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HRP20200384T1 - Humanizirana anti-tau(ps422) protutijela i načini uporabe - Google Patents

Humanizirana anti-tau(ps422) protutijela i načini uporabe Download PDF

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Publication number
HRP20200384T1
HRP20200384T1 HRP20200384TT HRP20200384T HRP20200384T1 HR P20200384 T1 HRP20200384 T1 HR P20200384T1 HR P20200384T T HRP20200384T T HR P20200384TT HR P20200384 T HRP20200384 T HR P20200384T HR P20200384 T1 HRP20200384 T1 HR P20200384T1
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HR
Croatia
Prior art keywords
sequences
antibody
variable domain
heavy chain
full
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HRP20200384TT
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English (en)
Inventor
Joerg Benz
Bernd Bohrmann
Guy Georges
Ulrich Goepfert
Fiona Grueninger
Hubert Kettenberger
Olaf Mundigl
Michael Schraeml
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F. Hoffmann - La Roche Ag
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Application filed by F. Hoffmann - La Roche Ag filed Critical F. Hoffmann - La Roche Ag
Publication of HRP20200384T1 publication Critical patent/HRP20200384T1/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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4711—Alzheimer's disease; Amyloid plaque core protein
    • 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
    • A61K2039/507—Comprising a combination of two or more separate antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (17)

1. Humanizirano protutijelo koje se specifično veže za ljudski Tau(pS422), naznačeno time, da protutijelo sadrži a) u varijabilnoj domeni teškog lanca HVR-ove ID BR. SEKVENCE: 08, 18 i 10, a u varijabilnoj domeni lakog lanca HVR-ove ID BR. SEKVENCE: 13, 14 i 15, ili b) u varijabilnoj domeni teškog lanca HVR-ove ID BR. SEKVENCE: 08, 09 i 10, a u varijabilnoj domeni lakog lanca HVR-ove ID BR. SEKVENCE: 12, 05 i 15, ili c) u varijabilnoj domeni teškog lanca HVR-ove ID BR. SEKVENCE: 08, 09 i 10, a u varijabilnoj domeni lakog lanca HVR-ove ID BR. SEKVENCE: 13, 14 i 15.
2. Humanizirano protutijelo prema patentnom zahtjevu 1, naznačeno time, da sadrži a) varijabilnu domenu teškog lanca ID BR. SEKVENCE: 20, i varijabilnu domenu lakog lanca ID BR. SEKVENCE: 17; ili b) varijabilnu domenu teškog lanca ID BR. SEKVENCE: 19, i varijabilnu domenu lakog lanca ID BR. SEKVENCE: 16; ili c) varijabilnu domenu teškog lanca ID BR. SEKVENCE: 19, i varijabilnu domenu lakog lanca ID BR. SEKVENCE: 17; ili d) varijabilnu domenu teškog lanca ID BR. SEKVENCE: 21, i varijabilnu domenu lakog lanca ID BR. SEKVENCE: 17.
3. Humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 2, naznačeno time, da je to protutijelo tiha efektorska funkcija.
4. Humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time, da to protutijelo i) specifično se veže na polipeptid koji ima aminokiselinsku sekvencu ID BR. SEKVENCE: 03, i/ili ii) ne veže se s humanim Tau pune duljine (ID BR. SEKVENCE: 01) pri 1 µg/ml, i/ili iii) specifično se veže na humani Tau fosforiliran pune duljine na serinu na položaju 422 (ID BR. SEKVENCE: 02), i/ili iv) specifično se veže na agregate humanog Tau fosforiliranog u serinu na položaju 422 (ID BR. SEKVENCE: 02).
5. Humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 4, naznačeno time, da protutijelo ima vrijednost EC50 za: a) fragment humanog Tau(pS422) koji ima aminokiselinsku sekvencu ID BR. SEKVENCE: 03, od 6 ng/ml ili manje, i/ili b) humani Tau(pS422) pune duljine koji ima aminokiselinsku sekvencu ID BR. SEKVENCE: 02, od 4,5 ng/ml ili manje, i/ili c) agregate humanog Tau(pS422) koji ima aminokiselinsku sekvencu ID BR. SEKVENCE: 02, od 30 ng/ml ili manje, i/ili d) humani Tau koji ima aminokiselinsku sekvencu ID BR. SEKVENCE: 01 i koji ima mutaciju aminokiseline S422A, od 125 ng/ml ili manje.
6. Humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 5, naznačeno time, da se protutijelo specifično veže na humani Tau(pS422) (ID BR. SEKVENCE: 02) i ne veže se za humani Tau (ID BR. SEKVENCE: 01).
7. Humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 6, naznačeno time, da je to protutijelo a) protutijelo pune duljine ljudskog podrazreda IgG1, ili b) protutijelo pune duljine ljudskog podrazreda IgG4, ili c) protutijelo pune duljine ljudskog podrazreda IgG1 s mutacijama L234A, L235A i P329G, d) protutijelo pune duljine ljudskog podrazreda IgG4 s mutacijama S228P, L235E i P329G, e) protutijelo pune duljine ljudskog podrazreda IgG1 s mutacijama L234A, L235A i P329G u oba teška lanca i mutacijama T366W i S354C u jednom teškom lancu i mutacijama T366S, L368A, Y407V i Y349C u odgovarajućem drugom teškom lancu, ili f) protutijelo pune duljine ljudskog podrazreda IgG4 s mutacijama S228P, L235E i P329G u oba teška lanca i mutacijama T366W i S354C u jednom teškom lancu i mutacijama T366S, L368A, Y407V i Y349C u odgovarajućem drugom teškom lancu.
8. Farmaceutska formulacija, naznačena time, da sadrži humanizirano protutijelo prema bilo kojem od patentnih zahtjeva 1 do 7 i farmaceutski prihvatljivi nosač.
9. Farmaceutska formulacija u skladu s patentnim zahtjevom 8, naznačena time, da nadalje sadrži protu-humano alfa-sinuklein-protutijelo ili anti-Abeta protutijelo.
10. Uporaba humaniziranog protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time, da služi u proizvodnji lijeka.
11. Uporaba prema patentom zahtjevu 10, naznačena time, da je lijek za liječenje Alzheimerove bolesti.
12. Uporaba prema bilo kojem od patentnih zahtjeva 10 do 11, naznačena time, da je lijek za liječenje prodromalne Alzheimerove bolesti.
13. Uporaba prema bilo kojem od patentnih zahtjeva 10 do 11, naznačena time, da je lijek za liječenje blage Alzheimerove bolesti.
14. Uporaba prema bilo kojem od patentnih zahtjeva 10 do 13, naznačena time, da je lijek za smanjenje neurodegeneracije inducirane Tau(pS422).
15. Uporaba prema bilo kojem od patentnih zahtjeva 10 do 14, naznačena time, da je lijek za održavanje kognitivnosti i funkcioniranja.
16. Uporaba prema bilo kojem od patentnih zahtjeva 11 do 15, naznačena time, da je lijek za usporavanje stope kognitivnog i funkcionalnog propadanja.
17. Uporaba humaniziranog protu-humanog Tau(pS422) protutijela prema bilo kojem od patentnih zahtjeva 1 do 7, naznačena time, da služi u smanjenju neurodegeneracije inducirane Tau(pS422).
HRP20200384TT 2013-12-20 2014-12-17 Humanizirana anti-tau(ps422) protutijela i načini uporabe HRP20200384T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP13199123 2013-12-20
EP14174047 2014-06-26
EP14827191.9A EP3083680B1 (en) 2013-12-20 2014-12-17 Humanized anti-tau(ps422) antibodies and methods of use
PCT/EP2014/078234 WO2015091656A1 (en) 2013-12-20 2014-12-17 HUMANIZED ANTI-Tau(pS422) ANTIBODIES AND METHODS OF USE

