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HRP20200272T1 - Kombinirana terapija za imunocitokine varijante il-2 usmjerene na tumor i protutijela protiv humanog pd-l1 - Google Patents

Kombinirana terapija za imunocitokine varijante il-2 usmjerene na tumor i protutijela protiv humanog pd-l1 Download PDF

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Publication number
HRP20200272T1
HRP20200272T1 HRP20200272TT HRP20200272T HRP20200272T1 HR P20200272 T1 HRP20200272 T1 HR P20200272T1 HR P20200272T T HRP20200272T T HR P20200272TT HR P20200272 T HRP20200272 T HR P20200272T HR P20200272 T1 HRP20200272 T1 HR P20200272T1
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HR
Croatia
Prior art keywords
seq
chain variable
variable domain
heavy chain
light chain
Prior art date
Application number
HRP20200272TT
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English (en)
Inventor
Pablo Umana
Christian Klein
Valeria G. Nicolini
Original Assignee
F. Hoffmann - La Roche Ag
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Application filed by F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20200272T1 publication Critical patent/HRP20200272T1/hr

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Claims (15)

1. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu kao kombinirana terapija u liječenju raka, za upotrebu kao kombinirana terapija u prevenciji ili liječenju metastaza, za upotrebu kao kombinirana terapija u liječenju upalnih bolesti ili za upotrebu kao kombinirana terapija u liječenju ili odgađanju progresije imunološkog oboljenja, poput imuniteta tumora, pri čemu je imunocitokin varijante IL-2 usmjeren na tumor koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži a) polipeptidne sekvence SEKV. ID BR.: 84 i SEKV. ID BR.: 86 i SEKV. ID BR.: 88 ili b) polipeptidne sekvence SEKV. ID BR.:108 i SEKV. ID BR.: 109 i SEKV. ID BR.: 110 ili c) polipeptidne sekvence SEKV. ID BR.: 79 i SEKV. ID BR.: 80 i SEKV. ID BR.: 81 ili d) polipeptidne sekvence SEKV. ID BR.: 124 i SEKV. ID BR.: 125 i SEKV. ID BR.: 126, te je protutijelo koje se veže na humani PD-L1 i koje se koristi u kombiniranoj terapiji, naznačeno time, da sadrži a) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 89, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 92 ili b) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 93 ili c) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 94 ili d) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 95 ili e) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 96 ili f) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 97 ili g) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 98 ili h) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 99 ili i) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 100 ili j) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 101 ili k) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 102 ili l) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 103 ili m) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 104 ili n) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 105 ili o) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 106 ili p) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 91, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 107.
2. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema patentnom zahtjevu 1, naznačen time, da se koristi u liječenju raka.
3. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema patentnom zahtjevu 2,naznačen time, da se koristi u liječenju raka dojke, raka pluća, raka debelog crijeva, raka jajnika, raka melanoma, raka mokraćnog mjehura, renalnog raka, raka bubrega, raka jetre, raka glave i vrata, kolorektalnog raka, melanoma, raka gušterače, raka želuca, raka jednjaka, mezotelioma, raka prostate, leukemije, limfoma, mijeloma.
4. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema patentnom zahtjevu 1, naznačen time, da se koristi u prevenciji ili liječenju metastaza.
5. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema patentnom zahtjevu 1, naznačen time, da se koristi u liječenju upalnih bolesti.
6. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema patentnom zahtjevu 1, naznačen time, da se koristi u liječenju ili odgađanju progresije imunološkog oboljenja, poput imuniteta tumora.
7. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu u i) inhibiciji rasta tumora kod tumora koji eksprimira cilj imunocitokina; i/ili ii) povećanju srednjeg i/ili potpunog preživljavanja ispitanika s tumorom koji eksprimira cilj imunocitokina; pri čemu je cilj predstavljen na tumorskoj stanici ili u okruženju tumorske stanice, gdje je imunocitokin varijante IL-2 usmjeren na tumor koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži a) polipeptidne sekvence SEKV. ID BR.: 84 i SEKV. ID BR.: 86 i SEKV. ID BR.: 88 ili b) polipeptidne sekvence SEKV. ID BR.:108 i SEKV. ID BR.: 109 i SEKV. ID BR.: 110 ili c) polipeptidne sekvence SEKV. ID BR.: 79 i SEKV. ID BR.: 80 i SEKV. ID BR.: 81 ili d) polipeptidne sekvence SEKV. ID BR.: 124 i SEKV. ID BR.: 125 i SEKV. ID BR.: 126; te je protutijelo koje se veže na humani PD-L1 i koje se koristi u kombiniranoj terapiji, naznačeno time, da sadrži a) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 89, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 92 ili b) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 93 ili c) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 94 ili d) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 95 ili e) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 96 ili f) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 97 ili g) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 98 ili h) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 99 ili i) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 100 ili j) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 101 ili k) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 102 ili l) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 103 ili m) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 104 ili n) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 105 ili o) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 106 ili p) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 91, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 107.
8. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 7, u i) inhibiciji rasta tumora u tumorima koji eksprimiraju CEA; i/ili ii) povećavanju srednjeg i/ili potpunog preživljavanja ispitanika s tumorom koji eksprimira CEA, pri čemu imunocitokin varijante IL-2 usmjeren na tumor je imunocitokin varijante IL-2 koji je usmjeren na karcinoembrijski antigen (CEA), gdje se imunocitokin varijante IL-2 usmjeren na CEA primjenjuje u kombinaciji s protutijelom koje se veže na humani PD-L1; pri čemu je imunocitokin varijante IL-2 usmjeren na CEA koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži a) polipeptidne sekvence SEKV. ID BR.: 84 i SEKV. ID BR.: 86 i SEKV. ID BR.: 88 ili b) polipeptidne sekvence SEKV. ID BR.: 108 i SEKV. ID BR.: 109 i SEKV. ID BR.: 110.
9. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 7, u i) inhibiciji rasta tumora kod tumora koji eksprimira FAP; i/ili ii) povećavanju srednjeg i/ili potpunog preživljavanja ispitanika s tumorom koji eksprimira FAP; pri čemu imunocitokin varijante IL-2 usmjeren na tumor je imunocitokin varijante IL-2 koji je usmjeren na aktivacijski protein fibroblasta (FAP), gdje je imunocitokin varijante IL-2 usmjeren na FAP koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži a) polipeptidne sekvence SEKV. ID BR.: 79 i SEKV. ID BR.: 80 i SEKV. ID BR.: 81 ili b) polipeptidne sekvence SEKV. ID BR.: 124 i SEKV. ID BR.: 125 i SEKV. ID BR.: 126.
10. Imunocitokin varijante IL-2 usmjeren na tumor, za upotrebu u liječenju pacijenta koji ima tumor koji eksprimira karcinoembrijski antigen (CEA) ili tumor koji je naznačen time, da eksprimira ili prekomjerno eksprimira CEA, koji ima tumor koji eksprimira aktivacijski protein fibroblasta (FAP) ili tumor koji je naznačen time, da eksprimira ili prekomjerno eksprimira FAP ili ima tumor povezan s ekspresijom ili prekomjernom ekspresijom CEA ili FAP-a, pri čemu se imunocitokin primjenjuje u kombinaciji s protutijelom koje se veže na humani PD-L1, gdje je imunocitokin varijante IL-2 usmjeren na tumor koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži a) polipeptidne sekvence SEKV. ID BR.: 84 i SEKV. ID BR.: 86 i SEKV. ID BR.: 88 ili b) polipeptidne sekvence SEKV. ID BR.:108 i SEKV. ID BR.: 109 i SEKV. ID BR.: 110 ili c) polipeptidne sekvence SEKV. ID BR.: 79 i SEKV. ID BR.: 80 i SEKV. ID BR.: 81 ili d) polipeptidne sekvence SEKV. ID BR.: 124 i SEKV. ID BR.: 125 i SEKV. ID BR.: 126; te je protutijelo koje se veže na humani PD-L1 i koje se koristi u kombiniranoj terapiji, naznačeno time, da sadrži a) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 89, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 92 ili b) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 93 ili c) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 94 ili d) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 95 ili e) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 96 ili f) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 97 ili g) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 98 ili h) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 99 ili i) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 100 ili j) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 101 ili k) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 102 ili l) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 103 ili m) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 104 ili n) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 105 ili o) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 90, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 106 ili p) varijabilnu domenu teškog lanca (VH) SEKV. ID BR.: 91, i varijabilnu domenu lakog lanca (VL) SEKV. ID BR.: 107.
11. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, gdje je imunocitokin varijante IL-2 usmjeren na tumor koji se primjenjuje u kombiniranoj terapiji, naznačen time, da sadrži polipeptidne sekvence SEKV. ID BR.: 84, SEKV. ID BR.: 86 i SEKV. ID BR.: 88 ili polipeptidne sekvence SEKV. ID BR.: 79, SEKV. ID BR.: 80 i SEKV. ID BR.: 81, te je protutijelo koje se veže na humani PD-L1 i koje se koristi u kombiniranoj terapiji, naznačeno time, da sadrži a) varijabilnu domenu teškog lanca VH od SEKV. ID BR.: 89, i varijabilnu domenu lakog lanca VL od SEKV. ID BR.: 92.
12. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da su komponenta protutijela imunocitokina i protutijelo iz podrazreda humanog IgG1 ili podrazreda humanog IgG4.
13. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da navedena protutijela imaju umanjenu ili minimalnu efektorsku funkciju.
14. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je minimalna efektorska funkcija rezultat mutacije Fc bez efektora.
15. Imunocitokin varijante IL-2 usmjeren na tumor u kombinaciji s protutijelom koje se veže na humani PD-L1 za upotrebu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da je Fc mutacija bez efektora L234A/L235A ili L234A/L235A/P329G ili N297A ili D265A/N297A.
HRP20200272TT 2014-08-29 2015-08-25 Kombinirana terapija za imunocitokine varijante il-2 usmjerene na tumor i protutijela protiv humanog pd-l1 HRP20200272T1 (hr)

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