ME02280B - Antagonisti toll-like receptora 3 - Google Patents

Antagonisti toll-like receptora 3

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Publication number
ME02280B
ME02280B MEP-2015-188A MEP18815A ME02280B ME 02280 B ME02280 B ME 02280B ME P18815 A MEP18815 A ME P18815A ME 02280 B ME02280 B ME 02280B
Authority
ME
Montenegro
Prior art keywords
amino acid
seq
acid sequence
isolated antibody
treatment
Prior art date
Application number
MEP-2015-188A
Other languages
English (en)
Inventor
Mark Cunningham
Fang Teng
Alexey Teplyakov
Sheng-Jiun Wu
Yiqing Feng
Katharine Heeringa
Jinquan Luo
Robert Rauchenberger
Mark Rutz
Mateo Lani San
Robert T Sarisky
Raymond Sweet
Original Assignee
Janssen Biotech 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
Priority claimed from US12/609,675 external-priority patent/US8409567B2/en
Application filed by Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of ME02280B publication Critical patent/ME02280B/me

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    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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Claims (9)

1.Izolovano antitelo ili njegov fragment, naznačeno time što se antitelo vezuje za aminokiselinske rezidue toll-like receptora 3 (TLR3): K416, K418, L440, N441, E442, Y465, N466, K467, Y468, R488, R489, A491, K493, N515, N516, N517, H539, N541, S571, L595 i K619 sekvence SEK ID NO: 2.
2.Izolovano antitelo prema zahtevu 1, naznačeno time što antitelo sadrži regione teških lanaca koji određuju komplementarnost (CDR regione) 1, 2 i 3 (HCDR1, HCDR2, HCDR3) koji imaju aminokiselinske sekvence prikazane u SEK ID NO 82, 86 i 84, respektivno, i regione lakih lanaca koji određuju komplementarnost 1, 2 i 3 (LCDR1, LCDR2, LCDR3) koji imaju amino kiselinske sekvence prikazane u SEK ID NO: 79, 80 i 87, respektivno, i sadrži okvirni region lakog lanca koji je najmanje 90% identičan sa aminokiselinskom sekvencom varijabilnog regiona lakog lanca kapa 1 okvira (Vki) i okvirni region teškog lanca koji je najmanje 90% identičan sa aminokiselinskom sekvencom okvira VF15 varijabilnog regiona teškog lanca (Vh5).
3.Izolovano antitelo prema zahtevu 2, naznačeno time što je Vki okvir kodiran IGKV1-39*01 genom koji ima amino kiselinsku sekvencu prikazanu u SEK ID NO: 221, i naznačeno time što je VF15 okvir kodiran IGHV5-51 * 01 genom koji ima aminokiselinsku sekvencu prikazanu u SEK ID NO: 222.
4.Izolovano antitelo prema zahtevu 3, koje sadrži varijabilni region teškog lanca koji ima aminokiselinsku sekvencu prikazanu u SEK ID NO: 216 i varijabilni region lakog lanca koji ima aminokiselinsku sekvencu prikazanu u SEK ID NO: 41.
5.Izolovano antitelo prema bilo kojem od prethodnih patentnih zahteva, naznačeno time što antitelo ima najmanje jedno od sledećih svojstava: a.vezuje se sa humanim TLR3 sa Kd <10 nM; b.smanjuje biološku aktivnost humanog TLR3 u in vitro poly(l:C) NF-kB testu reporterskog gena > 50% pri 1 pg/ml; c.inhibira > 60% produkciju IL-6 ili CXCLio/IP-io od strane BEAS-2B ćelija stimulisanih sa <100 ng/ml poly(l:C) pri 10 pg/ml; d.inhibira > 50% produkciju IL-6 ili CXCLio/IP-io od strane BEAS-2B ćelija stimulisanih sa <100 ng/ml poly (l:C) pri 0.4 