HRP20211333T1 - Molekule za vezanje pd-1 i lag-3 i postupci za njihovu uporabu - Google Patents

Molekule za vezanje pd-1 i lag-3 i postupci za njihovu uporabu Download PDF

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HRP20211333T1
HRP20211333T1 HRP20211333TT HRP20211333T HRP20211333T1 HR P20211333 T1 HRP20211333 T1 HR P20211333T1 HR P20211333T T HRP20211333T T HR P20211333TT HR P20211333 T HRP20211333 T HR P20211333T HR P20211333 T1 HRP20211333 T1 HR P20211333T1
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Croatia
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seq
domain
cancer
binding molecule
against human
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HRP20211333TT
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Kalpana SHAH
Douglas H. Smith
Ross La Motte-Mohs
Leslie S. Johnson
Paul A. Moore
Ezio Bonvini
Scott Koenig
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Macrogenics, Inc.
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Publication of HRP20211333T1 publication Critical patent/HRP20211333T1/hr

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Claims (18)

1. Multispecifična vezujuća molekula protiv ljudskog PD-1, naznačena time, da sadrži varijabilnu domenu teškog lanca i varijabilnu domenu lakog lanca gdje: navedena varijabilna domena teškog lanca sadrži aminokiselinski slijed SEQ ID NO: 147, i navedena varijabilna domena lakog lanca sadrži aminokiselinski slijed SEQ ID NO: 153.
2. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 1, naznačena time, da je navedena molekula bispecifična vezujuća molekula koja je sposobna za istovremeno vezanje na ljudski PD-1 i na drugi epitop.
3. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 2, naznačena time, da navedeni drugi epitop jest epitop molekule koja ima udjela u reguliranju imunosne kontrolne točke koja se nalazi na površini imunosne stanice, pri čemu navedeni drugi epitop je epitop od B7-H3, B7-H4, BTLA, CD40, CD40L, CD47, CD70, CD80, CD86, CD94, CD137, CD137L, CD226, CTLA-4, Galektin-9, GITR, GITRL, HHLA2, ICOS, ICOSL, KIR, LAG-3, LIGHT, MHC klase I ili II, NKG2a, NKG2d, OX40, OX40L, PD1H, PD-1, PD-L1, PD-L2, PVR, SIRPa, TCR, TIGIT, TIM-3 ili VISTA.
4. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 3, naznačena time, da navedeni drugi epitop jest epitop od LAG-3.
5. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 4, naznačena time, da mjesto vezanja navedenog epitopa LAG-3 sadrži: (A) (1) domenu CDRH1, domenu CDRH2 i domenu CDRH3 varijabilnog teškog lanca od LAG-3 mAb 1, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 42, SEQ ID NO: 43 i SEQ ID NO: 44; i (2) domenu CDRL1, domenu CDRL2 i domenu CDRL3 varijabilnog lakog lanca od LAG-3 mAb 1, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 46, SEQ ID NO: 47 i SEQ ID NO: 48; ili (B) (1) domenu CDRH1, domenu CDRH2 i domenu CDRH3 varijabilnog teškog lanca od hLAG-3 mAb 1 VH1, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 42, SEQ ID NO: 43 i SEQ ID NO: 44; i (2) domenu CDRL1, domenu CDRL2 i domenu CDRL3 varijabilnog lakog lanca od LAG-3 mAb 1 VL4, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 55, SEQ ID NO: 47 i SEQ ID NO: 48; ili (C) (1) domenu CDRH1, domenu CDRH2 i domenu CDRH3 varijabilnog teškog lanca od LAG-3 mAb 6, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 57, SEQ ID NO: 58 i SEQ ID NO: 59; i (2) domenu CDRL1, domenu CDRL2 i domenu CDRL3 varijabilnog lakog lanca od LAG-3 mAb 6, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 61, SEQ ID NO: 62 i SEQ ID NO: 63; ili (D) (1) domenu CDRH1, domenu CDRH2 i domenu CDRH3 varijabilnog teškog lanca od hLAG-3 mAb 6 VH1, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 57, SEQ ID NO: 58 i SEQ ID NO: 59; i (2) domenu CDRL1, domenu CDRL2 i domenu CDRL3 varijabilnog lakog lanca od LAG-3 mAb 6, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 298, SEQ ID NO: 62 i SEQ ID NO: 63.
6. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 5, naznačena time, da mjesto vezanja navedenog epitopa LAG-3 sadrži: (1) domenu CDRH1, domenu CDRH2 i domenu CDRH3 varijabilnog teškog lanca od hLAG-3 mAb 6 VH1, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 57, SEQ ID NO: 58 i SEQ ID NO: 59; i (2) domenu CDRL1, domenu CDRL2 i domenu CDRL3 varijabilnog lakog lanca od hLAG-3 mAb 6 VL1/VL2, i prema ovom redoslijedu sadrži aminokiselinske sljedove: SEQ ID NO: 298, SEQ ID NO: 62 i SEQ ID NO: 63.
7. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 6, naznačena time, da mjesto vezanja navedenog epitopa LAG-3 sadrži: (1) varijabilni teški lanac od hLAG-3 mAb 6 VH1 (SEQ ID NO: 294) i (2) varijabilni laki lanac od hLAG-3 mAb 6 VL1 (SEQ ID NO: 296).
8. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time, da spomenuta molekula je: (A) dijatijelo, pri čemu navedeno dijatijelo jest kovalentno vezani kompleks koji sadrži dva, tri, četiri ili pet polipeptidnih lanaca; ili (B) trovalentna vezujuća molekula, pri čemu navedena trovalentna vezujuća molekula jest kovalentno vezani kompleks koji sadrži tri, četiri ili pet polipeptidnih lanaca, ili (C) bispecifično protutijelo.
9. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 8, naznačena time, da spomenuta molekula jest dijatijelo i sadrži domenu koja veže albumin (ABD).
10. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 9, naznačena time, da spomenuta molekula sadrži Fc regiju, i time, da: (a) navedena Fc regija je izotipa IgG1, IgG2, IgG3 ili IgG4; (b) spomenuta molekula dodatno sadrži zglobnu domenu; (c) navedena Fc regija jest IgG4 Fc domena i navedeno protutijelo dodatno sadrži zglobnu domenu IgG4 koja sadrži stabilizirajuću mutaciju; ili (d) navedena Fc regija sadrži jednu ili više aminokiselinskih modifikacija koje smanjuju afinitet varijante Fc regije za FcyR; i/ili (e) navedena Fc regija sadrži jednu ili više aminokiselinskih modifikacija koje povećavaju poluživot varijante Fc regije u serumu.
11. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 10, naznačena time, da: (A) spomenuta jedna ili više modifikacija koja smanjuje afinitet varijante Fc regije za FcyR, i spomenute modifikacije sadrže supstitucije L234A; L235A; ili L234A i L235A, gdje je spomenuto numeriranje EU indeksa kao kod Kabata; i (B) spomenuta jedna ili više modifikacija koja povećava poluživot varijante Fc regije u serumu, i spomenute modifikacije koje povećavaju poluživot varijante Fc regije u serumu, sadrže supstitucije M252Y; M252Y i S254T; M252Y i T256E; M252Y, S254T i T256E; ili K288D i H435K, gdje je spomenuto numeriranje EU indeksa kao kod Kabata.
12. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 8, 10 ili 11, naznačena time, da spomenuta molekula jest dijatijelo koje sadrži: (a) SEQ ID NO: 267, gdje X1 je Ala; X2 je Tyr; X3 je Thr; X4 je Glu, i SEQ ID NO: 268; ili (b) SEQ ID NO: 267, gdje X1 je Gly; X2 je Tyr; X3 je Thr; X4 je Glu, i SEQ ID NO: 268; ili (c) SEQ ID NO: 267, gdje X1 je Gly; X2 je Met; X3 je Ser; X4 je Thr, i SEQ ID NO: 268; ili (d) SEQ ID NO: 269 i 270; ili (e) SEQ ID NO: 271 i 272; ili (f) SEQ ID NO: 273, 274, 275 i 276, ili (g) SEQ ID NO: 277, 278, 279 i 280, ili (h) SEQ ID NO: 281, 282 i 283, ili (i) SEQ ID NO: 290 i 291, ili (j) SEQ ID NO: 292 i 293.
13. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema patentnom zahtjevu 12, naznačena time, da spomenuta molekula jest dijatijelo koje sadrži SEQ ID NO: 290 i 291.
14. Pripravak, naznačen time, da sadrži: (A) multispecifičnu vezujuću molekulu protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 13; i (B) farmaceutski prihvatljiv nosač.
15. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 13, ili pripravak prema patentnom zahtjevu 14, naznačeni time, da su za uporabu u: (A) postupku stimuliranja imunosnog odgovora posredovanog T stanicama kod pojedinca kojemu je to potrebno; ili (B) liječenju bolesti ili stanja povezanog s oslabljenim imunosnim sustavom.
16. Multispecifična vezujuća molekula protiv ljudskog PD-1 ili pripravak prema patentnom zahtjevu 15, za uporabu prema patentnom zahtjevu 15, naznačeni time, da bolest ili stanje je rak ili infekcija, opcionalno gdje se navedeni rak bira iz skupine koju čine: tumor nadbubrežne žlijezde, rak povezan s AIDS-om, sarkom mekog dijela alveole, astrocitni tumor, rak mokraćnog mjehura, rak kostiju, rak mozga i kičmenog stuba, metastatski tumor na mozgu, rak dojke, tumori karotidnog tijela, rak grlića maternice, hondrosarkom, hordom, kromofobni karcinom bubrežnih stanica, karcinom svijetlih stanica, rak debelog crijeva, kolorektalni rak, benigni kožni fibrozni histiocitom, dezmoplastični tumor malih okruglih stanica, ependimom, Ewingov tumor, izvankoštani miksoidni hondrosarkom, fibrogenesis imperfecta ossium, fibrozna displazija kosti, rak žučnog mjehura ili žučnih vodova, rak želuca, gestacijska trofoblastična bolest, tumor zametne stanice, rak glave i vrata, hepatocelularni karcinom, tumor stanica otočića, Kaposijev sarkom, rak bubrega, leukemija, lipomski/benigni lipomatozni tumor, liposarkom/maligni lipomatozni tumor, rak jetre, limfom, rak pluća, meduloblastom, melanom, meningiom, multipla endokrina neoplazija, multipli mijelom, mijelodisplastični sindrom, neuroblastom, neuroendokrini tumori, rak jajnika, rak gušterače, papilarni tiroidni karcinom, paratiroidni tumor, pedijatrijski rak, tumor ovojnice perifernih živaca, feokromocitom, tumor hipofize, rak prostate, posteriorni melanom srednje očne ovojnice, rijetki hematološki poremećaj, bubrežni metastatski rak, rabdoidni tumor, rabdomiosarkom, sarkom, rak kože, sarkom mekog tkiva, rak rožnatih stanica, rak abdomena, sinovijalni sarkom, rak testisa, timusni karcinom, timom, tiroidni metastatski rak, i rak tijela maternice, opcionalno gdje je navedeni rak kolorektalni rak, hepatocelularni karcinom, gliom, rak bubrega, rak dojke, multipli mijelom, rak mokraćnog mjehura, neuroblastom; sarkom, ne-Hodgkinov limfom, rak ne-malih stanica pluća, rak jajnika, rak gušterače, rak rektuma, akutna mijeloična leukemija (AML), kronična mijeloična leukemija (CML), akutna B limfoblastična leukemija (B-ALL), kronična limfocitna leukemija (CLL), leukemija kosmatih stanica (HCL), neoplazma blastičnih plazmacitoidnih dendritičkih stanica (BPDCN), ne-Hodgkinovi limfomi (NHL), uključujući leukemiju plaštenih stanica (MCL), i limfom malih limfocita (SLL), Hodgkinov limfom, sustavnu mastocitozu, ili Burkittov limfom.
17. Multispecifična vezujuća molekula protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 13, naznačena time, da je spomenuta molekula za uporabu u postupku in vitro za otkrivanje PD-1, i pritom se navedena molekula ili navedeno protutijelo označava tako da se može prepoznati.
18. Uporaba multispecifične vezujuće molekule protiv ljudskog PD-1 prema bilo kojem od patentnih zahtjeva 1 do 13, naznačena time, da je za in vitro otkrivanje PD-1, pri čemu se navedena molekula ili navedeno protutijelo označava tako da se može prepoznati.
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