ME02085B - Sklerostin vezujuća sredstva - Google Patents

Sklerostin vezujuća sredstva

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Publication number
ME02085B
ME02085B MEP-2013-358A MEP35813A ME02085B ME 02085 B ME02085 B ME 02085B ME P35813 A MEP35813 A ME P35813A ME 02085 B ME02085 B ME 02085B
Authority
ME
Montenegro
Prior art keywords
bone
bone loss
disease
sclerostin
loss
Prior art date
Application number
MEP-2013-358A
Other languages
English (en)
French (fr)
Inventor
Christopher Paszty
Kevin Graham
John Latham
Alastair Lawson
David Winkler
Wenyan Shen
Andy Popplewell
Hsieng Sen Lu
Aaron George Winters
Martyn Kim Robinson
Alistair James Henry
Kelly Sue Hoffmann
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36992590&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME02085(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of ME02085B publication Critical patent/ME02085B/me

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Claims (33)

1.    Sklerostin-vezujuće antitelo, koje sadrži sledeće CDR sekvence:CDR-H1: DYNMH (SEQ ID NO:245);CDR-H2: EINPNSGGAGYNQKFKG (SEQ ID NO:246);CDR-H3: LGYDDIYDDWYFDV (SEQ ID NO:247);CDR-L1: RASQDISNYLN (SEQ ID NO:78);CDR-L2: YTSRLLS (SEQ ID NO:79) iCDR-L3: QQGDTLPYT (SEQ ID NO:80).
2.    Sklerostin-vezujuće antitelo prema zahtevu 1, koje sadrži teški lanac, koji uključuje polipeptidnu sekvencu, koja poseduje najmanje 85% identiteta sekvence SEQ ID NO: 378.
3.    Sklerostin-vezujuće antitelo prema zahtevu 1 ili 2, koje sadrži laki lanac, koji uključuje polipeptidnu sekvencu, koja poseduje najmanje 85% identiteta sekvence SEQ ID NO: 376.
4.    Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 3, koje sadrži i teški lanac, koji uključuje polipeptidnu sekvencu, koja poseduje najmanje 85% identiteta sekvence SEQ ID NO: 378 i laki lanac, koji uključuje polipeptidnu sekvencu, koja poseduje najmanje 85% identiteta sekvence SEQ ID NO: 376.
5.    Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 4, koje sadrži konstantni region lakog lanca i/ili teškog lanca.
6.    Sklerostin-vezujuće antitelo prema zahtevu 5, koje je IgG.
7.    Sklerostin-vezujuće antitelo prema zahtevu 5, koje sadrži konstantni region humanog IgG4 ili humanog IgG2.
8.    Sklerostin-vezujuće antitelo prema zahtevu 1, koje ima teške lance SEQ 1D NO: 137 i lake lance SEQ ID NO: 133.
9.    Sklerostin-vezujuće antitelo prema zahtevu 1, koje ima teške lance SEQ ID NO: 145 ili 392 i lake lance SEQ ID NO: 141.
10.    Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 4, naznačeno time što je navedeno antitelo fragment sklerostin-vezujućeg antitela, koji sadrži šest CDR-a, navedenih u zahtevu 1.
11. Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 9, koje je kompletno antitelo.
12.    Sklerostin-vezujuće antitelo prema zahtevu 10, naznačeno time što je navedeno antitelo F(ab’)2, Fab, Fab’ ili Fv fragment.
13.    Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 7, koje je humanizovano antitelo ili himerično antitelo.
14.    Sklerostin-vezujuće antitelo prema ma kom od prethodnih zahteva, naznačeno time što navedeno antitelo ima konstantu disocijacije za humani sklerostin, kako je izmereno posredstvom površinske plazmon rezonance, koja je manja ili jednaka 1 x 10-9 M, manja ili jednaka 1 x 10-10 M, manja ili jednaka 1 x 10-11 M ili je manja ili jednaka 1 x 10-12 M.
15.    Sklerostin-vezujuće antitelo prema ma kom od prethodnih zahteva, za koje je vezan jedan ili više efektorskih ili reporterskih molekula.
