HUE032563T2 - IL-6 elleni ellenanyagok és alkalmazásuk - Google Patents

IL-6 elleni ellenanyagok és alkalmazásuk Download PDF

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Publication number
HUE032563T2
HUE032563T2 HUE08756095A HUE08756095A HUE032563T2 HU E032563 T2 HUE032563 T2 HU E032563T2 HU E08756095 A HUE08756095 A HU E08756095A HU E08756095 A HUE08756095 A HU E08756095A HU E032563 T2 HUE032563 T2 HU E032563T2
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Hungary
Prior art keywords
antibody
cell
cells
disease
ser
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HUE08756095A
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English (en)
Inventor
Leon Garcia-Martinez
Anne Elisabeth Carvalho Jensen
Katie Olson
Ben Dutzar
Ethan Ojala
John Latham
Brian Kovacevich
Jeffrey T L Smith
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Alderbio Holdings Llc
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Application filed by Alderbio Holdings Llc filed Critical Alderbio Holdings Llc
Publication of HUE032563T2 publication Critical patent/HUE032563T2/hu

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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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Claims (3)

  1. SZA8 AOALM.I !Okik Y PONT* )K 1 ;\nîi-IL6 ellenanyag vagy ellenanyag fragment. amely tartalma* <i> egy variábilis könnyű láncot {Vü «mely tartalmaz egy CDRI polipepódeí, amely a 4. számú szekvenciának meg* téU'V ammosax, v’ek\en*oaM eh ec\ í UR' pohpepudet macisa N számú vekuuuanak megfő* lek* ammu-en áll. ce egv « íiRd poupeptmet, amely a 0 votmn vtesenesaual oergo léte uon-ov^ szekvemáábol all, és («) uuiáltMz egy steébilte nehéz láncot Αόρ, sínél?-tartalmaz egy CDRI polippildéL amely s l számú stmktebóláMk poitpépildét, amely tel. számú :^^gfnclÍp®á:m^étóó--;MiS^v s^ekvepeiiigk yt§p í jii;: sy# mű szekvenciának megfelelő anünosav szekvenciából áll, és egy CDR3 poltpepúden amely a 9. gzltnd :^eÄÄÄ megtblelö amioosáv szekvenciából áll. atel az ellenanyagunk vágy állandója kisebb, mim 50 pikomoh Bsacore-tíd nigghatarozva, 2 Az I. igénypont szerinti ellenanyag vagy ellenanyag iVagmetsse a) amely aglíkozilezett b) amely tan aie n.v egs te main: ug\ >ocgvthcoutxa dogs na g\ .»tewon ete Mos lim „ opi .. e <\y * \ es un. kerted el emel' egx b» n »m ♦ ellen nw ec' v» slum i elkm* \*<. ' λ\ - k «>» dim* &amp;$*$< itndy egy tetpgnifl etemmsag, macis egv nvui am.dunnn 11 m oneuanvagted szarrnazik, e) ameo vcv hkw' hetedik » ouu\tr seneUn n^pussz^«'«' y e mv e\s κο λ te s~ go IL-ó molekulákhoz ét cpry $ amé ly spéci tikusan kötőditek hnotin tejtilen vágy é-hoz egy olyan betegségben szenvedő hetegbeti:: abol az ILte szintek ntéptés el keekék. ahol a betegségei a következők közül választjuk ki: általános laradiság testgyakorlással nsdukált fáradtság, iákhoz kapcsolódó feudtság. gyulladásos megbetegedéshez kapcsolódé fáradtság, krimi* kos