HRP20171580T1 - Ljudska monoklonska protutijela koja su specifična za protein e denga virusa serotipa 1 i njihova upotreba - Google Patents

Ljudska monoklonska protutijela koja su specifična za protein e denga virusa serotipa 1 i njihova upotreba Download PDF

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HRP20171580T1
HRP20171580T1 HRP20171580TT HRP20171580T HRP20171580T1 HR P20171580 T1 HRP20171580 T1 HR P20171580T1 HR P20171580T T HRP20171580T T HR P20171580TT HR P20171580 T HRP20171580 T HR P20171580T HR P20171580 T1 HRP20171580 T1 HR P20171580T1
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antibody
fragment
amino acid
fragment according
constant domain
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HRP20171580TT
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Paul Anthony Macary
Ee Ping Evelyn Teoh
Brendon John Hanson
En Wei Teo
Angeline Pei Chiew Lim
Mah Lee Mary Ng
Shee Mei Lok
Petra Eveliina Kukkaro
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National University Of Singapore
Dso National Laboratories
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    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1081Togaviridae, e.g. flavivirus, rubella virus, hog cholera virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Claims (24)

1. Izolirano protutijelo ili njegov fragment koji se specifično veže za protein (E) omotača Denga virusa serotipa 1 ili njegov fragment, naznačeno time da je protutijelo ljudsko protutijelo s neutralizirajućom aktivnošću koje se veže preko dva proteina E u virusu, pri čemu vezivanje preko dva proteina E obuhvaća vezanje za DI i zglob između DI i II na jednom proteinu E i DIII na susjednom proteinu E.
2. Protutijelo ili njegov fragment prema zahtjevu 1, naznačeno time da se protutijelo ili njegov fragment bira iz skupine koja se sastoji od: (a) cijele molekule imunoglobulina; (b) scFv; (c) Fab fragmenta; (d) F(ab’)2; i (e) disulfidom povezanog Fv.
3. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: teški lanac konstantne domene imunoglobulina koji se bira iz skupine koju čine: (a) konstantna domena ljudskog IgM; (b) konstantna domena ljudskog IgG1; (c) konstantna domena ljudskog IgG2; (d) konstantna domena ljudskog IgG3; (e) konstantna domena ljudskog IgG4; i (f) konstantna domena ljudskog IgA1/2;
4. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: teški lanac koji se sastoji iz najmanje jednog CDR koji se bira iz skupine CDR-a sa sekvencama aminokiselina SYGMH, VIWYDGSKTYYGDSVKG ili GIAGGWAFW.
5. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: teški lanac koji sadrži tri CDR-a sa sekvencama aminokiselina SYGMH, VIWYDGSKTYYGDSVKG i GIAGGWAFW.
6. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: teški lanac sa sekvencom aminokiselina [image] [image]
7. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: okvir teškog lanca IGHV1-2*02 i najmanje jedan CDR sa sekvencom aminokiselina SYGMH, VIWYDGSKTYYGDSVKG ili GIAGGWAFW.;
8. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: laki lanac konstantne domene imunoglobulina koji se bira iz skupine koju čine: (a) ljudska Ig kapa konstantna domena; i (b) ljudska Ig lambda konstantna domena.;
9. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: laki lanac koji sadrži najmanje jedan CDR koji se bira iz skupine CDR-a sa sekvencama aminokiselina RASQNVYSYLG, GVTSRAT ili QQYAG.;
10. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: laki lanac koji sadrži tri CDR-a sa sekvencama aminokiselina RASQNVYSYLG, GVTSRAT i QQYAG.;
11. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: laki lanac sa sekvencom aminokiselina [image] ili [image] ;
