SI2644698T1 - Multispecifična antigen-vezavna molekula, ki ima alternativno funkcijo k funkciji faktorja strjevanja krvi viii - Google Patents
Multispecifična antigen-vezavna molekula, ki ima alternativno funkcijo k funkciji faktorja strjevanja krvi viii Download PDFInfo
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Claims (13)
- Multispecifična antigen-vezavna molekula, ki ima alternativno funkcijo k funkciji faktorja strjevanja krvi Vlil Patentni zahtevki1. Multispecifično protitelo, ki funkcionalno nadomešča faktor strjevanja krvi Vlil in ki obsega prvi polipeptid, ki obsega prvo antigen-vezavno mesto, ki prepozna faktor strjevanja krvi IX in/ali aktivirani faktor strjevanja krvi IX in tretji polipeptid, ki obsega tretje antigen-vezavno mesto, ki prepozna faktor strjevanja IX in/ali aktivirani faktor strjevanja krvi IX, in drugi polipeptid, ki obsega drugo antigen-vezavno mesto, ki prepozna faktor strjevanja krvi X in četrti polipeptid, ki obsega četrto antigen-vezavno mesto, ki prepozna faktor strjevanja krvi X, pri čemer prvi polipeptid oz. tretji polipeptid vsak obsegata antigen-vezavno mesto na H-verigi ali L-verigi protitelesa proti faktorju strjevanja krvi IX ali aktiviranemu faktorju strjevanja krvi IX; in drugi polipeptid oz. četrti polipeptid vsak obsegata antigen-vezavno mesto H-verige ali L-verige protitelesa proti faktorju strjevanja krvi X, pri čemer (a) antigen-vezavno mesto prvega polipeptida obsega antigen-vezavno mesto, ki obsega CDRje H-verige, ki sestojijo iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (a1) do (a11) in antigen-vezavno mesto drugega polipeptida obsega antigen-vezavno mesto, ki obsega CDR-je H-verige, ki sestojijo iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (b1) do (b11): (a1) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 75, 76 oz. 77 od CDR 1,2 in 3 H-verige (CDR-ji H-verige od Q1); (a2) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 78, 79 oz. 80 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q31); (a3) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 81, 82 oz. 83 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q64); (a4) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 84, 85 oz. 86 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q85); (a5) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 87, 88 oz. 89 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q153); (a6) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 90, 91 oz. 92 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q354); (a7) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 93, 94 oz. 95 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q360); (a8) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 96, 97 oz. 98 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q405); (a9) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 99, 100 oz. 101 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q458); (a10) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 102, 103 oz. 104 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od Q460); (a11) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 105, 106 oz. 107 od CDR 1,2 in 3 H-verige (CDR-ji H-verige od Q499); (b1) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 108, 109 oz. 110 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J232); (b2) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 111, 112 oz. 113 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J259); (b3) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 114,115 oz. 116od CDR 1,2 in 3 H-verige (CDR-ji H-verige od J268); (b4) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 117, 118 oz. 119 od CDR 1,2 in 3 H-verige (CDR-ji H-verige od J300); (b5) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 120, 121 oz. 122 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J321); (b6) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 123, 124 oz. 125 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J326); (b7) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 126, 127 oz. 128 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J327); (b8) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 129, 130 oz. 131 od CDR 1,2 in 3 H-verige (CDR-ji H-verige od J339); (b9) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 132, 133 oz. 134 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J344); (b10) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 135, 136 oz. 137 od CDR 1, 2 in 3 H-verige (CDR-ji H-verige od J346); (b11) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 174, 175 oz. 176 od CDR 1, 2 in 3 H-verige (CDR-ji Η-verige od J142); (b) antigen-vezavno mesto prvega polipeptida obsega antigen-vezavno mesto, ki obsega variabilno regijo H-verige, ki sestoji iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (a1) do (a11) in antigen-vezavno mesto drugega polipeptida obsega antigen-vezavno mesto, ki obsega variabilno regijo H-verige, ki sestoji iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (b1) do (b11): (a1) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 35 variabilne regije H-verige (variabilna regija H-verige od Q1); (a2) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 36 variabilne regije H-verige (variabilna regija H-verige od Q31); (a3) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 37 variabilne regije H-verige (variabilna regija H-verige od Q64); (a4) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 38 variabilne regije H-verige (variabilna regija H-verige od Q85); (a5) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 39 variabilne regije H-verige (variabilna