DK2604693T3 - Enkeltkædede TNFSF-molekyler - Google Patents

Enkeltkædede TNFSF-molekyler Download PDF

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DK2604693T3
DK2604693T3 DK13152482.9T DK13152482T DK2604693T3 DK 2604693 T3 DK2604693 T3 DK 2604693T3 DK 13152482 T DK13152482 T DK 13152482T DK 2604693 T3 DK2604693 T3 DK 2604693T3
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DK13152482.9T
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Christian Gieffers
Meinolf Thiemann
Oliver Hill
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Apogenix Gmbh
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    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/525Tumour necrosis factor [TNF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70575NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62DNA sequences coding for fusion proteins
    • 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
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/40Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41Glycosylation, sialylation, or fucosylation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/20Fusion polypeptide containing a tag with affinity for a non-protein ligand
    • C07K2319/22Fusion polypeptide containing a tag with affinity for a non-protein ligand containing a Strep-tag
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/32Fusion polypeptide fusions with soluble part of a cell surface receptor, "decoy receptors"
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/35Fusion polypeptide containing a fusion for enhanced stability/folding during expression, e.g. fusions with chaperones or thioredoxin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/70Fusion polypeptide containing domain for protein-protein interaction
    • C07K2319/74Fusion polypeptide containing domain for protein-protein interaction containing a fusion for binding to a cell surface receptor

Claims (12)

1. Enkeltkædet fusionspolypeptid, som omfatter: (i) et første opløseligt domæne fra et cytokin i TNF-familien, (ii) en første peptidli nker, (iii) et andet opløseligt domæne fra et cytokin i TNF-familien, (iv) en anden peptidlinker og (v) et tredje opløseligt domæne fra et cytokin i TNF-familien, hvor fusionspolypeptidet er i alt væsentligt ikke-aggregerende, og hvor domænerne (i), (iii) og (v) fra et cytokin i TNF-familien er opløselige humane LIGHT-domæner, som omfatter en aminosyresekvens, der begynder fra aminosyre 93, 94 eller 95 ifølge SEQ ID NO: 16.
2. Polypeptid ifølge krav 1, hvor det opløselige humane LIGHT-domæne omfatter aminosyrerne 93-240, 94-240 eller 95-240 ifølge SEQ ID NO: 16.
3. Polypeptid ifølge krav 1 eller 2, hvor de opløselige domæner omfatter mutationer, som ændrer de opløselige domæners bindingsegenskaber.
4. Polypeptid ifølge et hvilket som helst af kravene 1-3, hvor det andet og det tredje opløselige LIGFIT-domæne (iii) og (v) begynder mellem aminosyre Pro94 og Ala95 ifølge SEQ ID NO: 16.
5. Polypeptid ifølge et hvilket som helst af kravene 1 -4, hvor den første og den anden peptidlinker uafhængigt har en længde på fra 3 til 8 aminosyrer, navnlig en længde på 3, 4, 5, 6, 7 eller 8 aminosyrer, og fortrinsvis er glycin-/serinlinkere, eventuelt omfattende en asparaginrest, som kan være glycosyleret.
6. Polypeptid ifølge et hvilket som helst af kravene 1 -5, som endvidere omfatter et N-terminalt signalpeptiddomæne, som kan omfatte et proteasespaltningssted, og/eller som endvidere omfatter et C-terminalt element, som kan omfatte og/eller være forbundet til et genkendelses-/oprensningsdomæne.
7. Polypeptid ifølge et hvilket som helst af kravene 1 -6, som endvidere omfatter et yderligere domæne N-terminalt og/eller C-terminalt, f.eks. et enkeltkædet antistof eller antistoffragment, såsom et Fab- eller Fc-fragmentdomæne.
8. Nukleinsyremolekyle, som koder for et fusionspolypeptid ifølge et hvilket som helst af kravene 1-7, fortrinsvis operativt forbundet til en ekspressionskontrolsekvens.
9. Isoleret celle eller ikke-human organisme, som er transformeret eller transfi-ceret med et nukleinsyremolekyle ifølge krav 8, hvor cellen f.eks. er en prokaryot celle eller en eukaryot celle, fortrinsvis en pattedyrcelle eller, mere fortrinsvis, en human celle.
10. Farmaceutisk sammensætning, der som aktivt stof omfatter et fusionsprotein ifølge et hvilket som helst af kravene 1-7 eller et nukleinsyremolekyle ifølge krav 8.
11. Farmaceutisk sammensætning ifølge krav 10 til anvendelse til behandling.
12. Diagnostisk sammensætning, der som aktivt stof omfatter et fusionsprotein ifølge et hvilket som helst af kravene 1-7 eller et nukleinsyremolekyle ifølge krav 8.
DK13152482.9T 2008-07-21 2009-07-18 Enkeltkædede TNFSF-molekyler DK2604693T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08013112 2008-07-21
EP09780803.4A EP2310509B1 (en) 2008-07-21 2009-07-18 Tnfsf single chain molecules

Publications (1)

Publication Number Publication Date
DK2604693T3 true DK2604693T3 (da) 2016-05-30

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ID=41165705

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DK09780803.4T DK2310509T3 (da) 2008-07-21 2009-07-18 Enkeltkædede TNFSF-molekyler
DK13152482.9T DK2604693T3 (da) 2008-07-21 2009-07-18 Enkeltkædede TNFSF-molekyler

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US (10) US8450460B2 (da)
EP (4) EP3103875A1 (da)
JP (5) JP5674155B2 (da)
CA (3) CA2910512C (da)
CY (1) CY1116288T1 (da)
DK (2) DK2310509T3 (da)
ES (2) ES2538122T3 (da)
HR (1) HRP20150425T1 (da)
HU (1) HUE025236T2 (da)
PL (2) PL2604693T3 (da)
PT (1) PT2310509E (da)
SI (1) SI2310509T1 (da)
SM (1) SMT201500135B (da)
WO (1) WO2010010051A1 (da)

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