HUE026107T2 - Monoklonális antitest NKG2A ellen - Google Patents

Monoklonális antitest NKG2A ellen Download PDF

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Publication number
HUE026107T2
HUE026107T2 HUE11185913A HUE11185913A HUE026107T2 HU E026107 T2 HUE026107 T2 HU E026107T2 HU E11185913 A HUE11185913 A HU E11185913A HU E11185913 A HUE11185913 A HU E11185913A HU E026107 T2 HUE026107 T2 HU E026107T2
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antibody
nkg2a
cell
cells
human
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HUE11185913A
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Alessandro Moretta
Emanuela Marcenaro
François Romagne
Pascale Andre
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Innate Pharma
Univ Di Genova
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Application filed by Innate Pharma, Univ Di Genova filed Critical Innate Pharma
Publication of HUE026107T2 publication Critical patent/HUE026107T2/hu

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Claims (6)

  1. MONÛKLONÀUS A&amp;TiïIlf A&amp;GIAELGpi dZSttetlítUri igvoygonrok L Humán, kunéra vagy IstóanizáM: iamtöfclönáiisantitest vagy asrnak fiaignseme, azzal jeilsmezwjmgy s. Spe<dîîknt.an kötődik Μ1Κ02Α·Μζ,: almi m Mitest: vagy: fragmente azzal jelkiíízeít. hegy nem.MtöÄ speeltiknsan NKG2C'hez vagy Íyi&amp;G2tehezt,: b, nent kötődik Fey itesptorhez: C. amennyiben humán NK-sejtes NK GXÄrM? kÖbNÖtt, $i célsejt fetófái. MiA-B-í vagyiQaih-t hordozó humán célsejt MK-sep általi Hassál váltja ki, ggglgjipfdfjçejf érintkezésbe,ka® m NK-s«jítSÍ, és d, megakadályozza a humán NKG2A és
  2. 2, Az.1,.igénypont szermri mosoklonálm<mdjdSt Vagy ártsákíragmease,aholá? antitest olyamsgérr vagy kumsalgGlrréglót tartalmaz, amely égy tteddsltoih tegy az Fe receptorhoz íSítéíMkdtödés gátolt
  3. 3, Az I. vagy 2. ígési^nt vagy ar»i3k tegmepse, ahol. sz mítltesi: humán IgCI4 komtíáns régiét tartalmaz, 4, A 3. igénypont monokltelíÉ testest vagy atmak fegtnetise, ahol ág Ig04 konstans régió a 228.: amínosavrpezMÖbád lévé szama proimstSl tSríékői hélyeîlasltésével módosteth 5, A*· 1 igéttypooí sæérmti iteteklohlits ahltesf vagy annak fragnmnse* aMol a célsejt a következők ke-zSt vMssmottíemteri sejt: ámáMm sejfytálé:s s^é vikks^îtôaéb: se|f-. é. áz Ír5, igénypontok bármelyike szerdái steteklótiáíls amifest vagy ginÄ' ltögisesso^ m toVáhtó, hogy ambörlÓfMidobŐző fitenfôs 'NKG2 tseepleAúz sdtÓdlk. ?. Készítmény, amely tmzhn&amp;zz&amp; a következőket:; ä. 1 -fi, igásypöíkök Mnnslyike szerinti. numoklomtits antitest vagy fragmenséuek hatásos mennyisége, és fe, gÿëgyâSæâ&amp;g eliogMhstó hordozó vagy segédanyag,
    3. Á A igénypont szsrmfi kéaziméa;&amp; gyé^^Séát&amp;ttWéRŐ·alkalmazásra. :9i A ?. -igénypont szerinti készítmény, pteitensbea anttastmnm vajgy gyulladásos rendellenesség keselesi-hon-történő alkalmazásra* M. Késziteeay gyulladásos vagy jmtoinstptpt térténő sikaJmazásng amely' tartalmaz gyégyásaatilag elfogadható hordósét vagy segédanyagot, és humán, hamanizáli vagy kánéra tnotekÉmáMs antitest vagy iapssssehatásos mennyiségét, azzal Jetenazse, hogy a, speeiMkusan kötteifc ΝΚΟΜΑΜζ, almi aztmrilysi vagy Gagmens azzal jellearzett, hogy sem kötődik speeiistesttn NKG2C-tez vagy HKGSEitez, b, nem kötődik Fcy receptorhoz az Forégióián keresztül, c. mernem Misán MlGselten ÄGIAdmz kdtteőit a détsejí Mszmén fíLME-t vagy Qáb4 hordozd Misán célséll MCrsejt általi Maisét váltja ki, amikor a célsejt érintkezésbe kend az KlG-sej ttel, és d. megakadályozza a humán NKG2A és MLA*B MSaooiádéját.
