HRP20190740T1 - Kovalentna diatijela i njihove uporabe - Google Patents

Kovalentna diatijela i njihove uporabe Download PDF

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Publication number
HRP20190740T1
HRP20190740T1 HRP20190740TT HRP20190740T HRP20190740T1 HR P20190740 T1 HRP20190740 T1 HR P20190740T1 HR P20190740T T HRP20190740T T HR P20190740TT HR P20190740 T HRP20190740 T HR P20190740T HR P20190740 T1 HRP20190740 T1 HR P20190740T1
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HR
Croatia
Prior art keywords
domain
polypeptide
epitope
molecule according
binding
Prior art date
Application number
HRP20190740TT
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English (en)
Inventor
Leslie S. Johnson
Ling Huang
Original Assignee
Macrogenics, 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.)
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Publication date
Application filed by Macrogenics, Inc. filed Critical Macrogenics, Inc.
Publication of HRP20190740T1 publication Critical patent/HRP20190740T1/hr

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Claims (17)

1. Molekula diatijela koja sadrži prvi polipeptidni lanac i drugi polipeptidni lanac, polipeptidni lanci su kovalentno vezani jedan s drugim, pri čemu: I. prvi polipeptidni lanac sadrži, u smjeru od N-terminalnog kraja do C-terminalnog kraja: (i) prvu domenu koja sadrži područje vezanja varijabilne domene lakog lanca prvog imunoglobulina (VL1) specifičnog za epitop (1), (ii) drugu domenu koja sadrži područje vezanja varijabilne domene teškog lanca drugog imunoglobulina (VH2) specifičnog za epitop (2), i (iii) pozitivno ili negativno nabijenu polipeptidnu domenu koji spontano poprima spiralnu konformaciju, pri čemu pozitivno nabijena polipeptidna domena je separator E-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 299 i negativno nabijena polipeptidna domena je separator K-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 300; navedena prva domena i druga domena su kovalentno povezane tako da se prva domena i druga domena međusobno ne udružuju da tvore mjesto vezanja epitopa (1) ili mjesto vezanja epitopa (2); II. drugi polipeptidni lanac sadrži, u smjeru od N-terminalnog kraja do C-terminalnog kraja: (i) četvrtu domenu koja sadrži područje vezanja varijabilne domene lakog lanca drugog imunoglobulina (VL2) specifičnog za epitop (2), (ii) petu domenu koja sadrži područje vezanja varijabilne domene teškog lanca prvog imunoglobulina (VH1) specifičnog za epitop (1); (iii) pozitivno ili negativno nabijenu polipeptidnu domenu koji spontano poprima spiralnu konformaciju vezana za petu domenu, pri čemu pozitivno nabijena polipeptidna domena je separator E-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 299 i negativno nabijena polipeptidna domena je separator K-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 300, pri čemu kada prvi polipeptidni lanac sadrži separator E-uzvojnice, drugi polipeptidni lanac sadrži separator K-uzvojnice, ili kada prvi polipeptidni lanac sadrži separator K-uzvojnice, drugi polipeptidni lanac sadrži separator E-uzvojnice; navedena četvrta domena i peta domena su kovalentno povezane tako da se četvrta domena i peta domena međusobno ne udružuju da tvore mjesto vezanja epitopa (1) ili mjesto vezanja epitopa (2); pri čemu se prva domena i peta domena međusobno udružuju da tvore mjesto vezanja (VL1)(VH1) koje veže epitop (1); pri čemu se druga domena i četvrta domena međusobno udružuju da tvore mjesto vezanja (VL2)(VH2) koje veže epitop (2).
2. Molekula diatijela prema zahtjevu 1, naznačena time što prvi polipeptidni lanac dodatno obuhvaća treću domenu, pri čemu je treća domena Fc domena, i pri čemu je treća domena vezana za nabijenu polipeptidnu domenu, ili je treća domena vezana za N-terminalni kraj prve domene.
3. Molekula diatijela prema zahtjevu 1 ili 2, naznačena time što drugi polipeptidni lanac dodatno obuhvaća šestu domenu, pri čemu je šesta domena Fc domena, i pri čemu je šesta domena vezana za nabijenu polipeptidnu domenu, ili je šesta domena vezana za N-terminalni kraj četvrte domene.
4. Molekula diatijela prema zahtjevu 1 ili 2, naznačena time što molekula diatijela dodatno obuhvaća treći polipeptidni lanac i četvrti polipeptidni lanac, te su treći i četvrti polipeptidni lanci kovalentno vezani jedan na drugi, pri čemu: III. treći polipeptidni lanac sadrži, u smjeru od N-terminalnog kraja do C-terminalnog kraja: (i) sedmu domenu koja sadrži područje vezanja varijabilne domene lakog lanca trećeg imunoglobulina (VL3) specifičnog za epitop (3), (ii) osmu domenu koja sadrži područje vezanja varijabilne domene teškog lanca četvrtog imunoglobulina (VH4) specifičnog za epitop (4), (iii) pozitivno ili negativno nabijenu polipeptidnu domenu koji spontano poprima spiralnu konformaciju, pri čemu pozitivno nabijena polipeptidna domena je separator E-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 