HRP20180027T1 - Protutijela za neutraliziranje virusa ljudske imunodeficijencije (hiv) - Google Patents

Protutijela za neutraliziranje virusa ljudske imunodeficijencije (hiv) Download PDF

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Publication number
HRP20180027T1
HRP20180027T1 HRP20180027TT HRP20180027T HRP20180027T1 HR P20180027 T1 HRP20180027 T1 HR P20180027T1 HR P20180027T T HRP20180027T T HR P20180027TT HR P20180027 T HRP20180027 T HR P20180027T HR P20180027 T1 HRP20180027 T1 HR P20180027T1
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Croatia
Prior art keywords
antibody
hiv
antigen
binding fragment
clade
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Application number
HRP20180027TT
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English (en)
Inventor
Po-Ying Chan-Hui
Jennifer Mitcham
Ole Olsen
Steven Frey
Matthew Moyle
Sanjay K. Phogat
Dennis R. Burton
Laura Marjorie Walker
Pascal Raymond Georges Poignard
Melissa D. De Jean De St.Marcel Simek-Lemos
Wayne KOPF
Stephen KAMINSKY
Original Assignee
Theraclone Sciences, Inc.
The Scripps Research Institute
International Aids Vaccine Initiative
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Application filed by Theraclone Sciences, Inc., The Scripps Research Institute, International Aids Vaccine Initiative filed Critical Theraclone Sciences, Inc.
Publication of HRP20180027T1 publication Critical patent/HRP20180027T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • 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
    • C07K16/1036Retroviridae, e.g. leukemia viruses
    • C07K16/1045Lentiviridae, e.g. HIV, FIV, SIV
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/21Retroviridae, e.g. equine infectious anemia virus
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • 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
    • C07K16/1036Retroviridae, e.g. leukemia viruses
    • C07K16/1045Lentiviridae, e.g. HIV, FIV, SIV
    • C07K16/1063Lentiviridae, e.g. HIV, FIV, SIV env, e.g. gp41, gp110/120, gp160, V3, PND, CD4 binding site
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • AIDS & HIV (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Communicable Diseases (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (24)

