HRP20100303T1 - Cd20 antitijela s povećanim afinitetom vezivanja fc receptora i efektorskim djelovanjem - Google Patents

Cd20 antitijela s povećanim afinitetom vezivanja fc receptora i efektorskim djelovanjem Download PDF

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Publication number
HRP20100303T1
HRP20100303T1 HR20100303T HRP20100303T HRP20100303T1 HR P20100303 T1 HRP20100303 T1 HR P20100303T1 HR 20100303 T HR20100303 T HR 20100303T HR P20100303 T HRP20100303 T HR P20100303T HR P20100303 T1 HRP20100303 T1 HR P20100303T1
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Croatia
Prior art keywords
antibody
seq
variable region
sequence
heavy chain
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HR20100303T
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English (en)
Inventor
Umana Pablo
Br�nker Peter
Ferrara Koller Claudia
Suter Tobias
P�ntener Ursula
M�ssner Ekkehard
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Roche Glycart Ag
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34572912&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20100303(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Roche Glycart Ag filed Critical Roche Glycart Ag
Publication of HRP20100303T1 publication Critical patent/HRP20100303T1/hr

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Abstract

Humanizirano, gliko-inžinjeringom obrađeno anti-CD20 antitijelo Tipa II, naznačeno time, da ima povećan ADCC kao rezultat navedenog gliko-inžinjeringa i da ima povećanu sposobnost induciranja apoptoze ciljanih stanica nakon navedene humanizacije, pri čemu navedeo antitijelo sadrži težak lanac varijabilne regije koja sadrži komplementarno određujuće regije (CDRs) mišjeg B-Ly1 antitijela, gdje: a. težak lanac CDR1 je SEQ ID NO: 16; b. težak lanac CDR2 je SEQ ID NO: 26; tec. težak lanac CDR3 je SEQ ID NO: 28; gdje okvirna područja teškog lanca varijabilne regije (FRs) FR1, FR2 i FR3 navedenog antitijela su humane FR sekvence kodirane pomoću VH1-10 humane sekvence zametne-linije te težak lanac varijabilne regije FR4 navedenog antitijela je humana FR sekvenca kodirana pomoću JH4 humane sekvence zametne-linije, te gdje navedeno antitijelo nadalje sadrži lagani lanac varijabilne regije koji sadrži CDRs mišjeg B-Ly1 antitijela gdje: d. lagani lanac CDR1 je SEQ ID NO: 18; e. lagani lanac CDR2 je SEQ ID NO: 19; tef. lagani lanac CDR3 je SEQ ID NO: 20; gdje lagani lanac varijabilne regije FRs FR1, FR2 i FR3 navedenog antitijela su humane FR sekvence kodirane pomoću VK-2-40 humane sekvence zametne-linije i lagani lanac varijabile regije FR4 navedenog antitijela je humana FR sekvenca kodirana pomoću JK4 humane sekvence zametne-linije. Patent sadrži još 19 patentnih zahtjeva.

Claims (20)

