(12) Translation of european patent specification

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1 (12) Translation of european patent specification (11) NO/EP B1 (19) NO NORWAY (1) Int Cl. C12N 1/09 (06.01) A61K 39/39 (06.01) C12N 1/11 (06.01) Norwegian Industrial Property Office (21) Translation Published (80) Date of The European Patent Office Publication of the Granted Patent (86) European Application Nr (86) European Filing Date (87) The European Application s Publication Date () Priority , EP, (84) Designated Contracting States: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK TR (73) Proprietor Curevac GmbH, Paul-Ehrlich-Str. 1, 776 Tübingen, DE-Tyskland (72) Inventor KRAMPS, Thomas, Ebertstrasse 1, 772 Tübingen, DE-Tyskland VOSS, Söhnke, Savoyer Weg 12, 6911 Neckarsmünd, DE-Tyskland PROBST, Jochen, Kirchhofländern 19, Wolfschlugen, DE-Tyskland HOERR, Ingmar, Charlottenstrasse 16, 770 Tübingen, DE-Tyskland (74) Agent or Attorney Onsagers AS, Postboks 1813 Vika, 0123 OSLO, Norge (4) Title NUCLEIC ACIDS COMPRISING FORMULA (NuGiXmGnNv)a AND DERIVATIVES THEREOF AS AN IMMUNOSTIMULATING AGENTS /ADJUVANTS (6) References Cited: WO-A1-07/013 WO-A1-07/1247 WO-A2-0/ WO-A2-08/ PARKINSON JOHN ET AL: "A transcriptomic analysis of the phylum Nematoda" NATURE GENETICS, vol. 36, no. 12, December 04 (04-12), pages , XP & DATABASE CAPLUS CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; "Brugia malayi strain TRS Labs clone RRAMCA137 EST" retrieved from CAPLUS accession no BLAXTER MARK ET AL: "The Brugia malayi genome project: expressed sequence tags and gene discovery" TRANSACTIONS OF THE ROYAL SOCIETY OF TROPICAL MEDICINE AND HYGIENE, vol. 96, no. 1, 02, pages 1-17, XP & DATABASE EMBL "Brugia malayi strain TRS Labs clone PRAMCA137 EST" retrieved from EMBL accession no. AA481 DATABASE EMBL [Online] 11 February 0 ( ), "PST127-NR MICB1 Mus musculus genomic clone PST127-NR" XP retrieved from EBI Database accession no. CZ DATABASE EMBL [Online] 22 January 0 ( ), "Arabidopsis thaliana clone RAFL22-17-C17 EST" XP retrieved from EBI Database accession no. BP83669 DATABASE EMBL 2 April 0 (0-04-2), WISTOW G.: "NEIBank analysis of Dog lens" XP retrieved from EBI Database accession no. DN HELL F ET AL: "Species-specific recognition of single-stranded RNA via Toll-like receptor 7 and

2 8" SCIENCE, vol. 3, March 04 ( ), pages , XP AMERICAN ASSOCIATION FORTHE ADVANCEMENT OF SCIENCE, WASHINGTON, DC, US ISSN:

3 Enclosed is a translation of the patent claims in Norwegian. Please note that as per the Norwegian Patents Acts, section 66i the patent will receive protection in Norway only as far as there is agreement between the translation and the language of the application/patent granted at the EPO. In matters concerning the validity of the patent, language of the application/patent granted at the EPO will be used as the basis for the decision. The patent documents published by the EPO are available through Espacenet (http://worldwide.espacenet.com) or via the search engine on our website here: https://search.patentstyret.no/ NO/EP21768

