DK2689016T3 - Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf - Google Patents

Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf Download PDF

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DK2689016T3
DK2689016T3 DK12712389.1T DK12712389T DK2689016T3 DK 2689016 T3 DK2689016 T3 DK 2689016T3 DK 12712389 T DK12712389 T DK 12712389T DK 2689016 T3 DK2689016 T3 DK 2689016T3
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polypeptide
blp
protan
binding
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Cornelis Johannes Leenhouts
Bert Jan Haijema
Roosmalen Maarten Leonardus Van
Petrus Josephus Marie Rottier
Haan Cornelis Alexander Maria De
Berend Jan Bosch
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Mucosis Bv
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Claims (16)

1. Immunogen sammensætning i partikelform, hvilken sammensætning omfatter: i. en ikke-levedygtig bakterielignende partikel (BLP) opnået fra en Gram-positiv bakterie som partikelbærer; ii. oligomerer af et rekombinant produceret polypeptid, der ikke-kovalent er bundet til BLP’en, hvor det rekombinante polypeptid omfatter: A) et N- eller C-terminalt antigent domæne, der mindst omfatter et overfladeeksponeret polypeptid af patogen eller tumoroprindelse, eller en antigen del deraf, hvilket antigent domæne er kondenseret til B) et oligomeriseringsdomæne (OMD), hvilket oligomeriseringsdomæne er kondenseret via C) et linker-domæne til D) et peptidoglycan-bindende domæne (PBD) bestående af en enkelt kopi af et LysM-domæne, der medierer den ikke-kovalente binding af polypeptidet til BLP’en, og hvor polypeptidet som en helhed kun indeholder en enkelt kopi af et LysM-domæne; og iii. et farmaceutisk acceptabelt fortyndingsmiddel eller excipiens.
2. Immunogen sammensætning ifølge krav 1, hvor det overfladeeksponerede polypeptid i det antigene domæne af det rekombinante polypeptid omfatter et ektodomæne af et kappeklædt virusprotein, fortrinsvis hvor virusset er influenzavirus, animalsk coronavirus, humane respiratoriske coronavira, humant immundefekt virus (HIV) eller paramyxovirus, navnlig respiratorisk syncytialvirus (RSV) eller metapneumovirus.
3. Immunogen sammensætning ifølge krav 2, hvor det overfladeeksponerede polypeptid eller den antigene del deraf er udvalgt lfa gruppen bestående af influenzahæmagglutinin (HA) ektodomæne eller en del deraf, influenzaneuraminidase (NA) ektodomæne eller en del deraf, coronavirus spike- (S) protein ektodomæne eller en del deraf, RSV-glycoprotein F- eller G-ektodomæner eller dele deraf og HIV gpl40 ektodomæne eller en del deraf.
4. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor linker-domænet af det rekombinante polypeptid består af mellem 10 og 60, fortrinsvis 20-50, mere fortrinsvis 25-40 aminosyrer, for eksempel ca. 30 aminosyrer.
5. Immunogen sammensætning ifølge krav 4, hvor linker-domænet omfatter en aminosyresekvens udvalgt fra gruppen bestående af: GASSAGNTNSGGSTTTITNNNSGTNSSST, GSASSTNSGGSNNSASTTPTTSVTPAKPTSQ og QSAAASNPSTGSGSTATNNSNSTSSNSNAS.
6. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor oligomeriseringsdomænet (OMD) af det rekombinante polypeptid er et dimeriserings-, trimeriserings- eller tetrameriseringsdomæne, fortrinsvis hvor oligomeriseringsdomænet er udvalgt fra et GCN4-baseret di-, tri- eller tetrameriseringsdomæne, den C-terminale domænesekvens af T4 fibritin (foldon) eller en funktionel del eller analog deraf (C-terminale 27 til 30 rester) og det opløselige trimeriseringsdomæne af kyllingebruskmatrix- (CART) protein.
