DK2176408T5 - NUKLEINSYRER OMFATTENDE FORMEL (NuGiXmGnNv)a OG DERIVATER DERAF SOM IMMUNSTIMULERENDE MIDLER /ADJUVANSER. - Google Patents

NUKLEINSYRER OMFATTENDE FORMEL (NuGiXmGnNv)a OG DERIVATER DERAF SOM IMMUNSTIMULERENDE MIDLER /ADJUVANSER. Download PDF

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DK2176408T5
DK2176408T5 DK09705604.8T DK09705604T DK2176408T5 DK 2176408 T5 DK2176408 T5 DK 2176408T5 DK 09705604 T DK09705604 T DK 09705604T DK 2176408 T5 DK2176408 T5 DK 2176408T5
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rna
sequence
uridine
seq
nucleotides
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DK09705604.8T
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DK2176408T3 (da
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Thomas Kramps
Jochen Probst
Ingmar Hoerr
Söhnke Voss
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Curevac Gmbh
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Claims (7)

1. RNA-molekyle bestående af eller omfattende SEQ ID nr. 117, SEQ ID nr. 118 eller SEQ ID nr. 119, som stimulerer det medfødte immunrespons ved at adressere receptorerne TLR-7, TLR-8, TLR-3, RIG-I eller MDA-5.
2. RNA-molekyler ifølge krav 1 til anvendelse som et lægemiddel.
3. Farmaceutisk sammensætning, som indeholder et RNA-molekyle ifølge krav 1, et farmaceutisk acceptabelt bærestof og eventuelt yderligere hjælpestoffer, tilsætningsstoffer og/eller adjuvanser.
4. Farmaceutisk sammensætning ifølge krav 3, yderligere omfattende mindst én farmaceutisk aktiv bestanddel fortrinsvis valgt fra gruppen bestående af peptider, proteiner, nukleinsyrer, (terapeutisk aktive) organiske eller uorganiske forbindelser med lav molekylevægt, der har en molekylvægt mindre end 5000, sukre, antigener, antistoffer, patogener, svækkede patogener, deaktiverede patogener, (humane) celler, cellulære fragmenter eller fraktioner og andre terapeutiske midler, som er fortrinsvis tilpasset til at udvise øgede transfektionsegenskaber, herunder ved kompleksdannelse med lipider og/eller poly-kationiske forbindelser, herunder polykationiske peptider.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af krav 3 eller 4, k e n d e t e g n e t ved at sammensætningen indeholder mindst ét yderligere adjuvans, som er et immunstimulerende middel, valgt fra gruppen bestående af kationiske peptider herunder polypeptider, herunder protamin, nucleolin, spermin eller spermidin, kationiske polysac-charider, herunder chitosan, TDM, MDP, muramyldipeptid, pluronics, alunopløsning, aluminiumhydroxid, ADJUMER™ (polyphosphazen); aluminiumphosphat-gel; glucaner fra alger; algammulin; aluminiumhydroxid-gel (alun); stærkt protein-adsorberende aluminiumhydro-xid-gel; aluminiumhydroxid-gel med lav viskositet; AF eller SPT (emulsion af squalan (5%), tween 80 (0,2%), pluronic L121 (1,25%), phosphatbufferet saltopløsning, pH 7,4); AVRIDINE™ (propanediamin); BAY R1005™ ((N-(2-deoxy-2-L-leucylamino-b-D-glucopyranosyl)-N-octadecyldodecanoyl-amidhydroacetat); CALCITRIOL™ (l-alfa,25-dihydroxy-vitamin D3); calciumphosfat-gel; CAPTM (calciumphosphat-nanopartikler); kole-raholotoksin, koleratoksin-Al-protein-A-D-fragment-fusionsprotein, under-enhed-B af koleratoksinet; CRL 1005 (blokcopolymer P1205); cytokin-holdige liposomer; DDA (dimethyl-dioctadecylammoniumbromid); DFIEA (dehydroepiandrosteron); DMPC (dimy-ristoylphosphatidylcholin); DMPG (dimyristoylphosphatidylglycerol); DOC/alunkompleks (desoxycholsyre-natriumsalt); Freunds komplet adjuvans; Freunds inkomplet adjuvans; gamma-inulin; Gerbu-adjuvans (blanding af: i) N-acetylglucosaminyl-(Pl-4)-N- acetylmuramyl-L-alanyl-D-glutamin (GMDP), ii) dimethyldioctadecylammoniumchlorid (DDA), iii) zink-L-prolin-saltkompleks (ZnPro-8); GM-CSF); GMDP (N-acetylglucosaminyl-(bl-4)-N-acetylmuramyl-L-alanyl-D-isoglutamin); imiquimod (l-(2-methypropyl)-lFI-imidazo[4,5-c]quinolin-4-amin); ImmTher™ (N-acetylglucosaminyl-N-acetylmuramyl-L-Ala-D-iso-Glu-L-Ala-glyceroldipalmitat); DRV'er (immunliposomer tilvejebragt fra dehydrering-rehydreringsvesikler); interferon-gamma; interleukin-l-beta; interleukin-2; interleukin-7; interleukin-12; ISCOMS™ ("Immunstimulerende komplekser"); ISCOPREP 7.0.3. ™; liposo-mer; LOXORIBINE™ (7-allyl-8-oxoguanosin (-guanin)); LT-oraladjuvans (E.coli labil entero-toksin-protoksin); mikrokugler og mi kropartikler af en hvilken som helst sammensætning; MF59™; (squalen-vand-emulsion); MONTANIDE ISA 51™ (oprenset inkomplet Freunds ad-juvans); MONTANIDE ISA 720™ (metaboliserbar olieadjuvans); MPL™ (3-Q-desacyl-4'-monophosphoryl-lipid-A); MTP-PE og MTP-PE-liposomer ((N-acetyl-L-alanyl-D-isoglutaminyl-L-alanin-2-(l,2-dipalmitoyl-sn-glycero-3-(hydroxyphosphoryloxy))ethylamid, mononatriumsalt); MURAMETIDE™ (Nac-Mur-L-Ala-D-Gln-OCH3); MURAPALMITINE™ og D-MURAPALMITINE™ (Nac-Mur-L-Thr-D-isoGIn-sn-glyceroldipalmitoyl); NAGO (neuraminida-se-galaktose-oxidase); nanokugler eller nanopartikler af en hvilken som helst sammensætning; NISV'er (ikke-ioniske surfaktantvesikler); PLEURAN™ (beta-glucan); PLGA, PGA og PLA (homo- og copolymerer af mælkesyre og glycolsyre; mikrokugler/nanokugler); PLURONIC L121™; PMMA (polymethylmethacrylat); PODDS™ (proteinoide mikrokugler); polyethylencarbamatderivater; poly-rA: poly-rU (polyadenylsyre-polyuridylsyre-kompleks); polysorbat 80 (Tween 80); protein-cochleater (Avanti Polar Lipids, Inc., Alabaster, AL); STIMULON™ (QS-21); Quil-A (Quil-A-saponin); S-28463 (4-amino-otec-dimethyl-2-ethoxymethyl-lH-imidazo[4,5-c]quinolin-l-ethanol); SAF-1™ ("Syntex-adjuvans-formulering"); Sendai-proteoliposomer og Sendai-holdige lipidmatricer; Span-85 (sorbi-tantrioleat); Specol (emulsion af Marcol 52, Span 85 og Tween 85); squalen eller Robane® (2,6,10,15,19,23-hexamethyltetracosan og 2,6,10,15,19,23-hexamethyl-2,6,10,14,18,22-tetracosahexan); stearyltyrosin (octadecyltyrosinhydrochlorid); Theramid® (N-acetylglucosaminyl-N-acetylmuramyl-L-Ala-D-isoGlu-L-Ala-dipalmitoxypropylamid); Thero-nyl-MDP (Termurtide™ eller [thr 1]-MDP; N-acetylmuramyl-L-threonyl-D-isoglutamin); Ty partikler (Ty-VLP'er eller virus-lignende partikler); Walter-Reed-liposomer (liposomer indeholdende lipid-A adsorberet på aluminiumhydroxid) og lipopeptider herunder Pam3Cys i særdeleshed aluminiumsalte såsom Adju-phos, Alhydrogel, Rehydragel, osv.; emulsioner såsom CFA, SAF, IFA, MF59, provax, titerMax, montanide, vaxfectin, osv.; copolymerer såsom optivax (CRL1005), L121, Poloxamer4010), osv.; liposomer såsom stealth, osv., cochleater, såsom BIORAL, osv.; plante afledte adjuvanser, såsom QS21, Quil A, iscomatrix, ISCOM, osv.; foretrukkne adjuvanser egnet til co-stimulering kan indbefatte f.eks. Tomatin, biopolymerer, såsom PLG, PMM, Inu-lin, osv.; mikrobe-afledte adjuvanser, såsom romurtid, DETOX, MPL, CWS, mannose, CpG7909, ISS-1018, IC31, imidazoquinoliner, ampligen, Ribi529, IMOxinc, IRIV'er, VLP'er, koleratoksin, varme-labilt toksin, Pam3Cys, Flagellin, GPI-anker, LNFPIII/Lewis X, antimi-krobielle peptider, UC-1V150, RSV-fusionsprotein, cdiGMP, osv.; foretrukne adjuvanser egnede som antagonister kan f.eks. indbefatte