# US 2022/0204601 A1 · Anti-tau antibody and use of same

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- Number: US 2022/0204601 A1
- Document ID: US20220204601A1
- Status: Published application
- Kind: A1
- Application number: 17/574,227
- Filed: 2022-01-12
- Published: 2022-06-30
- Earliest claimed: 2019-07-15
- Assignees: Adel Inc.
- Applicants: Adel, Inc.
- Inventors: Seung-Yong YOON
- Web page: https://patentgrep.com/patent/US20220204601A1

## CPC

- C07K 16/18: against material from animals or humans
- A61P 25/28: 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
- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/565: Complementarity determining region [CDR]
- G01N 2800/2821: Alzheimer
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

An anti-tau antibody according to the present invention specifically binds to a tau protein, in which the 280th lysine is acetylated. The antibody can inhibit aggregation of abnormal tau proteins. The antibody can improve the motor function and cognitive function of animal models. It can be effectively used for preventing or treating a degenerative neurological disease.

## Claims

### Claim 1

An anti-tau antibody or an antigen-binding fragment thereof, comprising:
a heavy chain variable region (VH) that includes:
a heavy chain CDR1 having the amino acid sequence represented by SEQ ID NO: 1;
a heavy chain CDR2 having the amino acid sequence represented by SEQ ID NO: 2; and
a heavy chain CDR3 having the amino acid sequence represented by SEQ ID NO: 3, and
a light chain variable region (VL) that includes:
a light chain CDR1 having the amino acid sequence represented by SEQ ID NO: 4;
a light chain CDR2 having the amino acid sequence represented by SEQ ID NO: 5; and
a light chain CDR3 having the amino acid sequence represented by SEQ ID NO: 6.

### Claim 2 (depends on 1)

The anti-tau antibody or antigen-binding fragment thereof of claim 1, wherein the heavy chain variable region includes any one amino acid sequence selected from the group consisting of SEQ ID NOs: 7 to 11, and the light chain variable region includes any one amino acid sequence selected from the group consisting of SEQ ID NOs: 12 to 15.

### Claim 3 (depends on 1)

The anti-tau antibody or antigen-binding fragment thereof of claim 1, wherein the antibody or the antigen-binding fragment thereof is any one selected from the group consisting of:
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 7 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 12;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 8 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 13;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 8 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 14;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 8 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 15;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 9 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 13;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 9 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 14;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 9 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 15;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 10 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 13;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 10 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 14;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 10 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 15;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 11 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 13;
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 11 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 14; and
an anti-tau antibody or antigen-binding fragment thereof which comprises a heavy chain variable region having the amino acid sequence represented by SEQ ID NO: 11 and a light chain variable region having the amino acid sequence represented by SEQ ID NO: 15.

### Claim 4 (depends on 1)

The anti-tau antibody or antigen-binding fragment thereof of claim 1, wherein the fragment is any one selected from the group consisting of Fab, scFv, F(ab′)2, and Fv.

### Claim 5 (depends on 1)

A polynucleotide encoding the anti-tau antibody or antigen-binding fragment thereof of claim 1.

### Claim 6 (depends on 5)

An expression vector comprising the polynucleotide of claim 5.

### Claim 7 (depends on 6)

A host cell comprising the expression vector of claim 6.

### Claim 8 (depends on 7)

A method for producing an anti-tau antibody or antigen-binding fragment thereof, the method comprising a step of culturing the host cell of claim 7.

### Claim 9 (depends on 2)

A polynucleotide encoding a heavy or light chain of an antibody that includes the heavy chain variable region and the light chain variable region of claim 2.

### Claim 10

A hybridoma having accession number KCTC 14155BP.

### Claim 11 (depends on 1)

A pharmaceutical composition for preventing or treating a degenerative neurological disease, the pharmaceutical composition comprising as an active ingredient the anti-tau antibody or antigen-binding fragment thereof of claim 1.

### Claim 12 (depends on 11)

The pharmaceutical composition of claim 11, wherein the degenerative neurological disease is a tau protein-mediated neurological disease.

### Claim 13 (depends on 12)

The pharmaceutical composition of claim 12, wherein the tau protein-mediated neurological disease is tauopathy, primary age-related tauopathy, chronic traumatic encephalopathy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal dementia, Lytico-Bodig disease, Parkinsonism, subacute sclerosing meningitis, lead encephalopathy, tuberous sclerosis, ganglioglioma, gangliocytoma, meningioangiomatosis, subacute sclerosing panencephalitis, Hallervorden-Spatz disease, or lipofuscinosis.

### Claim 14 (depends on 13)

The pharmaceutical composition of claim 13, wherein the tauopathy is Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), Pick's disease (PiD), a group of related disorders collectively termed frontotemporal dementia with Parkinsonism linked to chromosome 17 (FTDP-17), amyotrophic lateral sclerosis (ALS), Creutzfeld-Jakob disease (CJD), dementia pugilitica (DP), Gerstmann-Sträussler-Scheinker disease (GSSD), Lewy body disease, chronic traumatic encephalopathy (CTE), or Huntington's disease.

### Claim 15 (depends on 11)

The pharmaceutical composition of claim 11, wherein the pharmaceutical composition is administered through any one route of administration selected from the group consisting of intracerebral, intracerebroventricular, intraperitoneal, percutaneous, intramuscular, intradural, intravenous, subcutaneous, and nasal routes of administration.

### Claim 16 (depends on 1)

A composition for diagnosing a degenerative neurological disease, the composition comprising the anti-tau antibody or antigen-binding fragment thereof of claim 1.

### Claim 17 (depends on 1)

A method for preventing or treating a degenerative neurological disease, the method comprising administering the anti-tau antibody or antigen-binding fragment thereof of claim 1 to a subject that is expected to have or currently has the degenerative neurological disease.

### Claim 18 (depends on 17)

The method of claim 17, wherein the degenerative neurological disease is a tau protein-mediated neurological disease.

### Claim 19 (depends on 18)

The method of claim 18, wherein the tau protein-mediated neurological disease is tauopathy, primary age-related tauopathy, chronic traumatic encephalopathy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal dementia, Lytico-Bodig disease, Parkinsonism, subacute sclerosing meningitis, lead encephalopathy, tuberous sclerosis, ganglioglioma, gangliocytoma, meningioangiomatosis, subacute sclerosing panencephalitis, Hallervorden-Spatz disease, or lipofuscinosis.

### Claim 20 (depends on 19)

The method of claim 19, wherein the tauopathy is Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), Pick's disease (PiD), a group of related disorders collectively termed frontotemporal dementia with Parkinsonism linked to chromosome 17 (FTDP-17), amyotrophic lateral sclerosis (ALS), Creutzfeld-Jakob disease (CJD), dementia pugilitica (DP), Gerstmann-Straussler-Scheinker disease (GSSD), Lewy body disease, chronic traumatic encephalopathy (CTE), or Huntington's disease.
