DK2486938T3 - Vaccinesammensætning indeholdende syntetisk adjuvans - Google Patents

Vaccinesammensætning indeholdende syntetisk adjuvans Download PDF

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DK2486938T3
DK2486938T3 DK12153256.8T DK12153256T DK2486938T3 DK 2486938 T3 DK2486938 T3 DK 2486938T3 DK 12153256 T DK12153256 T DK 12153256T DK 2486938 T3 DK2486938 T3 DK 2486938T3
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antigen
gla
composition
adjuvant
virus
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Steven G Reed
Darrick Carter
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Infectious Disease Res Inst
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Claims (17)

1. Sammensætning, som omfatter en glucopyranosyl-lipid-adjuvans (GLA), og en farmaceutisk acceptabel bærer eller excipiens, til anvendelse i en fremgangsmåde til behandling eller forebyggelse af en cancer, en infektionssygdom eller en autoimmunsygdom hos en vært; hvor nævnte fremgangsmåde inkluderer at administrere til værten simultant eller sekventielt, og i en hvilken som helst rækkefølge, GLA og et antigen, der er afledt fra, eller er immunologisk krydsreaktivt med, (i) mindst en epitop, biomolekyle, celle eller væv, der er associeret med en cancer, (ii) mindst et infektiøst patogen, der er associeret med en infektionssygdom eller (iii) mindst en epitop, biomolekyle, celle eller væv, der er associeret med en autoimmunsygdom; hvor GLA’en har formlen:
hvor: R1, R3, R5 og R6 er lig med undecyl, og R2 og R4 er lig med tridecyl.
2. Sammensætningen til anvendelse ifølge krav 1, hvor administreringen er separeret rumligt eller tidsmæssigt.
3. Sammensætningen til anvendelse ifølge krav 2, hvor administreringen er simultan, men separeret rumligt.
4. Sammensætningen til anvendelse ifølge krav 2, hvor administreringen er separeret tidsmæssigt.
5. Sammensætningen til anvendelse ifølge krav 1, hvor antigenet er tilvejebragt i formen af et rekombinant ekspressionskonstrukt, der koder for et polypeptid-antigen af interesse.
6. Sammensætningen til anvendelse ifølge krav 5, hvor det rekombinante ekspressionskonstrukt er til stede i en virusvektor.
7. Sammensætningen til anvendelse ifølge krav 6, hvor nævnte vektor er en adenovirus-, adeno-associeret virus-, herpesvirus-, lentivirus-, koppevirus- eller retrovirus-vektor.
8. Sammensætningen til anvendelse ifølge krav 1, hvor canceren er livmoderhalskræft, kræft i æggestokkene, brystcancer, prostatacancer, fibrosarkom, myxosarkom, liposarkom, chondrosarkom, osteogent sarkom, chordom, angiosarkom, endotheliosarkom, lymphangiosarkom, pseudomyxom petitonei, lymphangioendotheliosarkom, synoviom, mesotheliom, Ewings tumor, leiomyosarkom, rhabdomyosarkom, kolonkarcinom, kræft i bugspytkirtlen, pladeepithelkarcinom, basalcellekarcinom, adenokarcinom, svedkirtelkarcinom, talgkirtelkarcinom, papillomatøst karcinom, papillomatøst adenokarcinomer, cystadenokarcinom, medullært karcinom, bronchogent karcinom, nyrecellekarcinom, hepatom, galdevejkarcinom, choriokarcinom, seminom, embryokarcinom, Wilms tumor, testikeltumor, lungekarcinom, småcellet lungekarcinom, blærekarcinom, epitelkarcinom, gliom, astrocytom, medulloblastom, craniopharyngiom, ependymom, pinealom, hæmangioblastom, akustisk neurom, oliodendrogliom, meningiom, melanom, neuroblastom, retinoblastom, leukæmi, lymfom, multipel myelom, Waldenstroms makroglobulinæmie eller tungkædesygdom.
9. Sammensætningen til anvendelse ifølge krav 1, hvor antigenet er et cancerantigen valgt fra MAGE 1, 3 og MAGE 4, PRAME, BAGE, Lage (også kendt som NY Eos 1), SAGE, HAGE, eller GAGE, et tumor-associeret gangliosid, et selv-peptidhormon, et prostataantigen, Plu -1,HASH -1, HasH-2, Cripto, Criptin, tyrosinase og survivin.