CGRP-neuropeptid, eller fra kationiske eller polykationiske forbindelser, som er egnede til depot og levering herunder protamin, nucleolin, spermin eller spermidin, eller andre kationiske peptider eller proteiner herunder poly-L-lysin (PLL), poly-arginin, basiske polypeptider, cellepenet-rerende peptider (CPP'er), herunder HIV-bindende peptider, Tat, HIV-1 Tat (HIV), Tat- afledte peptider, Penetratin, VP22-afledte eller -analoge peptider, HSV VP22 (herpes simplex), MAP, KALA eller proteintransduktionsdomæner (PTD'er, PpT620, prolin-rige peptider, arginin-rige peptider, lysin-rige peptider, MPGpeptid(er), Pep-1, L-oligomerer, Calci-toninpeptid(er), antennapedia-afledte peptider (særligt fra Drosophila antennapedia), pAntp, plsl; FGF, Lactoferrin, Transportan, Buforin-2, Bac715-24, SynB, SynB(l), pVEC, hCT-afledte peptider, SAP, protamin, spermin, spermidin eller histoner. Yderligere, foretrukne kationiske eller polykationiske proteiner eller peptider kan vælges blandt følgende proteiner eller peptider, der har den følgende samlede formel: (Arg)i;(Lys)m;(FHs)n;(Om)0;(Xaa)x, hvor l + m + n + o + x = 8-15, og I, m, n eller o uafhængigt af hinanden kan være et hvilket som helst tal valgt blandt 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 eller 15, forudsat at det samlede indhold af Arg, Lys, His og Orn udgør mindst 50% af alle aminosyrer af oligopeptidet; og Xaa kan være en hvilken som helst aminosyre valgt blandt native (= naturligt forekommende) eller ikke-native aminosyrer undtagen Arg, Lys, His eller Om; og x kan være et hvilket som helst tal valgt blandt 0, 1, 2, 3 eller 4, forudsat, at det samlede indhold af Xaa ikke overstiger 50 % af alle aminosyrer af oligopeptidet, kationiske polysaccharider, for eksempel chitosan, polybren, kationiske polymerer herunder polyethylenimin (PEI), kationiske lipider herunder DOTMA: [1-(2,3-sioleyloxy)propyl)]-N,N,N-trimethylammoniumchlorid, DMRIE, di-C14-amidin, DOTIM, SAINT, DC-Chol, BGTC, CTAP, DOPC, DODAP, DOPE: Dioleylphosphatidylethanolamin, DOSPA, DODAB, DOIC, DMEPC, DOGS: Dioctadecylamidoglicylspermin, DIMRI: Dimyristo-oxypropyldimethylhydroxyethylammoniumbromid, DOTAP: dioleoyloxy-3- (trimethylammonlo)propan, DC-6-14: 0,0-ditetradecanoyl-N-(o- trimethylammoniacetyl)diethanolaminchlorid, CLIP1: rac-[(2,3-dioctadecyloxypropyl)(2- hydroxyethyl)]-dimethylammonlumchlorid, CLIP6: rac-[2(2,3-dihexadecyloxypropyl- oxymethyloxy)ethyl]trimethylammonium, CLIP9: rac-[2(2,3-dihexadecyloxypropyl- oxysuccinyloxy)ethyl]-trimethylammonium, oligofectamin, eller kationiske eller polykationiske polymerer, herunder modificerede polyaminosyrer, herunder β-aminosyre-polymerer eller omvendte polyamider, modificerede polyethylener, herunder PVP (poly(N-ethyl-4-vinylpyridiniumbromid)), modificerede acrylater, herunder pDMAEMA (po-ly(dimethylaminoethylmethylacrylat)), modificerede Amidoaminer, herunder pAMAM (po-ly(amidoamin)), modificerede polybetaaminoester (PBAE), herunder diamin-slut modificerede l,4-butanedioldiacrylate-co-5-amino-l-pentanol-polymerer, dendrimerer, herunder polypropylamindendrimerer eller pAMAM baserede dendrimerer, polyimin(er), herunder PEI: poly(ethyleneimin), poly(propyleneimin), polyallylamin, sukkerskelet-baserede polymerer, herunder cyclodextrin baserede polymerer, dextran-baserede polymerer, Chitosan, silanskelet-baserede polymerer, omfatter PMOXA-PDMS-copolymerer, blokpolymerer bestående af en kombination af én eller flere kationiske blokke (herunder valg af en kationisk polymer som nævnt ovenfor) og