HRP20230675T1 - Anti-trem2 protutijela i postupci njihove uporabe - Google Patents
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- HRP20230675T1 HRP20230675T1 HRP20230675TT HRP20230675T HRP20230675T1 HR P20230675 T1 HRP20230675 T1 HR P20230675T1 HR P20230675T T HRP20230675T T HR P20230675TT HR P20230675 T HRP20230675 T HR P20230675T HR P20230675 T1 HRP20230675 T1 HR P20230675T1
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Claims (30)
1. Protutijelo koje se veže na TREM2 protein, pri čemu protutijelo sadrži varijabilnu regiju teškog lanca i varijabilnu regiju lakog lanca, naznačeno time što:
(a) varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 64; i varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 108; ili
(b) varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 59; i varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 112.
2. Protutijelo prema zahtjevu 1, naznačeno time što varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 64 i varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 108.
3. Protutijelo prema zahtjevu 1, naznačeno time što varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 59 i varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 112.
4. Protutijelo prema bilo kojem od zahtjeva 1 do 3, naznačeno time što je protutijelo klase IgG, klase IgM ili klase IgA.
5. Protutijelo prema zahtjevu 4, naznačeno time što je protutijelo klase IgG i ima izotip IgG1, IgG2, IgG3, ili IgG4.
6. Protutijelo prema zahtjevu 5, naznačeno time što protutijelo sadrži jednu ili više aminokiselinskih supstitucija u Fc regiji na položaju ostatka odabranog iz skupine koju čine C127S, L234A, L234F, L235A, L235E, S267E, K322A, L328F, A330S, P331S, E345R, E430G, S440Y, i bilo koja njihova kombinacija, pri čemu je numeriranje ostataka prema EU ili Kabat numeriranju.
7. Protutijelo prema zahtjevu 6, naznačeno time što:
(a) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G, L234A, L235A, i P331S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(b) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G i P331S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(c) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G i K322A, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(d) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G, A330S, i P331S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(d) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G, K322A, A330S, i P331S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(e) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G, K322A, i A330S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(f) Fc regija sadrži aminokiselinsku supstituciju na položajima E430G, K322A, i P331S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(g) Fc regija sadrži aminokiselinsku supstituciju na položajima S267E i L328F, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(h) Fc regija sadrži aminokiselinsku supstituciju na položaju C127S, pri čemu je numeriranje položaja ostataka prema EU numeriranju;
(i) Fc regija sadrži aminokiselinsku supstituciju na položajima E345R, E430G i S440Y, pri čemu je numeriranje položaja ostataka prema EU numeriranju; ili
(j) Fc regija sadrži aminokiselinsku sekvencu odabranu iz skupine koju čine SEQ ID NOs: 146-156.
8. Protutijelo prema bilo kojem od zahtjeva 1-7, naznačeno time što je protein TREM2 ljudski protein.
9. Protutijelo prema zahtjevu 8, naznačeno time što je protein TREM2 protein divljeg tipa.
10. Protutijelo prema zahtjevu 8, naznačeno time što je protein TREM2 prirodna varijanta.
11. Protutijelo prema bilo kojem od zahtjeva 1-10, naznačeno time što je protutijelo fragment protutijela koji se veže na jedan ili više ljudskih proteina odabranih iz skupine koja se sastoji od ljudskog TREM2, prirodne varijante ljudskog TREM2, i bolesne varijante ljudskog TREM2, i po izboru pri čemu je fragment protutijela unakrsno povezan s drugim fragmentom protutijela koji se veže na jedan ili više ljudskih proteina odabranih iz skupine koja se sastoji od ljudskog TREM2, prirodne varijante ljudskog TREM2, te bolesne varijante ljudskog TREM2.
12. Protutijelo prema zahtjevu 11, naznačeno time što je fragment Fab, Fab', Fab'-SH, F(ab')2, Fv ili scFv fragment.
13. Protutijelo prema bilo kojem od zahtjeva 1-12, naznačeno time što je protutijelo bispecifično protutijelo koje prepoznaje prvi antigen i drugi antigen, pri čemu je prvi antigen ljudski TREM2 ili njegova prirodna varijanta, a drugi antigen je:
(a) antigen koji olakšava transport kroz krvno-moždanu barijeru;
(b) antigen koji olakšava transport kroz krvno-moždanu barijeru odabran iz skupine koja se sastoji od receptora transferina (TR), receptora inzulina (HIR), receptora faktora rasta sličnog inzulinu (IGFR), proteina povezanih s receptorom lipoproteina niske gustoće 1 i 2 (LPR-1 i -2), receptora toksina difterije, CRM197, protutijela s jednom domenom ljame, TMEM 30(A), domene proteinske transdukcije, TAT, Syn-B, penetratina, poli-argininskog peptida, angiopeptida, i ANG1005;
(c) uzročnik bolesti odabran iz skupine koju čine peptidi ili proteini koji uzrokuju bolest i nukleinske kiseline koje uzrokuju bolest, pri čemu su nukleinske kiseline koje uzrokuju bolest protusmislena GGCCCC (G2C4) ponovljena ekspandirajuća RNA, i peptidi ili proteini koji uzrokuju bolest su odabrani su iz skupine koju čine amiloid beta, oligomerni amiloid beta, amiloid beta plakovi, amiloidni prekursorski protein ili njegovi fragmenti, Tau, IAPP, alfa-sinuklein, TDP-43, FUS protein, C9orf72 (kromosom 9 otvoreni okvir za čitanje 72), c9RAN protein, prionski protein, PrPSc, huntingtin, kalcitonin, superoksid dismutaza, ataksin, ataksin 1, ataksin 2, ataksin 3, ataksin 7, ataksin 8, ataksin 10, Lewyjevo tijelo, atrijski natriuretski faktor, amiloidni polipeptid otočića, inzulin, apolipoprotein AI, serum amiloid A, medin, prolaktin, transtiretin, lizozim, beta 2 mikroglobulin, gelsolin, keratoepitelin, cistatin, , laki lanac imunoglobulina AL, S-IBM protein, produkti prevođenja koji nisu povezani s ponavljanjem ATG (RAN), peptidi dipeptidnog ponavljanja (DPR), peptidi ponavljanja glicin-alanin (GA), peptidi ponavljanja glicin-prolin (GP), peptidi ponavljanja glicin-arginin (GR), peptidi ponavljanja prolin-alanin (PA), ubikvitin, i peptidi ponavljanja prolin-arginin (PR);
(d) ligand i/ili protein eksprimiran na imunološkim stanicama, pri čemu je ligand i/ili protein odabran iz skupine koju čine CD40, OX40, ICOS, CD28, CD137/4-1BB, CD27, GITR, PD-L1, CTLA-4, PD-L2, PD-1, B7-H3, B7-H4, HVEM, BTLA, KIR, GAL9, TIM3, A2AR, LAG-3, i fosfatidilserin; ili
(e) protein, lipid, polisaharid ili glikolipid eksprimiran na jednoj ili više tumorskih stanica.