4 1 PATENTKRAV 1. RNA-molekyl bestående av eller omfattende SEQ ID nr. 117, SEQ ID nr. 118 eller SEQ ID nr. 119 som stimulerer den iboende immunresponsen ved å adressere reseptorene TLR-7, TLR-8, TLR-3, RIG-1 eller MDA-. 2. RNA-molekyl ifølge krav 1, for anvendelse som et medikament Farmasøytisk sammensetning inneholdende et RNA-molekyl ifølge krav 1, en farmasøytisk akseptabel bærer og eventuelt ytterligere hjelpestoffer, tilsetningsstoffer og/eller adjuvanser. 4. Farmasøytisk sammensetning ifølge krav 3, ytterligere omfattende minst én farmasøytisk aktiv komponent som fortrinnsvis er valgt fra gruppen som består av peptider, proteiner, nukleinsyrer (terapeutisk aktive) organiske og uorganiske lavmolekylvektforbindelser som har en molekylvekt som er lavere enn 000, sukkertyper, antigener, antistoffer, patogener, attenuerte patogener, deaktiverte patogener, (humane) celler, cellulære fragmenter eller fraksjoner og andre terapeutiske midler, som fortrinnsvis er tilpasset å oppvise forsterkede transfeksjonsegenskaper, inkludert ved kompleksdannelse med lipider og/eller polykationiske forbindelser, inkludert polykationiske peptider.. Farmasøytisk sammensetning ifølge ethvert av kravene 3 eller 4, karakterisert ved at sammensetningen inneholder minst én ytterligere adjuvans, som er et immunstimulerende middel, valgt fra gruppen som består av kationiske peptider, inkludert polypeptider som inkluderer protamin, nukleolin, spermin eller spermidin, kationiske polysakkarider, inkludert kitosan, TDM, MDP, muramyldipeptid, pluronics, alum-løsning, aluminiumhydroksid, ADJUMER (polyfosfasen), aluminiumfosfatgel, glukaner fra alger, algammulin, aluminiumhydroksidgel (alum), svært proteinadsorberende aluminiumhydroksidgel, lav-viskositets aluminiumhydroksidgel, AF eller SPT (emulsjon av squalan ( %), Tween 80 (0,2 %), Pluronic L121 (1,2 %), fosfatbuffret saltløsning, ph 7,4), AVRIDINE (propandiamin), BAY R0 ((N (2-deoksy-2-L-leucylamin-b- D-glukopyrasonyl)-N-oktadecyldodekanoyl-amid-hydroacetat), CALCITRIOL (1- alfa,2-dihydroksy-vitamin D3), kalsiumfosfatgel, CAPTM (kalsiumfosfatnanopartikler), kolera-holotoksin, koleratoksin-a1-protein-a-dfragmentfusjonsprotein, subenhet B av koleratoksinet, CRL 0 (blokk-kopolymer P1), cytokininneholdende liposomer, DDA (dimetyldioktadecylammoniumbromid), DHEA (dehydroepiandrosteron), DMPC (dimyristoylfosfatidylkolin), DMPG (dimyristoylfosfatidylglyserol), DOC/alum-

5 kompleks (deoksykolsyrenatriumsalt), Freunds komplette adjuvans, Frunds ukomplette adjuvans, gamma-inulin, Gerbu-adjuvans (blanding av: i) N- acetylglukosaminyl-(p1-4)-n-acetylmuramyl-l-alanyl-d-glutamin (GMDP), ii) dimetyldioktadecylammoniumklorid (DDA), iii) sink-l-prolinsaltkompleks (ZnPro- 8), GM-CSF), GMDP (N-acetylglukosaminyl-(b1-4)-acetylmuramyl-L-alanyl-Disoglutamin), imiquimod (1-(2-metylpropyl)-1H-imidazo[4,-c]-quionolin-4-amin), ImmTher (N-acetylglukosaminyl-N-acetylmuramyl-Ala-D-isoGlu-L-Alaglyseroldipalmitat), DRVs (immunliposomer fremstilt fra dehydrering-rehydrerings vesikler), interferon-gamma, interleukin-1beta, interleukin-2, interleukin-7, interleukin-12, ISCOMS (immunsimulerende komplekser), ISCOPREP 7.0.3, liposomer, LOXORIBINE (7-allyl-8-oksoguanosin (guanin)), LT oral adjuvans (E.coli labilt enterotoksin-protoksin), mikrokuler og mikropartikler av enhver sammensetning, MF9, (squalen-vann-emulsjon), MONTANIDE ISA 1 (renset ukomplett Freunds