16.    Sklerostin-vezujuće antitelo prema ma kom od prethodnih zahteva, naznačeno time što navedeno antitelo može povećati najmanje jedno od sledećih: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti kod sisara.
17.    Sklerostin-vezujuće antitelo prema ma kom od prethodnih zahteva, naznačeno time što navedeno antitelo može blokirati inhibitomo dejstvo sklerostina u testu mineralizaeije na ćelijskoj bazi.
18.    Izolovana polinukleotidna sekvenca koja kodira sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 17.
19.    Klonirajući ili ekspresioni vektor koji sadrži jednu ili više polinukleotidnih sekvenci prema zahtevu 18.
20.    Vektor prema zahtevu 19, naznačen time što vektor sadrži najmanje jednu sekvencu, datu u SEQ ID NO: 134, 136, 138,140, 142, 144, 146, 148 i 379.
21. Ćelija domaćina koja sadrži jedan ili više klonirajućih ili ekspresionih vektora prema zahtevu 19 ili zahtevu 20.
22. Postupak za proizvodnju sklerostin-vezujućeg antitela prema ma kom od zahteva 1 do 17, koji obuhvata kultivaciju domaćinske ćelije prema zahtevu 21 i izolovanje sklerostin-vezujućeg antitela.
23.    Farmaceutska smeša koja sadrži sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 17 u kombinaciji sa jednim ili više farmaceutski prihvatljivih ekscipijenata, razblaživača i nosača.
24.    Farmaceutska smeša prema zahtevu 23, koja dodatno sadrži druge aktivne sastojke.
25.    Sklerostin-vezujuće antitelo prema ma kom od zahteva 1 do 17 ili farmaceutska smeša prema zahtevu 23 ili zahtevu 24, za korišćenje u postupku lečenja koštanog poremećaja povezanog sa najmanje jednim od sledećih: slabo formiranje kosti, slaba mineralna gustina kosti, slab mineralni sadržaj kosti, mala koštana masa, slab kvalitet kosti i slaba jačina kosti kod ispitanika sisara, naznačeno time što postupak obuhvata davanje ispitaniku kome je takav tretman potreban količine navedenog antitela koja je dovoljna za povećanje barem jednog od sledećih: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti.
26.    Antitelo ili farmaceutska smeša prema zahtevu 25 za navedenu upotrebu, naznačeni time što je koštani poremećaj: osteopenija, osteoporoza, gubitak kosti ili abnormalni rast ili razvoj kosti, izazvan najmanje jednim od: ahondroplazije, kleidokranijalne disostoze, enhondromatoze, fibrozne displazije, Gaucherove bolesti, hipofosfatemijskog rahitisa, Marfanovog sindroma, multiple hereditame egzotoze, neurofibromatoze, osteogenesis imperfecta, osteopoikiloze, sklerotskih lezija, pseudoartroze, pijogenog osteomijelitisa, periodontalne bolesti, gubitka kosti indukovanog antiepileptičnim lekovima, primarnog i sekundarnog hiperparatiroidizma, familijarnih hiperparatiroidnih sindroma, gubitka kosti indukovanog bestežinskim stanjem, osteoporoze kod muškaraca, gubitka kosti u postmenopauzi, osteoartritisa, renalne osteodistrofije, infiltrativnih poremećaja kosti, gubitka oralne kosti, osteonekroze vilice, juvenilne Pagetove bolesti, meloreostoze, metaboličkih koštanih bolesti, mastocitoze, anemije/bolesti srpastih ćelija, gubitka kosti povezanog sa transplantacijom organa, gubitka kosti povezanog sa transplantacijom bubrega, sistemskog lupusa eritematozusa, ankilozirajućeg