laradtsag szindróma, rákhoz kacsolódó cachexia, keringette káppolódö: cachexia, légzéssel te p^oiatuseJüSiMa, vese* *,z \ | <,s<te Mo ,. ete\ * eb tev w kd|\ te -,te- temem, reumán ane m»; szisztémás lopus erythematosus (büß), szisztémás rúnáikon idtopunas artfnttó, pszonazis, pszori&amp;tikus ardíropatú'g ypondylitss ankylopoctka. gyulladásos bclbetetoa-g (IBI», pobndglgia reumaiika. óriássejtes asteritk autoimmun ergyuüaclas, graft-versus-host betegség (GY HD) Sjogren szindróma, felnőttkorban fellépő Still betegség, osteoarthritis, oszieoporözis, s osont Hagel beiegsé··· gc mie'caea muloplcv öodgk e h nm no·'''' von souo rr o "vAäU" R x\ u xs’xsop rák. multi een tri kn a Castkman betegseg, petefészek rak. gyogyszenwriizumeia rak kemoterápiában,, rák kemoterápia toxicités, iszkemias sxlvhetegseg, aiheroszklerózis, elínzás, cukorbetegség, asztma, vkluw^ ínuitipkv -\itbeov ko,, c^ebu^r^Aok«''- bemgsee \.o., akit cos salas/ alkpiak V emu o -,. 'Jack-, nemi a a ó vnku-< b ,Α'μ u m magax v. so a Λμονχ m -,g·, kr Osakas betegséghez. kapcsolódó depresszió, trombózis, irombociíózix. akié aeisciegtetenscg, mifetlmiikiit szindróma. vetélés, krónikus prosztaíagyuíladás, |ai*.;^il&amp;#á§#s bebgi* seg. reperinxiós sérülés, transzplantatum kilökődés, madárbulnengmllmló, jànâft$$ft^dédZIéM> mótikon légzési elégtelenség szindróma CARDS), súlyos akm légzést szindróma {SARS), szépíts, szisztémás gyulladásos válasz szindróma {SIRS), egyrák, egy gyulladásos rendellenesség, egy Gratis rendeden*. ^ egy antvimmun seraldieneaseu, utlnius, cadiexta cs sótxadaxos ar.ndruma, g) amely kózv<4|pil vagy közvetve;|agcsglii|ik egy kimutatható jelöléshez vagy egy terápiás sxe?hex. b) ahol a 3 (e) pont szerűm szóban forgó khuéra ellenanyag egy hantán Fc4 tartalmaz, eukh a k<'M^oto vm sV tíad valavAhato ki kOt lgu„k IgGu IgGi, lgOs igtm IgtG igi'G ig09, IgGIO IgGl I, lgG12, IgGO, IgGi-k lgG1\ IgGbx IgGI? IgGIk, IgCjiR iá altot a szóban forgó ellenanyag megköt legalább egy oldható I.L-ó'-őb se)t%L^á:nen oipyxnllli *oi, Il öli oR, II ο II R„o ''i Wrtpievekct a\^*\ evk malomét t j) ahol a szobán forgó eljemmyagNm található Vs; vagy Y*. hmeok egy vagy több nyel IG se;t popé, sex mól s- ,mü,um *\ k) ahol a szóban forgó ellébánylg eéib fóbbéliéáík kőtésfipielitlssá! az őtóbálótÍleó&amp;: Ihez t$lí.-őR) vagy a gpl 30-hoz. !) aboi a szóban forgó ellenanyag gátolja az IL-6 ex ez IL-őR assioxoialódáxaí és· vagy a/ 0Ι,-6ό1,~6Κύφ11b komplexek termelődései, év-vagy az fL-b/IL-OR/gpl 30 multimerek termelódesÉ, nő aoi o A o loi go fogo\.v, vmaki-vf kő xauvttux k I ab „mgrn. χ le iagmeos, vagy FCab'k fragment. n) aíől a szóban forgó ellenanyag tartalmaz még egy Effektor egységet, amelyet a kös-et-kezek közül választhatunk ki: ti) egy kimutatható egység, amely lehet egy fluoreszcens festek, egy enzim, egy sznbsrtt-.it, ovo bsbimmtvi/eens anyag, eg\ radioaktiv anyag, vugs egx kmodommes/eeax am ay, vagy (g) eg\ omUoomiliN egvse^, aroeh lehet vhtptaudnt mu dm mono ogs cneto ife egy chotoxikti« smvagy «gy radioaktiv anyag, o) i|of a ^#|»m:forgô ellenanyag a tdagomzilfe egy \?agp pbfepillafe ILA s^fefsz%§® mpt^m^Ê:, MM. jl^ilpe^poo 'imwgSmßk M«tgy m iL-Mt*6R/gpip· mdümetjei biológiai hats sat p) aboi a szobán il ago dlenaovag kombik egs kneas is sags konfermaeios b o plophoz:, g) amely egy egyl&amp;aeà ellenanf^r amely. 