en ROR1-specifik kimær antigen receptor ifølge et af kravene 1 til 18.
23. Ændret immuncelle ifølge krav 22, der stammer fra inflammatoriske T-lym-focytter, cytotoksiske T-lymfocytter, regulator-T-lymfocytter eller hjælper-T-lymfocytter.
24. Ændret immuncelle ifølge krav 22 eller 23, hvor ekspressionen af TCR undertrykkes i immuncellen.
25. Ændret immuncelle ifølge et af kravene 22 til 24, hvor cellen muteres til at give modstand overfor mindst et immunundertrykkende eller kemoterapeutisk lægemiddel.
26. Ændret immuncelle ifølge krav 22 til 25 til anvendelse i terapi.
27. Ændret immuncelle ifølge et af kravene 22 til 25 til anvendelse som et medikament ved behandling af cancer.
28. Ændret immuncelle ifølge et af kravene 22 til 26 til anvendelse ved terapi af en præ-malign eller malign cancertilstand kendetegnet ved ROR1-udtryk-kende celler.
29. Ændret immuncelle ifølge et af kravene 22 til 26 til anvendelse ved terapi af en hæmatologisk cancertilstand såsom leukæmi.
30. Ændret immuncelle ifølge et af kravene 22 til 26 til anvendelse ved terapi afen hæmatologisk cancertilstand, hvor den hæmatologiske cancertilstand er valgt fra gruppen bestående af: kronisk lymfatisk leukæmi (CLL), lille lymfocy-tisk lymfom (SLL), akut myeloid leukæmi, kronisk myelogen leukæmi, mye-lodysplastisk syndrom, kappecellelymfom (MCL) og akut lymfoblastisk leukæmi (ALL) med en t(1 ;19)-kromosomtranslokation.
31. Ændret immuncelle ifølge et af kravene 22 til 26 til anvendelse ved terapi, hvor tilstanden er en fast tumor.
DK15744216.1T 2014-07-29 2015-07-29 ROR1(NTRKR1)-specifikke kimære antigenreceptorer til cancerimmunterapi DK3174557T3 (da)

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