adjuvans), MONTANIDE ISA 7 (metaboliserbar olje-adjuvans), MPL (3-Q-desacyl-4 -monofosforyl-lipid A), MTP-PE og MTP- PE-liposomer ((N-acetyl-L-alanyl-D-isoglutaminyl L-alanin-2-(1,2-dipalmitoylsn-glysero-3-(hydroksyfosforyloksy))etylamid, mononatriumsalt), MURA- METIDE (Nac-Mur-L-Ala-D-Gln-OCH 3 ), MURAPALMITINE og D- MURAPALMITINE (Nac-Mur-L-Thr-D-iso-Gln-sn-glyserodipalmitoyl), NAGO (neuraminidase-galaktoseoksidase), nanokuler eller nanopartikler av enhver sammensetning, NISV er (ikke-ioniske surfaktantvesikler), PLEURAN (betaglukan), PLGA, PGA og PLA (homo- og ko-polymerer av melkesyre og glykolsyre, mikrokuler/nanokuler), PLURONIC L121, PMMA (polymetylmetakrylat), PODDS (proteinoid-mikrokuler), polyetylenkarbamatderivater, poly-ra: poly-ru (polyadenylsyre-polyuridylsyre-kompleks), polysorbat 80 (Tween 80), poteinkokleater (Avanti Polar Lipids, Inc., Alabaster, AL), STIMULON (QS-21), Quil- A (QuilA-saponin), S (4-amino-otec-dimetyl-2-etoksymetyl-1H-imidazo[4,- c]quinolin-1-etanol), SAF-1 (Syntex-adjuvansformulering), Sendaiproteoliposomer og Sendai-inneholdende lipidmatriser, Span-8 (sorbitantrioleat), Specol (emulsjon av Marcol 2, Span 8 og Tween 8), squalen eller Roban (2,6,,1,19,23-heksametyltetrakosan og 2,6,,1,19,23-heksametyl- 2,6,,14,18,22-tetrakosahekasan), stearyltyrosin (oktadecyltyrosin-hydroklorid), Theramid (N-acetylglukosaminyl-N-acetylmuramyl-L-Ala-D-isoGlu-L-Aladipalmitoksypropylamid), Theronyl-MDP (Temrirutid eller [thr 1]-MDP, N- acetylmuramyl-l-treonyl-d-isoglutamin), Ty-partikler (Ty-VLP er eller virusliknende partikler), Walter-Reed-liposomer (liposomer inneholdende lipid A adsorbert på aluminiumhydroksid) og lipopeptider, inkludert Pam3Cys, spesielt aluminiumsalter slik som Afju-phos, Alhydrogel, Rehydragel osv., emulsjoner slik som CFA, SAF, IFA, MF9, Provax, TiterMax, Montanide, Vaxfectin osv., kopolymerer slik som Optivax (CRL0), L121, Poloxamer) osv., liposomer slik som Stealth osv., kokleater slik som BIORAL osv., planteavledede derivater slik som QS21, Quil A, Iscomatrix, ISCOM osv., foretrukne adjuvanser som er

6 hensiktsmessige til ko-stimulering kan f.eks. inkludere Tomatin, biopolymerer slik som PLG, PMM, Inulin osv., mikrobeavledede adjuvanser slik som Romurtid, DETOX, MPL, CWS, mannose, CpG7909, ISS-18, IC31, Imidazoquinoliner, Ampligen, Kibi29, IMOxinc, IRIV er, VLP er, koleratoksin, varmelabilt toksin, Pam3Cys, Flagellin, GPI-anker, LNFPIII/Lewis X, antimikrobe-peptider, UC- 1V, RSV-fusjonsprotein, cdigmp osv., foretrukne adjuvanser som er hensiktsmessige som antagonister kan f.eks. inkludere CGRP-neuropeptider, eller fra kationiske eller polykationiske forbindelser som er hensiktsmessige som depot og levering, inkludert protamin, nukleolin, spermin eller spermidin, eller andre kationiske peptider eller proteiner, inkludert poly-l-lysin (PLL), poly-arginin, basiske polypeptider, cellepenetrerende peptider (CPP er) inkludert HIV-bindende peptider, Tat, HIV-1 Tat (HIV), Tat-avledede peptider, Penetratin, VP22-avledede eller analoge peptider, HSV VP22 (Herpes simplex), MAP, KALA eller proteintransduksjonsdomener (PTD er. PpT6, prolinrike peptider, argininrike peptider, lysinrike peptider, MPG-peptid(er), Pep-1, L-oligomerer, kalsitoninpeptid(er), Antennapedia-avledede