DK2572726T3 - Sammensætninger omfattende pneumokokantigener - Google Patents

Sammensætninger omfattende pneumokokantigener Download PDF

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DK2572726T3
DK2572726T3 DK12197549.4T DK12197549T DK2572726T3 DK 2572726 T3 DK2572726 T3 DK 2572726T3 DK 12197549 T DK12197549 T DK 12197549T DK 2572726 T3 DK2572726 T3 DK 2572726T3
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seq
antigen
amino acid
acid sequence
epitope
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DK12197549.4T
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Claudio Donati
Alessandro Muzzi
Vega Masignani
Fabio Bagnoli
Paolo Ruggiero
Michéle Barrochi
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Glaxosmithkline Biologicals Sa
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/315—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Streptococcus (G), e.g. Enterococci
    • C07K14/3156—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Streptococcus (G), e.g. Enterococci from Streptococcus pneumoniae (Pneumococcus)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/40—Fusion polypeptide containing a tag for immunodetection, or an epitope for immunisation
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Claims (14)

1. Immunogen sammensætning omfattende en kombination af S.pneumoniae-antigener, hvor kombinationen omfatter et spr0096-antigen og et spr2021-antigen, hvor: spr0096-antigenet er et polypeptid, som omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 12; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 12; og spr2021-antigenet er et polypeptid, som omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 11; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 11.
2. Immunogen sammensætning ifølge krav 1 omfattende ét eller flere antigen(er) valgt fra gruppen bestående af: (1) et sprl739-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 10; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 10; (2) et spr0867-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 8; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 8; (3) et sprl431-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 9; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 9; (4) et sprl433-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 13; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 13; (5) et sprl707-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 14; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 14; (6) et spr0057-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 1; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 1; (7) et spr0565-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 3; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 3; (8) et sprl345-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 5; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 5; (9) et sprl416-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 6; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 6; (10) et sprl418-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 7; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 8; (11) et sprl098-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 4; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 4; og/eller (12) et spr0286-antigen omfattende en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 2; og/eller (b) omfattende et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 2; hvor fortrinsvis, nævnte ét eller flere antigen(er) er valgt fra gruppen bestående af: (1) sprl739-antigen; (2) et spr0867-antigen; (3) et sprl431-antigen; (4) et sprl433-antigen; og/eller (5) et sprl707-antigen.
3. Immunogen sammensætning ifølge krav 1, omfattende et spr0057-antigen og/eller et spr0565-antigen.
4. Sammensætning ifølge krav 3, yderligere omfattende ét eller flere af: (a) et S.pneumoniae RrgA- og/eller RrgB-pilus-antigen; (b) et S.pneumoniae Pmp-antigen; og/eller (c) ét eller flere konjugat(er) af et kapselformigt pneumokok-saccharid og et bærerprotein, hvor (i) det kapselformige saccharid er fra én eller flere af de følgende pneumo-kok-serotyper: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F og 23F; og (ii) bærerproteinet er et bakterielt toksin eller toksoid, eller er protein-D fra H.influenzae. hvor: RrgA-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 172 eller 179; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 172 eller 179; RrgB-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 173, 174 eller 175; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 173, 174, eller 175; og/eller Pmp-antigen omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 28; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 28.
