DK3062815T3 - Vektorer til ekspression af prostata-associerede antigener - Google Patents
Vektorer til ekspression af prostata-associerede antigener Download PDFInfo
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- DK3062815T3 DK3062815T3 DK14802175.1T DK14802175T DK3062815T3 DK 3062815 T3 DK3062815 T3 DK 3062815T3 DK 14802175 T DK14802175 T DK 14802175T DK 3062815 T3 DK3062815 T3 DK 3062815T3
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Claims (24)
1. C68-vektor omfattende: (a) en C68-nukleotidsekvens; og (b) et multi-antigen-konstrukt, der omfatter mindst en nukleotidsekvens, der koder for et immunogent cytosolisk PSA-polypeptid, mindst en nukleotidsekvens, der koder for et immunogent PSCA-polypeptid, og mindst en nukleotidsekvens, der koder for et immunogent PSMA-polypeptid, og hvor multi-antigen-konstruktet yderligere omfatter en separatorsekvens mellem to nu-kleotidsekvenser, der koder for to forskellige immunogene polypeptider og har strukturen med formel (I): PAA1-SS1-PAA2-SS2-PAA3 (I) hvor i formel (I): (i) PAA1, PAA2 og PAA3 hver er en nukleotidsekvens, der koder for et immunogent PSA-polypeptid, en nukleotidsekvens, der koder for et immunogent PSCA-polypeptid, eller en nukleotidsekvens, der koder for et immunogent PSMA-polypeptid, forudsat at PAA1, PAA2 og PAA3 koder for forskellige PAA-polypeptider, og (ii) SS1 og SS2 er separatorsekvenser og kan være den samme eller forskellige.
2. C68-vektor ifølge krav 1, hvor C68-nukleotidsekvensen er sekvensen med SEQ ID NO: 57, som mangler mindst et gen udvalgt fra gruppen bestående af E1A-, E1B-, E2A-, E2B-, E3-, E4-, L1-, L2-, L3-, L4- og L5-gener, hvor det immunogene PSA-polypeptid omfatter aminosyre 27-263 med SEQ ID NO:15 eller aminosyre 4 - 240 med SEQ ID NO:17, hvor det immunogene PSCA-polypeptid omfatter aminosyresekvensen med SEQ ID NO:21 eller aminosyre 4-125 med SEQ ID NO:21, og hvor det immunogene PSMA-polypeptid er udvalgt fra gruppen bestående af: 1) et polypeptid omfattende aminosyre 15-750 med SEQ ID NO: 1; 2) et polypeptid omfattende aminosyresekvensen med SEQ ID NO:3; 3) et polypeptid omfattende aminosyresekvensen med SEQ ID NO:5; 4) et polypeptid omfattende aminosyresekvensen med SEQ ID NO:7; 5) et polypeptid omfattende aminosyre 4 - 739 med SEQ ID NO:9; 6) et polypeptid omfattende aminosyre 4 - 739 med SEQ ID NO:3; 7) et polypeptid omfattende aminosyre 4 - 739 med SEQ ID NO:5; 8) et polypeptid omfattende aminosyre 4 - 739 med SEQ ID NO:7; og 9) et polypeptid omfattende aminosyresekvensen med SEQ ID NO: 9.
3. C68-vektor ifølge krav 2, hvor C68-nukleotidsekvensen er sekvensen med SEQ ID NO: 57, som mangler generne E1 A, E1B og E3.
4. C68-vektoren ifølge krav 3, hvor separatorsekvenserne er udvalgt blandt 2A-peptidsekvenser og IRESs.
5. C68-vektor ifølge krav 4, hvor 2A-peptidsekvensen er udvalgt fra gruppen bestående af 2A-peptidsekvensen med FMDV, ERAV, PTV1, EMC-B, EMCV, TME-GD7, ERBV, TaV, DrosC, CrPV, ABPV, IFV, svine-rotavirus, human rotavirus, T brucei TSR1 og T cruzi AP-endonuklease; og hvor IRES'et er et EMCV-IRES.