peptider (spesielt fra Drosophila antennapedia), pantp, plsl, FGF, laktoferrin, transportan, buforin-2, Bac71-24, SynB, SynB(1), pvec, hct-avledede peptider, SAP, protamin, spermin, spermidin eller histoner, ytterligere, foretrukne kationiske eller polykationiske proteiner eller peptider kan bli valgt fra de følgende proteinene eller peptidene som har den følgende totalformelen: (Arg) ;(Lys) m ;(His) n ;(Orn) o ;(Xaa) x, der l+m+n+o+x = 8-1, og l, m, n eller o uavhengig av hverandre kan være ethvert tall valgt fra 0, 1, 2, 3, 4,, 6, 7, 8, 9,, 11, 12, 13, 14 eller 1, gitt at det totale innholdet av Arg, Lys, His og Orn representerer minst 0 % av alle aminosyrer i oligopeptidet, og Xaa kan være enhver aminosyre valgt fra native (= naturlig forekommende) eller ikke-native aminosyrer bortsett fra Arg, Lys, His eller Orn, og x kan være ethvert tall valgt fra 0, 1, 2, 3 eller 4, gitt at det totale innholdet av Xaa ikke overskrider 0 % av alle aminosyrene i oligopeptidet, kationiske polysakkarider, f.eks. kitosan, polybren, kationiske polymerer, inkludert polyetylenimin (PEI), kationiske lipider, inkludert DOTMA: [1-(2,3-sioleyloksy)propyl)]-N,N,N-trimetylammoniumklorid, DMRIE, di-c14-amidin, DOTIM, SAINT, DC-Chol, BGTC, CTAP, DOPC, DODAP, DOPE: dioleyl-fosfatidyletanolamin, DOSPA, DODAB, DOIC, DMEPC, DOGS: dioktadecylamidoglicylspermin, DIMRI: dimyristo-oksypropyl-dimetylhydroksyetylammoniumbromid, DOTAP: dioleoyloksy-3-(trimetylammonlo)propan, DC-6-14: O,O-ditetradekanoyl-N-(α-trimetylammoniacetyl)dietanolaminklorid, CLIP1: rac-[(2,3- dioktadecyloksypropyl)(2-hydroksyetyl)]-dimetylammoniumklorid, CLIP6: rac-[2(2,3- diheksadecyloksypropyl-oksymetyloksy)etyl]trimetylammonium, CLIP9: rac-[2(2,3- diheksadecyloksypropyl-oksysuksinyloksy)etyl]-trimetylammonium, oligofektamin, eller kationiske eller polykationiske polymerer, inkludert modifiserte polyaminosyrer, inkludert β-aminosyrepolymerer eller reverserte polyamider, modifiserte polyetylener, inkludert PVP (poly(n-etyl-4-vinylpyridiniumbromid)), modifiserte akrylater, inkludert pdmaema (poly(dimetylaminoetyl-metakrylat)), modifiserte amidoaminer inkludert pamam (poly(amidoamin)), modifisert polybeta-aminoester (PBAE), inkludert diaminendemodifisert 1,4-butandiol-diakrylat-ko--amino-1-pentanolpolymerer, dendrimerer, inkludert polypropylamin-dendrimerer eller pamam-baserte dendrimerer, polyimin(er),

7 inkludert PEI:poly(etylenimin), poly(propylenimin), polyallylamin, sukkerryggradsbaserte polymerer, inkludert syklodekstrinbaserte polymerer, dekstranbaserte polymerer, kitosan, silan-ryggradsbaserte polymerer, inkludert PMOXA-PDMS-kopolymerer, blokkpolymerer bestående av en kombinasjon av én eller flere kationiske blokker (inkludert valgte kationiske polymerer som nevnt ovenfor) og av én eller flere hydrofile eller hydrofobe blokker (f.eks. polyetylenglykol), eller kan bli valgt fra nukleinsyrer med formel (IV: G X m G n, der G er guanosin, uridin eller en analog av guanosin eller uridin, X er guanosin, uridin, adenosin, tymidin, cytidin eller en analog av de ovenfor nevnte nukleotidene, I er et heltall fra 1 til, der det er slik at når I=1så er G guanosin eller en analog derav, når I > 1 så er minst 0 % av nukleotidene guanosin eller en