Publications (1)

Publication Number Publication Date
HRP20200384T1 true HRP20200384T1 (hr) 2020-06-12

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HRP20200384TT HRP20200384T1 (hr) 2013-12-20 2014-12-17 Humanizirana anti-tau(ps422) protutijela i načini uporabe

Country Status (26)

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US (3) US9562091B2 (hr)
EP (1) EP3083680B1 (hr)
JP (1) JP6608827B2 (hr)
KR (1) KR20160099088A (hr)
CN (1) CN105899533B (hr)
AU (1) AU2014368696A1 (hr)
BR (1) BR112016013562A2 (hr)
CA (1) CA2932958A1 (hr)
CL (1) CL2016001519A1 (hr)
CR (1) CR20160270A (hr)
DK (1) DK3083680T3 (hr)
EA (1) EA201600473A1 (hr)
ES (1) ES2778498T3 (hr)
HR (1) HRP20200384T1 (hr)
IL (1) IL245862A0 (hr)
LT (1) LT3083680T (hr)
MX (1) MX2016007208A (hr)
PE (1) PE20161032A1 (hr)
PH (1) PH12016500940A1 (hr)
PL (1) PL3083680T3 (hr)
PT (1) PT3083680T (hr)
RS (1) RS60031B1 (hr)
SG (1) SG11201605044RA (hr)
SI (1) SI3083680T1 (hr)
TW (2) TWI545132B (hr)
WO (1) WO2015091656A1 (hr)

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