HRP20210680T1 - POBOLJŠANA PROTUTIJELA KOJA VEŽU Aβ PROTOFIBRIL - Google Patents

POBOLJŠANA PROTUTIJELA KOJA VEŽU Aβ PROTOFIBRIL Download PDF

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HRP20210680T1
HRP20210680T1 HRP20210680TT HRP20210680T HRP20210680T1 HR P20210680 T1 HRP20210680 T1 HR P20210680T1 HR P20210680T T HRP20210680T T HR P20210680TT HR P20210680 T HRP20210680 T HR P20210680T HR P20210680 T1 HRP20210680 T1 HR P20210680T1
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antibody
antigen
binding fragment
seq
amino acid
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HRP20210680TT
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Charlotte Nerelius
Hanna LAUDON
Jessica SIGVARDSON
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Bioarctic Ab
Eisai R&D Management Co., Ltd.
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    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
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    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00Drugs for disorders of the nervous system
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    • AHUMAN NECESSITIES
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    • 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
    • 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
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • C07K2317/00Immunoglobulins specific features
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • 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
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    • G01MEASURING; TESTING
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    • G01N2800/2814Dementia; Cognitive disorders
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Claims (20)

1. Protutijelo ili njegov ulomak koji veže antigen, naznačeno time što sadrži: (a) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 12; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 16; (b) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 9; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 15; (c) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 10; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 15; (d) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 11; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 15; (e) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 12; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 15; (f) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 9; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 16 (g) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 10; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 16; ili (h) varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 11; i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 16.
2. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1, naznačeno time što protutijelo ili njegov ulomak koji veže antigen sadrži konstantnu regiju IgG teškog lanca.
3. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time što se koristi u terapiji.
4. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time što je za upotrebu u liječenju i/ili profilaksi Alzheimerove bolesti i drugih poremećaja povezanih s agregacijom Aβ proteina, kao što je traumatska ozljeda mozga (TBI), demencija s Lewyjevim tjelešcima (LBD), Downov sindrom (DS), amiotrofična lateralna skleroza (ALS), frontotemporalna demencija, tauopatije, sistemske amiloidoze, ateroskleroza i Parkinsonova bolest s demencijom (PDD).
5. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time što se koristi u postupku smanjenja količine Aβ protofibrila kod subjekta, koji obuhvaća davanje navedenom subjektu terapeutski učinkovite količine protutijela ili njegovog ulomka koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2.
6. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time što se koristi u postupku za mjerenje količine Aβ protofibrila i/ili agregiranog Aβ proteina kod osobe, koji uključuje dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vivo, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2 i mjerenje količine navedenog protutijela ili njegovog ulomaka koji veže antigen vezane na navedene Aβ protofibrile i/ili agregirani Aβ protein.
7. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2 naznačeno time što se koristi u postupku za dijagnozu Alzheimerove bolesti kod osoba koje imaju ili su u opasnosti od razvoja bolesti, koji uključuje dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vivo, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, ili njegovim ulomkom, te mjerenje količine navedenog protutijela vezane za agregirani Aβ protein.
8. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2 naznačeno time što se koristi u postupku za dijagnozu traumatske ozljede mozga (TBI), demencije s Lewyjevim tjelešcima (LBD), Downovog sindroma (DS), amiotrofične lateralne skleroze (ALS), frontotemporalne demencije, tauopatija, sistemske amiloidoze, ateroskleroze i Parkinsonove bolesti s demencijom (PDD) kod osoba koje imaju ili su u opasnosti od razvoja bilo koje od navedenih bolesti, koji uključuje dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vivo, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, te mjerenje količine navedenog protutijela ili njegovog ulomaka koji veže antigen vezane za agregirani Aβ protein.
