SI2188313T1 - Humani c-fms antigen vezavni proteini - Google Patents

Humani c-fms antigen vezavni proteini Download PDF

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SI2188313T1
SI2188313T1 SI200831892T SI200831892T SI2188313T1 SI 2188313 T1 SI2188313 T1 SI 2188313T1 SI 200831892 T SI200831892 T SI 200831892T SI 200831892 T SI200831892 T SI 200831892T SI 2188313 T1 SI2188313 T1 SI 2188313T1
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seq
antibody
full
heavy chain
light chain
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Kenneth Allan Brasel
Stephen Foster
Douglas Pat Cerretti
Jilin Sun
James F. Smothers
Christopher Mehlin
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Amgen, Inc.
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Publication of SI2188313T1 publication Critical patent/SI2188313T1/sl

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Claims (29)

  1. HUMANI C-FMS ANTIGEN VEZAVNI PROTEINI PATENTNI ZAHTEVKI
    1. Protitelo, izbrano iz skupine, ki jo sestavljajo protitelo, ki obsega komplementarno, določujoče regije (CDR) CDRH1, CDRH2, CDRH3, CDRL1, CDRL2 in CDRL3, kjer navedeni CDR vsebujejo aminokislinska zaporedja, kot je navedeno spodaj: (a) CDRH1 obsega SEQ ID NO:147, CDRH2 obsega SEQ ID NO:163, CDRH3 obsega SEQ ID NO:186, CDRL1 obsega SEQ ID NO:193, CDRL2 obsega SEQ ID NO:214 in CDRL3 obsega SEQ ID NO:228, (b) CDRH1 obsega SEQ ID NO:137, CDRH2 obsega SEQ ID NO:150, CDRH3 obsega SEQ ID NO: 166, CDRL1 obsega SEQ ID NO:198, CDRL2 obsega SEQ ID NO:216 in CDRL3 obsega SEQ ID NO:233, (d) CDRH1 obsega SEQ ID NO:147, CDRH2 obsega SEQ ID NO:163, CDRH3 obsega SEQ ID NO: 186, CDRL1 obsega SEQ ID NO:195, CDRL2 obsega SEQ ID NO:214 in CDRL3 obsega SEQ ID NO:228, (e) CDRH1 obsega SEQ ID NO:137, CDRH2 obsega SEQ ID NO:152, CDRH3 obsega SEQ ID NO:170, CDRL1 obsega SEQ ID NO:198, CDRL2 obsega SEQ ID NO:216 in CDRL3 obsega SEQ ID NO:233, (f) CDRH1 obsega SEQ ID NO:147, CDRH2 obsega SEQ ID NO:163, CDRH3 obsega SEQ ID NO:186, CDRL1 obsega SEQ ID NO:194, CDRL2 obsega SEQ ID NO:214 in CDRL3 obsega SEQ ID NO:228, (g) CDRH1 obsega SEQ ID NO:141, CDRH2 obsega SEQ ID NO:156, CDRH3 obsega SEQ ID NO:172, CDRL1 obsega SEQ ID NO:209, CDRL2 obsega SEQ ID NO:223 in CDRL3 obsega SEQ ID NO:245, (i) CDRH1 obsega SEQ ID NO:140, CDRH2 obsega SEQ ID NO:155, CDRH3 obsega SEQ ID NO: 169, CDRL1 obsega SEQ ID NO:202, CDRL2 obsega SEQ ID NO:218 in CDRL3 obsega SEQ ID NO:236, 0) CDRH1 obsega SEQ ID NO:140, CDRH2 obsega SEQ ID NO:155, CDRH3 obsega SEQ ID NO:169, CDRL1 obsega SEQ ID NO:201, CDRL2 obsega SEQ ID NO:218 in CDRL3 obsega SEQ ID NO:236, (k) CDRH1 obsega SEQ ID NO:143, CDRH2 obsega SEQ ID NO:158, CDRH3 obsega SEQ ID NO:190, CDRL1 obsega SEQ ID NO:199, CDRL2 obsega SEQ ID NO:219 in CDRL3 obsega SEQ ID NO:237, (L) CDRH1 obsega SEQ ID NO:137, CDRH2 obsega SEQ ID NO:151, CDRH3 obsega SEQ ID NO: 167, CDRL1 obsega SEQ ID NO:199, CDRL2 obsega