6. Vektor ifølge krav 5, hvor PAA1 i formel (I) er en nukleotidsekvens, der koder for det immunogene cytosoliske PSA-polypeptid, eller en nukleotidsekvens, der koder for det immunogene PSCA-polypeptid.
7. Vektor ifølge krav 6, hvor: (i) PAA1 er en nukleotidsekvens, der koder for det immunogene cytosoliske PSA-polypeptid; (ii) PAA2 er en nukleotidsekvens, der koder for et immunogent PSCA eller PSMA-polypeptid; (iii) SS1 er en 2A-peptidsekvens; og (iv) SS2 er en 2A-peptidsekvens eller en EMCV-IRES.
8. C68-vektor ifølge krav 7, hvor 2A-peptidsekvensen er FMDV 2A-peptidse-kvensen eller TAV 2A-peptidsekvensen.
9. C68-vektor ifølge krav 8, hvor: (1) nukleotidsekvensen, der koder for det immunogene cytosoliske PSA-polypeptid, er udvalgt fra gruppen bestående af: (i) nukleotidsekvensen med SEQ ID NO: 18; (ii) nukleotidsekvensen omfattende nukleotid 10-720 med SEQ ID N0:18; (iii) nukleotidsekvensen omfattende nukleotid 1115-1825 med SEQ ID NO:58; og (iv) nukleotidsekvensen omfattende nukleotid 1106-1825 med SEQ ID NO:58; (2) nukleotidsekvensen, der koder for det immunogene PSCA-polypeptid, er udvalgt fra gruppen bestående af: (i) nukleotidsekvensen med SEQ ID NO:22; (ii) en nukleotidsekvens omfattende nukleotid 10-372 med SEQ ID NO:22; (iii) en nukleotidsekvens omfattende nukleotid 1892-2257 med SEQ ID NO:58; og (iv) en nukleotidsekvens omfattende nukleotid 1886-2257 med SEQ ID NO:58; og (3) nukleotidsekvensen, der koder for det immunogene PSMA-polypeptid, er udvalgt fra gruppen bestående af: (i) nukleotidsekvensen omfattende nukleotid 43-2250 med SEQ ID NO:2; (ii) nukleotidsekvensen med SEQ ID NO:4; (iii) nukleotidsekvensen med SEQ ID NO:6; (iv) nukleotidsekvensen med SEQ ID NO:8; (v) nukleotidsekvensen med SEQ ID NO:10; (vi) en nukleotidsekvens omfattende nukleotid 10 - 2217 med SEQ ID NO:4; (vii) en nukleotidsekvens omfattende nukleotid 10 - 2217 med SEQ ID NO:6; (viii) en nukleotidsekvens omfattende nukleotid 10 - 2217 med SEQ ID NO:8; (ix) en nukleotidsekvens omfattende nukleotid 10 - 2217 med SEQ ID NO:10; (x) en nukleotidsekvens omfattende nukleotid 2333-4543 med SEQ ID NO:58; og (xi) en nukleotidsekvens omfattende nukleotid 2324-4543 med SEQ ID NO:58.
10. C68-vektor ifølge krav 3, hvor, i formel (I): (1) PAA1 er en nukleotidsekvens, der koder for en immunogen cytosolisk PSA-polypeptid og omfatter nukleotid 1115-1825 med SEQ ID NO: 58; (2) PAA2 er en nukleotidsekvens, der koder for et immunogent PSCA-polypeptid og omfatter nukleotid 1892-2257 med SEQ ID NO: 58 eller omfatter 1886-2257 med SEQ ID NO: 58; (3) PAA3 er en nukleotidsekvens, der koder for et immunogent PSMA-polypeptid og omfatter nukleotid 2333-4543 med SEQ ID NO: 58 eller omfatter 2324-4543 med SEQ ID NO: 58; (4) SS1 er en nukleotidsekvens, der koder for T2A; og (5) SS2 er en nukleotidsekvens, der koder for F2A.