9. Farmaceutski pripravak naznačen time što sadrži protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, zajedno s farmaceutski prihvatljivim pomoćnim sredstvom i/ili razrjeđivačima.
10. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time što je za veterinarsku upotrebu.
11. Protutijelo ili njegov ulomak koji veže antigen koje ima afinitet prema Aβ protofibrilima, naznačeno time što protutijelo ili njegov ulomak koji veže antigen sadrži varijabilni laki lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 12 i varijabilni teški lanac koji sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 16.
12. Protutijelo prema patentnom zahtjevu 11, naznačeno time što protutijelo ili njegov ulomak koji veže antigen sadrži konstantnu regiju IgG teškog lanca.
13. Farmaceutski pripravak naznačen time što sadrži protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 11 ili zahtjevu 12, zajedno s farmaceutski prihvatljivim pomoćnim sredstvom i/ili razrjeđivačem.
14. Protutijelo ili njegov ulomak koji veže antigen prema patentnom zahtjevu 11 ili zahtjevu 12 naznačeno time što je za upotrebu u postupku smanjenja količine Aβ protofibrila kod subjekta, koji obuhvaća davanje navedenom subjektu terapeutski učinkovite količine protutijela ili njegovog ulomka koji veže antigen prema patentnom zahtjevu 11 ili zahtjevu 12.
15. Protutijelo ili njegov ulomak koji veže antigen patentnom zahtjevu 11 ili zahtjevu 12 naznačeno time što je za upotrebu u postupku liječenja Alzheimerove bolesti ili drugog poremećaja povezanog s agregacijom Aβ proteina kod subjekta koji ima navedenu bolest ili poremećaj, koji obuhvaća davanje navedenom subjektu terapeutski učinkovite količine protutijela ili njegovog ulomka koji veže antigen prema patentnom zahtjevu 11 ili zahtjevu 12.
16. Protutijelo ili njegov ulomak koji veže antigen patentnom zahtjevu 11 ili zahtjevu 12 naznačeno time što je za upotrebu u postupku liječenja Alzheimerove bolesti kod subjekta koji ima Alzheimerovu bolest, koji obuhvaća davanje navedenom subjektu terapeutski učinkovite količine protutijela ili njegovog ulomka koji veže antigen prema patentnom zahtjevu 11 ili zahtjevu 12.
17. Protutijelo ili njegov ulomak koji veže antigen patentnom zahtjevu 11 ili zahtjevu 12, naznačeno time što je za upotrebu u terapiji.
18. In vitro postupak za mjerenje količine Aβ protofibrila i/ili agregiranog Aβ proteina kod osobe, koji obuhvaća dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vitro, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2 i mjerenje količine protutijela ili njegovog ulomka koji veže antigen vezane za navedene Aβ protofibrile i/ili agregirani Aβ protein.
19. In vitro postupak za dijagnozu Alzheimerove bolesti kod osoba koje imaju ili su u opasnosti od razvoja bolesti, koji obuhvaća dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vitro, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, ili njegovim ulomkom, i mjerenje količine navedenog protutijela vezane za agregirani Aβ protein.
20. In vitro postupak za dijagnozu traumatske ozljede mozga (TBI), demencije s Lewyjevim tjelešcima (LBD), Downovog sindroma (DS), amiotrofične lateralne skleroze (ALS), frontotemporalne demencije, tauopatija, sistemske amiloidoze, ateroskleroze i Parkinsonove bolesti s demencijom (PDD) kod osoba koje imaju ili su u opasnosti od razvoja bilo koje od navedenih bolesti, koji uključuje dovođenje u kontakt tkiva ili tjelesne tekućine osobe, in vitro, s protutijelom ili njegovim ulomkom koji veže antigen prema patentnom zahtjevu 1 ili zahtjevu 2, i mjerenje količine navedenog protutijela ili njegovog ulomka koji veže antigen vezane za agregirani Aβ protein.
HRP20210680TT 2014-07-10 2021-04-29 POBOLJŠANA PROTUTIJELA KOJA VEŽU Aβ PROTOFIBRIL HRP20210680T1 (hr)

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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
EP15738876.0A EP3166970B1 (en) 2014-07-10 2015-07-08 Improved a-beta protofibril binding antibodies

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EP3826674A2 (en) 2018-07-24 2021-06-02 Eisai R&D Management Co., Ltd. Methods of treatment and prevention of alzheimer's disease
BR112023001061A2 (pt) 2020-07-23 2023-04-04 Othair Prothena Ltd Anticorpos antiabeta
TW202300517A (zh) 2021-03-12 2023-01-01 美商美國禮來大藥廠 抗類澱粉β抗體及其用途
WO2022251048A1 (en) 2021-05-24 2022-12-01 Eli Lilly And Company Anti-amyloid beta antibodies and uses thereof
AU2022307687A1 (en) 2021-07-09 2024-01-04 Eisai R&D Management Co., Ltd. Biomarkers for alzheimer's disease treatment
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IL314581A (en) 2022-02-02 2024-09-01 Eisai R&D Man Co Ltd Treatment methods using P-TAU181 LEVEL
CN114578066B (zh) * 2022-05-07 2022-08-19 北京第一生物化学药业有限公司 检测β-淀粉样蛋白的产品和方法
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