WO2009149171A4 - Fgf21 mutants and uses thereof - Google Patents

Fgf21 mutants and uses thereof Download PDF

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Publication number
WO2009149171A4
WO2009149171A4 PCT/US2009/046113 US2009046113W WO2009149171A4 WO 2009149171 A4 WO2009149171 A4 WO 2009149171A4 US 2009046113 W US2009046113 W US 2009046113W WO 2009149171 A4 WO2009149171 A4 WO 2009149171A4
Authority
WO
WIPO (PCT)
Prior art keywords
new
fusion polypeptide
seq
polypeptide
sequence
Prior art date
Application number
PCT/US2009/046113
Other languages
French (fr)
Other versions
WO2009149171A3 (en
WO2009149171A2 (en
Inventor
Edward John Belouski
Murielle Marie Ellison
Agnes Eva Hamburger
Randy Ira Hecht
Yue-Sheng Li
Mark Leo Michaels
Jeonghoon Sun
Jing Xu
Original Assignee
Amgen Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40984291&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009149171(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to BR122020010972-6A priority Critical patent/BR122020010972B1/en
Priority to CN200980130476.4A priority patent/CN102143758B/en
Priority to UAA201015922A priority patent/UA102395C2/en
Priority to BRPI0911385A priority patent/BRPI0911385B8/en
Priority to KR1020167010524A priority patent/KR101787300B1/en
Priority to EP09759330.5A priority patent/EP2296690B1/en
Priority to MX2010013333A priority patent/MX2010013333A/en
Priority to NZ590050A priority patent/NZ590050A/en
Priority to CA2726589A priority patent/CA2726589C/en
Application filed by Amgen Inc. filed Critical Amgen Inc.
Priority to AU2009256232A priority patent/AU2009256232B2/en
Priority to MX2012002985A priority patent/MX346396B/en
Priority to EA201001883A priority patent/EA017690B1/en
Priority to JP2011512611A priority patent/JP2011523561A/en
Priority to MA34197A priority patent/MA33142B1/en
Publication of WO2009149171A2 publication Critical patent/WO2009149171A2/en
Publication of WO2009149171A3 publication Critical patent/WO2009149171A3/en
Publication of WO2009149171A4 publication Critical patent/WO2009149171A4/en
Priority to IL209395A priority patent/IL209395A/en
Priority to TNP2010000563A priority patent/TN2010000563A1/en
Priority to ZA2010/08778A priority patent/ZA201008778B/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1825Fibroblast growth factor [FGF]
    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal 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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/01DNA viruses
    • C07K14/03Herpetoviridae, e.g. pseudorabies virus
    • C07K14/05Epstein-Barr virus
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/50Fibroblast growth factors [FGF]
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • 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
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10Cells modified by introduction of foreign genetic material
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Abstract

The invention provides nucleic acid molecules encoding FGF21 mutant polypeptides, FGF21 mutant polypeptides, pharmaceutical compositions comprising FGF21 mutant polypeptides, and methods for treating metabolic disorders using such nucleic acids, polypeptides, or pharmaceutical compositions.