af én eller flere hydrofile eller hydrofobiske blokke (f.eks. polyethylenglycol); eller kan være valgt blandt nukleinsyrer ifølge formel (IV: G|XmGn, hvor: G er guano- sin, uridin eller en analog af guanosin eller uridin; X er guanosin, uridin, adenosin, thymi-din, cytidin eller en analog af de ovennævnte nukleotider; I er et heltal fra 1 til 40, hvor, når I = 1 er G guanosin eller en analog deraf, når I > 1, er mindst 50% af nukleotiderne guanosin eller en analog deraf; m er et heltal og er mindst 3; hvor, når m = 3, er X uridin eller en analog deraf, når m > 3 forekommer mindst 3 efterfølgende uridiner eller analoger af uridin; n er et heltal fra 1 til 40, hvor, når n =1, er G guanosin eller en analog deraf, når n > 1 er mindst 50% af nukleotiderne guanosin eller en analog deraf; eller fra nukleinsyrer ifølge formel (V): C|XmCn, hvor: C er cytidin, uridin eller en analog af cytidin eller uridin; X er guanosin, uridin, adenosin, thymidin, cytidin eller en analog af de ovennævnte nukleotider; I er et heltal fra 1 til 40, hvor, når I = 1, er C cytidin eller en analog deraf, når I > 1, er mindst 50% af nukleotiderne cytidin eller en analog deraf; m er et heltal og er mindst 3; hvor, når m = 3, er X uridin eller en analog deraf, når m > 3, forekommer mindst 3 efterfølgende uridiner eller analoger af uridin; n er et heltal fra 1 til 40, hvor, når n = 1, er C cytidin eller en analog deraf, når n > 1, er mindst 50% af nukleotiderne cytidin eller en analog deraf.
6. Lægemiddelsammensætning ifølge et hvilket som helst af krav 3 til 5, k e n d e t e g n e t ved, at lægemiddelsammensætningen er en vaccine.
7. RNA-molekyle ifølge krav 1 til anvendelse i behandlingen af cancersygdomme, autoimmune sygdomme, allergier eller infektionssygdomme, hvor cancersygdommene er fortrinsvis valgt blandt colonkarcinomer, melanomer, ny-rekarcinomer, lymfomer, akut myeloid leukæmi (AML), akut lymfatisk leukæmi (ALL), kronisk myeloid leukæmi (CML), kronisk lymfatisk leukæmi (CLL), gastrointestinale tumorer, pulmonale karcinomer, gliomer, skjoldbruskkirteltumorer, brystkarcinomer, prostatatumo-rer, hepatomer, forskellige virus-inducerede tumorer såsom, for eksempel, papilloma-virus-inducerede karcinomer (f.eks. cervixkarcinom), adenokarcinomer, herpes-virus-inducerede tumorer (f.eks. Burkitts lymfom, EBV-induceret B-celle-lymfom), heptatitis-B-inducerede tumorer (hepatocellulært karcinom), HTLV-1- og HTLV-2-inducerede lymfomer, akustiske neuromer/neurinomer, cervixcancer, lungecancer, svælgcancer, anale karcinomer, glioblastomer, lymfomer, rektale karcinomer, astrocytomer, hjernetumorer, mave-cancer, retinoblastomer, basaliomer, hjernemetastaser, medulloblastomer, vaginal cancer, pankreascancer, testikelcancer, melanomer, thyroidale karcinomer, blærecancer, Hodgkins syndrom, meningiomer, Schneeberger-sygdom, bronkiale karcinomaer, hypofysetumor, mycosis fungoides, øsofaguscancer, brystcancer, karcinoider, neurinomer, spinaliomer, Burkitts lymfomer, larynxcancer, nyrecancer, tymomer, korpuskarcinomer, knoglecancer, Non-Hodgkins lymfomer, urethral cancer, CUP-syndrom, hoved-/nakketumorer, oligo-dendrogliomer, vulvacancer, intestinal cancer, colonkarcinomer, øsofaguskarcinomer, vorte involvering, tyndtarmstumorer, kraniofaryngeomer, ovariekarcinomer, blødvævs tumo-rer/sarkomer, ovariecancer, levercancer, pancreatiske karcinomer, cervikale karcinomer, endometriekarcinomer, levermetastaser, peniscancer, tungecancer, galdeblærecancer, leukæmi, plasmocytomer, uteruscancer, øjenlågstumor og