spondilitisa, epilepsije, juvenilnog artritisa, talasemije, mukopolisaharidoza, Fabrijeve bolesti, Turnerovog sindroma, Downovog sindroma, Klinefelterovog sindroma, gube, Perthesove bolesti, adolescentne idiopatske skolioze, multisistemske inflamatome bolesti s početkom u detinjstvu, sindroma Winchester, Menkesove bolesti, Wilsonove bolesti, ishemijske bolesti kosti (kao što je Legg-Calve-Perthesova bolest, regionalna migratoma osteoporoza), anemičnih stanja, stanja izazvanih steroidima, gubitka kosti indukovanog glukokortikoidima, gubitka kosti indukovanog heparinom, poremećaja koštane srži, skorbuta, malnutricije, deficijencije kalcijuma, alkoholizma, hronične bolesti jetre, stanja posle menopauze, hroničnih inflamatomih stanja, reumatoidnog artritisa, inflamatome bolesti creva, ulceroznog kolitisa, inflamatomog kolitisa, Crohnove bolesti, oligomenoreje, amenoreje, trudnoće, šećerne bolesti, hipertireoze, poremećaja štitne žlezde, paratiroidnih poremećaja, Cushingove bolesti, akromegalije, hipogonadizma, imobilizacije ili nekretanja, sindroma refleksne simpatičke distrofije, regionalne osteoporoze, osteomalacije, gubitka kosti povezanog sa zamenom zgloba, gubitka kosti povezanog sa HlV-om, gubitka kosti povezanog sa nedostatkom hormona rasta, gubitka kosti povezanog sa cističnom fibrozom, gubitka kosti povezanog sa hemioterapijom, gubitka kosti indukovanog tumorom, gubitka kosti povezanog sa malignom bolešću, hormon ablativnog gubitka kosti, multiplog mijeloma, gubitka kosti izazvanog lekovima, anoreksije nervoze, gubitka facijalne kosti povezane sa bolešću, gubitka kranijalne kosti povezanog sa bolešću, gubitka vilične kosti povezanog sa bolešću, gubitka kosti lobanje povezanog sa bolešću, gubitka kosti povezanog sa starenjem, gubitka facijalne kosti povezanog sa starenjem, gubitka kranijalne kosti povezanog sa starenjem, gubitka kosti vilice povezanog sa starenjem, gubitka kosti lobanje povezanog sa starenjem i gubitka kosti povezanog sa svemirskim putovanjem.
27.    Antitelo ili farmaceutska smeša prema zahtevu 25 za navedeno korišćenje, naznačeno time što je koštani poremećaj osteoporoza.
28.    Antitelo prema ma kom od zahteva 1 do 17 ili farmaceutska smeša prema zahtevu 23 ili 24, za korišćenje u postupku poboljšanja ishoda kod sisara koji se podvrgava jednom ili više od sledećih: ortopedska procedura, dentalna procedura, implant hirurgija, zamena zgloba, stavljanje koštanih graftova, kozmetička hirurgija kosti i obnova kosti, kao što je zaceljivanje frakture, zaceljivanje bez šava, odloženo zaceljivanje sa šavom i facijalna rekonstrukcija, pri čemu navedni postupak obuhvata primenu navedenog antitela ili smeše navedenom sisaru pre, tokom i/ili nakon navedene procedure, zamene, grafta, hirurške intervencije ili obnove.
29.    Dijagnostički komplet koji sadrži antitelo prema ma kom od zahteva 1 do 17.
30.    Korišćenje antitela prema ma kom od zahteva 1 do 17 za proizvodnju leka za lečenje koštanog premećaja, povezanog sa najmanje jednim od sledećih: slabo formiranje kosti, slaba mineralna gustina kosti, slab mineralni sadržaj kosti, mala koštana masa, slab kvalitet kosti i slaba jačina kosti kod ispitanika sisara.