10. Sammensætningen til anvendelse ifølge krav 9, hvor det tumor-associerede gangliosid er GM2 eller GM3; selv-peptidhormonet er Gonadotrophin-hormon-frigivende hormon; eller prostataantigenet er prostata-specifikt antigen (PSA), PAP, PSCA, PS MA STEAP eller Protase.
11. Sammensætningen til anvendelse ifølge krav 1, hvor nævnte antigen er fra HIV-1, human herpes-virus, cytomegalovirus, Rotavirus, Epstein Barr-virus, Varicella Zoster-Virus, en hepatitis-virus, en paramyxovirus, respiratorisk syncytialvirus, en parainfluenzavirus, mæslingevirus, fåresygevirus, human papillom virus, gul feber-virus, denguevirus, hjernebetændelsesvirus overført af mider, japansk hjernebetændelsesvirus eller influenzavirus.
12. Sammensætningen til anvendelse ifølge krav 1, hvor nævnte antigen er fra Neisseria gonorrhoea, eller N. meningitides; S. pyogenes, S. agalactiae, eller S. mutans: H. ducreyi; Moraxella cat ar r halis; Branham ella cat ar r halis; Bordet ella pertussis, B. parapertussis eller B. bronchiseptica; Mycobacterium tuberculosis, Μ. bovis, M. leprae, M. avium, M. paratuberculosis, eller M. smegmatis; Legionella pneumophila; Escherichia, coli, enterohæmoragisk E. coli, enteropatogen £ coli, Vibrio cholera; Shigella, sonnei, S. dysenteriae, eller S. flexnerii; Yersinia enterocolitica, Y. pestis, eller Y. pseudotuberculosis; Campylobacter jejuni, eller C. coli; Salmonella typhi, S. paratyphi, S. choleraesuis, eller S. enteritidis; Listeria monocytogenes; Helicobacter pylori; Pseudomonas aeruginosa; Staphylococcus aureus, eller S. epidermidis; Enterococcus, faecalis, eller £ faecium; Clostridium tetani, C. botulinum, eller C. difficile; Bacillus anthracis; Corynebacterium diphtheria; Borrelia burgdorferi, B. garinii, B. afzelii, B. andersonii, eller B. hermsii; Ehrlichia Equi; Rickettsia rickettsii; Chlamydia trachomtis, C. pneumoniae, eller C. psittaci; Leptospira interrogans; Treponema pallidum T. denticola, eller T. hyodysenteriae.
3. Sammensætningen til anvendelse ifølge krav 1, hvor nævnte antigen er fra Plasmodium spp.·, Toxoplasma spp.; Entamoeba spp.; Babesia spp.; Trypanosom spp.; Giardia spp.; Leshmania spp.; Pneumocystis spp.; Trichomonas spp.·, eller er fra en helminth i stand til at inficere et pattedyr.
14. Sammensætningen til anvendelse ifølge krav 13, hvor Plasmodium spp. er P. falciparum·, Toxoplasma spp. er T. gondi'r, Entamoeba spp. er E. histolytica; Babesia spp. er B. microti; Trypanosom spp. er T. cruzi; Giardia spp. er G. lamblia; Leshmania spp. er L. major, Pneumocystis spp. er P. carinii; eller Trichomonas spp. er T. Vaginalis.
15. Sammensætningen til anvendelse ifølge krav 1, hvor antigenet er associeret med en autoimmunsygdom valgt fra multipel sklerose, rheumatoid arthritis, Hashimoto thyroiditis, type I diabetes mellitus, autoimmun uvoretinitis, myasthenia gravis, systemisk lupus erythematosus, Graves sygdom, autoimmun hæmolytisk anæmi, autoimmun thrombocytopeni, autoimmun astma, cryoglobulinæmi, trombisk thrombocytopenisk purpura, primær biliær sklerose og perniciøs anæmi.
6. Sammensætningen til anvendelse ifølge krav 1, hvilken fremkalder i værten et TH1-type T lymphocyt-respons, et cytotoksisk T lymphocyt (CTL)-respons, et antistofrespons, et cytokin-respons, et lymfokin-respons, et kemokin-respons, eller et inflammatorisk respons.
7. Sammensætningen til anvendelse ifølge et hvilket som helst af de foregående krav, hvor individet er primet med et primingmiddel, der er valgt fra et bakterieekstrakt, en levende virus vaccine, mindst et rekombinant ekspressionskonstrukt, der omfatter en promoter funktionelt forbundet til en nukleinsyresekvens, der koder for antigenet, og en virusvektor, der omfatter en promoter funktionelt forbundet til en nukleinsyresekvens, der koder for antigenet.