14. Protutijelo prema bilo kojem od prethodnih zahtjeva, naznačeno time što se protutijelo specifično veže na oba ljudski TREM2 i TREM2 makaki majmuna.
15. Protutijelo prema zahtjevu 14, naznačeno time što protutijelo ima konstantu disocijacije (KD) za TREM2 makaki majmuna koja se kreće od 50 nM do 100 pM, ili manje od 100 pM, pri čemu se KD određuje na temperaturi od 25°C.
16. Protutijelo prema bilo kojem od prethodnih zahtjeva, naznačeno time što protutijelo smanjuje razine topljivog TREM2 u plazmi in vivo za najmanje 20%.
17. Protutijelo prema zahtjevu 16, naznačeno time što protutijelo smanjuje razine topljivog TREM2 u plazmi in vivo blokiranjem cijepanja i/ili induciranjem internalizacije.
18. Protutijelo prema zahtjevu 1, koje sadrži teški lanac i laki lanac, naznačeno time što:
(a) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 198, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214;
(b) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 199, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214;
(c) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 200, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214;
(d) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 201, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214;
(e) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 202, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215;
(f) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 203, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215;
(g) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 204, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215; ili
(h) teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 205, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215.
19. Protutijelo prema zahtjevu 1, naznačeno time što:
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 198, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214; ili
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 199, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214.
20. Protutijelo prema zahtjevu 1, naznačeno time što:
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 200, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214; ili
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 201, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 214.
21. Protutijelo prema zahtjevu 1, naznačeno time što:
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 204, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215; ili
teški lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 205, i laki lanac sadrži aminokiselinsku sekvencu SEQ ID NO: 215.
22. Izolirana nukleinska kiselina koja sadrži sekvencu nukleinske kiseline koja kodira protutijelo prema bilo kojem od prethodnih zahtjeva.
23. Vektor naznačen time što sadrži nukleinsku kiselinu prema zahtjevu 22.
24. Izolirana stanica domaćina naznačena time što sadrži vektor prema zahtjevu 23.
25. Postupak za proizvodnju protutijela koje se veže na TREM2, naznačen time što obuhvaća uzgoj stanice prema zahtjevu 24 tako da se proizvodi protutijelo, te po izboru dalje obuhvaća sakupljanje protutijela koje proizvodi stanica.
26. Izolirano protutijelo koje se veže na TREM2 proizvedeno postupkom prema zahtjevu 25.
27. Farmaceutski pripravak, naznačen time što sadrži protutijelo prema bilo kojem od zahtjeva 1 do 21 i farmaceutski prihvatljiv nosač.
28. Protutijelo prema bilo kojem od zahtjeva 1 do 21 za uporabu u postupku prevencije, smanjenja rizika od ili liječenja pojedinca koji ima bolest, poremećaj ili ozljedu odabranu iz skupine koju čine demencija, frontotemporalna demencija, Alzheimerova bolest, kognitivni deficit, gubitak pamćenja, ozljeda leđne moždine, traumatska ozljeda mozga, multipla skleroza, kronični kolitis, ulcerozni kolitis i rak.
29. Protutijelo za uporabu prema zahtjevu 28, naznačeno time što je bolest, poremećaj ili ozljeda odabrana iz skupine koju čine demencija, frontotemporalna demencija, Alzheimerova bolest, kognitivni deficit, gubitak pamćenja, ozljeda leđne moždine, traumatska ozljeda mozga i multipla skleroza.
30. Protutijelo za uporabu prema zahtjevu 28, naznačeno time što je bolest, poremećaj ili ozljeda Alzheimerova bolest.
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WO2016049641A1 (en) | 2014-09-28 | 2016-03-31 | The Regents Of The University Of California | Modulation of stimulatory and non-stimulatory myeloid cells |
JOP20190248A1 (ar) | 2017-04-21 | 2019-10-20 | Amgen Inc | بروتينات ربط مولد ضد trem2 واستخداماته |
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