1. Humanizirano, gliko-inžinjeringom obrađeno anti-CD20 antitijelo Tipa II, naznačeno time, da ima povećan ADCC kao rezultat navedenog gliko-inžinjeringa i da ima povećanu sposobnost induciranja apoptoze ciljanih stanica nakon navedene humanizacije, pri čemu navedeo antitijelo sadrži težak lanac varijabilne regije koja sadrži komplementarno određujuće regije (CDRs) mišjeg B-Ly1 antitijela, gdje: a. težak lanac CDR1 je SEQ ID NO: 16; b. težak lanac CDR2 je SEQ ID NO: 26; te c. težak lanac CDR3 je SEQ ID NO: 28; gdje okvirna područja teškog lanca varijabilne regije (FRs) FR1, FR2 i FR3 navedenog antitijela su humane FR sekvence kodirane pomoću VH1-10 humane sekvence zametne-linije te težak lanac varijabilne regije FR4 navedenog antitijela je humana FR sekvenca kodirana pomoću JH4 humane sekvence zametne-linije, te gdje navedeno antitijelo nadalje sadrži lagani lanac varijabilne regije koji sadrži CDRs mišjeg B-Ly1 antitijela gdje: d. lagani lanac CDR1 je SEQ ID NO: 18; e. lagani lanac CDR2 je SEQ ID NO: 19; te f. lagani lanac CDR3 je SEQ ID NO: 20; gdje lagani lanac varijabilne regije FRs FR1, FR2 i FR3 navedenog antitijela su humane FR sekvence kodirane pomoću VK-2-40 humane sekvence zametne-linije i lagani lanac varijabile regije FR4 navedenog antitijela je humana FR sekvenca kodirana pomoću JK4 humane sekvence zametne-linije.
2. Antitijelo u skladu sa zahtjevom 1, naznačeno time, da navedeno antitijelo sadrži izolirani polipeptid koji sadrži sekvencu teškog lanca varijabilne regije od SEQ ID NO: 32 ili SEQ ID NO: 40.
3. Antitijelo u skladu sa zahtjevom 1 ili zahtjevom 2, naznačeno time, da navedeno antitijelo sadrži izolirani polipeptid koji sadrži sekvencu teškog lanca varijabilne regije od SEQ ID NO: 40.
4. Antitijelo u skladu s bilo kojim zahtjevom 1-3, naznačeno time, da navedeno antitijelo sadrži izolirani polipeptid koji sadrži sekvencu lakog lanca varijabilne regije od SEQ ID NO: 76.
5. Antitijelo u skladu s bilo kojim zahtjevom 1-4, naznačeno time, da navedeno antitijelo sadrži prvi izolirani polipeptid koji sadrži sekvencu teškog lanca varijabilne regije od SEQ ID NO: 32 ili SEQ ID NO: 40 te drugi izolirani polipeptid koji sadrži sekvencu laganog lanca varijabilne regije od SEQ ID NO: 76.
6. Antitijelo u skladu s bilo kojim zahtjevom 1-5, naznačeno time, da navedeno antitijelo sadrži prvi izolirani polipeptid koji sadrži sekvencu teškog lanca varijabilne regije od SEQ ID NO: 40 te drugi izolirani polipeptid koji sadrži sekvencu laganog lanca varijabilne regije od SEQ ID NO: 76.
7. Antitijelo u skladu s bilo kojim zahtjevom 1-6, naznačeno time, da je navedeno antitijelo bilo obrađeno gliko-inžinjeringom tako da ima povećanje u količini dvosekcijskih kompleksnih oligosaharida.
8. Antitijelo u skladu s bilo kojim zahtjevom 1-7, naznačeno time, da je navedeno antitijelo bilo obrađeno gliko-inžinjeringom tako da ima smanjenje u količini fukoza ostataka.
9. Antitijelo u skladu s bilo kojim zahtjevom 1-8, naznačeno time, da navedeno antitijelo ima Fc regiju s modificiranim oligosaharidima.
10. Antitijelo u skladu sa zahtjevom 9, naznačeno time, da najmanje 20% oligosaharida u Fc regiji navedenog polipeptida je dvosekcijsko, ne-fukozilirano.
11. Antitijelo u skladu sa zahtjevom 9, naznačeno time, da najmanje 50% oligosaharida u Fc regiji je ne-fukozilirano.
12. Stanica domaćin, naznačena time, da vrši ekspresiju barem jednog polipeptida kodirajućeg za nukleinsku kiselinu koji ima β(1,4)-N-acetilglukozaminiltransferaza III djelovanje u količini dovoljnoj da djeluje gliko-inžinjeringom na Fc regiju polipeptida proizvedenog pomoću stanice domaćina, gdje navedeni polipeptid je antitijelo u skladu s bilo kojim zahtjevom 1-11.
13. Stanica domaćin u skladu sa zahtjevom 12, naznačena time, da navedeno antitijelo proizvedeno pomoću stanice domaćina pokazuje povećani afinitet vezivanja Fc receptora kao rezultat navedenog gliko-inžinjeringa.
14. Stanica domaćin u skladu sa zahtjevom 13, naznačena time, da navedeni Fc receptor je FcγRIIIA receptor.
15. Stanica domaćin u skladu sa zahtjevom 12, naznačena time, da navedeno antitijelo proizvedeno pomoću stanice domaćina pokazuje povećano efektorsko djelovanje kao rezultat navedenog gliko-inžinjeringa.
16. Stanica domaćin u skladu sa zahtjevom 15, naznačena time, da navedeno povećano efektorsko djelovanje je povećano izravnim signaliziranjem indukcije apoptoze.
17. Stanica domaćin u skladu sa zahtjevom 12, naznačena time, da nadalje sadrži najmanje jedan transfektiran polinukleotid kodirajući za polipeptid u skladu s bilo kojim zahtjevom 2, 3, 5 ili 6 te gdje navedena nukleinska kiselina sadrži sekvencu kodirajuću za regiju ekvivalentnu Fc regiji humanog imunoglobulina.
18. Farmaceutski pripravak, naznačen time, da sadrži antitijelo u skladu s bilo kojim zahtjevom 1-11 i farmaceutski prihvatljivu podlogu.
19. Antitijelo u skladu s bilo kojim zahtjevom 1-11, naznačeno time, da se koristi kao lijek za liječenje B staničnog limfoma.
20. Uporaba antitijela u skladu s bilo kojim zahtjevom 1-11, naznačena time, da se koristi za izradu lijeka za liječenje B staničnog limfoma.
HR20100303T 2003-11-05 2010-05-27 Cd20 antitijela s povećanim afinitetom vezivanja fc receptora i efektorskim djelovanjem HRP20100303T1 (hr)

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