5. Immunogen sammensætning ifølge krav 1 eller krav 2 omfattende: (a) ét eller flere konjugat(er) af et kapselformigt pneumokoksaccharid og et bærerprotein; (b) ét eller flere antigen(er) valgt fra gruppen bestående af: difteritoksoid; teta-nustoksoid; hepatitis B-virusoverfladeantigen; et inaktiveret poliovirusantigen; ét eller flere acellulær(t/e) pertussisantigen(/er); et konjugat af det kapselformige saccharidanti-gen fra H.influenzae type B; et konjugat af det kapselformige saccharidantigen fra se-rogruppe C af N.meningitidis; et konjugat af det kapselformige saccharidantigen fra se- rogruppe Y af N.meningitidis; et konjugat af det kapselformige saccharidantigen fra se-rogruppe W135 af N.meningitidis·, og et konjugat af det kapselformige saccharidantigen fra serogruppe A af N.meningitidis; eller (c) et temperaturbeskyttende middel, som forbedrer termostabiliteten af sammensætningen.
6. Polypeptid ifølge formel NH2-A-{-X-L-}n-B-COOH, hvor: X er en aminosyresekvens af et pneumokokantigen, valgt fra gruppen bestående af: (1) et spr0057-antigen; (2) et spr0096-antigen; (3) et spr0565-antigen; og (4) et spr2021-antigen; (5) et RrgA-antigen; og (6) et RrgB-antigen; L er en eventuel linker-aminosyresekvens; A er en eventuel N-terminal-aminosyresekvens; B er en eventuel C-terminal-aminosyresekvens, n er et heltal på 2 eller mere; og mindst én forekomst af X er spr0096 og mindst én forekomst af X er spr2021; hvor: spr0057-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 1; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 1; spr0096-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 12; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 12; spr0565-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 3; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 3; spr2021-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 11; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 11; RrgA-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 172 eller 179; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 172 eller 179; og/eller RrgB-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 173, 174 eller 175; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 173, 174, eller 175.
7. Polypeptid ifølge krav 6, der har formlen NH2-A-Xi-Li-X2-L2-B-COOH, hvor: (a) Xi er en aminosyresekvens af et spr0096-pneumokokantigen og X2 er en aminosyresekvens af et spr2021-pneumokokantigen; eller (b) Xi er en aminosyresekvens af et spr2021-pneumokokantigen og X2 er en aminosyresekvens af et spr0096-pneumokokantigen; L er en eventuel linker-aminosyresekvens; A er en eventuel N-terminal-aminosyresekvens; B er en eventuel C-terminal-aminosyresekvens; og, hvor: spr0096-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 12; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 12; og/eller spr2021-antigenet omfatter en aminosyresekvens: (a), der har 80% eller mere identitet med SEQ ID NO: 11; og/eller (b) omfatter et fragment af mindst 10 på hinanden følgende aminosyrer, omfattende en epitop ifølge SEQ ID NO: 11.
8. Polypeptidet ifølge krav 6 eller krav 7, hvor mindst én L-sekvens omfatter Glyx, hvor x = 2, 3, 4, 5, 6, 7, 8, 9 eller 10.
9. Polypeptidet ifølge krav 6 eller krav 7, omfattende en aminosyresekvens valgt fra gruppen bestående af SEQ ID NOs: 194 og 205.
10. Polypeptid, der har 75% eller mere sekvensidentitet med en aminosyresekvens valgt fra gruppen bestående af SEQ ID NOs: 194 og 205.
11. Immunogen sammensætning omfattende polypeptidet ifølge et hvilket som helst af krav 6 til 10.
12. Nukleinsyre, der koder for polypeptidet ifølge et hvilket som helst af krav 6 til 10.
13. Immunogen sammensætning ifølge et hvilket som helst af krav 1-5 eller 11 til anvendelse i en fremgangsmåde til fremkaldelse af et immunrespons hos et pattedyr.
14. Immunogen sammensætning ifølge krav 13 til anvendelse i beskyttelse af pattedyret mod pneumokokinfektion.
DK12197549.4T 2007-08-01 2008-08-01 Sammensætninger omfattende pneumokokantigener DK2572726T3 (da)

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GBGB0714963.6A GB0714963D0 (en) 2007-08-01 2007-08-01 Compositions comprising antigens
US96686607P 2007-08-29 2007-08-29
EP08826694A EP2197484A2 (en) 2007-08-01 2008-08-01 Compositions comprising pneumococcal antigens

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EP (2) EP2572726B1 (da)
JP (2) JP2010535025A (da)
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AP (1) AP2010005173A0 (da)
AU (1) AU2008281438A1 (da)
BR (1) BRPI0813892A2 (da)
CA (1) CA2695169A1 (da)
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