  4. 11. ÁIÖ. igénypont szerinti készítmény az ott meghatározott nlkalmazásra, áMdl az anloimttnm mndelie-pesség mutais arttitisz, Cmlm-hetegség, fékélyes v^iagMIgynlí adás vagy szkiérózis m«ii|piex.
  5. 12. A li). igénspost sissrinti késaífmény az ott meghatározott a&amp;aMsazásra, atel a Isészllntm^y á követkßr zök kézül választott második terápiás szerrel komfcináíasdó: ininusíszuppresszáns, kteikosztemid, TNF· itdbbtíör, TGFjSl mkiliíortp dfekiti-ttebite: hentaítelbdlkhs növekedési fekte, fejdtetesihapíté vagy gyulladásgádő szer. és aboi a második léíápiás szer Misti tbfegölási fonnában vagy a tedtméoy részeként kerül beadásra. 13. A 1.0. igénypont szerinti: készítmény az öü m0*MximM alksífaázásna, ahol ateásos mérteiig 0,5-20 æg/kg. .14,  ΙΟ.. ïgé&amp;yponî msêMti kfezitiusiry 4¾ ölt .tjsffeÄ^Ä alkalmazásra, aboil a íoeookkínábs: antitest vagy .annak fragmtmse tartálm&amp;zza a fcdveÉeÂeii - sekézíánc, amely az 1-2540 ayilvámttesi --satodÉ 4 C'NCM -ndl feléibe tüiyeaset': sejí: M tethék antitest ysöáfeillsnélfezláne régiójának í-es k:ömpéí?fekokííiásí megbaiáíéM régiónk (¢1111¾ CÖRS^ét és CPiRa^ jái iartatetzza, és - ternyikén«:, amely az t-3S4§ gp.lvá»íaí*lsi«deja®** a. CMGM-séi letétbe tegezeit sejtáltái tertelt Mtiíesi variábilist kötmySláac régiójának 1-es kompfemeaiariíást meghatámzó régióié* (CtïR 1¾ GfeRl-jet M C13E3-ját tartalmazza. §i'j Á 10-14;. igèsyposîtOk bármelyike szériái késziktfetsy az ott meghatározott alkalmazásra, ahol az set-Ölest: vagy Shite ftagmense hante !g(M koiSSfellS: régiOí tartalmaz, f&amp; Készítmény páciensben iaosigésoél síetoleol hiferante jttdoMfesto íörfenS albaknazásfs, amely ká-SsRméítty tanelni&amp;r gyógyászaillstg epígadkatb ittaíkíZÓti vagy segtediPite és egy hantán, htao&amp;mzálí vagy kágéra: te&amp;okkmális antitestet -v^k .p^lÉlÉ^pM^» azzal jeltempg,: h®$f a, speriílknsatt kötődik NRGMtefes: JÉ8l M imitas! vagy feapseí® áxz^ |elleRtzelí, bogy ries* kötődik spécink asm; MKG2C-hez vagy ŐTKCte-hez, fe, Stem kötődik Fcy receptorhoz az Fktegséján kereteik c, amrimyten humán NK-sejten NK02Λ-hoz kötMSR, » célsejt felszínéit MLA-E-t vagy Qsíh-t hordozó tette.célsejt NK -sejt általi bzisét váltja ki, amikor a célsejt érintkezésbe kerülaz PK-sejttel,:és d. 'megakadályozza a humán NKG2A és HLA-B asszbsiécióját, ahol a készítntey antígéste agyait alkalmazóit. î% A 26. igénypont szerinti készítmény, tttetmmttá betegség vagy allergia kéteésébeu törióhö alkalma- Zásra.
