DK2723379T3 - Anti-alpha-synuklein-bindende molekyler - Google Patents

Anti-alpha-synuklein-bindende molekyler Download PDF

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DK2723379T3
DK2723379T3 DK12802721.6T DK12802721T DK2723379T3 DK 2723379 T3 DK2723379 T3 DK 2723379T3 DK 12802721 T DK12802721 T DK 12802721T DK 2723379 T3 DK2723379 T3 DK 2723379T3
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antibody
synuclein
antigen
antibodies
human
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DK12802721.6T
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Andreas Weihofen
Jan Grimm
Christoph Hock
Roger Nitsch
Lihe Su
Paul Weinreb
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Biogen Int Neuroscience Gmbh
Univ Of Zuerich
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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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/68—Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders
    • G01N2800/2814—Dementia; Cognitive disorders
    • G01N2800/2828—Prion diseases
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/28—Neurological disorders
    • G01N2800/2835—Movement disorders, e.g. Parkinson, Huntington, Tourette

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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  • Neurosurgery (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
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  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (15)

1. Isoleret antistof eller antigenbindende fragment deraf, som binder til a-synuklein (SEQ ID NO:1), hvor antistoffet eller det antigenbindende fragment deraf omfatter (a) en variabel tungkæderegion (VH), der omfatter VH-komplementaritetsbestemmende regioner (CDR'er) 1,2, og 3, der omfatter (i) en CDR1-region, som er identisk med SEQ ID NO:16; (ii) en CDR2-region, som er identisk med SEQ ID NO:17; og (iii) en CDR3-region, som er identisk med SEQ ID NO:18; og (b) en variabel letkæderegion (VL), der omfatter VL-CDR'er 1, 2, og 3, der omfatter (i) en CDR1-region, som er identisk med SEQ ID NO:23; (ii) en CDR2-region, som er identisk med SEQ ID NO:24; og (iii) en CDR3-region, som er identisk med SEQ ID NO:25.
2. Antistof eller antigenbindende fragment deraf ifølge krav 1, der omfatter (a) VH-sekvens SEQ ID NO:15 og VL-sekvens SEQ ID NO:22; eller (b) VH-sekvens SEQ ID NO:20 og VL-sekvens SEQ ID NO:26.
3. Antistof eller antigenbindende fragment deraf ifølge krav 1 eller 2, som er (i) humaniseret; kimært eller fuldstændig humant; (ii) et Fab-fragment, et Fab'-fragment, et F(ab)2-fragment, et enkeltkædet Fv-fragment eller et enkeltkædet antistof; og/eller (iii) der endvidere omfatter et heterologt polypeptid, som er kondenseret dertil.
4. Antistof eller antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 3, hvor antistoffet eller det antigenbindende fragment deraf er konjugeret til et middel, der er valgt fra gruppen bestående af et terapeutisk middel, et prodrug, et peptid, et protein, et enzym, et virus, et lipid, en modifikator af biologisk respons, et farmaceutisk middel og polyethylenglycol (PEG).
5. Farmaceutisk sammensætning, der omfatter antistoffet eller det antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4 og en farmaceutisk acceptabel bærer.
6. Isoleret polynukleotid eller isolerede polynukleotider, som omfatter en nukleinsyre eller nukleinsyrer, der koder for antistoffet eller det antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4.
7. Vektor eller vektorer, der omfatter polynukleotidet eller polynukleotiderne ifølge krav 6.
8. Værtscelle, der omfatter (i) polynukleotidet eller polynukleotiderne ifølge krav 6 eller vektoren eller vektorerne ifølge krav 7; eller (ii) mindst en første og en anden vektor, hvor den første og den anden vektor er ikke-identiske, hvor den første vektor omfatter polynukleotidet ifølge krav 6, der koder for VH'en, og hvor den anden vektor omfatter polynukleotidet ifølge krav 6, der koder for VL'en i antistoffet eller det antigenbindende fragment deraf.