31.    Korišćenje prema zahtevu 30, naznačeno time što je koštani poremećaj: osteopenija, osteoporoza, gubitak kosti ili abnormalni rast ili razvoj kosti, izazvan najmanje jednim od: ahondroplazije, kleidokranijalne disostoze, enhonđromatoze, fibrozne displazije, Gaucherove bolesti, hipofosfatemijskog rahitisa, Marfanovog sindroma, multiple hereditame egzotoze, neurofibromatoze, osteogenesis imperfecta, osteopetroze, osteopoikiloze, sklerotskih lezija, pseudoartroze, pijogenog osteomijelitisa, periodontalne bolesti, gubitka kosti indukovanog antiepileptičnim lekovima, primarnog i sekundarnog hiperparatiroidizma, familijarnih hiperparatiroidnih sindroma, gubitka kosti indukovanog bestežinskim stanjem, osteoporoze kod muškaraca, gubitka kosti u postmenopauzi, osteoartritisa, renalne osteodistrofije, infiltrativnih poremećaja kosti, gubitka oralne kosti, osteonekroze vilice, juvenilne Pagetove bolesti, meloreostoze, metaboličkih koštanih bolesti, mastocitoze, anemije/bolesti srpastih ćelija, gubitka kosti povezanog sa transplantacijom organa, gubitka kosti povezanog sa transplantacijom bubrega, sistemskog lupusa eritematozusa, ankilozirajućeg spondilitisa, epilepsije, juvenilnog artritisa, talasemije, mukopolisaharidoza, Fabrijeve bolesti, Tumerovog sindroma, Downovog sindroma, Klinefelterovog sindroma, gube, Perthesove bolesti, adolescentne idiopatske skolioze, multisistemske inflamatome bolesti s početkom u detinjstvu, sindroma Winchester, Menkesove bolesti, Wilsonove bolesti, ishemijske bolesti kosti (kao što je Legg-Calve-Perthesova bolest, regionalna migratoma osteoporoza), anemičnih stanja, stanja izazvanih steroidima, gubitka kosti indukovanog glukokortikoidima, gubitka kosti indukovanog heparinom, poremećaja koštane srži, skorbuta, malnutricije, deficijencije kalcijuma, alkoholizma, hronične bolesti jetre, stanja posle menopauze, hroničnih inflamatomih stanja, reumatoidnog artritisa, inflamatome bolesti creva, ulceroznog kolitisa, inflamatomog kolitisa, Crohnove bolesti, oligomenoreje, amenoreje, tmdnoće, šećerne bolesti, hipertireoze, poremećaja štitne žlezde, paratiroidnih poremećaja, Cushingove bolesti, akromegalije, hipogonadizma, imobilizacije ili nekretanja, sindroma refleksne simpatičke distrofije, regionalne osteoporoze, osteomalacije, gubitka kosti povezanog sa zamenom zgloba, gubitka kosti povezanog sa HlV-om, gubitka kosti povezanog sa nedostatkom hormona rasta, gubitka kosti povezanog sa cističnom fibrozom, gubitka kosti povezanog sa hemioterapijom, gubitka kosti indukovanog tumorom, gubitka kosti povezanog sa malignom bolešću, hormon ablativnog gubitka kosti, multiplog mijeloma, gubitka kosti izazvanog lekovima, anoreksije nervoze, gubitka facijalne kosti povezane sa bolešću, gubitka kranijalne kosti povezanog sa bolešću, gubitka vilične kosti povezanog sa bolešću, gubitka kosti lobanje povezanog sa bolešću, gubitka kosti povezanog sa starenjem, gubitka facijalne kosti povezanog sa starenjem, gubitka kranijalne kosti povezanog sa starenjem, gubitka kosti vilice povezanog sa starenjem, gubitka kosti lobanje povezanog sa starenjem i gubitka kosti povezanog sa svemirskim putovanjem.
32.    Korišćenje prema zahtevu 30, naznačeno time što je poremećaj kosti osteoporoza.
33.    Korišćenje antitela prema ma kom od zahteva 1 to 17 za proizvodnju leka za poboljšanja ishoda kod sisara koji se podvrgava jednom ili više od sledećih: ortopedska procedura, dentalna procedura, implant hirurgija, zamena zgloba, stavljanje koštanih graftova, kozmetička hirurgija kosti i obnova kosti, kao što je zaceljivanje frakture, zaceljivanje bez šava, odloženo zaceljivanje sa šavom i facijalna rekonstrukcija, pri čemu je lek za primenu navedenom sisaru pre, tokom i/ili nakon navedene procedure, zamene, grafita, hirurške intervencije ili obnove.
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