HRP20161141T1 - Anti-il-23 protutijela - Google Patents

Anti-il-23 protutijela Download PDF

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Publication number
HRP20161141T1
HRP20161141T1 HRP20161141TT HRP20161141T HRP20161141T1 HR P20161141 T1 HRP20161141 T1 HR P20161141T1 HR P20161141T T HRP20161141T T HR P20161141TT HR P20161141 T HRP20161141 T HR P20161141T HR P20161141 T1 HRP20161141 T1 HR P20161141T1
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Croatia
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antibody
amino acid
acid sequence
seq
antigen
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HRP20161141TT
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English (en)
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Rachel Rebecca Barrett
Keith Canada
Katrina Mary Catron
Robert Copenhaver
Lee Edward Frego
Ernest Lee Raymond
Sanjaya Singh
Xiangyang Zhu
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Boehringer Ingelheim International Gmbh
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Publication of HRP20161141T1 publication Critical patent/HRP20161141T1/hr

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    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • 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
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • 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
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/56Immunoglobulins 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
    • 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

Claims (26)

1. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju: a) varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 19 (CDR1-L), aminokiselinski slijed SEQ ID NO: 20 (CDR2-L); i aminokiselinski slijed SEQ ID NO : 21 (CDR3-L), i b) varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 66 ili 67 (CDR1-H), aminokiselinski slijed SEQ ID NO: 64 (CDR2-H); i aminokiselinski slijed SEQ ID NO : 65 (CDR3-H).
2. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 1, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju: a) varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 19 (CDR1-L), aminokiselinski slijed SEQ ID NO: 20 (CDR2-L); i aminokiselinski slijed SEQ ID NO : 21 (CDR3-L), i b) varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 66 (CDR1-H), aminokiselinski slijed SEQ ID NO: 64 (CDR2-H); i aminokiselinski slijed SEQ ID NO : 65 (CDR3-H).
3. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 1, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju: a) varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 19 (CDR1-L), aminokiselinski slijed SEQ ID NO: 20 (CDR2-L); i aminokiselinski slijed SEQ ID NO : 21 (CDR3-L), i b) varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 67 (CDR1-H), aminokiselinski slijed SEQ ID NO: 64 (CDR2-H); i aminokiselinski slijed SEQ ID NO : 65 (CDR3-H).
4. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 1, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed bilo kojeg od SEQ ID NO: 158, 160, 162 ili 164; i varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed bilo kojeg od SEQ ID NO: 166 ili 168.
5. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 4, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 160 i varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 166.
6. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 4, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 160 i varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 168.
7. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 4, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju varijabilnu regiju lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 158 i varijabilnu regiju teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 166.
8. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 4, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju aminokiselinski slijed SEQ ID NO: 166 ili 168 vezan za ljudsku konstantnu regiju IgG1 teškog lanca; i aminokiselinski slijed SEQ ID NO: 158 ili 160 vezan za ljudsku konstantnu regiju kappa lakog lanca.
9. Humanizirano anti-IL-23p19 protutijelo ili njegov antigen-vezujući fregment u skladu s patentnim zahtjevom 1, pri čemu protutijelo ili njegov antigen-vezujući fregment obuhvaćaju: a) humaniziranu varijabilnu domenu lakog lanca koja sadrži CDR-ove sa SEQ ID NO: 158 ili 160 i regije okvira koje imaju aminokiselinski slijed najmanje 90% identičan aminokiselinskom slijedu regija okvira varijabilne domene lakog lanca aminokiselinskog slijeda SEQ ID NO: 158 ili 160; i b) humaniziranu varijabilnu domenu teškog lanca koja sadrži CDR-ove sa SEQ ID NO: 166 ili 168 i regije okvira koje imaju aminokiselinski slijed najmanje 90% identičan aminokiselinskom slijedu regija okvira varijabilne domene teškog lanca aminokiselinskog slijeda SEQ ID NO: 166 ili 168.
10. Humanizirano anti-IL-23p19 protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 9, pri čemu je protutijelo monoklonsko protutijelo.
11. Humanizirano anti-IL-23p19 protutijelo u skladu s patentnim zahtjevom 1, pri čemu je protutijelo monoklonsko protutijelo anti-IL-23p19 koje sadrži laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 174 ili 180 i teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 176 ili 178.
12. Humanizirano anti-IL-23p19 protutijelo u skladu s patentnim zahtjevom 11, pri čemu navedeno protutijelo sadrži laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 174 i teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 176.
13. Humanizirano anti-IL-23p19 protutijelo u skladu s patentnim zahtjevom 11, pri čemu navedeno protutijelo sadrži laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 174 i teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 178.
14. Humanizirano anti-IL-23p19 protutijelo u skladu s patentnim zahtjevom 11, pri čemu navedeno protutijelo sadrži laki lanac koji sadrži aminokiselinski slijed SEQ ID NO: 180 i teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 176.
15. Protutijelo ili antigen-vezujući fragment u skladu s bilo kojim od patentnih zahtjeva 1 do 14 za uporabu u medicini.
16. Protutijelo ili antigen-vezujući fragment u skladu s patentnim zahtjevom 15, pri čemu je uporaba tretiranje upalne bolesti, autoimune bolesti, respiratorne bolesti, metaboličkog poremećaja ili raka.
17. Protutijelo ili antigen-vezujući fragment u skladu s patentnim zahtjevom 16, pri čemu je uporaba tretiranje psorijaze, upalne bolesti crijeva, psorijatičnog artrirtisa, multiple skleroze, reumatoidnog artritisa, Chronove bolesti, ulceroznog kolitisa ili ankilozantnog spondilitisa.
18. Protutijelo ili antigen-vezujući fragment u skladu s patentnim zahtjevom 16, pri čemu je uporaba tretiranje astme ili COPD (kronične opstruktivne bolesti pluća).
19. Farmaceutski sastav obuhvaća protutijelo ili antigen-vezujući fragment u skladu s bilo kojim od patentnih zahtjeva 1 do 14 i farmaceutski prihvatljivi nosač.
20. Izolirani polinukleotid obuhvaća slijed koji kodira varijabilnu regiju lakog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 158, 160, 162 ili 164 i koji kodira varijabilnu regiju teškog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 166 ili 168.
21. Izolirani polinukleotid u skladu s patentnim zahtjevom 20, pri čemu navedeni polinukleotid obuhvaća slijed koji kodira varijabilnu regiju lakog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 174 ili 180 i koji kodira varijabilnu regiju teškog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 176 ili 178.
22. Ekspresijski vektor koji obuhvaća polinukleotid iz patentnog zahtjeva 20 ili 21.
23. Stanica domaćin obuhvaća: a) izolirani polinukleotid koji sadrži slijed koji kodira varijabilnu regiju lakog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 158, 160, 162 ili 164; i b) izolirani polinukleotid koji sadrži slijed koji kodira varijabilnu regiju teškog lanca protutijela ili fragmenta protutijela koji ima aminokiselinski slijed SEQ ID NO: 166 ili 168.
24. Stanica domaćin obuhvaća: a) izolirani polinukleotid koji sadrži slijed koji kodira laki lanac protutijela koji ima aminokiselinski slijed SEQ ID NO: 174 ili 180; i b) izolirani polinukleotid koji sadrži slijed koji kodira teški lanac protutijela koji ima aminokiselinski slijed SEQ ID NO: 176 ili 178.
25. Metoda za stvaranje protutijela ili antigen-vezujućeg fragmenta obuhvaća: a) dobivanje stanice domaćina u skladu s patentnim zahtjevom 23 ili 24; i b) kultiviranje stanice domaćina.
26. Metoda u skladu s patentnim zahtjevom 25, nadalje obuhvaća obnavljanje i pročišćavanje protutijela ili antigen-vezujućeg fragmenta.
HRP20161141TT 2010-11-04 2016-09-06 Anti-il-23 protutijela HRP20161141T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US41015810P 2010-11-04 2010-11-04
US41195310P 2010-11-10 2010-11-10
US41259410P 2010-11-11 2010-11-11
US201161448785P 2011-03-03 2011-03-03
EP11781949.0A EP2635601B1 (en) 2010-11-04 2011-11-02 Anti-il-23 antibodies
PCT/US2011/058869 WO2012061448A1 (en) 2010-11-04 2011-11-02 Anti-il-23 antibodies

