HRP20180753T1 - Antagonistička protutijela specifična za peptid koji je u vezi s genom za kalcitonin za liječenje cluster glavobolje - Google Patents

Antagonistička protutijela specifična za peptid koji je u vezi s genom za kalcitonin za liječenje cluster glavobolje Download PDF

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HRP20180753T1
HRP20180753T1 HRP20180753TT HRP20180753T HRP20180753T1 HR P20180753 T1 HRP20180753 T1 HR P20180753T1 HR P20180753T T HRP20180753T T HR P20180753TT HR P20180753 T HRP20180753 T HR P20180753T HR P20180753 T1 HRP20180753 T1 HR P20180753T1
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antibody
cgrp
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cdr
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Joerg Zeller
Kristian Todd Poulsen
Yasmina Noubia Abdiche
Jaume Pons
Arnon Rosenthal
Sierra Jones Collier
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Teva Pharmaceuticals International Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/4045Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • 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
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/26Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • 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
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • 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
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C07K2317/52Constant or Fc region; Isotype
    • 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
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • 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
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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
    • C07K2317/71Decreased effector function due to an Fc-modification
    • 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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  • Cardiology (AREA)
  • Rheumatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (16)

1. Anti-CGRP antagonističko protutijelo naznačeno time da je za uporabu u prevenciji ili liječenju cluster glavobolje.
2. Anti-CGRP antagonističko protutijelo za uporabu prema zahtjevu 1, naznačeno time da je protutijelo ljudsko protutijelo ili humanizirano protutijelo.
3. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da protutijelo ima afinitet vezanja (KD) za ljudski α-CGRP od 50 nM ili manji koji se mjeri rezonancijom površinskog plazmona kod 37°C.
4. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo veže na (a) C-terminalni fragment koji ima aminokiseline 25-37 od CGRP ili (b) C-terminalni epitop unutar aminokiselina 25-37 od CGRP.
5. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da protutijelo ima konstantnu regiju teškog lanca IgG.
6. Anti-CGRP antagonističko protutijelo prema zahtjevu 5, naznačeno time da protutijelo ima konstantnu regiju teškog lanca IgG1, IgG2, IgG3 ili IgG4.
7. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da je protutijelo: (a) protutijelo koje ima CDR H1 kao što se navodi u SEQ ID NO: 3; CDR H2 kao što se navodi u SEQ ID NO: 4; CDR H3 kao što se navodi u SEQ ID NO: 5; CDR L1 kao što se navodi u SEQ ID NO: 6; CDR L2 kao što se navodi u SEQ ID NO: 7; i CDR L3 kao što se navodi u SEQ ID NO: 8; ili (b) varijantu protutijela pod (a) kao što je prikazano u Tablici 6.
8. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da protutijelo sadrži VH domenu koja je najmanje 90% identična u sekvenci aminokiselina sa SEQ ID NO: 1 i VL domenu koja je najmanje 90% identična u sekvenci aminokiselina sa SEQ ID NO: 2; na primjer, pri čemu protutijelo sadrži VH domenu SEQ ID NO: 1 i VL domenu SEQ ID NO: 2.
9. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da protutijelo sadrži lagani lanac koji je proizveden od ekspresijskog vektora s ATCC pristupnim br. PTA-6866 i/ili teški lanac koji je proizveden od ekspresijskog vektora s ATCC pristupnim br. PTA-6867.
10. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da protutijelo blokira ili smanjuje aktivaciju receptora za CGRP (uključujući aktivaciju cAMP).
11. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo daje injekcijom; na primjer, intraperitonealno, intravenozno, subkutano, ili intramuskularno.
12. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo daje 1 do 4 puta tjedno.
13. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo daje u dnevnoj dozi od 3 µg/kg do 100 mg/kg.
14. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo daje oko 2 mg/kg.
15. Anti-CGRP antagonističko protutijelo za uporabu prema bilo kojem prethodnom zahtjevu, naznačeno time da se protutijelo daje čovjeku.
16. Uporaba anti-CGRP antagonističkog protutijela naznačena time da je za dobivanje lijeka za prevenciju ili liječenje cluster glavobolje.
HRP20180753TT 2005-11-14 2018-05-14 Antagonistička protutijela specifična za peptid koji je u vezi s genom za kalcitonin za liječenje cluster glavobolje HRP20180753T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US73662305P 2005-11-14 2005-11-14
EP16154418.4A EP3045182B1 (en) 2005-11-14 2006-11-02 Antagonist antibodies directed against calcitonin gene-related peptide for treating cluster headache

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HRP20180753TT HRP20180753T1 (hr) 2005-11-14 2018-05-14 Antagonistička protutijela specifična za peptid koji je u vezi s genom za kalcitonin za liječenje cluster glavobolje
HRP20180752TT HRP20180752T1 (hr) 2005-11-14 2018-05-14 Antagonističko protutijelo specifično za peptid koji je u vezi s genom za kalcitonin

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US (20) US8007794B2 (hr)
EP (6) EP3069731A1 (hr)
JP (1) JP5123197B2 (hr)
KR (2) KR101250049B1 (hr)
CN (2) CN103421114B (hr)
AP (1) AP2008004467A0 (hr)
AU (1) AU2006313434B2 (hr)
BR (1) BRPI0618705B8 (hr)
CA (1) CA2626120C (hr)
CR (1) CR9975A (hr)
CU (1) CU23872B1 (hr)
CY (3) CY1120249T1 (hr)
DK (3) DK2380592T3 (hr)
EA (1) EA015526B1 (hr)
EC (1) ECSP088451A (hr)
ES (3) ES2664854T3 (hr)
GE (1) GEP20115333B (hr)
HK (2) HK1125837A1 (hr)
HR (2) HRP20180753T1 (hr)
HU (3) HUE036940T2 (hr)
IL (3) IL190876A (hr)
LT (3) LT3045182T (hr)
LU (2) LUC00119I2 (hr)
MA (1) MA30136B1 (hr)
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UA (1) UA94244C2 (hr)
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