prostata-cancer, og hvor infektionssygdommene er fortrinsvis valgt blandt influenza, malaria, SARS, gul feber, AIDS, Lyme borreliose , leishmaniasis, miltbrand, meningitis, virale infektionssygdomme såsom AIDS, Condyloma acuminata, hudvorter med fordybning, denguefeber, tredagsfeber, ebolavirus, forkølelse, tidlig-sommer-meningoencephalitis (FSME), influenza, helvedesild, hepatitis, herpes simplex type I, herpes simplex type II, herpes zoster, influenza, Japansk encephalitis, Lassafeber, Marburg-virus, mæslinger, fod- og mundsygdom, mononukleose, fåresyge, mavetarminfektion, kyssesyge, kopper, polio (børnelammelse), falsk krupp, den femte sygdom, rabies, hudvorter, vestnilfeber, skoldkopper, cytomegalovirus (CMV), blandt bakterielle infektionssygdomme såsom spontan abort (prostatainflam-mation), miltbrand, blindtarmsbetændelse, borreliose, botulisme, Campylobacter, Chlamydia trachomatis (inflammation af urinrøret, conjunctivitis), kolera, difteri, donavanosis, epiglottitis, tyfusfeber, gasgangræn, gonoré, tularæmi, Helicobacter pylori, kighoste, lym-fogranuloma venereum, osteomyelitis, legionærsygdom, spedalskhed, listeriose, pneumoni, meningitis, bakteriel meningitis, miltbrand, otitis media, Mycoplasma hominis, neonatal sepsis (chorioamnionitis), noma, paratyfus, pest, Reiters syndrom, Rocky-Mountain-plettet-feber (RMSF), Salmonella paratyfus, Salmonella tyfus, skarlagensfeber, syfilis, stivkrampe, gonoré, tsutsugamushi-sygdom, tuberkulose, tyfus, vaginitis (kolpitis), blød chan-ker og fra infektionssygdomme forårsaget af parasiter, protozoer eller svampe, såsom amøbiasis, bilharziose, Chagas' sygdom, tinea pedis, gærsvamp i huden, fnat, malaria, onchocercosis (flodblindhed), eller svampesygdomme, toxoplasmose, trichomoniasis, trypanosomiasis (sovesyge), visceral leishmaniasis, bledermatitis, schistosomiasis, fiskeforgiftning (ciguatera), candidiasis, kutan leishmaniasis, lambliasis (giardiasis) eller sovesyge eller fra infektionssygdomme forårsaget af Echinococcus, fiskebændelorm, rævens lille bændelorm, bændelorm hos hunde , lus, bændelorm hos kvæg, bændelorm hos svin og dværgbændelorm, og hvor de autoimmune sygdomme er fortrinsvis valgt fra gruppen bestående af type I-autoimmune-sygdomme eller type II-autoimmune-sygdomme eller type III-autoimmune-sygdomme eller type IV-autoimmune-sygdomme, såsom, for eksempel, multipel sklerose (MS), rheumatoid arthrit, diabetes, type I-diabetes (Diabetes mellitus), systemisk lupus erythematosus (SLE), kronisk polyarthritis, Basedows sygdom, autoimmune former af kronisk hepatitis, colitis ulcerosa, type I-allergisygdomme, type-II-allergisygdomme, type-III-allergisygdomme, type-IV-allergisygdomme, fibromyalgi, hårtab, Bechterews sygdom, Crohns sygdom, myasthenia gravis, neurodermitis, polymyalgia rheumatica, progressiv systemisk sklerose (PSS), psoriasis, Reiters syndrom, rheumatisk arthrit, psoriasis, vasculitis, osv., eller type II-diabetes, og hvor allergierne er fortrinsvis valgt fra gruppen bestående af allergisk astma (som fører til hævelse af de nasale slimhinder), allergisk conjunctivitis (som fører til rødme og kløe af bindehinden), allergisk rhinitis ("høfeber"), anafylaksi, angioødem, atopisk dermatitis (eksem), urticaria (nældefeber), eosinofili, respiratorisk allergi, allergier over for insektstik, hudallergier (som fører til og omfatter diverse udslæt, såsom eksem, nældefeber (urticaria) og (kontakt-) dermatitis), fødemiddelallergier og allergier over for lægemidler.
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