analog derav, m er et heltall og er minst 3, der det er slik at når m = 3 så er X uridin eller en analog derav, når m 3 så forekommer minst 3 suksessive uridiner eller analoger av uridin, n er et heltall fra 1 til, der det er slik at når n = 1 så er G guanosin eller en analog derav, når n > 1 så er minst 0 % av nukleotidene guanosin eller en analog derav, eller fra nukleinsyrer med formel (V): C X m C n, der; C er cytidin, uridin eller en analog av cytidin eller uridin, X er guanosin, uridin, adenosin, tymidin, cytidin eller en analog av de ovenfor nevnte nukleotidene, I er et heltall fra 1 til, der det er slik at når I = 1 så er C cytidin eller en analog derav, når I > 1 så er minst 0 % av nukleotidene cytidin eller en analog derav, m er et heltall og er minst 3, der det er slik at når m = 3 så er X uridin eller en analog derav, når m > 3 så forekommer minst 3 suksessive uridiner eller analoger av uridin, n er et heltall fra 1 til, der det er slik at når n = 1 så er C cytidin eller en analog derav, når n > 1 så er minst 0 % av nukleotidene cytidin eller en analog derav. 6. Farmasøytisk sammensetning ifølge ethvert av kravene 3 til, karakterisert ved at den farmasøytiske sammensetningen er en vaksine. 7. RNA-molekyl ifølge krav 1 for anvendelse i behandlingen av kreftsykdommer, autoimmunsykdommer, allergier eller smittsomme sykdommer, der kreftsykdommene fortrinnsvis er valgt fra kolonkarsinomer, melanomer, nyrekarsinomer, lymfomer, akutt myeloid leukemi (AML), akutt lymfoid leukemi (ALL), kronisk myeloid leukemi (CML), kronisk lymfocyttleukemi (CLL), gastrointestinaltumorer, pulmonale karsinomer, gliomer, tyroidtumorer, brystkarsinomer, prostatatumorer, hepatomer, ulike virusinduserte tumorer slik som f.eks. papillomvirus-induserte karsinomer (f.eks. livmorhalskarsinom), adenokarsinomer, herpes virus-induserte tumorer (f.eks. Burkitts lymfom, EBV-indusert B-cellelymfom), hepatitt B-induserte tumorer (hepatocellekarsinom), HTLV-1- og HTLV-2-induserte lymfomer, akustiske neuro-mas/neurinomer, livmorhalskreft, farynks-kreft, anal-karsinomer, glioblastomer, lymfomer, rektalkarsinomer, astrocytomer, hjernetumorer, magekreft, retinoblastomer, basaliomer, hjernemetastaser, medulloblastomer, vaginalkreft, pankreaskreft, testikkelkreft, melanomer, skjoldbruskkjertel-karsinomer, blærekreft, Hodgkins syndrom, meningiomer, Schneebergers sykdom, bronkiekarsinomer, hypofysetumor, Mycosis fungoides, øsofagkreft, brystkreft, karsinoider, neurinomer, spinaliomer, Burkitts lymfomer, larynkskreft, nyrekreft, tymomer, corpus-karsinomer, beinkreft, non-hodkins lymfomer, uretralkreft, CUP-syndrom, hode(nakke-tumorer, oligodendrogliomer, vulvakreft,

8 tarmkreft, kolonkarsinomer, øsofaus-karsinumer, vorteinvolvering, tumorer i tynntarmen, kraniefaryngeomer, ovariekarsinomer, bløtvevstumorer/sarkomer, ovariekreft, leverkreft, pankreaskarsinomer, livmorhalskarsinomer, endometriekarsinomer, levermetastaser, peniskreft, tungekreft, galleblærekreft, leukemi, plasmocytomer, livmorkreft, lid-tumor og prostatakreft, og der de smittsomme sykdommene fortrinnsvis er valgt fra influensa, malarie, SARS, gul feber, AIDS, Lyme borreliose, Leishmaniasis, antrax, meningitt, smittsomme virussykdommer slik som AIDS, Condyloma