HUE030944T2 - Anti-C5 antitestek javított farmakokinetikával - Google Patents
Anti-C5 antitestek javított farmakokinetikával Download PDFInfo
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- HUE030944T2 HUE030944T2 HUE15710396A HUE15710396A HUE030944T2 HU E030944 T2 HUE030944 T2 HU E030944T2 HU E15710396 A HUE15710396 A HU E15710396A HU E15710396 A HUE15710396 A HU E15710396A HU E030944 T2 HUE030944 T2 HU E030944T2
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Claims (5)
- SEABÄDALHI IGÉNYPONTOK 1, izolált antitest vagy ennek antigén-kötő fragmentuma, amely (a) kötődik humán C5 komplement komponenshez; (b) gátolja a 05 C5a ás C5h fragmentumokká való hasításét; (c) tartalmaz; (I) egy CDR1 nehézláncot, amely tartalmazza a SEQ ID Nö;23 szekvenciában leírt a ml n osa v-szekve n csá 1 : β) egy CDR2 nehézláncat. amely tartalmazza a SEQ ID NO; 19 szekvenciában leírt arnInosa v-szekvenmát, (ils) egy CDR3 nehéz-láncéi amely tartalmazza a SEQ ID NO: 3 szekvenciában leírt amirmsav-szekvenc-iáf, (ív) egy ODRI könnye láncok amely lartalmazza a SEQ ID NO:4 szekvenciában leírt am inosa v-szekveneiát. (v) egy CDR2 könnyüláncot, amely tartalmazza a SEQ !0 NÖ:5 szekvencíá&én leírt aminosav-szekvenoát és (vi) egy CDR3 könnyűláncok amely tartalmazza a SEQ 10 Nö:6 szekvenciában leírt amlnosav-szekvonclát.
- 2, Az 1. Igénypont szerinti izolált antitest vagy ennek antigén-kötő fragmenta-rha, amely tartalmaz egy, a SEQ ID NG:12 szekvenciában leírt nehézlánc variábilis régiót és egy, a SEQ ID NO;8 szekvenciában leírt könnyűlánc variábilis régiót.
- 3, Az 1. vagy 2. Igénypont szartntl Izolált antitest vagy ennék antigén-kötő fragmentuma, amely továbbá tartalmaz égy, a SEQ ID NQ;íS szakvénclábad léirt könnyűiánc konstans régiót, 4 Az. előző igénypontok bármelyike, szerinti izolált antitest vagy ennek antigén-kötő fragmentuma, amely tartalmaz egy nebézlánc pollpepfldet, amely tartalmazza á SEQ l'D MQ:14 azékyenQában leírt amínésav-szekveneiát és egy könnyCMnc polspepfidet, amely tartálntázzá a SEQ IQ NO. 11 szekvenciában leírt arnihosáv··' szekvenciát I* Az i. vagy 2. igénypont szerinti izolált antitest vagy ennek antigén-kötő fragmentuma, amely továbbá tartalmaz egy variábilis humán Fc konstans régiói, ahol a variábilis humán Fc konstans régió tartalmaz egy métlódlhf a 42S-hélyzetben és egy aazparaglnt a 434-helyzefben, mindegyiket EU számozás szerint, ik Az előző Igénypontok bármelyike szerinti Izolált antitest vagy ennek antigén-kötő fragmentuma, ahol az antitest szérum feiezöldeie emberben legalább 25 nap. 7« Az előző igénypontok bármelyike szerinti izolált a nőiest vagy ennek antigén-kötő fragmentuma, ahol az antitest vagy ennek antigén-kötő fragmentuma- <i) humán 05-höz, / A'es pH-η és 25'Όνοι egy, a 0,1 nf-2 P HA £ nid tartományba eső affinitás dtsszoeláciős áilanclóvai kötődik: Où vagy humán C5-höz, 6.0-es pH-η és 25°C"On KA a 10 nrn-m kötődik. i, Az előző igénypontok bármelyike szerinti izolált antitest vagy ennek antigén-kötő fragmentuma, amelyben a [{humán Űrére. 6,0-es pH-η és 25*0-00 vett antitest vagy ennek antigén-kötő fragmentumának HA értéke) / (humán CŐ-ra, 7 4-es pH-η és irCéeri vett, antitest: vagy ehhék; imigéh-köíő fragmenty mának K0 értéke)) nagyobb, mint :2§. i, Az éíőzé igénypontok bánpélyike szerinti izolált antitest, éhéi. az antitestet egy CHÖ sejtben állítottuk elő, 10. A 9, igénypont szerinti izolált antitest ahol az antitest nem tartalmaz észlelhető szialinsav-maradékokat. 11· Gyógyszerkészítmény, amely tartalmaz egy gyégyszerészetlág elfogadható hordozót valamint egy, az 1 10, igénypontok bármelyike szerinti antitestet vagy ennek antigén-kötő fragmentumát, 12« Terápiás készlet, amely tartalmaz: íi) egy, az 1-10, igénypontok bármelyike szerinti antitpefit vagy antigén-kötő fragmentumot; és <«} az antitest vagy ennék antigén-kőtö fragmentumának egy embert ©gyedbe való célba juttatására szolgáié eszközt, ahol az eszköz adott esetben egy fecskendő,
- 13, Gyártott termék, amely tartalmaz' egy tartályt, amely tartalmaz egy címkét', és egy készítményt, amely tarialmez: 0) egy, m MO, igényponti béfméiyie szerinti Izolált antitestet vagy antigén-kőtö fragmentumot, ahol rí otmke Ihéikáoleja az, hogy a készítményt egy olyan humán egyednéh kell beadni, aki egy kompiernentrend-szef-vonatkozású körülményt mutat fel, gyaníthatóan ennek vagy kifejlődésének kockázatával rendelkezik.
- 14. Az 1-10. Igénypontok bármelyike szprihii izolált antitest vagy ennek antigén-kötő fragmentuma egy komplementrendszeAvonafkozásé körülmény által sújtott: beteg kezelésére szolgáló eljárásban való alkalmazásra:. 10« Izolált antitest vagy ennek, antigén-kötő fragmentuma a 14. igénypont szerinti alkalmazásra, ahol a kompismentrendszenvonatkozású körülmény parovysmalis noktunmáHs hemoglobinuria (PNR) vagy aiípusos hemolitikü^ uréitliis szindróma: íaHUS).
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