DK2450056T3 - Forebyggelse og behandling af synucleinopatisk og amyloidogen sygdom - Google Patents

Forebyggelse og behandling af synucleinopatisk og amyloidogen sygdom Download PDF

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Publication number
DK2450056T3
DK2450056T3 DK11175183.0T DK11175183T DK2450056T3 DK 2450056 T3 DK2450056 T3 DK 2450056T3 DK 11175183 T DK11175183 T DK 11175183T DK 2450056 T3 DK2450056 T3 DK 2450056T3
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Denmark
Prior art keywords
antibody
synuclein
alpha
antibodies
human
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DK11175183.0T
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English (en)
Inventor
Dale B Schenk
Eliezer Masliah
Manuel J Buttini
Tamie J Chilcote
Edward Rockenstein
Dora Kate Games
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Prothena Biosciences Ltd
Univ California
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Priority claimed from US11/185,907 external-priority patent/US8506959B2/en
Application filed by Prothena Biosciences Ltd, Univ California filed Critical Prothena Biosciences Ltd
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Publication of DK2450056T3 publication Critical patent/DK2450056T3/da

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    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/0005Vertebrate antigens
    • A61K39/0007Nervous system antigens; Prions
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (10)

1. Antistof der binder til human alpha-synuclein til anvendelse til profylakse eller behandling af en Lewy body sygdom, hvor antistoffet er: det 8A5-monoklonale antistof produceret af hybridomacellen med ATCC-accessionsnummer PTA-6909; en kimær form af 8A5-antistoffet; eller en humaniseret version af 8A5-antistoffet omfattende CDR'erne fra 8A5-antistoffet.
2. Antistof til anvendelse ifølge krav 1, hvor antistoffet er et antistof af human IgGl-isotype.
3. Antistof til anvendelse ifølge krav 1 eller krav 2, hvor antistoffet indgives i en dosis på 1 mg til 100 mg antistof per kg kropsvægt.
4. Antistof til anvendelse ifølge et hvilket som helst af de foregående krav, hvor antistoffet indgives i flere doser over mindst seks måneder.
5. Antistof til anvendelse ifølge et hvilket som helst af de foregående krav, hvor antistoffet indgives intraperitonealt, oralt, subkutant, intrakranialt, intramuskulært, topikalt, intranasalt eller intravenøst.
6. Hybridomacelle med ATCC accessionsnummer PTA-6909.
7. Farmaceutisk sammensætning omfattende et kimært eller humaniseret antistof ifølge krav 1.
8. Fremgangsmåde til humanisering af det monoklonale antistof 8A5 produceret af hybridomacellen med ATCC-accessionsnummer PTA-6909, omfattende: at bestemme aminosyresekvensen af CDR'erne af det monoklonale antistof; at udvælge et acceptor-antistof; og at producere et humaniseret antistof omfattende CDR'erne fra det monoklonale antistof og variable region-skelet fra acceptor-antistoffet, eventuelt hvor fremgangsmåden endvidere omfatter at substituere en udvalgt rest fra human variabel region-skelet med en tilsvarende skelet-aminosyre fra 8A5-antistoffet når aminosyren (1) ikke-kovalent binder antigen direkte, (2) støder op til en CDR-region af antistoffet, (3) på anden måde interagerer med en CDR-region af antistoffet, eller (4) deltager i VL-VH-grænsefladen, eller at substituere en human skelet-aminosyre der er usædvanlig for en human immunglobulin i den position med en aminosyre fra den tilsvarende position af 8A5-antistoffet eller fra den tilsvarende position afen mere typisk human immunglobulin.
9. Fremgangsmåde til fremstilling afen kimær form af det monoklonale antistof 8A5 produceret af hybridomacellen med ATCC-accessionsnummer PTA-6909, omfattende: at bestemme aminosyresekvensen aflet- og tungkæde variabelregionerne af det monoklonale antistof; at udvælge tung- og letkæde konstantregion; at producere et kimært antistof omfattende en letkæde omfattende letkæde variabelregionen fusioneret med letkæde konstantregionen, og en tungkæde omfattende tungkæde variabelregionen fusioneret med tungkæde konstantregionen.
10. Antistof til anvendelse ifølge krav 1, hvor sygdommen er Parkinsons sygdom.
DK11175183.0T 2005-07-19 2006-07-19 Forebyggelse og behandling af synucleinopatisk og amyloidogen sygdom DK2450056T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/185,907 US8506959B2 (en) 2002-11-01 2005-07-19 Prevention and treatment of synucleinopathic and amyloidogenic disease
PCT/US2005/028166 WO2006020581A2 (en) 2004-08-09 2005-08-09 Prevention and treatment of synucleinopathic and amyloidogenic disease
EP06800177.5A EP1910829B1 (en) 2005-07-19 2006-07-19 Prevention and treatment of synucleinopathic and amyloidogenic disease

Publications (1)

Publication Number Publication Date
DK2450056T3 true DK2450056T3 (da) 2017-05-22

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DK11175183.0T DK2450056T3 (da) 2005-07-19 2006-07-19 Forebyggelse og behandling af synucleinopatisk og amyloidogen sygdom

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EP (2) EP1910829B1 (da)
CA (1) CA2616047C (da)
DK (1) DK2450056T3 (da)
EA (1) EA013752B1 (da)
MX (1) MX2007001679A (da)
WO (1) WO2007012061A2 (da)

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EP1910829A2 (en) 2008-04-16
WO2007012061A2 (en) 2007-01-25
CA2616047C (en) 2018-01-09
EA013752B1 (ru) 2010-06-30
EA200700427A1 (ru) 2008-02-28
EP2450056A1 (en) 2012-05-09
EP1910829B1 (en) 2016-03-02
MX2007001679A (es) 2007-05-23
EP1910829A4 (en) 2009-04-22
EP2450056B1 (en) 2017-03-15
WO2007012061A3 (en) 2007-12-13
CA2616047A1 (en) 2007-01-25

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