HRP20161146T1 - Anti-c5 antitijela s poboljšanom farmakokinetikom - Google Patents

Anti-c5 antitijela s poboljšanom farmakokinetikom Download PDF

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Publication number
HRP20161146T1
HRP20161146T1 HRP20161146TT HRP20161146T HRP20161146T1 HR P20161146 T1 HRP20161146 T1 HR P20161146T1 HR P20161146T T HRP20161146T T HR P20161146TT HR P20161146 T HRP20161146 T HR P20161146T HR P20161146 T1 HRP20161146 T1 HR P20161146T1
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Croatia
Prior art keywords
antigen
binding fragment
isolated antibody
antibody
seq
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HRP20161146TT
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English (en)
Inventor
Bruce A. Andrien Jr.
Douglas L. Sheridan
Paul P. Tamburini
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Alexion Pharmaceuticals, Inc.
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Application filed by Alexion Pharmaceuticals, Inc. filed Critical Alexion Pharmaceuticals, Inc.
Publication of HRP20161146T1 publication Critical patent/HRP20161146T1/hr

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Claims (15)

1. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, naznačeno time, da: (a) veže se na ljudsku komponentu komplementa C5; (b) inhibira cijepanje C5 na fragmente C5a i C5b; i (c) sadržava: (i) teški lanac CDR1 koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 23, (ii) teški lanac CDR2 koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 19, (iii) teški lanac CDR3 koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 3, (iv) laki lanac CDR1 koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 4, (v) laki lanac CDR2, koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 5 i (vi) laki lanac CDR3 koji sadržava aminokiselinski slijed prikazan u SEQ ID NO: 6.
2. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s patentnim zahtjevom 1, naznačeno time, da sadržava varijabilnu regiju teškog lanca prikazanu u SEQ ID NO: 12 i varijabilnu regiju lakog lanca prikazanu u SEQ ID NO: 8.
3. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time, da sadržava konstantnu regiju teškog lanca prikazanu u SEQ ID NO: 13.
4. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da sadržava polipeptid teškog lanca koja sadržava aminokiselinski slijed prikazan u SEQ ID NO: 14 i polipeptid lakog lanca koji obuhvaća aminokiselinski slijed prikazan u SEQ ID NO: 11.
5. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s patentnim zahtjevom 1 ili 2, naznačeno time, da nadalje sadržava varijantu humane konstantne regije Fc, pri čemu varijanta humane konstantne regije Fc sadržava metionin na poziciji 428 i asparagin na položaju 434, u skladu s EU numeracijom za svaki od njih.
6. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da antitijelo ima poluživot u serumu kod ljudi od najmanje 25 dana.
7. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da se antitijelo ili njegov fragment koji se veže na antigen: (i) veže na ljudski C5 pri pH 7,4 i 25 °C s konstantom afiniteta disocijacije (KD) u rasponu od 0,1 nM ≤ KD ≤ 1 nM ili (ii) veže na ljudski C5 pri pH 6,0 i 25°C uz KD ≥ nm.
8. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je [(KD antitijela, ili njegov fragment koji se veže na antigen za ljudski C5 pri pH 6,0 i pri 25°C)/(KD antitijela, ili njegov fragment koji se veže na antigen ljudski C5 pri pH 7,4 i pri 25 °C)] veći od 25.
9. Izolirano antitijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je antitijelo proizvedeno u CHO stanici.
10. Izolirano antitijelo prema zahtjevu 9, naznačeno time, da antitijelo ne sadržava mjerljive ostatke sijalne kiseline.
11. Farmaceutski pripravak, naznačen time, da sadržava farmaceutski prihvatljivi nosač i antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 10.
12. Terapijski komplet, naznačen time, da uključuje: (i) izolirano antitijelo ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 10 i (ii) sredstvo za administriranje antitijela ili njegovog fragmenta koji se veže na antigen, ljudskom subjektu, pri čemu je sredstvo po izboru šprica.
13. Proizvodni artikl koji sadržava: spremnik s oznakom i pripravak koji sadržava: (i) izolirano antitijelo ili njegov fragment koji se veže na antigen u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time, da oznaka ukazuje da se pripravak primjenjuje na čovjeku koji ima, sumnja se da ima ili predstavlja rizik za razvoj stanja povezanog sa sustavom komplementa.
14. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačeno time, da se rabi u postupku liječenja pacijenta pogođenog stanjem povezanim sa sustavom komplementa.
15. Izolirano antitijelo, ili njegov fragment koji se veže na antigen, namijenjen upotrebi u skladu s patentnim zahtjevom 14, naznačeno time, da je stanje povezano sa sustavom komplementa paroksizmalna noćna hemoglobinuria (PNH) ili atipični hemolitički uremijski sindrom (aHUS).
HRP20161146TT 2014-03-07 2016-09-06 Anti-c5 antitijela s poboljšanom farmakokinetikom HRP20161146T1 (hr)

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