12. Protutijelo ili njegov fragment prema zahtjevu 1 ili 2, naznačeno time da protutijelo ili njegov fragment sadrže: okvir lakog lanca IGKV3-20*01 i najmanje jedan od CDR-a sa sekvencama amino kiselina RASQNVYSYLG, GVTSRAT ili QQYAG.
13. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-12, naznačeno time da je protutijelo: koje se veže za Denga virus sa specifičnošću vezanja protutijela sa sekvencom aminokiselina teškog lanca EVQLVESGGGVVQPGRSLRLSCAASGFSFSSYGMHWVRQAPGKG LEWVAVIWYDGSKTYYGDSVKGRFTISKDNSKKMVNLQMDSLGV EDTAFYYCARGIAGGWAFWGIDLWGQGTLVTVSS i sekvencom aminokiselina lakog lanca [image] ili [image]
14. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-12, naznačeno time da protutijelo: je protutijelo sa sekvencom aminokiselina teškog lanca EVQLVESGGGVVQPGRSLRLSCAASGFSFSSYGMHWVRQAPGKGLEWVAVIWYDGSKTYYGDSVKGRFTISKDNSKKMVNLQMDSLGV EDTAFYYCARGIAGGWAFWGIDLWGQGTLVTVSS i sekvencom aminokiselina lakog lanca [image] [image] ili [image]
15. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-14, naznačeno time da se protutijelo ili njegov fragment vežu za antigen s konstantom afiniteta (KD) koja je manja od 1 x 10-8 M, i proizvoljno vežu za antigen s konstantom afiniteta (KD) koja je manja od 1 x 10-9 M.
16. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-15, naznačeno time da je protutijelo porijeklom od B stanica pacijenta koji se oporavio od infekcije Denga virusom.
17. Farmaceutski pripravak naznačen time da sadrži protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-16 i farmaceutski prihvatljiv nosač koji je učinkovit za smanjenje ili prevenciju infekcije Denga virusom kod subjekta.
18. Farmaceutski pripravak prema zahtjevu 17, naznačen time da nadalje sadrži drugo sredstvo.
19. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-16 naznačeno time da je za upotrebu u postupku pasivne imunizacije protiv infekcije Denga virusom koji obuhvaća davanje subjektu učinkovite količine protutijela ili njegovog fragmenta prema bilo kojem od zahtjeva 1-16.
20. Protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-16 naznačeno time da je za upotrebu u postupku liječenja infekcije Denga virusom koji obuhvaća davanje subjektu kojem je potrebno količine protutijela ili njegovog fragmenta prema bilo kojem od zahtjeva 1-16 koja je učinkovita da se bolest ublaži ili spriječi.
21. Protutijelo za upotrebu prema zahtjevu 20, naznačeno time da: se protutijelo daje intravenozno (IV), supkutano (SC), intramuskularno (IM), transdermalno, ili oralno; ili se protutijelo daje u količini koja je u rasponu od 1 do 100 miligrama po kilogramu tjelesna mase subjekta; ili navedena upotreba nadalje sadrži davanje drugog sredstva, proizvoljno kada je drugo sredstvo antivirusni lijek ili analgetički lijek.
22. Izolirana nukleinska kiselina naznačena time da kodira protutijelo ili njegov fragment prema bilo kojem od zahtjeva 1-16.
23. Ekspresijski vektor naznačen time da sadrži nukleinsku kiselinu prema zahtjevu 22.
24. Stanica domaćin naznačena time da sadrži ekspresijski vektor 23, proizvoljno kada je stanica domaćin bakterijska stanica, eukariotska stanica, ili stanica sisavca.
HRP20171580TT 2010-12-14 2017-10-17 Ljudska monoklonska protutijela koja su specifična za protein e denga virusa serotipa 1 i njihova upotreba HRP20171580T1 (hr)

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US42308510P 2010-12-14 2010-12-14
PCT/SG2011/000436 WO2012082073A1 (en) 2010-12-14 2011-12-14 Human monoclonal antibody with specificity for dengue virus serotype 1 e protein and uses thereof
EP11848839.4A EP2651975B1 (en) 2010-12-14 2011-12-14 Human monoclonal antibody with specificity for dengue virus serotype 1 e protein and uses thereof

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AU (2) AU2011341744B2 (hr)
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