1. Protutijelo protiv HIV-a, naznačeno time što je navedeno protutijelo PG9, koji ima teški lanac, koji sadrži aminokiselinski slijed SEQ ID NO: 39, i laki lanac, koji sadrži aminokiselinski slijed SEQ ID NO: 40.
2. Protutijelo u skladu s patentnim zahtjevom 1, naznačeno time što je protutijelo ljudsko ili humanizirano monoklonsko protutijelo.
3. Protutijelo u skladu s patentnim zahtjevom 1 ili 2, naznačeno time što protutijelo neutralizira vrste HIV-1 koje pripadaju u dva ili više kladova, te što se potentnost neutraliziranja najmanje jednog člana svakog klada određuje vrijednošću IC50 manjom od 0,2 µg/ml.
4. Protutijelo u skladu s patentnim zahtjevom 3, naznačeno time što protutijelo neutralizira HIV-1 koji pripada u dva ili više kladova, koje se bira između Klada A, Klada B, Klada C, Klada D i Klada AE.
5. Protutijelo u skladu s patentnim zahtjevom 4, naznačeno time što su HIV-1 koji pripadaju u dva ili više kladova virusi koji ne pripadaju Kladu B.
6. Protutijelo u skladu s patentnim zahtjevom 4, naznačeno time što protutijelo (a) neutralizira najmanje jedan član svakog klada s potentnošću većom od one za bNAbs b12, 2G12, 2F5 odnosno 4E10, (b) ne veže se na monomerne proteine gp120 ili gp41 iz HIV-1 env gena ili (c) veže se većim afinitetom prema trimernim oblicima HIV-1 Env koji se eksprimiraju na površini stanice nego prema monomernom gp120 ili gp140 trimeriziranom na umjetan način.
7. Protutijelo u skladu s patentnim zahtjevom 6, naznačeno time što se protutijelo veže s visokim afinitetom na necijepane HIV-1 trimere gp160 na površini stanice.
8. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 3 do 6, naznačeno time što se protutijelo veže na epitop u varijabilnoj omči gp120, gdje epitop sadrži očuvana područja omči V2 i V3 u gp120.
9. Protutijelo u skladu s patentnim zahtjevom 8, naznačen time što epitop sadrži N-glikozilacijsko mjesto na ostatku Asn-160 u omči V2 u gp120.
10. Protutijelo u skladu s patentnim zahtjevom 8, naznačen time što protutijelo ne neutralizira HIV-1 u odsutnosti N-glikozilacijskog mjesta na ostatku Asn-160 u omči V2 u gp120.
11. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 3 do 6, naznačeno time što se protutijelo veže na epitop kojeg prezentira trimerni šiljak gp120 na površini stanice, gdje se epitop ne prezentira kada je gp120 trimeriziran na umjetan način.
12. Antigenski vežući fragment, naznačen time što je fragment protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 11.
13. Antigenski vežući fragment u skladu s patentnim zahtjevom 12, naznačen time što se bira iz skupine koju čine fragmenti Fab, Fab’, F(ab’)2, Fv, jednolančanog Fv, dijatijela i jedne varijabilne domene imunoglobulina.
14. Molekula nukleinske kiseline, naznačena time što kodira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 11, ili njegov antigenski vežući fragment u skladu s patentnim zahtjevom 12 ili 13.
15. Vektor, naznačen time što sadrži molekulu nukleinske kiseline u skladu s patentnim zahtjevom 14.
16. Stanica, naznačena time što sadrži vektor u skladu s patentnim zahtjevom 15.
17. Imortalizirani klon B-stanica, naznačen time što eksprimira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 11.
18. Farmaceutski pripravak, naznačen time što u najmanju ruku sadrži protutijelo ili antigenski vežući fragment u skladu s bilo kojim od patentnih zahtjeva 1 do 13, kao i farmaceutski prihvatljiv nosač.
19. Farmaceutski pripravak u skladu s patentnim zahtjevom 18, naznačen time što dodatno sadrži drugo protutijelo ili antigenski vežući fragment specifičan za drugi epitop.
20. Protutijelo ili antigenski vežući fragment u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačeni time što su namijenjeni upotrebi u liječenju ili slabljenju učinka zaraze HIV-om ili bolesti povezane s HIV-om ili u profilaksi nakon izlaganja.
21. Protutijelo ili antigenski vežući fragment, namijenjeni upotrebi u skladu s patentnim zahtjevom 20, naznačeni time što se primjenjuje drugo terapijsko sredstvo.
22. Protutijelo ili antigenski vežući fragment, namijenjeni upotrebi u skladu s patentnim zahtjevom 21, naznačeni time što je navedeno drugo terapijsko sredstvo protuvirusno sredstvo.
23. Protutijelo ili antigenski vežući fragment u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačeni time što su namijenjeni upotrebi u liječenju osobe od više vrsta HIV-1.
24. Postupak proizvodnje protutijela u skladu s patentnim zahtjevom 1, naznačen time što se sastoji u: (i) uzgoju imortalizirani klon B-stanica koji eksprimira protutijelo u skladu s patentnim zahtjevom 1 i (ii) izdvajanju protutijela
HRP20180027TT 2009-03-17 2018-01-08 Protutijela za neutraliziranje virusa ljudske imunodeficijencije (hiv) HRP20180027T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US16101009P 2009-03-17 2009-03-17
US16582909P 2009-04-01 2009-04-01
US22473909P 2009-07-10 2009-07-10
US28566409P 2009-12-11 2009-12-11
EP10722810.8A EP2408476B1 (en) 2009-03-17 2010-03-17 Human immunodeficiency virus (hiv) -neutralizing antibodies
PCT/US2010/027695 WO2010107939A2 (en) 2009-03-17 2010-03-17 Human immunodeficiency virus (hiv) -neutralizing antibodies

Publications (1)

Publication Number Publication Date
HRP20180027T1 true HRP20180027T1 (hr) 2018-04-20

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HRP20180027TT HRP20180027T1 (hr) 2009-03-17 2018-01-08 Protutijela za neutraliziranje virusa ljudske imunodeficijencije (hiv)

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US (7) US9051362B2 (hr)
EP (5) EP2408476B1 (hr)
AU (5) AU2010226668B2 (hr)
CA (2) CA2755821C (hr)
CY (1) CY1121323T1 (hr)
DK (1) DK2408476T3 (hr)
ES (4) ES2848555T3 (hr)
HR (1) HRP20180027T1 (hr)
HU (1) HUE036031T2 (hr)
LT (1) LT2408476T (hr)
NO (1) NO2408476T3 (hr)
PL (4) PL3542817T3 (hr)
PT (4) PT2408476T (hr)
SI (4) SI3260136T1 (hr)
WO (1) WO2010107939A2 (hr)

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