9. Fremgangsmåde til fremstilling af et anti-humant α-synuklein-antistof eller et antigenbindende fragment deraf, hvilken fremgangsmåde omfatter dyrkning af værtscellen ifølge krav 8 og isolering af antistoffet eller det antigenbindende fragment deraf fra cellekulturen.
10. Anti-humant α-synuklein-antistof eller et antigenbindende fragment deraf, fremstillet ved fremgangsmåden ifølge krav 9.
11. Antistof eller antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4 eller 10, den farmaceutiske sammensætning ifølge krav 5, polynukleotidet ifølge krav 6, vektoren ifølge krav 7 eller værtscellen ifølge krav 8 til anvendelse ved behandling eller forebyggelse afen synukleinopatisk sygdom hos et individ.
12. In wiro-fremgangsmåde til diagnosticering af en synukleinopatisk sygdom hos et individ, hvilken fremgangsmåde omfatter: (a) bedømmelse af niveauet, lokaliseringen, konformationen eller en kombination deraf af a-synuklein hos et individ, som skal diagnosticeres med antistoffet eller det antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4 eller 10, og (b) sammenligning af niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos individet med én eller flere referencestandarder, som stammer fra af én eller flere kontrolprøver, hvor en forskel eller lighed mellem niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos individet og referencestandarden viser, hvorvidt individet har en synukleinopatisk sygdom.
13. Antistof eller antigenbindende fragment deraf til anvendelse ifølge krav 11 eller fremgangsmåde ifølge krav 12, hvor den synukleinopatiske sygdom er Parkinsons sygdom (PD), Lewy body-demens (DLB), multipel system-atrofi (MSA) eller en kombination deraf, og/eller hvor individet er et pattedyr, fortrinsvis hvor pattedyret er et menneske.
14. Antistof eller antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4 eller 10 til anvendelse ved en fremgangsmåde til diagnosticering af en synukleinopatisk sygdom hos et individ, hvilken fremgangsmåde omfatter: (a) bedømmelse af niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos et individ, som skal diagnosticeres med antistoffet eller det antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 4 eller 10, og (b) sammenligning af niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos individet med én eller flere referencestandarder, som stammer fra af én eller flere kontrolprøver, hvor en forskel eller lighed mellem niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos individet og referencestandarden viser, hvorvidt individet har en synukleinopatisk sygdom, fortrinsvis hvor den synukleinopatiske sygdom er Parkinsons sygdom (PD), Lewy body-demens (DLB), multipel system-atrofi (MSA) eller en kombination deraf, og/eller hvor individet er et pattedyr, fortrinsvis hvor pattedyret er et menneske.
15. Antistof eller antigenbindende fragment deraf ifølge krav 14, hvor niveauet, lokaliseringen, konformationen eller en kombination deraf af α-synuklein hos individet måles med in v'/Vo-billeddannelse, fortrinsvis hvor in vivo-billeddannelsen omfatter positronemissionstomografi (PET), enkeltfotonemissionstomografi (SPECT), nær-infrarød (NIR), optisk billeddannelse eller magnetisk resonans-billeddannelse (MRI).
DK12802721.6T 2011-06-23 2012-06-22 Anti-alpha-synuklein-bindende molekyler DK2723379T3 (da)

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US201161500580P 2011-06-23 2011-06-23
PCT/US2012/043701 WO2012177972A1 (en) 2011-06-23 2012-06-22 Anti-alpha synuclein binding molecules

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EP (1) EP2723379B1 (da)
JP (2) JP2014528695A (da)
KR (1) KR101976887B1 (da)
CN (1) CN103796679B (da)
AU (1) AU2012272790B2 (da)
BR (1) BR112013033258B1 (da)
CA (1) CA2839563C (da)
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DK (1) DK2723379T3 (da)
EA (1) EA030777B9 (da)
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HR (1) HRP20181553T1 (da)
HU (1) HUE041391T2 (da)
IL (1) IL230028B (da)
LT (1) LT2723379T (da)
MX (1) MX357193B (da)
PL (1) PL2723379T3 (da)
PT (1) PT2723379T (da)
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