regija H-verige od Q153); (a6) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 40 variabilne regije H-verige (variabilna regija H-verige od Q354); (a7) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 41 variabilne regije H-verige (variabilna regija H-verige od Q360); (a8) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 42 variabilne regije H-verige (variabilna regija H-verige od Q405); (a9) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 43 variabilne regije H-verige (variabilna regija H-verige od Q458); (a10) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 44 variabilne regije H-verige (variabilna regija H-verige od Q460); (a11) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 45 variabilne regije H-verige (variabilna regija H-verige od Q499); (b1) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 46 variabilne regije H-verige (variabilna regija H-verige od J232); (b2) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 47 variabilne regije H-verige (variabilna regija H-verige od J259); (b3) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 48 variabilne regije H-verige (variabilna regija H-verige od J268); (b4) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 49 variabilne regije H-verige (variabilna regija H-verige od J300); (b5) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 50 variabilne regije H-verige (variabilna regija H-verige od J321); (b6) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 51 variabilne regije H-verige (variabilna regija H-verige od J326); (b7) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 52 variabilne regije H-verige (variabilna regija H-verige od J327); (b8) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 53 variabilne regije H-verige (variabilna regija Η-verige od J339); (b9) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 54 variabilne regije H-verige (variabilna regija H-verige od J344); (b10) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 55 variabilne regije H-verige (variabilna regija H-verige od J346); in (b11) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 172 variabilne regije H-verige (variabilna regija H-verige od J142); pri čemer (a) antigen-vezavna mesta, vključena v tretjem polipeptidu in četrtem polipeptidu obsegajo antigen-vezavno mesto, ki obsega CDRje L-verige, ki sestojijo iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (c1) do (c10): (c1) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 138, 139 oz. 140 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L2); (c2) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 141, 142 oz. 143 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L45); (c3) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 144, 145 oz. 146 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L248); (c4) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 147, 148 oz. 149 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L324); (c5) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 150, 151 oz. 152 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L334); (c6) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 153, 154 oz. 155 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L377); (c7) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 156, 157 oz. 158 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L404); (c8) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 159, 160 oz. 161 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L406); (c9) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 137, 138 oz. 139 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L408); in (c10) antigen-vezavno mesto, ki obsega aminokislinska zaporedja SEQ ID NOs: 177, 178 oz. 179 od CDR 1, 2 in 3 L-verige (CDR-ji L-verige od L180); ali (b) antigen-vezavna mesta, vključena v tretjem polipeptidu in četrtem polipeptidu obsegajo antigen-vezavno mesto, ki obsega variabilno regijo L-verige, ki sestoji iz katerih koli aminokislinskih zaporedij, izbranih izmed naslednjih od (c1) do (c10): (c1) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 56 variabilne regije L-verige (variabilna regija L-verige od L2); (c2) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 57 variabilne regije L-verige (variabilna regija L-verige od L45); (c3) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 58 variabilne regije L-verige (variabilna regija L-verige od L248); (c4) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 59 variabilne regije L-verige (variabilna regija L-verige od L324); (c5) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 60 variabilne regije L-verige (variabilna regija L-verige od L334); (c6) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 61 variabilne regije L-verige (variabilna regija L-verige od L377); (c7) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 62 variabilne regije L-verige (variabilna regija L-verige od L404); (c8) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 63 variabilne regije L-verige (variabilna regija L-verige od L406); (c9) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 64 variabilne regije L-verige (variabilna regija L-verige od L408); in (c10) antigen-vezavno mesto, ki obsega aminokislinsko zaporedje SEQ ID NO: 173 variabilne regije L-verige (variabilna regija L-verige od L180), pri čemer je funkcionalna zamenjava za faktor strjevanja krvi Vlil rezultat aktivnosti, ki pospešuje tvorbo aktiviranega faktorja strjevanja krvi X (F.Xa), ki je večja od aktivnosti bispecifičnega protitelesa hA69-KQ/hB26-PF/hAL-AQ, ki obsega H-verigo, ki obsega SEQ ID NOs: 165 in 166 in skupno deljeno L-verigo, ki obsega SEQ ID NO: 167.
