HRP20170037T1 - Ljudski proteini koji vežu antigen il-23 - Google Patents

Ljudski proteini koji vežu antigen il-23 Download PDF

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Publication number
HRP20170037T1
HRP20170037T1 HRP20170037TT HRP20170037T HRP20170037T1 HR P20170037 T1 HRP20170037 T1 HR P20170037T1 HR P20170037T T HRP20170037T T HR P20170037TT HR P20170037 T HRP20170037 T HR P20170037T HR P20170037 T1 HRP20170037 T1 HR P20170037T1
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Croatia
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antigen
binding protein
seq
nucleic acid
variable region
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HRP20170037TT
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English (en)
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Jennifer E. Towne
Janet D. Cheng
Jason C. O'neill
Yu Zhang
Yu Sun
Heather Cerne
Derek E. Piper
Randal R. Ketchem
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Amgen Inc.
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Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of HRP20170037T1 publication Critical patent/HRP20170037T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6813—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin the drug being a peptidic cytokine, e.g. an interleukin or interferon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6845—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a cytokine, e.g. growth factors, VEGF, TNF, a lymphokine or an interferon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/626—Diabody or triabody
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (17)

1. Protein koji veže antigen koji se veže za ljudski IL-23, pri čemu navedeni protein koji veže antigen obuhvaća: (i) (a) varijabilnu regiju teškog lanca koja obuhvaća CDRH1 koja ima SEQ ID NO:91, CDRH2 koja ima SEQ ID NO:92, i CDRH3 koja ima SEQ ID NO:93, i varijabilnu regiju lakog lanca koja obuhvaća CDRL1 koja ima SEQ ID NO:62, CDRL2 koja ima SEQ ID NO:63, i CDRL3 koja ima SEQ ID NO:64; ili (b) varijabilnu regiju teškog lanca koja obuhvaća CDRH1 koja ima SEQ ID NO:109, CDRH2 koja ima SEQ ID NO:116, i CDRH3 koja ima SEQ ID NO:111, i varijabilnu regiju lakog lanca koja obuhvaća CDRL1 koja ima SEQ ID NO:80, CDRL2 koja ima SEQ ID NO:81, i CDRL3 koja ima SEQ ID NO:76; i pri čemu se navedeni protein koji veže antigen u skladu s (a) ili (b) veže za ljudski IL-23 s KD ≤5x10-12M; ili (ii) varijabilnu regiju teškog lanca sa SEQ ID NO:31 i varijabilnu regiju lakog lanca sa SEQ ID NO:1; ili varijabilnu regiju teškog lanca sa SEQ ID NO:46 ili 153 i varijabilnu regiju lakog lanca sa SEQ ID NO:15; pri čemu je navedeni protein koji veže antigen monoklonsko protutijelo, rekombinantno protutijelo, ljudsko protutijelo, kimerično protutijelo, multispecifično protutijelo ili fragment protutijela.
2. Protein koji veže antigen u skladu s patentnim zahtjevom 1 dio (i)(a), pri čemu se navedeni protein koji veže antigen veže za ljudski IL-23 s KD ≤5x10-13M.
3. Protein koji veže antigen u skladu s patentnim zahtjevom 1 dio (i)(b), pri čemu navedeni protein koji veže antigen ima Koff udio ≤5x10-6 1/s.
4. Protein koji veže antigen u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu je navedeni protein koji veže antigen protutijelo, opcionalno protutijelo IgG1-, IgG2-, IgG3- ili IgG4-klase.
5. Protein koji veže antigen u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu navedeni fragment protutijela je Fab fragment, Fab' fragment, F(ab')2 fragment, Fv fragment, dijatijelo, ili jednolančana molekula protutijela; navedeni protein koji veže antigen je ljudsko protutijelo; ili navedeni protein koji veže antigen je monoklonsko protutijelo.
6. Molekula nukleinske kiseline, pri čemu navedena molekula nukleinske kiseline kodira protein koji veže antigen iz bilo kojeg od prethodnih patentnih zahtjeva, navedena molekula nukleinske kiseline je operabilno povezana s kontrolnim slijedom.
7. Molekula nukleinske kiseline u skladu s patentnim zahtjevom 6, pri čemu molekula nukleinske kiseline obuhvaća nukleinsku kiselinu varijabilne regije teškog lanca SEQ ID NO:32 i nukleinsku kiselinu varijabilne regije lakog lanca SEQ ID NO:2.
8. Molekula nukleinske kiseline u skladu s patentnim zahtjevom 6, pri čemu molekula nukleinske kiseline obuhvaća nukleinsku kiselinu varijabilne regije teškog lanca SEQ ID NO:47 i nukleinsku kiselinu varijabilne regije lakog lanca SEQ ID NO:16.
9. Vektor koji sadrži molekulu nukleinske kiseline u skladu s bilo kojim od patentnih zahtjeva 6-8.
10. Stanica domaćin sadrži molekulu nukleinske kiseline u skladu s bilo kojim od patentnih zahtjeva 6-8 ili vektor iz patentnog zahtjeva 9.
11. Metoda za izradu proteina koji veže antigen iz bilo kojeg od patentnih zahtjeva 1-5 obuhvaća korak priprave navedenog proteina koji veže antigen iz stanice domaćina koja izlučuje navedeni protein koji veže antigen.
12. Protein koji veže antigen iz bilo kojeg od patentnih zahtjeva 1-5, pri čemu navedeni protein koji veže antigen ima najmanje jedno svojstvo odabrano iz grupe koja se sastoji od: a) smanjivanja aktivnosti ljudskog IL-23 u određivanju metodom STAT-luciferaze; b) smanjivanje stvaranja proupalnih citokina; c) ima Koff udio ≤5x10-6 1/s; i d) ima IC50 ≤400 pM.
13. Farmaceutski sastav sadrži najmanje jedan protein koji veže antigen iz bilo kojeg od patentnih zahtjeva 1-5 i farmaceutski prihvatljivi ekscipijens.
14. Farmaceutski sastav iz patentnog zahtjeva 13, pri čemu navedeni farmaceutski sastav (i) nadalje sadrži grupu obilježivača ili efektorsku grupu; (ii) nadalje sadrži grupu obilježivača, pri čemu je grupa obilježivač odabrana iz grupe koja se sastoji od izotopnih obilježivača, magnetskih obilježivača, redoks reaktivnih dijelova, optičkih boja, biotiniliranih grupa i predodređenih polipeptidnih epitopa koje prepoznaje sekundarni receptor; (iii) nadalje sadrži efektorsku grupu, pri čemu je navedena efektorska grupa odabrana iz grupe koja se sastoji od radioizotopa, radionuklida, toksina, terapijske grupe i kemoterapijske grupe; ili (iv) nadalje sadrži grupu obilježivača, pri čemu je navedeni protein koji veže antigen vezan za grupu obilježivača.
15. Najmanje jedan protein koji veže antigen iz bilo kojeg od patentnih zahtjeva 1-5 za uporabu u liječenju ili prevenciji stanja povezanih s IL-23 u pacijenta; pri čemu je stanje odabrano iz grupe koja se sastoji od (i) upalnog poremećaja, reumatskog poremećaja, autoimunog poremećaja, onkološkog poremećaja i gastrointestinalnog poremećaja; ili (ii) multiple skleroze, reumatoidnog artritisa, raka, psorijaze, upalne bolesti crijeva, Crohnove bolesti, ulceroznog kolitisa, sustavnog eritemskog lupusa, psorijatičnog artritisa, autoimunog miokarditisa; dijabetesa tipa 1 i ankiloznog spondilitisa.
16. Protein koji veže antigen za uporabu u skladu s patentnim zahtjevom 15, pri čemu se protein koji veže antigen daje zasebno ili kao kombinirana terapija.
17. Najmanje jedan protein koji veže antigen iz bilo kojeg od patentnih zahtjeva 1-5 za uporabu u liječenju, pri čemu navedeni protein koji veže antigen smanjuje aktivnost IL-23 u pacijenta i pri čemu navedena aktivnost IL-23 potiče stvaranje proupalnih citokina.
HRP20170037TT 2009-10-26 2010-10-26 Ljudski proteini koji vežu antigen il-23 HRP20170037T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US25498209P 2009-10-26 2009-10-26
US38128710P 2010-09-09 2010-09-09
EP10774095.3A EP2493925B1 (en) 2009-10-26 2010-10-26 Human il-23 antigen binding proteins
PCT/US2010/054148 WO2011056600A1 (en) 2009-10-26 2010-10-26 Human il-23 antigen binding proteins

