HRP20220405T1 - Protutijela protiv ngf i njihova upotreba - Google Patents

Protutijela protiv ngf i njihova upotreba Download PDF

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HRP20220405T1
HRP20220405T1 HRP20220405TT HRP20220405T HRP20220405T1 HR P20220405 T1 HRP20220405 T1 HR P20220405T1 HR P20220405T T HRP20220405T T HR P20220405TT HR P20220405 T HRP20220405 T HR P20220405T HR P20220405 T1 HRP20220405 T1 HR P20220405T1
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Croatia
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antibody
seq
antigen
amino acid
acid sequence
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HRP20220405TT
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English (en)
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Susan E. Lacey
Jeffrey A. Barbon
Meha Chhaya
Emma Fung
Charles W. Hutchins
Diane M. Lang
Eve H. Barlow
Mary Leddy
Ravi Chari
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Zoetis Belgium S.A.
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Publication of HRP20220405T1 publication Critical patent/HRP20220405T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/566—Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
    • 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
    • C07K2317/24—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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • 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
    • C07K2317/50—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
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • 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
    • 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
    • C07K2317/624—Disulfide-stabilized antibody (dsFv)
    • 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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
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Claims (14)

1. Protutijelo ili njegov fragment koji se veže na antigen koji se mogu specifično vezati na čimbenik rasta živaca (NGF) koji sadrže: a) varijabilno područje teškog lanca (VH) koje sadrži: (a) područje određivanja komplementarnosti 1 (CDR1) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 61; (b) područje određivanja komplementarnosti 2 (CDR2) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 62; i (c) područje određivanja komplementarnosti 3 (CDR3) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 63; i b) varijabilno područje lakog lanca (VL) koje sadrži: (a) područje određivanja komplementarnosti 1 (CDR1) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 64; (b) područje određivanja komplementarnosti 2 (CDR2) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 65; i (c) područje određivanja komplementarnosti 3 (CDR3) koje se sastoji od aminokiselinskog slijeda kao što je iznijet u SEQ ID NO: 66; naznačeni time što konstanta brzine Koff iznosi najviše 10–3 s–1, što je izmjereno površinskom plazmonskom rezonancijom.
2. Protutijelo ili njegov fragment koji se veže na antigen koji se mogu specifično vezati na čimbenik rasta živaca (NGF) koji sadrže: a) varijabilno područje teškog lanca (VH) koje sadrži aminokiselinski slijed koji je najmanje 90% slijedom istovjetan aminokiselinskom slijedu kojeg se bira iz skupine koju čine: SEQ ID NO: 6; SEQ ID NO: 37; SEQ ID NO: 166; i SEQ ID NO: 197; i b) varijabilno područje lakog lanca (VL) koje sadrži aminokiselinski slijed koji je najmanje 90% slijedom istovjetan aminokiselinskom slijedu kojeg se bira iz skupine koju čine: SEQ ID NO: 8; SEQ ID NO: 38; SEQ ID NO: 172; i SEQ ID NO: 196; naznačeni time što konstanta brzine Koff iznosi najviše 10–3 s–1, što je izmjereno površinskom plazmonskom rezonancijom.
3. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 2, naznačeni time što varijabilno područje teškog lanca sadrži aminokiselinski slijed koji je najmanje 90% istovjetan slijedu SEQ ID NO: 37, a varijabilno područje lakog lanca sadrži aminokiselinski slijed koji je najmanje 90% istovjetan slijedu SEQ ID NO: 38.
4. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 2, naznačeni time što varijabilno područje teškog lanca sadrži aminokiselinski slijed koji je najmanje 90% istovjetan slijedu SEQ ID NO: 166, a varijabilno područje lakog lanca sadrži aminokiselinski slijed koji je najmanje 90% istovjetan slijedu SEQ ID NO: 172.
5. Protutijelo ili fragment koji se veže na antigen u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeni time što se navedeno protutijelo ili fragment koji se veže na antigen bira iz skupine koju čine: imunoglobulin molekula, disulfidno spojeni Fv, monoklonsko protutijelo, scFv, kimerno protutijelo, jednodomensko protutijelo, protutijelo s presađenim CDR, dijatijelo, humanizirani mAb, kaninizirani mAb, pseći mAb, mačji mAb, felinizirani mAb, konjski mAb, ekvinizirani mAb, polispecifično protutijelo, Fab, dvojno specifično protutijelo, DVD-Ig, Fab’, bispecifično protutijelo, F(ab’)2, te Fv.
6. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 5, naznačeni time što je navedeno protutijelo ili fragment koji se veže na antigen monoklonsko protutijelo.
7. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 5, naznačeni time što je navedeno protutijelo ili fragment koji se veže na antigen kaninizirani mAb.
8. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 5, naznačeni time što je navedeno protutijelo ili fragment koji se veže na antigen humanizirani mAb.
9. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 1, naznačeni time što protutijelo ili fragment koji se veže na antigen sadrži konstantnu domenu teškog lanca koju se bira iz skupine koju čine: konstantna domena IgM, konstantna domena IgG4, konstantna domena IgG1, konstantna domena IgE, konstantna domena IgG2, konstantna domena IgG3, te konstantna domena IgA.
10. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 1, naznačeni time što se konstantnu domenu teškog lanca bira između konstantne domene ljudskog imunoglobulina ili konstantne domene psećeg imunoglobulina.
11. Protutijelo ili fragment koji se veže na antigen u skladu s patentnim zahtjevom 1, naznačeni time što sadrže konstantno područje koje ima aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 52 i SEQ ID NO: 54.
12. Protutijelo ili fragment koji se veže na antigen u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeni time što protutijelo ili fragment koji se veže na antigen može modulirati biološku funkciju NGF.
13. Farmaceutski pripravak, naznačen time što sadrži protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva i farmaceutski prihvatljivi nosač, razrjeđivač ili pomoćno sredstvo.
14. Farmaceutski pripravak u skladu s patentnim zahtjevom 13, namijenjen upotrebi u postupku liječenja subjekta koji boluje od poremećaja kod kojeg je aktivnost NGF štetna, naznačen time što se postupak sastoji u primjeni na subjektu terapijski djelotvorne količine navedenog protutijela ili fragmenta koji se veže na antigen.
HRP20220405TT 2010-08-19 2011-08-19 Protutijela protiv ngf i njihova upotreba HRP20220405T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37519310P 2010-08-19 2010-08-19
EP18153957.8A EP3333188B1 (en) 2010-08-19 2011-08-19 Anti-ngf antibodies and their use

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HRP20220405T1 true HRP20220405T1 (hr) 2022-05-27

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US (4) US9505829B2 (hr)
EP (3) EP3333188B1 (hr)
JP (5) JP6121903B2 (hr)
AU (1) AU2011291462A1 (hr)
CA (1) CA2808577C (hr)
DK (1) DK3333188T3 (hr)
ES (2) ES2910305T3 (hr)
HR (1) HRP20220405T1 (hr)
HU (1) HUE058226T2 (hr)
LT (1) LT3333188T (hr)
PL (1) PL3333188T3 (hr)
PT (1) PT3333188T (hr)
RS (1) RS63063B1 (hr)
SI (1) SI3333188T1 (hr)
WO (1) WO2012024650A2 (hr)

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