DK2456786T4 - Lentivirusvektorer, der er pseudotypebestemt med et kappeglycoprotein fra sindbis-virus - Google Patents
Lentivirusvektorer, der er pseudotypebestemt med et kappeglycoprotein fra sindbis-virus Download PDFInfo
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Claims (23)
1. Lentivirusvektorpartikel, der omfatter: (a) en kappe, der omfatter (i) et Sindbis-virus E2-glycoprotein ifølge SEQ ID NO: 1, hvori 160X er fraværende eller er en anden aminosyre end glutaminsyre, eller en variant af SEQ ID NO: 1 med mindst 80 % identitet med SEQ ID NO: 1, og hvori 160X er fraværende eller er en anden aminosyre end glutaminsyre, der er i stand til at inficere dendritceller; hvor E2 ikke er en del af et fusionsprotein med Sindbis-virus E3; og (b) et lentivirusvektorgenom, der omfatter en eller flere sekvenser af interesse.
2. Lentivirusvektorpartikel ifølge krav 1, hvor 160X er fraværende eller er glycin, alanin, valin, leucin eller isoleucin, såsom udvalgt blandt glycin, valin, leucin eller isoleucin.
3. Lentivirusvektorpartikel ifølge krav 1 eller 2, hvor E2-glycoproteinvarianten har mindst én aminosyre, der er ændret, så dens positive nettoladning er reduceret.
4. Lentivirusvektorpartikel ifølge krav 3, hvor den mindst ene aminosyre, der er ændret for at reducere den positive nettoladning, er udvalgt blandt lysin 70, lysin 76 eller lysin 159 i SEQ ID NO: 1, og fortrinsvis hvor substituenterne er udvalgt uafhængigt blandt glutaminsyre eller asparaginsyre.
5. Lentivirusvektorpartikel ifølge krav 1, hvor E2- variantsekvensen er aminosyreresterne 66 til 488 af SEQ ID NO: 3, aminosyreresterne 66 til 488 af SEQ ID NO: 4 eller aminosyreresterne 66 til 486 af SEQ ID NO: 5; (variant 1, 2 og 3) .
6. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-5, som er en variant, hvori sekvensen af resterne 71-75 af SEQ ID NO: 1 er uændret eller har en eller to substitutioner, som ikke påvirker variantens evne til at inficere DC'er, men ikke ændrer antallet af aminosyrer i dette område.
7. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-6, hvor sekvensen af interesse udtrykker et produkt, som er et antigen fra et sygdomsforårsagende middel eller en angreben celle.
8. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-6, hvor sekvensen af interesse koder for et tumorspecifikt antigen, eventuelt NY-ESO-1, MAGE, MART-1/Melan-A, BAGE, RAGE, et antigen fra en melanocyt-melanom-cellelinje, såsom gplOO, gp75, mda-7, tyrosinase eller tyrosinase-relateret protein; renalcellekarcinom-antigen, 5T4, SM22-alfa, carboanhydrase I, carboanhydrase IX (også kendt som G250) , hypoxia-inducerbare faktorer (valgfrit HIF-l-alfa eller HIF-2-alfa) , VEGF eller prostataspecifikt membranantigen (PSMA), prostataspecifikt antigen (PSA), prostatasyrephosphater, seks-transmembrant epitelialt antigen fra prostata (STEAP), NKX3.1, epitopproteiner/peptider, der er afledt fra gener, der er muteret i tumorceller, eller gener, der transkriberes ved andre niveauer i tumor sammenlignet med normale celler, såsom telomerase-enzym, survivin, mesothelin, muteret ras, bcr/abl-omlejring, Her2/neu, muteret eller vildtype-p53, cytochrom P450-1B1, anormalt udtrykte intronsekvenser, såsom N-acetylglucosaminyltransferase-V; klonale omlejringer af immunoglobulingener, der frembringer unikke idiotyper i myelom eller B-cellelymfomer; epitopproteiner/peptider, der stammer fra onkovirale processer, såsom humane papillomavirusproteiner E6 eller E7; eller ikke-muterede onkoføtale proteiner med en tumorselektiv ekspression, såsom karcinoembryonisk antigen eller alfa-fetoprotein.
9. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-7, hvor sekvensen af interesse koder for et virusafledt antigen, såsom et HIV- eller SIV-antigen, adenovirus-polypeptid, alfavirus-polypeptider, calicivirus- polypeptider, f.eks. et calicivirus-capsidantigen, coronavirus-polypeptider, distempervirus-polypeptid, Ebolavirus-polypeptid, enterovirus-polypeptid, flavivirus- polypeptid, hepatitisvirus (AE)-polypeptid, f.eks. et hepatitis B-kerne- eller overfladeantigen, eller hepatitis C-virus El- eller E2-glycoproteiner, kerne- eller ikke-strukturproteiner, herpesvirus-polypeptid, f.eks. et herpes simplex virus- eller varicella zoster virus- glycoprotein, immundefektvirus-polypeptid, f.eks. human immundefektvirus-kappe eller protease, infektiøs peritonitisvirus-polypeptid, influenzavirus-polypeptid, f.eks. et influenza A-hemagglutinin, neuraminidase; eller nukleoprotein, leukæmivirus-polypeptid, Marburg-virus- polypeptid, orthomyxovirus-polypeptid, papillomavirus- polypeptid, parainfluenzavirus-polypeptid, f.eks. hemagglutinin/neuraminidase, paramyxovirus-polypeptid, parvovirus-polypeptid, pestivirus-polypeptid, picornavirus-polypeptid, f.eks. et polioviruscapsid-polypeptid, poxvirus-polypeptid, f.eks. et vacciniavirus-polypeptid, rabiesvirus-polypeptid, f.eks. et rabiesvirus-glycoprotein G, reovirus-polypeptid, retrovirus-polypeptid eller rotavirus-polypeptid.
10. Sammensætning, der omfatter en lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-9, hvor sammensætningen har en IU på mindst 105/ml.
11. Lentivirusvektorpakningssystem til frembringelse af en pseudotype lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10, der omfatter: (i) et første nukleinsyremolekyle, der koder for Sindbis-virus E2-glycoproteinet ifølge krav 1 (a)(i), og; (ii) et andet nukleinsyremolekyle, der koder for gag- og polproteiner, (iii) et tredje nukleinsyremolekyle, der koder for rev; (iv) et lentivirusvektorgenom, der omfatter en sekvens af interesse; og (v) en pakningscelle.
12. Lentivirusvektorpakningssystem ifølge krav 11, hvor: (a) pol-proteinet har en ikke-funktionel integrase; og/eller (b) pol-proteinet har en ikke-funktionel integrase med en D64V-mutation; og/eller (c) lentivirusvektorgenomet er et ikke-integrerende lentivirusgenom; og/eller (d) pakningscellen er stabilt transformeret med (ii) og (iii); og/eller (e) pakningscellen er transficeret med (i) og (iv).
13. Isoleret nukleinsyremolekyle, der omfatter en nukleotidsekvens, der koder for E2-glycoproteinet eller varianten ifølge krav 1 (a) (i) eller et hvilket som helst af kravene 2-9.
14. Nukleinsyremolekyle ifølge krav 13, hvor proteinet er et Sindbis E3/E2/6K/El-polyprotein, der er processeret, således at E2-proteinet ikke er en del af et fusionsprotein med E3, når det inkorporeres i en viruskappe.
15. Nukleinsyremolekyle ifølge krav 14, hvor E3-sekvensen svarer til (a) resterne 1-65 af SEQ ID NO: 20 eller (b) en variant deraf, der har mindst 80 % sekvensidentitet med resterne 1-65 af SEQ ID NO: 20, hvor resterne 62-65 er RSKR (SEQ ID NO: 27), og varianten er i stand til at blive inkorporeret i en pseudotype-viruskappe.