acuminata, hule vorter, Dengue-feber, tredagers feber, Ebola-virus, forkjølelse, tidlig sommer meningoencefalitt (FSME), influensa, helvetesild, hepatitt, herpes simplex type I, herpes simplex tupe II, Herpes zoster, influensa, Japansk encefalitt, Lassa-feber, Marburg-virus, meslinger, munn- og klovsyke, mononukleose, kusma, Norwalk-virusinfeksjon, Pfeiffers kjertelfeber, kopper, polio (barnelammelse), falsk krupp, femte barnesykdom, rabies, vorter, West Nile feber, vannkopper, cytomegalusvirus (CMV), fra smittsomme bakteriesykdommer slik som spontanabort (prostatainflammasjon), antrax, blindtarmbetennelse, borreliose, botulisme, Campylobacter, Chlamydia trachomatis (inflammasjon i urinveiene, konjunktivitt), kolera, difteri, donovanose, epiglottider, tyfusfeber, gassgangren, gonoré, harepest, Heliobacter pylori, kikhoste, climatic bubo, osteomyelitt, legionella, spedalskhet, listeriose, lungebetennelse, meningitt, bakteriell meningitt, antrax, otitis media, Mycoplasma hominis, neonatal sepsis (Chorioamnionitt), noma, paratyfus, pest, Reiters syndrom, Rocky Mountain flekktyfus, Salmonella paratyfus, Salmonella tyfus, skarlagensfeber, syfilis, tetanus, tripper, tsutsugamushi-sykdom, tuberkulose, tyfus, vaginitt (colpitis), bløt sjanker, og fra smittsomme sykdommer forårsaket av parasitter, protozoer eller sopper, slik som amøbeinfeksjon, bilharziose, Chagas-sykdom, fotsopp, gjærsoppflekker, skabb, malaria, onchocercosis (elveblindhet), eller soppsykdommer, toksoplasmoser, trikomonasinfeksjon, trypanosomniasis (sovesyke), innvolls-leishmaniose, bleie-dermatitt, bilharzia, fiskeforgiftning (Ciguatera), candidose, kutan Leishmaniose, lambliasis (giardiasis), eller sovesyke, eller fra smittsomme sykdommer forårsaket av Echinococcus, fiskebendelorm, revebendelorm, hundebendelorm, lus, oksebendelorm, svinebendelorm, og miniaturbendelorm, og der autoimmunsykdommene fortrinnsvis er valgt fra gruppen som består av type I autoimmunsykdommer eller type II autoimmunsykdommer eller type III autoimmunsykdommer eller type IV autoimmunsykdommer, slik som f.eks. multippel sklerose (MS), reumatoid artritt, diabetes, type I diabetes (Diabetes mellitus), systemisk lupus erytematosus (SLE), kronisk polyartritt, Basedows sykdom, autoimmune former av kronisk hepatitt, colitis ulcerosa, type I allergisykdommer, type II allergisykdommer, type III allergisykdommer, type IV allergisykdommer, fibromyalgi, håravfall, Bechterews sykdom, Crohns sykdom, Myasthenia gravis, neurodermitt, Polymyalgia rheumatica, progressiv systemisk sklerose (PSS), psoriasis, Reiters syndrom, reumatisk artritt, psoriasis, vaskulitt osv., eller type II diabetes, og der allergiene fortrinnsvis er valgt fra gruppen som består av allergisk astma (som fører til svelling av slimhinnene i nesen), allergisk bindehinnekatarr (som fører til rødhet og kløe i øyets bindehinne), allergisk rinitt («høysnue»), anafylakse, angiodeina, atopisk dermatitt

9 6 (eksem), urticaria (elveblest), eosinofili, respiratorisk, allergier overfor insektstikk, hudallergier (som fører til og inkluderer ulike utslett, slik som eksem, elveblest (urticaria) og (kontakt-) dermatitt), matvareallergier og allergier overfor medisin.

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