DK1896071T3 - Fremgangsmåder og sammensætninger med forøget terapeutisk aktivitet - Google Patents

Fremgangsmåder og sammensætninger med forøget terapeutisk aktivitet Download PDF

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DK1896071T3
DK1896071T3 DK06774442.5T DK06774442T DK1896071T3 DK 1896071 T3 DK1896071 T3 DK 1896071T3 DK 06774442 T DK06774442 T DK 06774442T DK 1896071 T3 DK1896071 T3 DK 1896071T3
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protein
cells
binding
antibody
target
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Ann Cai
Cam Ngo
T Shantha Raju
Bernard Scallon
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Janssen Biotech Inc
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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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (25)

1
1. In v/'fro-fremgangsmåde til at styre egenskaberne af et Fc-indeholdende molekyle, omfattende ændring af sialyleringen af oligosacchariderne i Fc-regionen til den G2S2 sialylerede glycoform, hvor sialyleringen forøges i Fc-regionen, hvor sialyleringen ændres fra vild-type-Fc-regionen ved enzymatisk behandling eller enzymatisk modifikation af molekylet af en a-(2,3)-sialyltransferase, og hvor de styrede egenskaber er valgt fra gruppen bestående af affinitet for én eller flere af FcyRI-, FcyRIIA-, og FcyRIIIA-receptorerne, ADCC-aktivitet, makrofag- eller monocytaktivering, serum-halveringstid, og aviditet.
2. Fremgangsmåden ifølge krav 1, hvor det Fc-indeholdende molekyle har et binding-domæne der er specifikt for et target, hvilket target er et immobiliseret target.
3. Fremgangsmåden ifølge krav 1, hvor det Fc-indeholdende molekyle har et bindings-domæne der er specifikt for et target, hvilket target udtrykkes på overfladen afen celle.
4. Fremgangsmåden ifølge krav 1, hvor det Fc-indeholdende molekyle er et antistof.
5. In vitro-fremgangsmåde til at styre egenskaberne af et Fc-indeholdende terapeutisk protein kendetegnet ved at have en biantennær oligosaccharid covalent vedhæftet til en asparaginrest i CH2-immunoglobulin-domænet af dette protein, omfattende omdannelse af et Fc-indeholdende terapeutisk protein ikke af G2S2-glycoformen, til et oligosaccharid der er af den G2S2-sialylerede glycoform, hvor omdannelsestrinnet omfatter anvendelse af en a-(2,3)-sialyltransferase til at tilsætte sialinsyreresterne, og hvor det Fc-indeholdende protein har én eller flere af egenskaberne valgt fra gruppen bestående af nedsat affinitet over for FcyRIIA og FcyRIIIA, nedsat aktivitet i NK-celle-medierede ADCC-assay, forøget affinitet over for FcyRI, forøget evne til at aktivere makrofager, og kortere serumhalveringstid sammenlignet med det samme Fc-indeholdende terapeutisk protein der ikke er af G2S2-glycoformen. 2
6. Fc-indeholdende protein fremstillet eller ændret ved fremgangsmåden ifølge et hvilket som helst af kravene 1-5.
7. Fc-indeholdende terapeutisk protein kendetegnet ved at have et biantennær oligosaccharid kovalent vedhæftet til en asparaginrest i CH2-immunoglobulin-domænet af dette protein værende af den G2S2 a-(2,3)-sialylerede glycoform, hvor det Fc-indeholdende protein har nedsat affinitet over for FcyRIIA og FcyRIIIA, nedsat aktivitet i NK celle-medierede ADCC-assay, forøget affinitet for FcyRI, forøget evne til at aktivere makrofager, og kortere serum-halveringstid sammenlignet med en fremstilling af det samme Fc-indeholdende terapeutiske protein i de ikke-sialylerede GO-, GI-, eller G2-glycoformer.
8. Proteinet ifølge krav 7, hvor target bundet af proteinets target-bindings-domæne er et immobiliseret target.
9. Proteinet ifølge krav 7, hvor target bundet af proteinets bindings-domæne udtrykkes på overfladen af en celle.