pg/ml; e.inhibira> 50% produkciju IL-6 od strane NHBE ćelija stimulisanih sa 62.5 ng/ml poly(l:C) pri 5 pg/ml; f.inhibira> 50% produkciju IL-6 od strane NHBE ćelija stimulisanih sa 62.5 ng/ml poly(l:C) pri 1 pg/ml; g.inhibira> 20% poly(l:C) indukovanu produkciju IFN-y, IL-6 ili IL-12 od strane PBMC pri 1 pg/ml; h.inhibira biološku aktivnost cynomologus TLR3 u in vitro NF-kB testu reporterskog gena sa IC50 <10 pg/ml; ili i.inhibira biološku aktivnost cynomologus TLR3 u in vitro ISRE testu reporterskog gena sa IC50<5 pg/ml.
6. Izolovano antitelo ili fragment prema bilo kojem od prethodnih patentnih zahteva, naznačeno time što je antitelo a.potpuno humano; b.humano-adaptirano; c.konjugovano sa polietilen glikolom; d.lgC4 izotipa; ili e.njegov Fc domen sadrži S229P, P235A ili L236A mutacije.
7.Izolovano antitelo prema bilo kojem od prethodnih patentnih zahteva, koje sadrži teški lanac koji ima amino kiselinsku sekvencu prikazanu u SEK ID NO: 220 i laki lanac koji ima aminokiselinsku sekvencu prikazanu u SEK ID NO: 156.
8.Farmaceutska kompozicija koja sadrži izolovano antitelo ili fragment iz bilo kojeg od patentnih zahteva 1-7 i farmaceutski prihvatljiv nosač.
9.Izolovano antitelo prema bilo kojem od patentnih zahteva 1 do 7 ili farmaceutska kompozicija prema zahtevu 8 za upotrebu u: a)lečenju inflamatornog stanja, pri čemu to lečenje sadrži administraciju terapeutski efikasne količine antitela ili farmaceutske kompozicije pacijentu kome je to potrebno tokom vremena dovoljnog za lečenje ili prevenciju inflamatornog stanja gde je inflamatorno stanje na primer: i.stanje pulmonalne inflamacije, pri čemu je stanje pulmonalne inflamacije opciono: astma, hronična opstruktivna bolest pluća (COPD), hiperosetljivost disajnih puteva, ili je indukovano atipičnom Hemofilus influencom; ii.inflamatorna bolest creva; iii.autoimuna bolest; iv.sistemsko inflamatorno stanje, pri čemu je sistemsko inflamatorno stanje opciono: citokinska oluja ili hipercitokinemija, sindrom sistemskog inflamatornog odgovora (SIRS), graft versus host sindrom (CVHD), akutni respiratorni distres sindrom (ARDS), teški akutni respiratorni distres sindrom (SARS), katastrofalni anti-fosfolipidni sindrom, teške virusne infekcije, influenca, pneumonija, stanje šoka ili sepsa; v.reumatoidni artritis; ili vi.povezano sa gastrointestinalnom ulceracijom, pri čemu je gastrointestinalna ulceracija opciono povezana sa infektivnim kolitisom, ishemijskim kolitisom, kolagenim ili limfocitnim kolitisom ili nekrotizirajućim enterokolitisom; b)lečenju dijabetesa tipa II, hiperglikemije ili hiperinsulinemije, pri čemu lečenje obuhvata administraciju terapeutski efikasne količine antitela ili farmaceutskog preparata pacijentu kome je to potrebno tokom vremena dovoljnog za lečenje dijabetesa tipa II, hiperglikemije ili hiperinsulinemije; ili c)lečenju ili prevenciji virusnih infekcija, gde pomenuto lečenje ili prevencija obuhvata administraciju terapeutski efikasne količine antitela ili farmaceutskog preparata pacijentu kome je to potrebno, tokom vremena dovoljnog za tretiranje ili prevenciju virusne infekcije, pri čemu je virusna infekcija opciono influenca virus A.
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