8. Sammensætningen til anvendelse ifølge et hvilket som helst af de foregående krav, hvor sammensætningen yderligere omfatter (a) en toll-lignende receptor (TLR) agonist; (b) et saponin eller saponin-mimetikum; (c) en bærer der omfatter mindst en af en olie og ISCOMATRIX™; (d) en imidazoquinolin-immunresponsmodifikator; (e) en dobbelthårnål-immunmodifikator (dSLIM); eller (f) en co-adjuvans.
9. Sammensætningen til anvendelse ifølge et hvilket som helst af de foregående krav, der yderligere omfatter mindst en yderligere komponent valgt fra gruppen bestående af: (i) co-adjuvans valgt fra gruppen bestående af alun, et plantealkaloid og en detergent, hvor plantealkaloidet er valgt fratomatin og detergenten er valgt fra saponin, Polysorbat 80, Span 85 og Stearyl-tyrosin; (ii) TLR agonist valgt fra gruppen bestående af lipopolysaccharid, peptidoglycan, poly: I C, CpG, 3M003, flagellin, Leishmania-homolog af eukaryotisk ribosomal forlængelse og initieringsfaktor 4a (LeIF) og mindst et hepatitis C-antigen; (iii) imidazoquinolin-immunresponsmodifikator valgt fra gruppen bestående af resiquimod (R848), imiquimod og gardiquimod; (iv) co-adjuvans valgt fra gruppen bestående af en cytokin, en detergent, og en blok-copolymer eller bionedbrydelig polymer; og (v) en bærer valgt fra gruppen bestående af calciumphosphat, en olie-i-vand-emulsion, en vand-i-olie-emulsion, et liposom, og en mikropartikel.
20. Sammensætningen til anvendelse ifølge et hvilket som helst af de foregående krav, hvor GLA’en omfatter: (i) en diglucosamin-backbone med en reducerende terminus-glucosamin forbundet til en ikke-reducerende terminus-glucosamin igennem en ether-forbindelse mellem hexosamin-position 1 af den ikke-reducerende terminus-glucosamin og hexosamin-position 6 af den reducerende terminus-glucosamin; (ii) en O-phosphorylgruppe fastgjort til hexosamin-position 4 af den ikke-reducerende terminus-glucosamin; og (iii) op til seks fedtacylkæder; hvor en af fedtacylkæderne er fastgjort til 3-hydroxy af den reducerende terminus-glucosamin igennem en esterforbindelse, hvor en af fedtacylkæderne er fastgjort til en 2-amino af den ikke-reducerende terminus-glucosamin igennem en amidforbindelse og omfatter en tetradecanoylkæde forbundet til en alkanoylkæde på mere end 12 kulstofatomer igennem en esterforbindelse, og hvor en af fedtacylkæderne er fastgjort til 3-hydroxy af den ikke-reducerende terminus-glucosamin igennem en esterforbindelse og omfatter en tetradecanoyl kæde forbundet til en alkanoylkæde på mere end 12 kulstofatomer igennem en esterforbindelse.
21. Kit omfattende en vaccinesammensætning omfattende GLA i en eller flere beholdere, hvor GLA’en har formlen:
hvor: R1, R3, R5 og R6 er lig med undecyl, og R2 og R4 er lig med tridecyl.
22. Sammensætning, som omfatter en glucopyranosyl-lipid-adjuvans (GLA), og en farmaceutisk acceptabel bærer eller excipiens, til anvendelse i en fremgangsmåde til at inducere eller fremme et immunrespons mod et antigen hos en vært; hvor nævnte fremgangsmåde inkluderer at administrere nævnte GLA og nævnte antigen til værten simultant eller sekventielt, og i en hvilken som helst rækkefølge, og hvor nævnte antigen er afledt fra, eller er immunologisk krydsreaktivt med, (i) mindst en epitop, biomolekyle, celle eller væv, der er associeret med en cancer, (ii) mindst et infektiøst patogen, der er associeret med en infektionssygdom, eller (iii) mindst en epitop, biomolekyle, celle eller væv, der er associeret med en autoimmunsygdom; hvor GLA’en har formlen:
hvor: R1, R3, R5 og R6 er lig med undecyl, og R2 og R4 er lig med tridecyl.
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