11. C68-vektor ifølge krav 1, hvor multi-antigen-konstruktet omfatter en nukleotidsekvens, der koder for aminosyresekvensen med SEQ ID NQ:60 eller SEQ ID NO:64.
12. C68-vektor ifølge krav 1, hvor multi-antigen-konstruktet omfatter en nukleotidsekvens med SEQ ID NO:61, SEQ ID NO:65, SEQ ID NO:66 eller en degenereret variant af nukleotidsekvensen med SEQ ID NO:61, SEQ ID NO:65, SEQ ID NO:66.
13. C68-vektor ifølge krav 11 eller krav 12, yderligere omfattende en CMV-promoter.
14. C68-vektor ifølge krav 1, som omfatter nukleotidsekvensen med SEQ ID NO:58, nukleotid 9-34811 med SEQ ID NO:58 eller nukleotidsekvensen med SEQ ID NO:63.
15. Sammensætning omfattende en C68-vektor ifølge et hvilket som helst af kravene 1-14.
16. Celle omfattende en C68-vektor ifølge et hvilket som helst af kravene 1-14.
17. Farmaceutisk sammensætning omfattende en vektor ifølge et hvilket som helst af kravene 1-14 og en farmaceutisk acceptabel excipiens.
18. Farmaceutisk sammensætning ifølge krav 17 til anvendelse i en fremgangsmåde til behandling af prostatacancer hos et menneske.
19. Farmaceutisk sammensætning til anvendelse ifølge krav 18, hvor fremgangsmåden yderligere omfatter indgivelse til mennesket af en virksom mængde af en immunmodulator.
20. Farmaceutisk sammensætning til anvendelse ifølge krav 18, hvor fremgangsmåden yderligere omfatter indgivelse til mennesket af (a) en virksom mængde af mindst en inhibitor af immunsuppressive celler og (b) en virksom mængde af mindst en enhancer af immuneffektorceller.
21. Farmaceutisk sammensætning til anvendelse ifølge krav 20, hvor inhibitoren af immunsuppressive celler er udvalgt fra gruppen bestående af en prote-inkinase-inhibitor, en COX-2-inhibitor og en PDE5-inhibitor, og hvor enhance-ren af immuneffektorceller er udvalgt fra gruppen bestående af en CTLA-4-inhibitor, en CD40-agonist, en TLR-agonist, en 4-1 BB-agonist, en OX40-ago-nist, en GITR-agonist, en PD-1-antagonist og en PD-L1-antagonist.
22. Farmaceutisk sammensætning til anvendelse ifølge krav 21, hvor: (1) proteinkinase-inhibitoren er udvalgt fra gruppen bestående af imatinib, sorafenib, lapatinib, zactima MP-412, dasatinib, lestaurtinib, sunitinibmalat, axitinib, erlotinib, gefitinib, bosutinib, temsirolismus og nilotinib; (2) CTLA-4-inhibitoren er udvalgt fra gruppen bestående af ipilimumab og tre-melimumab; (3) CD40-agonisten er et anti-CD40-antistof udvalgt fra gruppen bestående af G28-5, mAb89, EA-5, S2C6, CP870893 og dacetuzumab; og (4) TLR-agonisten er et CpG-oligonukleotid udvalgt fra gruppen bestående af CpG 24555, CpG 10103, CpG7909 og CpG1018.
23. Farmaceutisk sammensætning til anvendelse ifølge krav 22, hvor inhibitoren af immunsuppressive celler er en proteinkinase-inhibitor udvalgt fra gruppen bestående af sorafenib, dasatinib, imatinib, axitinib og sunitinibmalat, og hvor enhanceren af immuneffektorceller er tremelimumab.
24. Farmaceutisk sammensætning til anvendelse ifølge krav 22, hvor inhibitoren af immunsuppressive celler er en proteinkinase-inhibitor udvalgt fra gruppen bestående af sorafenib, dasatinib, imatinib, axitinib og sunitinibmalat, og hvor enhanceren af immuneffektorceller er et CpG-oligonukleotid udvalgt fra gruppen bestående af CpG24555, CpG10103, CpG7909 og CpG1018.
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