- 2. Multispecifično protitelo po zahtevku 1, pri čemer (a) prvi in drugi polipeptid dalje obsegata konstantno regijo H-verige protitelesa in tretji in četrti polipeptid obsegata konstantno regijo L-verige protitelesa; ali (b) prvi in drugi polipeptid obsegata konstantno regijo H-verige protitelesa in tretji in četrti polipeptid obsegata konstantno regijo L-verige protitelesa in pri čemer sta tretji in četrti polipeptid skupno deljena L-veriga.
- 3. Multispecifično protitelo po zahtevku 2, pri čemer (a) prvi polipeptid obsega konstantno regijo H-verige protitelesa, ki sestoji iz katerih koli aminokislinskih zaporedij, izbranih iz skupine, ki sestoji iz naslednjih od (d1) do (d6), ali skupine, ki sestoji iz naslednjih od (d7) do (d9), in drugi polipeptid obsega konstantno regijo H-verige protitelesa, ki sestoji iz katerih koli aminokislinskih zaporedij, izbranih iz skupine, ki se razlikuje od skupine zgoraj navedenega prvega polipeptida: (d1) konstantna regija H-verige od SEQ ID NO: 65; (d2) konstantna regija H-verige od SEQ ID NO: 66; (d3) konstantna regija H-verige od SEQ ID NO: 67; (d4) konstantna regija H-verige od SEQ ID NO: 68; (d5) konstantna regija H-verige od SEQ ID NO: 69; (d6) konstantna regija H-verige od SEQ ID NO: 70; (d7) konstantna regija H-verige od SEQ ID NO: 71; (d8) konstantna regija H-verige od SEQ ID NO: 72; in (d9) konstantna regija H-verige od SEQ ID NO: 73; (b) tretji in četrti polipeptid obsegata konstantno regijo L-verige protitelesa, ki sestoji iz naslednjega aminokislinskega zaporedja: (e) konstantne regije L-verige od SEQ ID NO: 74; ali (c) prvi polipeptid obsega katero koli H-verigo protitelesa, izbrano izmed naslednjih od (a1) do (a14), drugi polipeptid obsega katero koli H-verigo protitelesa, izbrano izmed naslednjih od (b1) do (b12), in tretji polipeptid in četrti polipeptid obsegata katero koli L-verigo protitelesa, izbrano izmed naslednjih od (c1) do (c10): (a1) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 1; (a2) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 2; (a3) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 3; (a4) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 10; (a5) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 11; (a6) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 12; (a7) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 13; (a8) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 14; (a9) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 15; (a10) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 16; (a11) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 17; (a12) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 18; (a13) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 19; (a14) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 20; (b1) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 4; (b2) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 5; (b3) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 6; (b4) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 7; (b5) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 21; (b6) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 22; (b7) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 23; (b8) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 24; (b9) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 25; (b10) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 26; (b11) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 27; (b12) H-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 170; (c1) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 8; (c2) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 9; (c3) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 28; (c4) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 29; (c5) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 30; (c6) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 31; (c7) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 32; (c8) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 33; (c9) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 34; in (c10) L-veriga protitelesa, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 171.