7. Immunogen sammensætning ifølge et hvilket som helst af kravene 1 -6, hvor det rekombinante polypeptid endvidere omfatter, i tilfælde af et N-terminalt antigent domæne, en C-terminal capping-sekvens, eller i tilfælde af et C-terminalt antigent domæne, en N-terminal capping-sekvens.
8. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor bakterien er en ikke-patogen bakterie, fortrinsvis en bakterie af fødevarekvalitet, mere fortrinsvis hvor bakterien er udvalgt fra gruppen bestående af en Lactococcus, en Lactobacillus, en Bacillus og en Mycobacterium ssp.
9. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor partikelbæreren ikke-kovalent er forsynet med mindst en første oligomer af polypeptider omfattende overfladeeksponerede polypeptider eller antigene dele deraf afledt af et første patogen og en anden oligomer af polypeptider omfattende overfladeeksponerede polypeptider eller antigene dele deraf afledt af et andet patogen.
10. Fremgangsmåde til tilvejebringelse af en immunogen sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvilken fremgangsmåde omfatter følgende trin: a) tilvejebringelse af et rekombinant polypeptid som anført i et hvilket som helst af kravene 1-7, omfattende dyrkning af en værtscelle omfattende en ekspressionsvektor, der koder for polypeptidet i et egnet medium, der muliggør ekspression af polypeptidet, og isolering af polypeptidet; b) tilvejebringelse af en ikke-levedygtig bakterielignende partikel (BLP) opnået fra en Gram-positiv bakterie, c) tilladelse til ikke-kovalent binding af polypeptidet/-peptideme til BLP’en for at danne et immunogent kompleks omfattende oligomerer af et overfladeeksponeret polypeptid af patogen oprindelse eller en antigen del deraf, der er ikke-kovalent bundet til en partikelbærer, og d) formulering af det immunogene kompleks til en immunogen sammensætning.
11. Immunogen sammensætning ifølge et hvilket som helst af kravene 1 til 9 til anvendelse i en fremgangsmåde til fremkaldelse af et immunrespons mod et patogen hos et individ, hvilken fremgangsmåde omfatter administration af sammensætningen til individet.
12. Immunogen sammensætning til anvendelse ifølge krav 11 til fremkaldelse af et immunrespons mod en virussygdom hos et individ, fortrinsvis hvor virussygdommen er forårsaget af influenzavirus, animalsk coronavirus, humane respiratoriske coronavira, humant immundefekt virus (HIV) eller paramyxovirus, navnlig respiratorisk syncytialvirus (RSV) eller metapneumo virus.
13. Rekombinant polypeptid omfattende: A) et N- eller C-terminalt antigent domæne, der mindst omfatter et overfladeeksponeret polypeptid (f.eks. af patogen eller tumorcelleoprindelse) eller en antigen del deraf, hvilket antigent domæne er kondenseret til B) et oligomeriseringsdomæne (OMD), hvilket oligomeriseringsdomæne er kondenseret via C) et linker-domæne til D) et peptidoglycan-bindende domæne (PBD) bestående af en enkelt kopi af et LysM-domæne, der er i stand til at mediere den ikke-kovalente binding af polypeptidet til en peptidoglycanbærerpartikel, der er en ikke-levedygtig bakterielignende partikel (BLP), der er opnået fra en Gram-positiv bakterie, og hvor polypeptidet som en helhed kun indeholder en enkelt kopi af et LysM-domæne.
14. Nukleinsyresekvens, der koder for et polypeptid ifølge krav 13.
15. Vektor omfattende en nukleinsyresekvens ifølge krav 14.
16. Værtscelle, der omfatter en nukleinsyresekvens ifølge krav 14 eller en vektor ifølge krav 15, fortrinsvis hvor værtscellen er en eukaryot værtscelle, mere fortrinsvis en pattedyreværtscelle.
DK12712389.1T 2011-03-22 2012-03-22 Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf DK2689016T3 (da)

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