HRP20210650T1 - Protutijela koja vežu timusni stromalni limfopoetin (tslp) i postupci uporabe protutijela - Google Patents

Protutijela koja vežu timusni stromalni limfopoetin (tslp) i postupci uporabe protutijela Download PDF

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HRP20210650T1
HRP20210650T1 HRP20210650TT HRP20210650T HRP20210650T1 HR P20210650 T1 HRP20210650 T1 HR P20210650T1 HR P20210650T T HRP20210650T T HR P20210650TT HR P20210650 T HRP20210650 T HR P20210650T HR P20210650 T1 HRP20210650 T1 HR P20210650T1
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seq
amino acid
antibody fragment
acid sequence
pharmaceutical preparation
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HRP20210650TT
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Jean-Michel Rene RONDEAU
Matthew John EDWARDS
Danforth Miller
Daniel Huang
Rene HEMMIG
Hans-Peter Knopf
Kapil Gupta
Gino Anselmus VAN HEEKE
Nicole Haubst
Barbara ANDLAUER
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Novartis Ag
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Priority claimed from PCT/IB2016/055336 external-priority patent/WO2017042701A1/en
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Publication of HRP20210650T1 publication Critical patent/HRP20210650T1/hr

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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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Claims (43)

1. Ulomak protutijela koje specifično veže ljudski timusni stromalni limfopoetin (TSLP), naznačen time, što je odabran od bilo kojeg od sljedećih: a) ulomka protutijela koji sadrži: regiju koja određuje komplementarnost teškog lanca 1 (HCDR1) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 4; regiju koja određuje komplementarnost teškog lanca 2 (HCDR2) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 2; regiju koja određuje komplementarnost teškog lanca 3 (HCDR3) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; regiju koja određuje komplementarnost lakog lanca 1 (LCDR1) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 11; regiju koja određuje komplementarnost lakog lanca 2 (LCDR2) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 12; i regiju koja određuje komplementarnost lakog lanca 3 (LCDR3) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 13, pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema Kabat shemi označavanja, i pri čemu je ulomak protutijela Fab; b) ulomka protutijela koji sadrži: HCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 5; HCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 6; HCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; LCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 14; LCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 15; i LCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 16; pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema Chothia shemi označavanja, i pri čemu je ulomak protutijela Fab; c) ulomka protutijela koji sadrži HCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 1; HCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 2; HCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; LCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 11; LCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 12; i LCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 13, pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema kombinaciji shema označavanja Chothia i Kabat; i pri čemu je ulomak protutijela Fab.
2. Ulomak protutijela prema patentnom zahtjevu 1, naznačen time, što obuhvaća varijabilnu regiju teškog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO: 7, i varijabilnu regiju lakog lanca koja sadrži aminokiselinsku sekvencu SEQ ID NO: 17.
3. Ulomak protutijela prema patentnom zahtjevu 1, naznačen time, što sadrži teški lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 22, i laki lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 25.
4. Ulomak protutijela prema patentnom zahtjevu 1, naznačen time, što sadrži teški lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 9, i laki lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 19.
5. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, što Fab je ljudski Fab.
6. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, što molekula veže ljudski TSLP s konstantom disocijacije (KD) od manje od 100 pM.
7. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, što molekula veže ljudski TSLP s konstantom disocijacije (KD) od manje od 10 pM.
8. Farmaceutski pripravak, naznačen time, što sadrži ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-7 i najmanje jednu farmaceutski prihvatljivu pomoćnu tvar.
9. Farmaceutski pripravak prema patentnom zahtjevu 8, naznačen time, što ulomak protutijela iznosi oko 5% do oko 95%, ili oko 10% do oko 90%, ili oko 15% do oko 85%, ili oko 20% do oko 80%, ili oko 25% do oko 75%, ili oko 30% do oko 70%, ili oko 40% do oko 60%, ili oko 40-50% (m/m) pripravka.
