HRP20191219T1 - Molekule protutijela koje imaju specifičnost za ljudski ox40 - Google Patents

Molekule protutijela koje imaju specifičnost za ljudski ox40 Download PDF

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HRP20191219T1
HRP20191219T1 HRP20191219TT HRP20191219T HRP20191219T1 HR P20191219 T1 HRP20191219 T1 HR P20191219T1 HR P20191219T T HRP20191219T T HR P20191219TT HR P20191219 T HRP20191219 T HR P20191219T HR P20191219 T1 HRP20191219 T1 HR P20191219T1
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Croatia
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fusion protein
seq
variable domain
antibody fusion
bispecific antibody
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HRP20191219TT
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Ralph Adams
Pallavi BHATTA
Sam Philip Heywood
David Paul Humphreys
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Ucb Biopharma Sprl
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Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of HRP20191219T1 publication Critical patent/HRP20191219T1/hr

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    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
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    • A61P13/00Drugs for disorders of the urinary system
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    • A61P21/04Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
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    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
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    • A61P37/00Drugs for immunological or allergic disorders
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    • AHUMAN NECESSITIES
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    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/624Disulfide-stabilized antibody (dsFv)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
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Claims (19)

1. Fuzijski protein bispecifičnog protutijela koji veže ljudski OX40 i ljudski serumski albumin, te antagonizira vezanje OX40 na OX40L, te fuzijski protein bispecifičnog protutijela obuhvaća: teški lanac koji sadrži, u slijedu od N-terminalnog kraja, prvu varijabilnu domenu teškog lanca (VH1), CHI domenu i drugu varijabilnu domenu teškog lanca (VH2), lagani lanac koji sadrži, u slijedu od N-terminalnog kraja, prvu varijabilnu domenu lakog lanca (VL1), CL domenu i drugu varijabilnu domenu laganog lanca (VL2), pri čemu su navedeni teški i lagani lanci poravnani tako da VH1 i VL1 tvore prvo mjesto vezanja antigena i VH2 i VL2 tvore drugo mjesto vezanja antigena, pri čemu je antigen vezan za prvo mjesto vezanja antigena ljudski OX40 i antigen vezan za drugo mjesto vezanja antigena je ljudski serumski albumin, pri čemu prva varijabilna domena teškog lanca (VH1) sadrži sekvencu navedenu u SEQ ID NO:1 za CDR-H1, sekvencu navedenu u SEQ ID NO:2 za CDR-H2 i sekvencu navedenu u SEQ ID NO:3 za CDR-H3 i prva varijabilna domena laganog lanca (VL1) sadrži sekvencu navedenu u SEQ ID NO:4 za CDR-L1, sekvencu navedenu u SEQ ID NO:5 za CDR-L2 i sekvencu navedenu u SEQ ID NO:6 za CDR-L3, pri čemu druga varijabilna domena teškog lanca (VH2) ima sekvencu navedenu u SEQ ID NO:11 i druga varijabilna domena laganog lanca (VL2) ima sekvencu navedenu u SEQ ID NO: 12 i druga varijabilna domena teškog lanca (VH2) i druga varijabilna domena laganog lanca (VL2) su povezane disulfidnom vezom.
2. Fuzijski protein bispecifičnog protutijela prema patentnom zahtjevu 1 naznačen time što postoji peptidna poveznica između CHI domene i druge varijabilne domene teškog lanca (VH2).
3. Fuzijski protein bispecifičnog protutijela prema patentnom zahtjevu 1 ili zahtjevu 2 naznačen time što postoji peptidna poveznica između CL domene i druge varijabilne domene laganog lanca (VL2).
4. Fuzijski protein protutijela prema bilo kojem od patentnih zahtjeva 1 do 3 naznačen time što prva varijabilna domena teškog lanca (VH1) sadrži sekvencu navedenu u SEQ ID NO:8.
5. Fuzijski protein protutijela prema bilo kojem od patentnih zahtjeva 1 do 4 naznačen time što prva varijabilna domena lakog lanca (VL1) sadrži sekvencu navedenu u SEQ ID NO:7.
6. Fuzijski protein protutijela prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time što teški lanac sadrži ili se sastoji od sekvence navedene u SEQ ID NO:15.
7. Fuzijski protein protutijela prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time što lagani lanac sadrži ili se sastoji od sekvence navedene u SEQ ID NO:16.
8. Fuzijski protein bispecifičnog protutijela koji veže ljudski OX40 i ljudski serumski albumin, te antagonizira vezanje OX40 do OX40L, naznačen time što fuzijski protein bispecifičnog protutijela ima teški lanac koji sadrži sekvencu navedenu u SEQ ID NO:15 i lagani lanac koji sadrži sekvencu navedenu u SEQ ID NO:16.
9. Izolirana sekvenca DNA naznačena time što kodira fuzijski protein protutijela prema bilo kojem od patentnih zahtjeva 1 do 8.
10. Vektor kloniranja ili ekspresije naznačen time što sadrži jednu ili više DNA sekvenci prema patentnom zahtjevu 9.
11. Vektor prema patentnom zahtjevu 10, naznačen time što vektor sadrži sekvence navedene u SEQ ID NO:22 i SEQ ID NO:24.
12. Stanica domaćin naznačena time što sadrži jedan ili više vektora kloniranja ili ekspresije prema patentnom zahtjevu 10 ili zahtjevu 11.
13. Postupak za proizvodnju fuzijskog proteina protutijela prema bilo kojem od zahtjeva 1 do 8, naznačen time što obuhvaća kultiviranje stanice domaćina prema zahtjevu 12 i izoliranje fuzijskog proteina protutijela.
14. Farmaceutski pripravak naznačen time što sadrži fuzijski protein bispecifičnog protutijela prema bilo kojem od patentnih zahtjeva 1 do 8, u kombinaciji s jednim ili više farmaceutski prihvatljivih pomoćnih sredstava, razrjeđivača ili nosača.
15. Farmaceutski pripravak prema patentnom zahtjevu 14, naznačen time što dodatno sadrži druge aktivne sastojke.
16. Fuzijski protein bispecifičnog protutijela prema bilo kojem od patentnih zahtjeva 1 do 8 ili farmaceutski pripravak prema patentnom zahtjevu 14 ili zahtjevu 15, naznačen time što je za uporabu u terapiji.
17. Fuzijski protein bispecifičnog protutijela prema bilo kojem od patentnih zahtjeva 1 do 8 ili farmaceutski pripravak prema patentnom zahtjevu 14 ili zahtjevu 15, naznačen time što je za uporabu za liječenje ili profilaksu patološkog poremećaja odabranog iz skupine koju čine alergija, KOPB, autoimuna bolest, reumatoidni artritis, astma, bolest presatka protiv domaćina, Crohnova bolest, ulcerativni kolitis, dijabetes tipa 1, multipla skleroza, sistemski eritemski lupus, lupusni nefritis, mijastenija gravis, Gravesova bolest, odbacivanje transplantata, Wegenerova granulomatoza, Henoch-Schonlein purpura, sistemska skleroza i virusna upala pluća.
18. Fuzijski protein bispecifičnog protutijela ili farmaceutski pripravak za uporabu prema patentnom zahtjevu 17, naznačen time što patološki poremećaj je bolest presatka protiv domaćina.
19. Fuzijski protein bispecifičnog protutijela ili farmaceutski pripravak za uporabu prema patentnom zahtjevu 17, naznačen time što patološki poremećaj je sistemski eritemski lupus.
HRP20191219TT 2011-11-11 2019-07-05 Molekule protutijela koje imaju specifičnost za ljudski ox40 HRP20191219T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161558545P 2011-11-11 2011-11-11
PCT/EP2012/072325 WO2013068563A2 (en) 2011-11-11 2012-11-09 Antibody molecules having specificity for human ox40
EP12803508.6A EP2776469B1 (en) 2011-11-11 2012-11-09 Antibody molecules having specificity for human ox40