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HRP20161141T1 true HRP20161141T1 (hr) 2016-12-02

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HRP20161141TT HRP20161141T1 (hr) 2010-11-04 2016-09-06 Anti-il-23 protutijela

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US (5) US8778346B2 (hr)
EP (4) EP3456740A1 (hr)
JP (3) JP6126532B2 (hr)
KR (2) KR102049223B1 (hr)
CN (2) CN103282382B (hr)
AP (1) AP3953A (hr)
AR (1) AR083747A1 (hr)
AU (3) AU2011323426B2 (hr)
BR (1) BR112013011065B1 (hr)
CA (2) CA3017116A1 (hr)
CO (1) CO6801628A2 (hr)
CY (2) CY1118014T1 (hr)
DK (1) DK2635601T3 (hr)
EA (2) EA030436B1 (hr)
EC (1) ECSP13012649A (hr)
ES (1) ES2593754T3 (hr)
GE (1) GEP201706733B (hr)
HK (1) HK1247940A1 (hr)
HR (1) HRP20161141T1 (hr)
HU (2) HUE030916T2 (hr)
IL (2) IL225648A (hr)
LT (2) LT2635601T (hr)
LU (1) LUC00132I2 (hr)
MA (1) MA34641B1 (hr)
ME (1) ME02499B (hr)
MX (3) MX2019000046A (hr)
MY (1) MY162791A (hr)
NL (1) NL301013I2 (hr)
NO (1) NO2019038I1 (hr)
NZ (1) NZ610592A (hr)
PE (1) PE20141162A1 (hr)
PL (1) PL2635601T3 (hr)
PT (1) PT2635601T (hr)
RS (1) RS55161B1 (hr)
SG (2) SG190006A1 (hr)
SI (1) SI2635601T1 (hr)
TW (2) TWI545133B (hr)
UY (1) UY33703A (hr)
WO (1) WO2012061448A1 (hr)

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