Claims

AMENDED CLAIMS received by the International Bureau on 17 March 2010 (17.03.10)
51. (New) A polypeptide comprising the amino acid sequence of SEQ ID NO:4, further comprising the mutations L98R and P 171 G.
52. (New) A fusion polypeptide comprising the polypeptide of claim 51 linked to a heterologous sequence.
53. (New) The fusion polypeptide of claim 52, wherein, the heterologous sequence is a Fc sequence.
54. (New) The fusion polypeptide of claim 53, wherein the Fc sequence comprises the amino acid sequence of SEQ ID NO: 13.
55. (New) The fusion polypeptide of claim 54, wherein the polypeptide is joined to the heterologous sequence by a linker.
56. (New) The fusion polypeptide of claim 55 wherein the linker is GGGGGSGGGSGGGGS (SEQ ID NO.-23).
57. (New) The fusion polypeptide of claim 55 wherein the linker is GGGGSGGGGSGGGGS (SEQ ID NO:31).
58. (New) The fusion polypeptide 56, wherein the fusion polypeptide is encoded by the nucleic acid sequence of SEQ ED NO:37.
59. (New) A multimer comprising two or more copies of the fusion polypeptide of claim 58.
60. (New) A pharmaceutical composition comprising the fusion polypeptide of claim 58 and a pharmaceutically acceptable formulation agent.
PCT/US2009/046113 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof WO2009149171A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
MA34197A MA33142B1 (en) 2008-06-04 2009-06-03 FGF21 MUTANTS AND USES THEREOF
MX2012002985A MX346396B (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof.
AU2009256232A AU2009256232B2 (en) 2008-06-04 2009-06-03 FGF21 mutants and uses thereof
EA201001883A EA017690B1 (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof
CN200980130476.4A CN102143758B (en) 2008-06-04 2009-06-03 Fgf21 mutant and uses thereof
EP09759330.5A EP2296690B1 (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof
MX2010013333A MX2010013333A (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof.
NZ590050A NZ590050A (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof
CA2726589A CA2726589C (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof
BR122020010972-6A BR122020010972B1 (en) 2008-06-04 2009-06-03 isolated and fusion polypeptide, its pharmaceutical composition and multimer
UAA201015922A UA102395C2 (en) 2008-06-04 2009-06-03 Fgf21 mutants and use thereof
KR1020167010524A KR101787300B1 (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof
BRPI0911385A BRPI0911385B8 (en) 2008-06-04 2009-06-03 isolated polypeptide, fusion polypeptide, multimer and pharmaceutical composition
JP2011512611A JP2011523561A (en) 2008-06-04 2009-06-03 FGF21 mutants and uses thereof
IL209395A IL209395A (en) 2008-06-04 2010-11-17 Fgf21 mutants and pharmaceutical compositions comprising them
TNP2010000563A TN2010000563A1 (en) 2009-06-03 2010-12-03 Fgf 21 mutants and uses thereof
ZA2010/08778A ZA201008778B (en) 2008-06-04 2010-12-07 Fgf21 mutants and uses thereof

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US5886108P 2008-06-04 2008-06-04
US5891908P 2008-06-04 2008-06-04
US61/058,861 2008-06-04
US61/058,919 2008-06-04
US16436409P 2009-03-27 2009-03-27
US61/164,364 2009-03-27
US17573609P 2009-05-05 2009-05-05
US61/175,736 2009-05-05

Publications (3)

Publication Number Publication Date
WO2009149171A2 WO2009149171A2 (en) 2009-12-10
WO2009149171A3 WO2009149171A3 (en) 2010-03-11
WO2009149171A4 true WO2009149171A4 (en) 2010-05-06

Family

ID=40984291

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/046113 WO2009149171A2 (en) 2008-06-04 2009-06-03 Fgf21 mutants and uses thereof

Country Status (23)

Country Link
US (9) US8034770B2 (en)
EP (1) EP2296690B1 (en)
JP (5) JP2011523561A (en)
KR (2) KR101651697B1 (en)
CN (1) CN102143758B (en)
AR (1) AR072009A1 (en)
AU (1) AU2009256232B2 (en)
BR (2) BRPI0911385B8 (en)
CA (1) CA2726589C (en)
CL (1) CL2010001346A1 (en)
CO (1) CO6341566A2 (en)
CR (1) CR11851A (en)
EA (3) EA024751B8 (en)
IL (1) IL209395A (en)
JO (1) JOP20190083A1 (en)
MA (1) MA33142B1 (en)
MX (2) MX346396B (en)
MY (1) MY152721A (en)
NZ (1) NZ590050A (en)
PE (1) PE20100253A1 (en)
SG (1) SG193860A1 (en)
TW (2) TWI526220B (en)
WO (1) WO2009149171A2 (en)

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