1$|$: #%jpÀ%ïÂ^ IgpÄ, IgilP, es ozek kombinációk à Ajk I igénypont szerinti aMbtÎ.,6 ellenanyag, vagy annak ellenanyag iggmanse, amely sin,nemz eg> V* láncot es egy V« láncot es tartalmazza a 2 es i számú szekvenciának megtelek* immosäv szekvenciát a 2, es 18 számú szekvenciának megfelelő aminnsav szekvenciát á 2, éyjfe vs.vii5 -<a P- encvi ük negl elő mm v'\a \ do cm ,at a 2' es > wn s veeweneuimik metefelo *minosav szekvenciát a 20. és 18. számú sz#vegm|pak megfelelő mmnpfev fedcvdteiáb vagy m >o és 19 számú szekvenciának megfelelő a«s|iö» ^«kvenc% :vagy ezeknek egy ellenanyagig a- X , K mrs u ma e on aeeh « talmaz egy Ve latxm illetve ea\ %*« I meet es >hu » az ami-sósav szekvenciája, hogy legalább 90°o~ös vágy »i|ydbb;.g-ii^öl^4|áezekbe*.,
  2. 4. Núkfeínsgv sfekvenclfe:jpJély a^ felk Igénypontok bármelyike szerinti antl-humán il..- ó ellenanyagot, vagy annak ellenanyag íragtnens|í tartalmazza, ;1 Vektor, amely a 4 igénypont szerinti nukleinsav szekvenciát tartalmaz. b. Rekomb'máns sejt, amely az l-d igénypontok bármelyike szerinti ellenanyagot vagy iídlabpl feagfeénki expresszálja. 7 Oyógyászab vagy diagnosztikaí készítmény, amely legalább egy, az 1-3. igenypon-tok barmélylke szerimi IL~6 ellenanyagot vagy ellenanyag ilgmebsb valamltií egy gfogyáfeatilgg dlógadható hordozót tartalmaz I:, A ?.. igénypont szeri nti gyógyászai mgy dtagnosztikai készítmény, a) amely tartalmaz még legalább egy stabilizáló szert, b) amely hoblezve van, vagy pj mods eav vags tóim aoinli -o eslemnnagoí tataim*,» mneh tilalmaz t,<n ogs \ x láncot, amelynek az ammopv szekvenciája á3H,: !&amp;,. vaggb íidazárou szekvenciának felel magi es (b) tartalmaz eav V= láncot nmeivé <v \ mm ,kh szelve χ t> i 'ég' szarni ^οκ^ιν,«^m felelófep vagy egf ldfcilÂSÿâgot egy humanizált ellenanvapt vagy ypmaekódl spemáző bágmenst #; % v\ ' >geo\ λ>ο*ο'\ banned He mu cdonmtxj^ wgo album \ g l· ^muo vágy dlsgiÄilÄä veiként történő alkahnMâë cédára. It); Az I -3, |g#^)óiSöÍ Mfmtív ike szerinti eilenan\ ág vef^ e!!er»|ei fI§ntens Imfck náltnn egy gyógyír flSálIltássbao, vágy egy olyan szer efoaihtaaában. amelyet e§y kezelési eljárásban aikfdmaznafc. ri- Egy y igém yont szériáit ellenanyag vagy fmomeos te; apóm serkent történő A LA mhzÉM a lé. igénypont szeriéi;: ái| ekéi: a keadendö betegségit vágy llâplot a KóveiU-rók közöl válásijuk ki: áItaÍ|ndsstegÉSia|s, testgyakorlással ittíidillf Äadtsag. rákhoz kapcsolódé fáradtság, gyulladásos megbetegedeshez; kapcsolódó ükadtság, krónikus fáradtság