ME02247B - Sklerostin vezujuća sredstva - Google Patents

Sklerostin vezujuća sredstva

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Publication number
ME02247B
ME02247B MEP-2015-373A MEP37315A ME02247B ME 02247 B ME02247 B ME 02247B ME P37315 A MEP37315 A ME P37315A ME 02247 B ME02247 B ME 02247B
Authority
ME
Montenegro
Prior art keywords
bone
antibody
disease
bone loss
monoclonal antibody
Prior art date
Application number
MEP-2015-373A
Other languages
German (de)
English (en)
French (fr)
Inventor
Christopher Paszty
Martyn Kim Robinson
Kevin Graham
Alistair James Henry
Kelly Sue Hoffmann
John Latham
Alastair Lawson
Hsieng Sen Lu
Aaron George Winters
David Winkler
Wenyan Shen
Andy Popplewell
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=ME02247(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 ME02247B publication Critical patent/ME02247B/me

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    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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    • C07K16/22—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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Claims (15)

1.    Monoklonsko antitelo za korišćenje u postupku povećavanja najmanje jednog od sledećeg: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti kod sisara, a time lečenje stanja u kome je poželjno povećavanje najmanje jednog od sledećeg: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti, pri čemu se monoklonsko antitelo (a) vezuje za humani sklerostin sa afinitetom vezivanja manjim od ili jednakim 1 x IO'10 M i (b) unakrsno blokira vezivanje antitela At-13 ili At-14 za sklerostin i/ili unakrsno je blokirano da se veže za sklerostin antitelom At-13 ili At-14, pri čemu At-13 ima lake lance SEQ ID NO: 205 i teške lance SEQ ID NO: 209 i antitelo At-14 ima lake lance SEQ ID NO: 213 i teške lance SEQ ID NO: 217 ili 393.
2.    Monoklonsko antitelo za korišćenje prema zahtevu 1, koje uključuje konstantni region lakog lanca i/ili teškog lanca.
3.    Monoklonsko antitelo za korišćenje prema zahtevu 2, koje uključuje konstantni region IgG.
4.    Monoklonsko antitelo za korišćenje prema zahtevu 3, koje uključuje konstantni region IgG4 ili IgG2.
5.    Monoklonsko antitelo za korišćenje prema zahtevu 1, koje je antitelo sa jednim domenom, jednolančano antitelo, ili F(ab’)2, Fab, Fab’ ili Fv fragment.
6.    Monoklonsko antitelo za korišćenje prema ma kom od zahteva 1 do 5, koje je humanizovano antitelo ili humano antitelo.
7.    Monoklonsko antitelo za korišćenje prema ma kom od zahteva 1 do 6, koje se vezuje za sklerostin sa afinitetom vezvanja manjim ili jednakim 1 x 10-11 M ili manjim ili jednakim 1 x 10-12 M.
8. Monoklonsko antitelo za korišćenje prema ma kom od zahteva 1 do 7, koje se vezuje za humani sklerostin sa afinitetom koji je najmanje 50, 100, 250, 500, 1000 ili 10,000 puta veći od afiniteta belog lisosima kokošjeg jajeta.
9.    Monoklonsko antitelo za korišćenje prema ma kom od zahteva 1 do 8, pri čemu se unakrsno blokiranje određuje površinskom plazmon rezonancom ili pomoću ELISA.
10.    Monoklonsko antitelo za korišćenje prema zahtevu 9, pri čemu se antitelo koje je unakrsno-blokirajuće antitelo, vezuje za sklerostin u testu Biacore unakrsnog blokiranja tako, daje tokom testa i u prisustvu drugog antitela zabeleženo vezivanje od 75% do 4% maksimalnog teoretskog vezivanja dva antitela u kombinaciji.
11.    Monoklonsko antitelo za korišćenje prema zahtevu 9, koje u rastvorenoj fazi ELISA-e dovodi do smanjivanja od između 60% i 100% količine sklerostina vezanog za antitelo kojim je obložena ELISA ploča, u poređenju sa količinom sklerostina vezanog za oblažuće antitelo u odsustvu antitela u rastvorenoj fazi.
12.    Monoklonsko antitelo prema ma kom od zahteva 1 do 11, za korišćenje u lečenju osteoporoze ili osteopenije.
13.    Monoklonsko antitelo prema ma kom od zahteva 1 do 11, za korišćenje u lečenju sledećeg: osteopenija, osteoporoza, gubitak kosti izazvan ahondroplazijom, kleidokranijalne disostoze, enhondromatoze, fibrozne displazije, Gaucherove bolesti, hipofosfatemijskog rahitisa, Marfanovog sindroma, multiple hereditarne 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, Tumerovog sindroma, Downovog sindroma, Klinefelterovog sindroma, gube, Perthesove bolesti, adolescentne idiopatske skolioze, multisistemske inflamatorne 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, idiopatske osteopenije ili osteoporoze, alkoholizma, hronične bolesti jetre, stanja posle menopauze, hroničnih inflamatomih stanja, reumatoidnog artritisa, inflamatorne 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, fibrozne displazije, 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 i gubitka kosti povezanog sa svemirskim putovanjem.
14. Monoklonsko antitelo prema ma kom od zahteva 1 do 11, za korišćenje poboljšanja ishoda: ortopedskih procedura, dentalnih procedura, implantne hirurgija, zamene zgloba, stavljanja koštanih graftova, kozmetičke hirurgije kostiju ili kostne obnove, kao stoje zaceljivanje frakture, zaceljivanje bez šava, odloženo zaceljivanje sa šavom ili facijalna rekonstrukcija.
15. Farmaceutska smeša koja sadrži antitelo i farmaceutski prihvatljiv nosač, podlogu ili diluent, pri čemu je antitelo monoklonsko antitelo koje (a) vezuje za humani sklerostin sa afinitetom vezivanja manjim od ili jednakim 1 x 10-10M i (b) unakrsno blokira vezivanje antitela At-13 ili At-14 za sklerostin i/ili unakrsno je blokirano da se veže za sklerostin antitelom At-13 ili At-14, pri čemu At-13 ima lake lance SEQ ID NO: 205 i teške lance SEQ ID NO: 209 i antitelo At-14 ima lake lance SEQ ID NO: 213 i teške lance SEQ ID NO: 217 ili 393 i, pri čemu se farmaceutska smeša koristi u postupku povećavanja najmanje jednog od: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti kod sisara, a time lečenje stanja u kome je poželjno povećavanje najmanje jednog od sledećeg: formiranje kosti, mineralna gustina kosti, mineralni sadržaj kosti, koštana masa, kvalitet kosti i jačina kosti.
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