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HRP20170037T1 true HRP20170037T1 (hr) 2017-03-10

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US (9) US8722033B2 (hr)
EP (3) EP2493925B1 (hr)
JP (5) JP5930968B2 (hr)
KR (3) KR101568461B1 (hr)
CN (3) CN102741285B (hr)
AR (1) AR078778A1 (hr)
AU (1) AU2010315557B2 (hr)
BR (2) BR122020002402B8 (hr)
CA (2) CA3030092C (hr)
CL (1) CL2012001096A1 (hr)
CO (1) CO6531481A2 (hr)
CR (1) CR20120210A (hr)
CY (1) CY1118576T1 (hr)
EA (1) EA025366B1 (hr)
ES (1) ES2613236T3 (hr)
HK (1) HK1212357A1 (hr)
HR (1) HRP20170037T1 (hr)
HU (1) HUE030871T2 (hr)
IL (3) IL219241A (hr)
JO (1) JO3244B1 (hr)
LT (1) LT2493925T (hr)
MA (1) MA33757B1 (hr)
MX (1) MX358249B (hr)
MY (1) MY156286A (hr)
NZ (2) NZ625630A (hr)
PE (2) PE20121579A1 (hr)
PH (1) PH12012500771A1 (hr)
PL (1) PL2493925T3 (hr)
PT (1) PT2493925T (hr)
RS (1) RS55666B1 (hr)
SG (2) SG10202103260TA (hr)
SI (1) SI2493925T1 (hr)
SM (1) SMT201700069T1 (hr)
TN (1) TN2012000167A1 (hr)
TW (2) TW201417830A (hr)
UA (1) UA113609C2 (hr)
UY (1) UY32971A (hr)
WO (1) WO2011056600A1 (hr)
ZA (1) ZA201203058B (hr)

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