16. Fremgangsmåde til fremstilling af en lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10, som omfatter dyrkning af lentivirusvektorpakningssystemet ifølge krav 11.
17. Lentiviruspartikel ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10, hvor lentivirusvektorgenomet (a) har en inaktiveret eller selv-inaktiverende 3'-LTR (long terminal repeat); og/eller (b) omfatter et U3-element, der mangler mindst det ene af: (i) en enhancersekvens; (ii) en TATA-box; (i i i) et Spl-sted; (iv) et NK-kappa B-sted; og (v) et polypurin-spor (PPT) ; og/eller (c) omfatter nukleotidsekvensen ifølge SEQ ID NO: 21, 22 eller 23; og/eller, (d) omfatter en nukleotidsekvens, der koder for en modningsfaktor/stimulatorisk faktor fra en dendritcelle.
18. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10 til anvendelse i en fremgangsmåde til behandling af et menneske eller et dyr, der eventuelt omfatter fremføring af lentivirusvektorpartikler til dendritceller ex vivo.
19. Lentivirusvektorpartikel ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10 til anvendelse til inducering af en antigenspecifik immunrespons, eventuelt en humoral respons og/eller cellular respons.
20. Terapeutisk eller profylaktisk vaccine, der omfatter lentivirusvektorpartikler ifølge et hvilket som helst af kravene 1-9 eller sammensætning ifølge krav 10 og et farmaceutisk acceptabelt excipiens.
21. Terapeutisk eller profylaktisk vaccine ifølge krav 20, der yderligere omfatter en adjuvans.
22. Terapeutisk eller profylaktisk vaccine ifølge krav 21, hvor adjuvansen er en adjuvans med formel (I):
(i) hvor Δ1 og A2 er udvalgt uafhængigt fra gruppen, der består af hydrogen, phosphat og phosphatsalte, og delene R1, R2, R3, R4, R5 og R6 er udvalgt uafhængigt fra gruppen af hydrocarbyl med 3 til 23 carboner som vist ved C3-C23.
23. Terapeutisk eller profylaktisk vaccine ifølge krav 22, hvor (a) A1 er phosphat eller et phosphatsalt, og A2 er hydrogen, og (b) (i) R1, R3, R5 og R6 er Cn-C2o-alkyl, og R2 og R4 er C12-C20- hydrocarbyl; eller (ii) R1, R3, R5 og R6 er Cn-alkyl, og R2 og R4 er C13- hydrocarbyl; eller (iii) R1, R3, R° og R6 er undecyl, og R2 og R4 er tridecyl.
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| US22849109P | 2009-07-24 | 2009-07-24 | |
| PCT/US2010/042870 WO2011011584A1 (en) | 2009-07-24 | 2010-07-22 | Lentiviral vectors pseudotyped with a sindbis virus envelope glycoprotein |
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| DK2456786T4 true DK2456786T4 (da) | 2017-08-07 |
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| DK10737715.2T DK2456786T4 (da) | 2009-07-24 | 2010-07-22 | Lentivirusvektorer, der er pseudotypebestemt med et kappeglycoprotein fra sindbis-virus |
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| DK13194273.2T DK2770061T3 (da) | 2009-07-24 | 2010-07-22 | Ikke-integrerende lentivirusvektorer |
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| ES2459192T3 (es) | 2006-07-21 | 2014-05-08 | California Institute Of Technology | Introducción selectiva de genes para la vacunación con células dendríticas |
| ES2657392T3 (es) | 2006-09-26 | 2018-03-05 | Infectious Disease Research Institute | Composición de vacuna que contiene un adyuvante sintético |
| WO2009035528A2 (en) | 2007-09-07 | 2009-03-19 | University Of Georgia Research Foundation, Inc. | Synthetic lipid a derivative |
| HUE036103T2 (hu) * | 2007-12-11 | 2018-06-28 | Univ North Carolina Chapel Hill | Polipurin szakaszon módosított retrovirális vektorok |
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