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HRP20191219T1 true HRP20191219T1 (hr) 2019-10-04

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HRP20191219TT HRP20191219T1 (hr) 2011-11-11 2019-07-05 Molekule protutijela koje imaju specifičnost za ljudski ox40

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US (2) US9040048B2 (hr)
EP (1) EP2776469B1 (hr)
JP (1) JP6367714B2 (hr)
KR (1) KR102071054B1 (hr)
CN (1) CN103946240B (hr)
AP (1) AP2014007668A0 (hr)
AR (1) AR088820A1 (hr)
AU (1) AU2012333997B2 (hr)
BR (1) BR112014011404A2 (hr)
CA (1) CA2855174C (hr)
CL (1) CL2014001193A1 (hr)
CO (1) CO7010784A2 (hr)
CY (1) CY1122073T1 (hr)
DK (1) DK2776469T3 (hr)
EA (1) EA035112B1 (hr)
EC (1) ECSP14000329A (hr)
ES (1) ES2737998T3 (hr)
HR (1) HRP20191219T1 (hr)
HU (1) HUE044333T2 (hr)
IL (1) IL232420B (hr)
LT (1) LT2776469T (hr)
MA (1) MA35724B1 (hr)
MX (1) MX358391B (hr)
MY (1) MY183795A (hr)
PE (1) PE20141995A1 (hr)
PL (1) PL2776469T3 (hr)
PT (1) PT2776469T (hr)
SG (1) SG11201402093RA (hr)
SI (1) SI2776469T1 (hr)
TN (1) TN2014000206A1 (hr)
TR (1) TR201910721T4 (hr)
TW (1) TWI588155B (hr)
UA (1) UA112203C2 (hr)
WO (1) WO2013068563A2 (hr)

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