HRP20190690T1 - Postupci i pripravci za povećanje aktiviteta iduronat-2-sulfataze u centralnom nervnom sustavu - Google Patents

Postupci i pripravci za povećanje aktiviteta iduronat-2-sulfataze u centralnom nervnom sustavu Download PDF

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Publication number
HRP20190690T1
HRP20190690T1 HRP20190690TT HRP20190690T HRP20190690T1 HR P20190690 T1 HRP20190690 T1 HR P20190690T1 HR P20190690T T HRP20190690T T HR P20190690TT HR P20190690 T HRP20190690 T HR P20190690T HR P20190690 T1 HRP20190690 T1 HR P20190690T1
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Croatia
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amino acid
acid sequence
fusion antibody
iduronate
sulfatase
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HRP20190690TT
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English (en)
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William N. Pardridge
Ruben J. Boado
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Armagen, Inc.
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Publication of HRP20190690T1 publication Critical patent/HRP20190690T1/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
    • 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
    • A61P25/28—Drugs 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C07K2317/90—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
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Neurology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Endocrinology (AREA)
  • General Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hospice & Palliative Care (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Psychiatry (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (10)

1. Fuzijsko protutijelo, naznačeno time, da obuhvaća sljedeće: (a) fuzijski protein koji obuhvaća aminokiselinske sekvence jednog imunoglobulinskog teškog lanca i jedne iduronat-2-sulfataze (IDS), pri čemu je aminokiselinska sekvenca iduronat-2-sulfataze kovalentno vezana na karboksi-završetak od aminokiselinske sekvence imunoglobulinskog teškog lanca; i (b) jedan imunoglobulinski laki lanac; pri čemu fuzijsko protutijelo prelazi krvnu pregradu u mozgu (engl. blood brain barrier – BBB) putem vezanja inzulinskog receptora, te može katalizirati lizosomalno uklanjanje sulfatnih skupina iz sulfatirane alfa-L-iduron-kiselinske jedinice od glikozaminglikan-dermatan-sulfata, heparan-sulfata i heparina, gdje se kod imunoglobulinskog teškog lanca radi o imunoglobulinskom teškom lancu od IgG, te time, da aminokiselinska sekvenca od IDS obuhvaća aminokiselinsku sekvencu od SEQ ID NO: 9, i gdje aminokiselinska sekvenca imunoglobulinskog lakog lanca obuhvaća aminokiselinsku sekvencu od SEQ ID NO: 8, te pritom aminokiselinska sekvenca od imunoglobulinskog teškog lanca obuhvaća aminokiselinsku sekvencu od SEQ ID NO: 7.
2. Fuzijsko protutijelo prema zahtjevu 1, naznačeno time, da fuzijski protein prema značajki (a) nadalje obuhvaća poveznicu između aminokiselinske sekvence iduronat-2-sulfataze i karboksi-završetka od aminokiselinske sekvence imunoglobulinskog teškog lanca.
3. Fuzijsko protutijelo prema zahtjevu 1 ili 2, naznačeno time, da je IDS modificiran posttranslacijski pomoću faktora modifikacije sulfataze tipa 1 (SUMF1), dok pritom IDS opcionalno obuhvaća formilglicin.
4. Fuzijsko protutijelo prema bilo kojem od zahtjeva 1 do 3, naznačeno time, da specifični aktivitet iduronat-2-sulfataze od fuzijskog protutijela iznosi najmanje oko 10 000 jedinica/mg.
5. Farmaceutski pripravak, naznačen time, da obuhvaća terapeutski učinkovitu količinu fuzijskog protutijela u skladu s bilo kojim od zahtjeva 1 do 4, i farmaceutski prihvatljivo pomoćno sredstvo.
6. Fuzijsko protutijelo prema bilo kojem od zahtjeva 1 do 4, naznačeno time, da se upotrebljava u postupku liječenja deficijencije iduronat-2-sulfataze u centralnom nervnom sustavu pojedinca, pri čemu postupak obuhvaća sustavnu primjenu terapeutski učinkovite doze fuzijskog protutijela na pojedincu, dok se pritom opcionalno radi o sustavnoj primjeni koja je parenteralna, intravenozna, subkutana, intramuskularna, transnazalna, intraarterijska, transdermalna ili respiratorna primjena.
7. Fuzijsko protutijelo prema zahtjevu 6, naznačeno time, da se najmanje oko 10 000 jedinica aktiviteta iduronat-2-sulfataze dovodi u mozak, normirano po 50 kg tjelesne težine ili, time da terapeutski učinkovita doza obuhvaća najmanje 250 000 jedinica aktiviteta iduronat-2-sulfataze ili najmanje oko 25 000 jedinica, normirano po 50 kg tjelesne težine.
8. Izolirani polinukleotid, naznačen time, da kodira fuzijsko protutijelo u skladu s bilo kojim od zahtjeva 1 do 4, gdje izolirani polinukleotid opcionalno obuhvaća sekvencu nukleinske kiseline od SEQ ID NO: 14.
9. Vektor, naznačen time, da obuhvaća izolirani polinukleotid u skladu sa zahtjevom 8.
10. Stanica domaćina, naznačena time, da obuhvaća vektor u skladu sa zahtjevom 9, pri čemu ta stanica domaćina je opcionalno stanica jajnika kineskog hrčka (engl. Chinese Hamster Ovary (CHO) cell).
HRP20190690TT 2009-10-09 2019-04-12 Postupci i pripravci za povećanje aktiviteta iduronat-2-sulfataze u centralnom nervnom sustavu HRP20190690T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US25037809P 2009-10-09 2009-10-09
US25604909P 2009-10-29 2009-10-29
PCT/US2010/052113 WO2011044542A1 (en) 2009-10-09 2010-10-08 Methods and compositions for increasing iduronate 2-sulfatase activity in the cns
EP10822810.7A EP2485761B1 (en) 2009-10-09 2010-10-08 Methods and compositions for increasing iduronate 2-sulfatase activity in the cns

Publications (1)

Publication Number Publication Date
HRP20190690T1 true HRP20190690T1 (hr) 2019-06-28

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Country Status (11)

Country Link
US (4) US8834874B2 (hr)
EP (3) EP4273164A3 (hr)
JP (5) JP2013507131A (hr)
DK (1) DK2485761T3 (hr)
ES (1) ES2725200T3 (hr)
HR (1) HRP20190690T1 (hr)
HU (1) HUE044865T2 (hr)
PL (1) PL2485761T3 (hr)
PT (1) PT2485761T (hr)
SI (1) SI2485761T1 (hr)
WO (1) WO2011044542A1 (hr)

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