[go: up one dir, main page]

NZ727338B2 - IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES - Google Patents

IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES Download PDF

Info

Publication number
NZ727338B2
NZ727338B2 NZ727338A NZ72733815A NZ727338B2 NZ 727338 B2 NZ727338 B2 NZ 727338B2 NZ 727338 A NZ727338 A NZ 727338A NZ 72733815 A NZ72733815 A NZ 72733815A NZ 727338 B2 NZ727338 B2 NZ 727338B2
Authority
NZ
New Zealand
Prior art keywords
antibody
binding fragment
seq
amino acid
antigen binding
Prior art date
Application number
NZ727338A
Other versions
NZ727338A (en
Inventor
Hanna Laudon
Charlotte Nerelius
Jessica Sigvardson
Original Assignee
Bioarctic Neuroscience Ab
Eisai R&D Management Co Ltd
Filing date
Publication date
Application filed by Bioarctic Neuroscience Ab, Eisai R&D Management Co Ltd filed Critical Bioarctic Neuroscience Ab
Priority claimed from PCT/EP2015/065633 external-priority patent/WO2016005466A2/en
Publication of NZ727338A publication Critical patent/NZ727338A/en
Publication of NZ727338B2 publication Critical patent/NZ727338B2/en

Links

Classifications

    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • 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
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/461Igs containing Ig-regions, -domains or -residues form different species
    • C07K16/464Igs containing CDR-residues from one specie grafted between FR-residues from another
    • C07K16/465Igs containing CDR-residues from one specie grafted between FR-residues from another with additional modified FR-residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4709Amyloid plaque core protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/28Neurological disorders
    • G01N2800/2814Dementia; Cognitive disorders
    • G01N2800/2821Alzheimer
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical 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
    • G01N33/6896Neurological disorders, e.g. Alzheimer's disease

Abstract

The present invention relates to the amyloid beta peptide (Aß) and more specifically to antibodies binding to Aß protofibrils and their use in therapy and/or prophylactic treatment of Alzheimer's disease and other disorders associated with Aß protein aggregation. Further the invention may relate to diagnosis of such diseases as well as monitoring of disease progression by use of the antibodies of the invention. Further, the invention may relate to veterinary use of the antibodies of the invention.

Claims (19)

Claims
1. An antibody or antigen binding fragment thereof having affinity against Aß ibrils, wherein the antibody or antigen binding fragment thereof comprises a variable light chain comprising an amino acid sequence as set out in SEQ ID NO: 12; 5 and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 16.
2. An antibody or antigen binding fragment thereof having affinity against Aß ibrils, wherein the antibody or antigen binding fragment thereof comprises a 10 variable light chain comprising an amino acid sequence as set out in SEQ ID NO: 9; and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 15.
3. An antibody or antigen binding fragment thereof having affinity against Aß 15 protofibrils, wherein the antibody or antigen binding fragment thereof comprises a le light chain comprising an amino acid sequence as set out in SEQ ID NO: 10; and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 15. 20
4. An antibody or antigen binding fragment f having ty against Aß protofibrils, wherein the antibody or antigen binding fragment thereof comprises a variable light chain comprising an amino acid ce as set out in SEQ ID NO: 11; and a variable heavy chain comprising an amino acid ce as set out in SEQ ID NO: 15.
5. An antibody or n binding fragment thereof having affinity against Aß protofibrils, wherein the antibody or antigen g fragment thereof comprises a variable light chain comprising an amino acid sequence as set out in SEQ ID NO: 12; and a variable heavy chain sing an amino acid sequence as set out in SEQ ID 30 NO: 15.
6. An antibody or antigen binding fragment thereof having affinity against Aß protofibrils, n the antibody or n binding fragment thereof comprises a variable light chain comprising an amino acid sequence as set out in SEQ ID NO: 9; and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 16.
7. An antibody or antigen binding fragment thereof having affinity against Aß 5 protofibrils, wherein the antibody or antigen binding fragment thereof comprises a variable light chain sing an amino acid sequence as set out in SEQ ID NO: 10; and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 16. 10
8. An antibody or antigen binding fragment f having affinity against Aß protofibrils, wherein the antibody or antigen binding fragment thereof comprises a le light chain comprising an amino acid ce as set out in SEQ ID NO: 11; and a variable heavy chain comprising an amino acid sequence as set out in SEQ ID NO: 16.
9. The antibody or antigen binding fragment according to any one of claims 1 to 8, wherein the antibody or the antigen g fragment comprises an IgG heavy chain constant region. 20
10. An antibody according to any one of claims 1 to 9, for use in therapy.
11. An antibody according to any one of claims 1 to 9, for use in treatment and/or prophylaxis of Alzheimer’s disease and other disorders associated with Aß protein aggregation.
12. An antibody according to claim 11, for use, wherein the other disorders associated with Aß protein ation are selected from tic brain injury (TBI), Lewy body dementia (LBD), Downs syndrome (DS), ophic lateral sclerosis (ALS), Frontotemporal dementia, tauopathies, systemic amyloidoses, atherosclerosis and 30 Parkinson’s disease dementia (PDD).
13. Use of an antibody according to any one of claims 1 to 9, in the manufacture of a medicament useful in the treatment and/or prophylaxis of Alzheimer’s disease and other disorders associated with Aß protein aggregation.
14. The use according to claim 13, wherein the other disorders associated with Aß protein aggregation are selected from Traumatic brain injury (TBI), Lewy body ia (LBD), Downs syndrome (DS), Amyotrophic lateral sclerosis (ALS), 5 Frontotemporal dementia, tauopathies, systemic doses, atherosclerosis and Parkinson’s disease dementia (PDD).
15. A method for measuring amount of Aß protofibrils and/or aggregated Aß protein in a 10 person, comprising contacting the person’s tissue or body fluid in vitro with the antibody or antigen binding fragment according to claims 1 to 9 and measuring the amount of antibody or antigen binding fragment bound to said Aß protofibrils and/or aggregated Aß protein. 15 16. A method for sis of Alzheimer’s disease in persons having or at risk of developing the disease, comprising contacting the person’s tissue or body fluid in vitro with the antibody or antigen binding fragment ing to claims 1 to 9, or a fragment f, and measuring the amount of said dy bound to ated
Aß protein.
17. A method for diagnosis of traumatic brain injury (TBI), Lewy body dementia (LBD), Down me (DS), Amyotrophic lateral sclerosis (ALS), Frontotemporal dementia, tauopathies, systemic amyloidosis, atherosclerosis and Parkinson’s disease dementia (PDD)in persons having or at risk of developing any of said es, comprising 25 contacting the person’s tissue or body fluid in vitro with the antibody or antigen g fragment according to claims 1 to 9, or a fragment thereof, and measuring the amount of said antibody bound to aggregated Aß protein.
18. A pharmaceutical composition comprising the antibody or n binding fragment 30 according to any one of claims 1 to 9, together with pharmaceutically acceptable excipient and/or diluents.
19. An antibody according to any one of claims 1 to 9, for veterinary use. Figurel Contra! vs A170 E 0.8 S , a 0-5 " E —I— Momma-[Comm 0 % D'?’ " +Monomea’_A17D E —|:|— Protn?bri?tontmi 2 9,2 —0— Protafiba'ii__A17‘D 0.0 mmmmmwwmj—MMWMMMWW "mm? 0.001 0.01 0.1 1 10 100 1000 10000 100000 Amyloid B (nM) Cantral; vs A17D/R825 g +Monomer_Controi z 02 +Monomer_A17D/RSZS —I:I— bfii?ontr? —0— Prota?briLAWD/RBZS 9.0 ~T-----------------T ----------"r~~~~~~~~~~~2 . .“——T 0.001 0.01 0.1 1 10 100 1000 10000 100000 Amvloid [3 {mm} SUBSTITUTE SHEET (RULE 26)
NZ727338A 2015-07-08 IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES NZ727338B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462022952P 2014-07-10 2014-07-10
PCT/EP2015/065633 WO2016005466A2 (en) 2014-07-10 2015-07-08 IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES

Publications (2)

Publication Number Publication Date
NZ727338A NZ727338A (en) 2024-08-30
NZ727338B2 true NZ727338B2 (en) 2024-12-03

Family

ID=

Similar Documents

Publication Publication Date Title
RU2017103446A (en) IMPROVED ANTIBODIES BINDING β-PROFIBRILLA
MX2021012867A (en) THERAPEUTICS OF FULLY HUMAN POST-TRANSLATIONALLY MODIFIED ANTIBODIES.
JP6424210B2 (en) Treatment of a subpopulation of Alzheimer's disease with pooled immunoglobulin G
AU2017291414B2 (en) Anti-N3pGLu amyloid beta peptide antibodies and uses thereof
WO2021021979A3 (en) Hdac6 inhibitors and uses thereof
JOP20220092A1 (en) Anti-beta-amyloid antibody for treating alzheimer's disease
EP4317185A3 (en) Fully-human post-translationally modified antibody therapeutics
MY205774A (en) Human il-4r binding antibody, antigen binding fragment thereof, and medical use thereof
EP4631944A3 (en) Rimegepant for cgrp related disorders
BR112021023487A2 (en) Anti-tdp-43 binding molecules and uses thereof
BR112014006376A2 (en) protein-based therapy and diagnosis of tau-mediated pathology in alzheimer's disease
WO2016087944A3 (en) Method for treating alzheimer's disease
WO2020132658A3 (en) Tubulysins and protein-tubulysin conjugates
MX2021012608A (en) Novel molecules for therapy and diagnosis.
PH12023550032A1 (en) Tubulysins and protein-tubulysin conjugates
MX2025001920A (en) Treatment of mitochondrial associated diseases and disorders, including symptoms thereof using pridopidine
BR112021017203A2 (en) Leucine, acetyl leucine and related analogues for the treatment of diseases
BR112018010337A2 (en) anti-alpha-v integrin antibody for the treatment of fibrosis and / or fibrotic disorders
MX2021011596A (en) Compounds and compositions as modulators of tlr signaling.
NZ593312A (en) Remedies for pemphigus containing anti fas ligand antibodies
NZ727338B2 (en) IMPROVED Aß PROTOFIBRIL BINDING ANTIBODIES
WO2023081194A3 (en) Methods for treating alzheimer's disease
WO2020123977A3 (en) Glial fibrillary acidic protein targeting immuno-and aptamer-based-therapy for neuroinjury, neurodegeneration, neuro-disease, and neuro-repair
JOP20200046A1 (en) Methods for treating diseases associated with TNF?
AlJadani Risperidone and carbamazepine combination in treatment of Kluver-Bucy syndrome: a case report