szindróma, rákhoz kapcsolódó cachexia, kenogëshez kapcsolódó cachexia, iég/.exse! kapcsolatos cachexia, veséhez kapcsolódé cachexia, életkorhoz kapcsoló·' dó cnchfcia, reumás arthritis, srisztemás lupus erythematosus t$l E}; sris/tetnas fiatalkori ídiopáiás arthritis, pszorlazts. pszorkéikus itrlhropátiu, spondylitis asdxsis'»poetica, gyulladásos belbí-tegseg (IBP), poltmíalgta retmnüika, óriáxseites intends. autditnnun ergudiad&amp;s, inatVversns-host betegség íOVHD), Sjogren szindróma, felnőttkorban fellépő Süli betegesig, osxleuarthriüs, oszteojxsroris a csont Paget betegségé, oíMőíuu mmuph-x Hongéin litntemn. non-Hodgkin linubma, prosztatarák, leukémia, vescaejt rak, inultieentriimsCasriemae betegség, petefészek rák, kemoterápiában, rák kemoterápia toxicités, iszkémias sast betegség, atheroszklbróiriA :#?teág :#ök^· betegség, asztma. szkJerotns multiplex, Alzheimer kór, cerebrovasxktílàris betegség; láz, akut. taxis valasz, allergiák, anémia, gvulladas anémiáin ('krónikus betegség mtérmája), ntagas yétnyöiÉg del--ressxio, egy krónikus betegséghez kapcsolod« depresszió, trombózis, fcombocitózil* akut izlyelégté' lertseg, metabolikus szindróma, vetélés,. krónikus proszMagyuliadás, giotneruloneAtüse, kjipedenggi gyulladásos betegség, Kperftkios sérülés, íraosxglaoiápm kilökődés, madiflpllnefiza, huilé, jfe#· nyes inüuenza, felnőttkori légzési elégtelenség szindróma (ÂRDS), súlyos akut légzési szindróma (SAKS), szepszis, szisztémás gyulladásos válasz szindróma (SÍRS), arthritis, egy rák, egy lőtóhimdn rentkáknesség. vagv egy gyulladásos teudellenéÉiljgg b) ahoi a kozeles tartalmazza még más terápiás szer beadását vagv kezelést rómá|;;gmelyel:a köfétkec 0'\ , o cvtha.c^ \ xornen a.\< ,Λοΐΐ,ηφη, cito 'Wo getttcíama cl amit rák '.agy vsrusfeaoz.es mellékhatásának kezelésére használónk.
  3. 12. Egy ellenanyag vagy ellenanyag frogmens P igénypont szerinti alkalmazása, ahol az alkalmazás diagnosztikus m von képalkotás a) álnál a szóban tót go alkalmazás kimutatja. IL-**ot expusszulo sejtek jelenlétet, and •l·' m, hóm lemé uh o«o i exxp' ? * vu itt anü t n < t '' o tbc i « \b ü mm nov oLum b|tékohy éiennylsegei adunk be, s szobán forgó be&amp;das tartalmazza nteg fa<hoa*.ox UCh<^} v'5^ e-> ^eiv megkönnyíti az ellenanyag Îdmutatàsèï a* Π..-&amp;<* *xprefcfc*ak» koros miye>\en ^ gävseiye! Π,,-b-oi espresszaîô tárnotok vagy attetek kimutatáséi δ lehet nasxnálni» ,|s amelyet az IL~6*ot expresszálö sejtekhez kapcsolódó gyn|las||sps Nflyek jólealéilnyk tehet hasasnál«), vagy e) ahol az eredményeket egy megölelő kezelést sémi tefyézéséítek: megkönttyólsétl; lehet használni. F.gv ellenanyag vagy ellenanyag fragment 0 ókus szerként, «hoi •az alkalmazás diagnosztikus in vow képalkotás, ahol az alkalmazás ·% 11 6-ot expresszfdo hooo'oL xag> ittetek *> mim,iía$d vam ielcpexeso, vagy M á ou Vpressese o., J. >\Kohií 1 m ..\ou\.-go okopo ev
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