- 4. Bispecifično protitelo po katerem koli od naslednjih od (a) do (u): (a) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 1, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 4, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 9; (b) bispecifično protitelo, pri čemer je prvi polipeptid Η-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 1, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 5, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 9; (c) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 2, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 6, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 8; (d) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 3, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 7, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 9; (e) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 10, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 6, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 30; (f) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 10, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 7, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 33; (g) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 11, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 4, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 33; (h) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 11, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 5, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 30; (i) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 12, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 21, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 33; (j) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 13, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 22, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 29; (k) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 14, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 21, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 33; (l) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 15, drugi polipeptid je Η-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 23, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 30; (m) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 16, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 21, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 28; (n) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 17, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 27, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 34; (o) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 18, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 25, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 30; (p) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 19, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 24, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 30; (q) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 19, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 24, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 31; (r) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 19, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 27, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 28; (s) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 20, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 25, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 32; (t) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 20, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 26, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 31; in (u) bispecifično protitelo, pri čemer je prvi polipeptid H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 12, drugi polipeptid je H-veriga, ki sestoji iz aminokislinskega zaporedja SEQ ID NO: 170, in tretji polipeptid in četrti polipeptid sta skupno deljena L-veriga SEQ ID NO: 171.
- 5. Nukleinska kislina, ki kodira multispecifično protitelo po katerem koli od zahtevkov od 1 do 3 ali bispecifično protitelo po zahtevku 4.
- 6. Vektor, vstavljen z nukleinsko kislino po zahtevku 5.
- 7. Celica, ki obsega nukleinsko kislino po zahtevku 5 ali vektor po zahtevku 6.
- 8. Postopek za izdelavo multispecifičnega protitelesa po katerem koli od zahtevkov od 1 do 3 ali bispecifičnega protitelesa po zahtevku 4 z gojenjem celice po zahtevku 7.
- 9. Farmacevtski sestavek, ki obsega multispecifično protitelo po katerem koli od zahtevkov od 1 do 3 ali bispecifično protitelo po zahtevku 4 in farmacevtsko sprejemljiv nosilec.
- 10. Sestavek po zahtevku 9, ki je farmacevtski sestavek za uporabo pri preprečevanju in/ali zdravljenju krvavitve, bolezni, ki spremlja krvavitev ali bolezni, ki jo povzroča krvavitev.
- 11. Sestavek za uporabo po zahtevku 10, pri čemer gre pri krvavitvi, bolezni, ki spremlja krvavitev ali bolezni, ki jo povzroča krvavitev za bolezen, ki se razvije in/ali napreduje zaradi zmanjšane ali pomanjkljive aktivnosti faktorja strjevanja krvi Vlil in/ali aktiviranega faktorja strjevanja krvi Vlil.
- 12. Sestavek za uporabo po zahtevku 11, pri čemer (a) je bolezen, ki se razvije in/ali napreduje zaradi zmanjšane ali pomanjkljive aktivnosti faktorja strjevanja krvi Vlil in/ali aktiviranega faktorja strjevanja krvi Vlil, hemofilija A; (b) je bolezen, ki se razvije in/ali napreduje zaradi zmanjšane ali pomanjkljive aktivnosti faktorja strjevanja krvi Vlil in/ali aktiviranega faktorja strjevanja krvi Vlil, bolezen, pri kateri se kaže nastop inhibitorja proti faktorju strjevanja krvi Vlil in/ali aktiviranemu faktorju strjevanja krvi Vlil; (c) je bolezen, ki se razvije in/ali napreduje zaradi zmanjšane ali pomanjkljive aktivnosti faktorja strjevanja krvi Vlil in/ali aktiviranega faktorja strjevanja krvi Vlil, pridobljena hemofilija; ali (d) je bolezen, ki se razvije in/ali napreduje zaradi zmanjšane ali pomanjkljive aktivnosti faktorja strjevanja krvi Vlil in/ali aktiviranega faktorja strjevanja krvi Vlil, von VVillebrandova bolezen.
- 13. Komplet, ki obsega vsaj multispecifično antigen-vezavno molekulo po katerem koli od zahtevkov od 1 do 3 ali bispecifično protitelo po zahtevku 4 ali sestavek po katerem koli od zahtevkov od 9 do 12.
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