SEQ ID NO:217 in CDRL3 obsega SEQ ID NO:233, (m) CDRH1 obsega SEQ ID NO:137, CDRH2 obsega SEQ ID NO:150, CDRH3 obsega SEQ ID NO: 173, CDRL1 obsega SEQ ID NO:198, CDRL2 obsega SEQ ID NO:216 in CDRL3 obsega SEQ ID NO:233, (n) CDRH1 obsega SEQ ID NO:142, CDRH2 obsega SEQ ID NO:157, CDRH3 obsega SEQ ID NO: 187, CDRL1 obsega SEQ ID NO:206, CDRL2 obsega SEQ ID NO:221 in CDRL3 obsega SEQ ID NO:242, (o) CDRH1 obsega SEQ ID NO:143, CDRH2 obsega SEQ ID NO:158, CDRH3 obsega SEQ ID NO:177, CDRL1 obsega SEQ ID NO:200, CDRL2 obsega SEQ ID NO:216 in CDRL3 obsega SEQ ID NO:235, ali (p) CDRH1 obsega SEQ ID NO:142, CDRH2 obsega SEQ ID NO:157, CDRH3 obsega SEQ ID NO:176, CDRL1 obsega SEQ ID NO:207, CDRL2 obsega SEQ ID NO:224 in CDRL3 obsega SEQ ID NO:243; in kjer se omenjeno protitelo veže na human c-fms s Ko manj kot 10"8M, merjeno tako, kot je opisano tukaj.
  2. 2. Protitelo po zahtevku 1, kjer protitelo vsebuje variabilno težko verigo (VH) in variabilno lahko verigo (VL), pri čemer VH in VL obsegata aminokislinske sekvence, navedene spodaj: (a) VH obsega SEQ ID NO:77 in VL obsega SEQ ID NO:109; (b) VH obsega SEQ ID NO:77 in VL obsega SEQ ID NO:110; (c) VH obsega SEQ ID NO:78 in VL obsega SEQ ID NO:133; (e) VH obsega SEQ ID NO:80 in VL obsega SEQ ID NO:112; (f) VH obsega SEQ ID NO:84 in VL obsega SEQ ID NO:115; (g) VH obsega SEQ ID NO:85 in VL obsega SEQ ID NO:116; (h) VH obsega SEQ ID NO:86 in VL obsega SEQ ID NO:117; G) VH obsega SEQ ID NO:70 in VL obsega SEQ ID NO:102; (k) VH obsega SEQ ID NO:70 in VL obsega SEQ ID NO:103; (l) VH obsega SEQ ID NO:73 in VL obsega SEQ ID NO:105; (m) VH obsega SEQ ID NO:74 in VL obsega SEQ ID NO:106; (n) VH obsega SEQ ID NO:89 in VL obsega SEQ ID NO:121; (o) VH obsega SEQ ID NO:93 in VL obsega SEQ ID NO:123; (p) VH obsega SEQ ID NO:94 in VL obsega SEQ ID NO:124; (q) VH obsega SEQ ID NO:97 in VL obsega SEQ ID NO:127; ali (r) VH obsega SEQ ID NO:98 in VL obsega SEQ ID NO:128.
  3. 3. Protitelo po zahtevku 1 ali zahtevku 2, kjer je vezava med omenjenim protitelesom in mutantnim humanim cfms manj kot 50% vezave med navedenim protitelesom in humanim c-fms, ki ima zaporedje aminokislinskih zaporedij določeno v SEQ ID NO:1 in kjer mutant humani c-fms obsega aminokislinsko sekvenco, izbrano izmed: (a) aminokislinske sekvence, navedene v SEQ ID NO:1, kjer je vsaj ena mutacija, izbrana izmed K102E, R144E, R146E, D174R in A226R so prisotni, (b) aminokislinske sekvence, navedene v SEQ ID NO:1, kjer je vsaj ena mutacija izbrana izmed E29R, Q 121R, T152R in K185E, (c) aminokislinske sekvence, navedene v SEQ ID NO:1, kjer je vsaj ena mutacija, izbrana izmed E29R, Q121R, S172R, G274R in Y276R, ali (d) aminokislinske sekvence, navedene v SEQ ID NO:1, kjer je vsaj ena mutacija izbrana izmed R106E, H151R, T152R, Y154R, S155R, W159R, Q171R, S172R, Q173R, G183R, R184E, K185E, E218R, A220R, S228R, H239R, N240R, K259E, G274R, N275R, Y276R, S277R in N282R.
