HRP20160638T1 - Antigen vezujući proteini sposobni vezati timusni stromalni limfopoetin - Google Patents

Antigen vezujući proteini sposobni vezati timusni stromalni limfopoetin Download PDF

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HRP20160638T1
HRP20160638T1 HRP20160638TT HRP20160638T HRP20160638T1 HR P20160638 T1 HRP20160638 T1 HR P20160638T1 HR P20160638T T HRP20160638T T HR P20160638TT HR P20160638 T HRP20160638 T HR P20160638T HR P20160638 T1 HRP20160638 T1 HR P20160638T1
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seq
amino acid
human antibody
tslp
acid sequence
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HRP20160638TT
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Michael R. Comeau
James F. Smothers
Bo-Rin P. Yoon
Christopher Mehlin
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Amgen Inc.
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Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of HRP20160638T1 publication Critical patent/HRP20160638T1/hr

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    • C07ORGANIC CHEMISTRY
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    • 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
    • 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
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
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    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic 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
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • 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
    • A61P31/20Antivirals for DNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P37/08Antiallergic agents
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    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
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    • 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
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    • C07ORGANIC CHEMISTRY
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    • 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
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    • 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
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    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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    • C07K2317/55Fab or Fab'
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    • 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]
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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
    • C07K2317/622Single chain antibody (scFv)
    • 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
    • C07K2317/626Diabody or triabody
    • 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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    • C07ORGANIC CHEMISTRY
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    • 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

Claims (17)