10. Proteinet ifølge et hvilket som helst af kravene 7-9, hvor proteinet er indikeret til behandlingen af onkologi-relaterede lidelser, kroniske sygdomme, eller infektionssygdomme.
11. Proteinet ifølge krav 10, hvor infektionssygdommene involverer FcR-medieret opklaring af antistof-opsonikerede celler eller partikler omfattende ét eller både virus og bakterie og de kroniske sygdomme kræver langtidsbehandling.
12. Proteinet ifølge krav 7, hvor proteinet omfatter et rekombinant udtrykt monoklonalt antistof eller et antistof modificeret enzymatisk under anvendelse af sialyltransferaser.
13. Proteinet ifølge krav 7, hvor the protein is valgt fra gruppen bestående af Abl, Ab2, Ab3, or Ab5.
14. In vitro-fremgangsmåde til fremstilling afen batch af terapeutisk rekombinant Fc-indeholdende protein af den G2S2-sialylerede glycoform kendetegnet som 3 omfattende et immunoglobulin IgG isotype-domæne af mindst én hængselsregion, et CH2-, og et CH3-domæne, hvor fremgangsmåden omfatter behandling af batchen med et a-(2,3)-sialyltransferaseenzym til at tilføje sialinsyrerester til polysaccharidkæderne vedhæftet dette protein.
15. Farmaceutisk sammensætning omfattende et protein fremstillet ved fremgangsmåden ifølge krav 14 i kombination med en farmaceutisk acceptabel bærer.
16. Proteinet fremstillet ved fremgangsmåden ifølge krav 14 til anvendelse i behandling afen sygdom eller tilstand.
17. Proteinet fremstillet ved fremgangsmåden ifølge krav 14 til anvendelse in vivo i diagnose af en sygdom eller tilstand.
18. Proteinet ifølge krav 16, hvor proteinet anvendes til at behandle en neoplastisk sygdom valgt fra gruppen bestående af et carcinom, et lymfom, et sarcom, og et myelom.
19. Proteinet ifølge krav 16, hvor proteinet anvendes til at behandle en inflammatorisk lidelse valgt fra gruppen bestående af psoriasis, rheumatoid arthritis, ulcerativ colitis, inflammatorisk tarmsygdom, Crohn's sygdom, og systemisk lupus erythematosus.
20. Proteinet ifølge krav 16, hvor proteinet anvendes til at behandle lidelser der involverer corneal eller retinal neovaskularisering.
21. In vitro-fremgangsmåde til at styre bindingsaffinitet for et target af et Fc-indeholdende molekyle der har et bindingsdomæne specifikt for target, omfattende ændring af sialyleringen af oligosacchariderne i Fc-regionen til den G2S2 sialylerede glycoform, hvor sialyleringen forøges i Fc-regionen og aviditeten sænkes, og hvor sialyleringen ændres fra vild-type-Fc-regionen ved enzymatisk behandling eller enzymatisk modifikation af molekylet med en a-(2,3)-sialyltransferase. 4
22. Fremgangsmåden ifølge krav 21, hvor target er et immobiliseret target.
23. Fremgangsmåden ifølge krav 21, hvor target udtrykkes på overfladen afen celle
24. Fremgangsmåden ifølge krav 21, hvor det Fc-indeholdende molekyle er et antistof.
25. In vitro-fremgangsmåde omfattende proteinet fremstillet ved fremgangsmåden ifølge krav 14 til diagnose af en sygdom eller tilstand.
DK06774442.5T 2005-06-30 2006-06-30 Fremgangsmåder og sammensætninger med forøget terapeutisk aktivitet DK1896071T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US69576905P 2005-06-30 2005-06-30
US80910606P 2006-05-26 2006-05-26
PCT/US2006/025906 WO2007005786A2 (en) 2005-06-30 2006-06-30 Methods and compositions with enhanced therapeutic activity

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EP (1) EP1896071B1 (da)
JP (1) JP2009504569A (da)
CN (1) CN101506238B (da)
AU (1) AU2006265676B2 (da)
CA (1) CA2614046C (da)
DK (1) DK1896071T3 (da)
ES (1) ES2543685T3 (da)
IL (1) IL188420A (da)
PT (1) PT1896071E (da)
SG (1) SG163548A1 (da)
WO (1) WO2007005786A2 (da)

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