  4. 4. Protitelo po katerem koli izmed zahtevkov od 1 do 3, kjer je omenjeno protitelo sposobno vezati polipeptid ki sestoji iz aminokislinske sekvence SEQ ID NO:326, kjer omenjeno protitelo ne veže polipeptida, ki ga sestavljajo aminokisline 20-126 SEQ ID NO:1 in ne veže polipeptida, ki ga sestavljajo aminokisline 85-223 SEQ ID NO:1.
  5. 5. Protitelo po zahtevku 2, ki obsega dve identični VH in dve identični VL.
  6. 6. Protitelo po zahtevku 2 ali zahtevku 5, kjer omenjeno protitelo obsega polno težko verigo in polno lahko verigo, pri čemer omenjena polna težka veriga in polna lahka veriga obsegata aminokislinske sekvence, predstavljene spodaj: (a) polna težka veriga obsega SEQ ID NO:11 in polna lahka veriga obsega SEQ ID NO:43; (b) polna težka veriga obsega SEQ ID NO:11 in polna lahka veriga obsega SEQ ID NO:44; (c) polna težka veriga obsega SEQ ID NO: 12 in polna lahka veriga obsega SEQ ID NO:67; (e) polna težka veriga obsega SEQ ID NO:14 in polna lahka veriga obsega SEQ ID NO:46; (f) polna težka veriga obsega SEQ ID NO:18 in polna lahka veriga obsega SEQ ID NO:49; (g) polna težka veriga obsega SEQ ID NO:19 in polna lahka veriga obsega SEQ ID NO:50; (h) polna težka veriga obsega SEQ ID NO:20 in polna lahka veriga obsega SEQ ID NO:51; (j) polna težka veriga obsega SEQ ID NO:4 in polna lahka veriga obsega SEQ ID NO:36; (k) polna težka veriga obsega SEQ ID NO:4 in polna lahka veriga obsega SEQ ID NO:37; (l) polna težka veriga obsega SEQ ID NO:7 in polna lahka veriga obsega SEQ ID NO:39; (m) polna težka veriga obsega SEQ ID NO:8 in polna lahka veriga obsega SEQ ID NO:40; (n) polna težka veriga obsega SEQ ID NO:23 in polna lahka veriga obsega SEQ ID NO:55; (o) polna težka veriga obsega SEQ ID NO:27 in polna lahka veriga obsega SEQ ID NO:57; (p) polna težka veriga obsega SEQ ID NO:28 in polna lahka veriga obsega SEQ ID NO:58; (q) polna težka veriga obsega SEQ ID NO:31 in polna lahka veriga obsega SEQ ID NO:61; ali (r) polna težka veriga obsega SEQ ID NO:32 in polna lahka veriga obsega SEQ ID NO:62.
  7. 7. Protitelo po katerem koli od zahtevkov 1,2,5 ali 6, kjer: (a) CDRH1 obsega SEQ ID NO:147, CDRH2 obsega SEQ ID NO:163, CDRH3 obsega SEQ ID NO:186, CDRL1 obsega SEQ ID NO:193, CDRL2 obsega SEQ ID NO:214, in CDRL3 obsega SEQ ID NO:228; (b) CDRH1 obsega SEQ ID NO:140, CDRH2 obsega SEQ ID NO:155, CDRH3 obsega SEQ ID NO:169, CDRL1 obsega SEQ ID NO:202, CDRL2 obsega SEQ ID NO:218, in CDRL3 obsega SEQ ID NO:236; (c) CDRH1 obsega SEQ ID NO:140, CDRH2 obsega SEQ ID NO:155, CDRH3 obsega SEQ ID NO:169, CDRL1 obsega SEQ ID NO:201, CDRL2 obsega SEQ ID NO:218, in CDRL3 obsega SEQ ID NO:236; ali (d) CDRH1 obsega SEQ ID NO:142, CDRH2 obsega SEQ ID NO:157, CDRH3 obsega SEQ ID NO:187, CDRL1 obsega SEQ ID NO:206, CDRL2 obsega SEQ ID NO:221, in CDRL3 obsega SEQ ID NO:242.