1. Anti-TSLP ljudsko protutijelo sadrži: a. varijabilnu domenu lakog lanca koja sadrži: i. CDR1 slijed lakog lanca koji sadrži aminokiselinski slijed SEQ ID NO:13; ii. CDR2 slijed lakog lanca koji sadrži aminokiselinski slijed SEQ ID NO:60; i iii. CDR3 slijed lakog lanca koji sadrži aminokiselinski slijed SEQ ID NO:105; i b. varijabilnu domenu teškog lanca koja sadrži: i. CDR1 slijed teškog lanca koji sadrži aminokiselinski slijed SEQ ID NO:145; ii. CDR2 slijed teškog lanca koji sadrži aminokiselinski slijed SEQ ID NO:173; i iii. CDR3 slijed teškog lanca koji sadrži aminokiselinski slijed SEQ ID NO:212.
2. Anti-TSLP ljudsko protutijelo iz patentnog zahtjeva 1, sadrži: a. varijabilnu domenu lakog lanca izabranu iz grupe koja sadrži: i. aminokiseline koje imaju slijed najmanje 80% identičan slijedu SEQ ID NO:363; ii. slijed aminokiselina kodiran polinukleotidnim slijedom koji je najmanje 80% identičan slijedu SEQ ID NO:362; iii. slijed aminokiselina kodiran polinukleotidnim slijedom koji hibridizira pod umjereno strogim uvjetima s komplementarnim polinukleotidom koji se sastoji od SEQ ID NO:362; i b. varijabilnu domenu teškog lanca izabranu iz grupe koja sadrži: i. slijed aminokiselina najmanje 80% identičan slijedu SEQ ID NO:361; ii. slijed aminokiselina kodiran polinukleotidnim slijedom koji je najmanje 80% identičan slijedu SEQ ID NO:360; iii. slijed aminokiselina kodiran polinukleotidnim slijedom koji hibridizira pod umjereno strogim uvjetima s komplementarnim polinukleotidom koji se sastoji od SEQ ID NO:360;
3. Anti-TSLP ljudsko protutijelo iz patentnog zahtjeva 1, sadrži: varijabilnu domenu lakog lanca koja sadrži SEQ ID NO:363 i varijabilnu domenu teškog lanca koja sadrži SEQ ID NO:361.
4. Anti-TSLP ljudsko protutijelo iz bilo kojeg od patentnih zahtjeva 1-2, pri čemu a. anti-TSLP ljudsko protutijelo veže se za TSLP sa značajno istom Kd kao referentno protutijelo, i/ili b. pri čemu anti-TSLP ljudsko protutijelo inhibira TSLP aktivnost u skladu s primarnim OPG određivanjem s istim IC50 kao referentno protutijelo, pri čemu je referentno protutijelo protutijelo koje se sastoji od varijabilne domene lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO:363 i varijabilne domene teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO:361.
5. Farmaceutski sastav koji sadrži anti-TSLP ljudsko protutijelo iz bilo kojeg od patentnih zahtjeva 1-4.
6. Nukleinska kiselina koja sadrži polinukleotidni slijed koji kodira varijabilnu domenu lakog lanca i varijabilnu domenu teškog lanca anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4.
7. Rekombinantni ekspresijski vektor koji sadrži nukleinsku kiselinu iz patentnog zahtjeva 6.
8. Stanica domaćin koja sadrži a) ekspresijski vektor koji sadrži polinukleotid koji kodira varijabilnu domenu lakog lanca i varijabilnu domenu teškog lanca anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4; ili b) ekspresijski vektor koji sadrži polinukleotid koji kodira varijabilnu domenu lakog lanca anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4 i ekspresijski vektor koji sadrži polinukleotid koji kodira varijabilnu domenu teškog lanca anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4.
9. Hibridoma sposobna za stvaranje anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4.
10. Metoda za stvaranje anti-TSLP ljudskog protutijela iz bilo kojeg od patentnih zahtjeva 1-4, obuhvaća inkubiranje stanice domaćina iz patentnog zahtjeva 8 pod uvjetima koji joj omogućavaju ekspresiju protutijela.
11. Sastav u skladu s patentnim zahtjevom 5 za uporabu u liječenju a. TSLP-povezanog upalnog stanja kod subjekta kojem je takvo liječenje potrebno; ili b. TSLP-povezanog fibrotičnog poremećaja kod subjekta kojem je takvo liječenje potrebno.
12. Sastav za uporabu u skladu s patentnim zahtjevom 11, pri čemu je upalno stanje odabrano iz grupe koja se sastoji od alergijske astme, alergijskog rinosinusitisa, alergijskog konjuktivitisa i atopijskog dermatitisa.
13. Sastav za uporabu u skladu s patentnim zahtjevom 11, pri čemu je fibrotično stanje odabrano iz grupe koja se sastoji od skleroderme, intersticijske bolesti pluća, idopatske plućne fibroze, fibroze koja nastaje iz kroničnog hepatitisa B ili C, zračenjem inducirane fibroze i fibroze koja nastaje zacjeljivanjem rana.
14. Anti-TSLP ljudsko protutijelo iz patentnog zahtjeva 1, pri čemu je navedeno anti-TSLP ljudsko protutijelo monoklonsko protutijelo.
15. Anti-TSLP ljudsko protutijelo iz patentnog zahtjeva 1, pri čemu navedeno anti-TSLP ljudsko protutijelo sadrži a) laki lanac koji sadrži varijabilnu domenu lakog lanca koja sadrži aminokiselinski slijed pretpostavljen u SEQ ID NO:363 i konstantnu domenu lambda lakog lanca koja sadrži aminokiselinski slijed pretpostavljen u SEQ ID NO: 369; i b) teški lanac koji sadrži varijabilnu domenu teškog lanca koja sadrži aminokiselinski slijed pretpostavljen u SEQ ID NO:361 i konstantnu domenu IgG2 teškog lanca koja sadrži aminokiselinski slijed pretpostavljen u SEQ ID NO: 365.
16. Metoda iz patentnog zahtejva 10, pri čemu je stanica domaćin CHO stanica.
17. Anti-TSLP ljudsko protutijelo dostižno metodom iz patentnog zahtjeva 16.
HRP20160638TT 2007-09-10 2016-06-09 Antigen vezujući proteini sposobni vezati timusni stromalni limfopoetin HRP20160638T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US97117807P 2007-09-10 2007-09-10
US9167608P 2008-08-25 2008-08-25
EP08830362.3A EP2205635B1 (en) 2007-09-10 2008-09-09 Antigen binding proteins capable of binding thymic stromal lymphopoietin
PCT/US2008/010510 WO2009035577A1 (en) 2007-09-10 2008-09-09 Antigen binding proteins capable of binding thymic stromal lymphopoietin

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HRP20160638T1 true HRP20160638T1 (hr) 2016-07-01

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US (5) US7982016B2 (hr)
EP (3) EP2703414A1 (hr)
JP (7) JP5956716B2 (hr)
KR (2) KR101597371B1 (hr)
CN (2) CN104231081B (hr)
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AU (1) AU2008300028B2 (hr)
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EA (2) EA201590631A1 (hr)
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FR (1) FR22C1059I2 (hr)
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