10. Farmaceutski pripravak prema patentnom zahtjevu 8 ili zahtjevu 9, naznačen time, što pripravak sadrži sredstvo koje tvori omotač.
11. Farmaceutski pripravak prema patentnom zahtjevu 10, naznačen time, što je sredstvo koje tvori omotač trileucin ili leucin.
12. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 11, naznačen time, što pripravak sadrži najmanje jedan pomoćni sastojak koji tvori staklo.
13. Farmaceutski pripravak prema patentnom zahtjevu 12, naznačen time, što je najmanje jedan pomoćni sastojak koji tvori staklo odabran od histidina, trehaloze, manitola, saharoze, natrijevog citrata ili smjese trehaloze i manitola.
14. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 13, naznačen time, što pripravak sadrži pufer.
15. Farmaceutski pripravak prema patentnom zahtjevu 14, naznačen time, što je pufer odabran od histidina, glicina, acetata, ili fosfatnog pufera.
16. Farmaceutski pripravak prema patentnom zahtjevu 14 ili 15, naznačen time, što pufer iznosi oko 5-13% pripravka.
17. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 16, naznačen time, što je pripravak formuliran kao suha praškasta formulacija.
18. Farmaceutski pripravak prema patentnom zahtjevu 17, naznačen time, što je pripravak formuliran kao suha praškasta formulacija pogodna za inhalaciju.
19. Farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 18, naznačen time, što pripravak sadrži: raspršivanjem osušene čestice koje obuhvaćaju jezgru i omotač, pri čemu omotač sadrži trileucin ili leucin i jezgra sadrži: i) ulomak protutijela, trehalozu, manitol, i pufer; ili ii) ulomak protutijela, trehalozu, pufer, i HCl.
20. Farmaceutski pripravak prema patentnom zahtjevu 19, naznačen time, što je pufer odabran od histidina, glicina, acetata, ili fosfatnog pufera.
21. Farmaceutski pripravak koji sadrži raspršivanjem osušene čestice, naznačen time, što one sadrže: i) jezgru koja sadrži trehalozu, manitol, histidin, i ulomak protutijela koji veže TSLP, ili jezgru koja sadrži trehalozu, histidin, HCl, i ulomak protutijela koji veže TSLP, pri čemu ulomak protutijela koji veže TSLP je Fab ulomak protutijela koji sadrži: a) HCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 4; HCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 2; HCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; LCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 11; LCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 12; i LCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 13; pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema Kabat shemi označavanja, ili b) HCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 5; HCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 6; HCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; LCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 14; LCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 15; i LCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 16; pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema Chothia shemi označavanja, ili c) HCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 1; HCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 2; HCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3; LCDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 11; LCDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 12; i LCDR3 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 13; pri čemu su HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 definirane prema kombinaciji shema označavanja Chothia i Kabat; i ii) omotač koji sadrži trileucin ili leucin.
22. Farmaceutski pripravak prema patentnom zahtjevu 21, naznačen time, što sadrži: a) 40% (m/m) ulomka protutijela koji veže TSLP, 25% (m/m) trileucina, 30% (m/m) kombinirane mase trehaloze i manitola, i 5% (m/m) histidina; b) 50% (m/m) ulomka protutijela koji veže TSLP, 15% (m/m) trileucin, 2,6% (m/m) HCl, 5,6% (m/m) histidina, i 26,8% (m/m) kombinirane mase trehaloze i baze; ili c) 50% (m/m) ulomka protutijela koji veže TSLP, 15% (m/m) trileucin, 19,4% (m/m) trehaloze, 13,04% (m/m) histidina, i 2,56% (m/m) HCl.
23. Komplet, naznačen time, što sadrži ulomak protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, ili farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 22, te uređaj za isporuku ulomka protutijela ili farmaceutskog pripravaka pojedincu.