299 i negativno nabijena polipeptidna domena je separator K-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 300, i (iv) devetu domena, pri čemu deveta domena je Fc domena; navedena sedma domena i osma domena su kovalentno povezane tako da se sedma domena i osma domena međusobno ne udružuju da tvore mjesto vezanja epitopa (3) ili mjesto vezanja epitopa (4); IV. četvrti polipeptidni lanac sadrži, u smjeru od N-terminalnog kraja do C-terminalnog kraja: (i) desetu domenu koja sadrži područje vezanja varijabilne domene lakog lanca četvrtog imunoglobulina (VL4) specifičnog za epitop (4), (ii) jedanaestu domenu koja sadrži područje vezanja varijabilne domene teškog lanca trećeg imunoglobulina (VH3) specifičnog za epitop (3); (iii) pozitivno ili negativno nabijenu polipeptidnu domenu koji spontano poprima spiralnu konformaciju vezana za jedanaestu domenu, pri čemu pozitivno nabijena polipeptidna domena je separator E-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 299 i negativno nabijena polipeptidna domena je a separator K-uzvojnice koji ima sekvencu aminokiseline od SEQ ID NO: 300, pri čemu kada treći polipeptidni lanac sadrži separator E-uzvojnice, četvrti polipeptidni lanac sadrži separator K-uzvojnice, ili kada treći polipeptidni lanac sadrži separator K-uzvojnice, četvrti polipeptidni lanac sadrži separator E-uzvojnice; navedena deseta domena i jedanaesta domena su kovalentno povezane tako da se deseta domena i jedanaesta domena međusobno ne udružuju da tvore mjesto vezanja epitopa (3) ili mjesto vezanja epitopa (4); pri čemu se sedma domena i jedanaesta domena međusobno udružuju da tvore mjesto vezanja (VL3)(VH3) koje veže epitop (3); pri čemu se osma domena i deseta domena međusobno udružuju da tvore mjesto vezanja (VL4)(VH4) koje veže epitop (4).
5. Molekula diatijela prema zahtjevu 1, naznačena time što prvi polipeptidni lanac dodatno sadrži: (iv) polipeptidni dio proteina koji se veže na serumski protein, te se polipeptidni dio može vezati na serumski protein.
6. Molekula diatijela prema zahtjevu 5, naznačena time što drugi polipeptidni lanac dodatno sadrži: (iv) polipeptidni dio proteina koji se veže na serumski protein, te se polipeptidni dio može vezati na serumski protein.
7. Molekula diatijela prema zahtjevu 5 ili 6, naznačena time što protein koji se veže na serumski protein je protein koji veže albumin.
8. Molekula diatijela prema zahtjevu 7, naznačena time što protein koji veže albumin je streptokokni protein G i polipeptidni dio je albumin-vezujuća domena (ABD) streptokoknog proteina G.
9. Molekula diatijela prema zahtjevu 8, naznačena time što domena vezanja albumina (ABD) streptokoknog proteina G je albumin-vezujuća domena 3 (ABD3) proteina G soja Streptococcus G 148.
10. Molekula diatijela prema bilo kojem od zahtjeva 1-9, naznačena time što ima domenu koja veže epitop CD16.
11. Molekula diatijela prema bilo kojem od zahtjeva 1-9, naznačena time što ima vezujuću domenu T-staničnog receptora (TCR).
12. Molekula diatijela prema bilo kojem od zahtjeva 1-9, naznačena time što ima domenu koja veže epitop CD79b i domenu koja veže epitop CD32B.
13. Molekula diatijela prema bilo kojem od zahtjeva 1-12, naznačena time što se molekula diatijela veže na antigen povezan s tumorom.
14. Molekula diatijela prema zahtjevu 13, naznačena time što antigen povezan s tumorom je antigen karcinoma dojke, antigen karcinoma jajnika, antigen karcinoma prostate, antigen karcinoma vrata maternice, antigen karcinoma gušterače, antigen karcinoma pluća, antigen karcinoma mjehura. antigen karcinoma debelog crijeva, antigen karcinoma testisa, antigen karcinoma glioblastoma, antigen povezan s malignitetom B stanica, antigen povezan s multiplim mijelomom, antigen povezan s ne-Hodgkinovim limfomom, ili antigen povezan s kroničnom limfocitnom leukemijom.
15. Molekula diatijela prema zahtjevu 13, naznačena time što antigen povezan s tumorom je A33; ADAM-9; ALCAM; B1; BAGE; beta-katenin; CA125; karboksipeptidaza M; CD5; CD19; CD20; CD22; CD23; CD25; CD27; CD28; CD32B; CD36; CD40; CD45; CD46; CD56; CD79a; CD79b; CD103; CD154; CDK4; CEA; CTLA4; Citokeratin 8; EGF-R; receptor efrina; ErbB1; ErbB3; ErbB4; GAGE-1; GAGE-2; GD2; GD3; GM2; gp100; HER-2/neu; ljudski papilomavirus-E6; ljudski papilomavirus-E7; Integrin Alfa-V-Beta-6; JAM-3; KID3; KID31; KSA (17-1A); LUCA-2; MAGE-1; MAGE-3; MART; MUC-1; MUM-1; N-acetilglukozaminiltransferaza; Onkostatin M (Onkostatin Receptor Beta); p15; PIPA; PSA; PSMA; RAAG10; ROR1; SART; sTn; TES7; receptor TNF-α; receptor TNF-β; receptor TNF-γ; receptor transferina ili receptor VEGF.
16. Molekula diatijela prema zahtjevu 15, naznačena time što antigen povezan s tumorom je HER-2/neu.
17. Farmaceutski pripravak naznačen time što sadrži molekulu diatijela prema bilo kojem od prethodnih zahtjeva i farmaceutski prihvatljiv nosač.
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