  6. 13. Készítmény páeiesshea ítemaíopofetikds sejtek- henketésések (^ésgítdknmh^Fjavítására történő alkalmazásra, amely készítmény tartalmaz győgyászahte elfepáhalö hordozót vagy ssgéd&amp;nyagst, és egy hatnám humanizált vagy kánéra mmtoklonális antitestet vagy annak ímgrnsnseknzaal jelleteeve, hogy a. sped füaisan kötődik NRGM-hoz, ahol az amitest vagy ttapmsas azzal jeiemzeít, hogy nem kötődik síx;cjE,lmsaaNKQ2C-M^:',^P'*ö2E-h«z> b, nem kötődik Fcy receptorhoz azFe-régjón keresztté,, e> ammmyibes, tette : IN&amp;tepe®. MK£i2A-te kSlődöt|: s célsejt feMmÉt. ffltA-E-t vagy Qslh-t htmfezó luitnáts çéfeyjt klR-stgt âltaM IMsét vaitja Id, amikor a célseit érmtkszésbe k«ralm MK-sejhel, és d. ítregalmdáiyozza a tettén hlkGlÁ és RLA-E asazociáotóiái lk. in vitm eljite8 hP átítitest:|4K.:G2 Adms töffel# kötődésének: kimutatására amely magabatt: jogl^ja a kővetkező lépéseket: a, könjngáivm érintksztetése hlK332A-t tartalmazó atiyaggal, ahol ateii^phtm tarlalm&amp;s: antitestet vagy tatnak őttgoseasét, azzal jellemezve, hogy : i. specifikusan kötődik NKG2A4oz, ahoi az antitest vagy feagísess a*zssi jdlétszeííi, hogy sem kötődik specifikusamé vagy NKG2E-hez, II. sem köiSdik Fcy pêcepKsrboz a» Fc-taglóján kere$ziÄ Ä. »«aæplm barnán NK.-sejten NK.G2A-hoz kötödöa* á: célsejt lllszinsa llkA-ibí vágy Qalbn kmiszö humán eéisep NK-seji általi líztsét váltja ki, sötófer; a eëiSe|t érmtktósbé kéről i® sajtó, as dtetótómté teánkért, és iv. megakadályozza a hsnÄ ÄG3Ä és MA-E asszociációját,b. az MKGM't tartalmazd- anyaghoz kötött, detektálható marker metmy Gégéitek maghatätMasa, ©. aköujngábmr is as antitest érintkezíeíésc az HKG2-ÄH tartalmazó anyaggal, ë. m antitest. Sídsaiétébes az NKö2A-t tartalmazó .aayaghoz kötött, detekiálhsiö mssrker mssíipságéisék nnrghátáfözssa, s> »ti lépésbe» megleuatozotl detektálható anyag- mennyiségének őszehasonlíilss a d lépésben a#A* zött mennyiséggé!,, eaSíai annak meglmtározása, hogy az aütilést kötódikbé az N.Kö2A-t tattähnazö anyaghoz. M. El|átó énÉ«rben betegség taÂéb® töztáiő alkalmazásra alkalmas antitest előállítására, íursely magában foglalja » következőket: a. enfomibl különböző emlős inmmnMlása barna« HKG2A4: tartalmazó: készítménnyel, b. menoktonáíis antitest- Mvaiasztása, amely L specifikusan kötődik HKG2A-.bos, ahol az antitest vagy fmgmms azzal jeiScsnzett, hogy sem kötődik specifikusa» MKG2C-bes vagy KKG2B-bsz, Ii nem kötődik l'ev reeepíorhöz az Fc-régjöjjis: jtóess&amp;Sl, IS,: ;mmnnyiben humán blK-sejten NKö2Avboz kötődött, a célsejt jeiszíndn. W-E-t vagy Qafo-t hordozó humán célsejt NK-sejt általi iizsset váltja ki, amikör a célsejt éömkezésbe kerül az NK-:»ejltelyés: detektálható marker, sv. megakadályozza a humán NKG2Á és HLA-E asszociációját, c. az antitest alkalmassá tétek emberben történő alkalmazásra. d. az antitest beadása embertől kőiőnbőző foendősnek, és e. az antitest a főemlősben, in vivo ffiSttèœ történő kötődési képességének és a főemlős antitest Irányában Matatott toelarncíájánsk értékelése, ahol a az áru «est kötődésének és a humántól különböző foemlős általi trücranciáiának meghatározása jelzi, hogy az antitest alkalmas emberbe» betegség kezelésében történő alkalmazásra. 2í. Monoklonálk aabtesí vagy annak fisgmense, azzal jÄtöezve, hogy a, specifikusan kötődik NEGkA-hoz, és azzal jellemezve, begy tnegákadályozáa a humán NfâS2A és ΗΊ..Α-Ε asszociációját, b. aern kötődik Fcy receptorhoz az Pc-régiöjimkereszíöl, c. amennyiben humán NK.-sejten NKG2A4oz kötődött, a célsejt jfelsz-foéo HLA-E-t vagy Qaib-t hordozó Mzisét váltja ki, araikor a célsejt érintkezésbe kerül azÄ-sejttsl, és d, specifikusan kőtődÉ SlKö2A%;a, ahol m áhfitesí vagy annak fiagmense azzal jellemzett högy nem köfodik specifikuson ÍMMi2C-ltez vagy bllö32E4őz,
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