24. Komplet prema patentnom zahtjevu 23, naznačen time, što uređaj isporučuje ulomak protutijela ili farmaceutski pripravak u aerosoliziranom obliku.
25. Komplet prema patentnom zahtjevu 24, naznačen time, što je navedeni uređaj inhalator za suhi prah.
26. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-7, ili farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8-22, naznačen time, što je za uporabu kao lijek.
27. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, ili farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 22, naznačen time, što je za uporabu u liječenju astme, kronične opstruktivne plućne bolesti, alergijskog rinitisa, alergijskog rinosinusitisa, alergijskog konjunktivitisa, eozinofilnog ezofagitisa, ili atopijskog dermatitisa.
28. Ulomak protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, ili farmaceutski pripravak prema bilo kojem od patentnih zahtjeva 8 do 22, naznačen time, što je za uporabu u liječenju astme.
29. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 28, naznačen time, što je ulomak protutijela formuliran kao suha praškasta formulacija pogodna za inhalaciju.
30. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 29, naznačen time, što se ulomak protutijela treba davati pojedincu oralno ili intranazalno.
31. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 30, naznačen time, što se ulomak protutijela treba davati pojedincu u aerosoliziranom obliku.
32. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 31, naznačen time, što se ulomak protutijela treba davati pojedincu inhalatorom za suhi prah.
33. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 32, naznačen time, što pojedinac jest čovjek.
34. Ulomak protutijela ili farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 26 do 33, naznačen time, što se drugo sredstvo treba nadalje davati pojedincu, po izboru je pritom drugo sredstvo odabrano iz skupine koja sadrži kortikosteroide, bronhodilatatore, antihistaminike, antileukotriene, i inhibitore PDE-4.
35. Nukleinska kiselina, naznačena time, što kodira ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-7.
36. Nukleinska kiselina prema patentnom zahtjevu 35, naznačena time, što sadrži: a) SEQ ID NO: 21; b) SEQ ID NO: 24; c) SEQ ID NO: 23; ili d) SEQ ID NO: 26.
37. Vektor, naznačen time, što sadrži nukleinsku kiselinu prema bilo kojem od patentnih zahtjeva 35 ili 36.
38. Stanica domaćina, naznačena time, što sadrži nukleinsku kiselinu prema patentnom zahtjevu 35 ili 36 ili vektor prema patentnom zahtjevu 37.
39. Postupak za proizvodnju ulomka protutijela prema bilo kojem od patentnih zahtjeva 1-7, naznačen time, što postupak obuhvaća: kultiviranje stanice domaćina koja eksprimira nukleinsku kiselinu koja kodira ulomak protutijela; i prikupljanje ulomka protutijela iz medija za kultiviranje.
40. Postupak za dobivanje suhe praškaste formulacije koja sadrži ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-7, naznačen time, što postupak obuhvaća: (a) pripremanje vodene otopine koja sadrži ulomak protutijela prema bilo kojem od patentnih zahtjeva 1-7, trileucin ili leucin, pomoćnu tvar koja tvori staklo te pufer; (b) sušenje raspršivanjem vodene otopine iz koraka (a) na temperaturi između raspona oko 120°C do oko 200°C (ulaz) i raspona 55°C do oko 75°C (izlaz), kako bi se dobile suhe čestice praha; i (c) sakupljanje čestica suhog praha.
41. Postupak prema patentnom zahtjevu 40, naznačen time, što se pufer bira od histidina, glicina, acetata ili fosfatnog pufera.
42. Postupak prema patentnom zahtjevu 40 ili 41, naznačen time, što se pomoćna tvar za stvaranje stakla bira od histidina, histidina HCl, trehaloze, manitola, saharoze, ili natrijevog citrata, ili smjese trehaloze i manitola.
43. Farmaceutski pripravak prema patentnom zahtjevu 8, naznačen time, što je maseni omjer pomoćna tvar : ulomak protutijela veći od 0,5.
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