  8. 8. Protitelo po katerem koli od zahtevkov 1,2,5,6 ali 7, kjer je protitelo izbrano iz skupine, ki sestoji Iz protitelesa, kjer: (a) VH obsega SEQ ID NO:77 in VL obsega SEQ ID NO:109, (b) VH obsega SEQ ID NO:77 in VL obsega SEQ ID NO:110, (c) VH obsega SEQ ID NO:70 in VL obsega SEQ ID NO:102, (d) VH obsega SEQ ID NO:70 in VL obsega SEQ ID NO:103, (e) VH obsega SEQ ID NO:93 in VL obsega SEQ ID NO:123, ali (f) VH obsega SEQ ID NO:94 in VL obsega SEQ ID NO:124.
  9. 9. Protitelo po katerem koli od zahtevkov 1,2, 5, 6, 7 ali 8, kjer je protitelo izbrano iz skupine, ki sestoji iz protitelesa, kjer: (a) polna težka veriga obsega SEQ ID NO:11 in polna lahka veriga obsega SEQ ID NO:43, (b) polna težka veriga obsega SEQ ID NO:11 in polna lahka veriga obsega SEQ ID NO:44, (c) polna težka veriga obsega SEQ ID NO:4 in polna lahka veriga obsega SEQ ID NO:36, (d) polna težka veriga obsega SEQ ID NO:4 in polna lahka veriga obsega SEQ ID NO:37, (e) polna težka veriga obsega SEQ ID NO:27 in polna lahka veriga obsega SEQ ID NO:57, ali (f) polna težka veriga obsega SEQ ID NO:28 in polna lahka veriga obsega SEQ ID NO:58.
  10. 10. Protitelo po katerem koli od zahtevkov 1 do 9, ki: (a) je monoklonsko protitelo, rekombinantno protitelo, humano protitelo, himemo protitelo, bispecifično protitelo, multispecifično protitelo ali njegov fragment; (b) je lgG1, lgG2, lgG3 ali podtip lgG4; (c) je humano protitelo lgG1, lgG2, lgG3 ali podtipa lgG4; (d) je fragment Fab, fragment Fab\ fragment F(ab’)2, fragment Fv, diatelo, domensko protitelo, ali molekula enoverižnega protitelesa; ali (e) je imunološko funkcionalen fragment imunoglobulina in izhaja iz humanega vira.
  11. 11. Nukleinska kislina, ki kodira protitelo po katerem koli od zahtevkov 1 do 10, po izbiri kjer je navedena nukleinska kislina operativno vezana na kontrolno sekvenco.
  12. 12. Vektor, ki obsega nukleinsko kislino po zahtevku 11.
  13. 13. Gostiteljska celica, ki obsega vektor po zahtevku 12 in/ali nukleinsko kislino po zahtevku 11.
  14. 14. Farmacevtski sestavek, ki obsega vsaj eno protitelo po katerem koli od zahtevkov 1 do 10 in farmacevtsko sprejemljiv ekscipient.
  15. 15. Farmacevtski sestavek po zahtevku 14, ki nadalje obsega: (a) dodatno aktivno sredstvo; ali (b) dodatno aktivno sredstvo, izbrano iz skupine, ki jo sestavljajo radioizotop, radionuklid, toksin, terapevtska in kemoterapevtska skupina.
  16. 16. Protitelo po katerem koli od zahtevkov 1 do 10 za uporabo v terapiji.
  17. 17. Protitelo po katerem koli od zahtevkov 1 do 10 za uporabo pri zdravljenju ali preprečevanju stanja, povezanega s c-fms pri pacientu, pri čemer je stanje izbrano izmed raka, bolezni kosti in vnetne bolezni.
  18. 18. Protitelo za uporabo po zahtevku 17, kjer je vnetna bolezen izbrana iz skupine, ki jo sestavljajo vnetni artritis, ateroskleroza, multipla skleroza, vnetna črevesna bolezen, Crohnova bolezen, ulcerozni kolitis, revmatoidni spondilitis, ankilozirajoči spondilitis, artritis, psoriatični artritis, revmatoidni artritis, osteoartritis, ekcem, kontaktni dermatitis, psoriaza, sindrom toksičnega šoka, sepsa, septični šok, endotoksični šok, astma, kronična pljučna vnetna bolezen, silikoza, pljučna sarkoidoza, restenoza, srčna in ledvična reperfuzijska poškodba, tromboza, glomerulonefritis, diabetes, reakcija presadka proti gostitelju, zavrnitev alogenskega presadka, multipla skleroza, mišična degeneracija, mišična distrofija, Alzheimerjeva bolezen, možganska kap in kaheksija.
  19. 19. Protitelo za uporabo po zahtevku 17, kjer je rak izbran iz skupine, ki jo sestavljajo rak dojk, rak prostate, kolorektalni rak, endometrijski adenokarcinom, levkemija, limfom, melanom, ezofagealni skvamoznocelični rak, želodčni rak, astrocitični rak, endometrijski rak, rak materničnega vratu, rak na mehurju, ledvični rak, pljučni rak in rak jajčnikov.
  20. 20. Protitelo za uporabo po zahtevku 17, kjer je bolezen kosti izbrana iz skupine, ki jo sestavljajo: (a) zdravstvene motnje, ki vključujejo čezmerno izgubo kosti; (b) zdravstvene motnje, ki zahtevajo nastanek nove kosti; (c) osteopenske motnje, ki vključujejo prekomerno osteoklastno aktivnost; (d) sistemska izguba kosti, povezana z artritisom; in (e) kostne bolezni, povezane z odpovedjo ledvic.
  21. 21. Protitelo za uporabo po zahtevku 20, pri čemer: (a) je protitelo za uporabo po zahtevku 20(a) in pri čemer je medicinska motnja izbrana izmed raka dojk, raka prostate, multiplega mieloma in osteosarkoma; ali (b) protitelo je za uporabo po zahtevku 20(c), kjer je osteopenična motnja izbrana iz skupine, ki jo sestavljajo osteopenija, osteoporoza, periodontitis, Pagetova bolezen, izguba kosti zaradi imobilizacije, litične kostne metastaze in artritis.
  22. 22. Protitelo za uporabo po zahtevku 20(d) ali zahtevku 21 (b), kjer je artritis izbran iz skupine, ki jo sestavljajo osteoartritis, revmatoidni artritis, psoriatični artritis in vnetni artritis.
  23. 23. Protitelo za uporabo po zahtevku 17, kjer je stanje bolezen kosti in pri čemer je bolezen kosti kostna motnja; kjer se protitelo daje v kombinaciji z: (a) nadaljnjim terapevtskim sredstvom; ali (b) nadaljnjim terapevtskim sredstvom, izbranim izmed agensa za zdravljenje raka, sredstva, ki inhibira osteoklastno aktivnost, in sredstvo, ki krepi osteoblastno aktivnost.
  24. 24. Protitelo za uporabo po zahtevku 23, kjer je pacient rakavi pacient, ki je izpostavljen sevalni terapiji ali kemoterapiji.
  25. 25. Protitelo za uporabo po katerem koli od zahtevkov 17 in 19-23, kjer je stanje rak ali kostna bolezen; pri čemer se protitelo daje v kombinaciji z agensom za zdravljenje raka.
  26. 26. Protitelo za uporabo po katerem koli od zahtevkov 17, 20 in 21, kjer je stanje bolezen kosti, ki rezultira v izgubi kostne mase in kjer se protitelo daje v kombinaciji z nadaljnjim terapevtskim sredstvom izbranim izmed promotorja za rast kosti (anaboličnega) in kostno anti-resorpcijskega sredstva.
  27. 27. Protitelo za uporabo po katerem koli od zahtevkov 17, 18 in 22, kjer je stanje vnetna bolezen; in kjer se protitelo daje v kombinaciji s protivnetnim sredstvom.
  28. 28. Farmacevtski sestavek po zahtevku 14 ali 15 za uporabo pri zdravljenju pacienta, kjer je farmacevtsko sprejemljiv ekscipient izbran izmed farmacevtsko sprejemljivega razredčila, nosilca, pospeševalca raztapljanja, emulgatorja, konzervansa in/ali adjuvansa; in kjer je pacient človeški pacient.
  29. 29. Postopek za pripravo protitelesa po katerem koli od zahtevkov 1 do 10, ki obsega korak priprave omenjenega protitelesa iz gostiteijske celice, ki izloča navedeno protitelo.
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