# US 10,118,960 B2 · Humanized antibodies that recognize alpha-synuclein

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- Number: US 10,118,960 B2
- Document ID: US10118960B2
- Status: Granted
- Kind: B2
- Application number: 15/587,255
- Filed: 2017-05-04
- Published: 2018-01-18
- Granted: 2018-11-06
- Earliest claimed: 2012-01-27
- Assignees: Prothena Biosciences Limited
- Applicants: Prothena Biosciences Limited
- Inventors: Jose Saldanha; Tarlochan S. Nijjar
- Web page: https://patentgrep.com/patent/US10118960B2

## CPC

- C07K 16/18: against material from animals or humans
- A61K 49/0004: {Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions}
- A61K 49/0058: {Antibodies}
- A61K 49/16: Antibodies; Immunoglobulins; Fragments thereof
- A61K 51/1018: {against material from animals or humans}
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/16: Anti-Parkinson drugs
- 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
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/55: Fab or Fab'
- C07K 2317/56: variable (Fv) region, i.e. VH and/or VL
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/64: comprising a combination of variable region and constant region components
- C07K 2317/71: Decreased effector function due to an Fc-modification
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present application discloses humanized 1H7 antibodies. The antibodies bind to human alpha synuclein and can be used for treatment and diagnosis of Lewy body disease.

## Claims

### Claim 1

An antibody comprising a mature heavy chain variable region comprising the three Kabat CDRs of SEQ ID NO: 44, and being at least 90% identical to SEQ ID NO: 44, and a mature light chain comprising the three Kabat CDRs of SEQ ID NO: 45, and being at least 90% identical to SEQ ID NO: 45, wherein: (a) position L46 (Kabat numbering) is occupied by F, position L49 (Kabat numbering) is occupied by C and position L83 (Kabat numbering) is occupied by A; or (b) position H67 (Kabat numbering) is occupied by A and position H71 (Kabat numbering) is occupied by A.

### Claim 2 (depends on 1)

A pharmaceutical composition comprising an antibody as defined by claim 1.

### Claim 3 (depends on 2)

The pharmaceutical composition of claim 2, wherein position L46 (Kabat numbering) is occupied by F, position L49 (Kabat numbering) is occupied by C and position L83 (Kabat numbering) is occupied by A.

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein position H67 (Kabat numbering) is occupied by A and position H71 (Kabat numbering) is occupied by A.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the mature heavy chain variable region has an amino acid sequence comprising SEQ ID NO: 23 and the mature light chain variable region has an amino acid sequence comprising SEQ ID NO: 33.

### Claim 6 (depends on 5)

The pharmaceutical composition of claim 5, wherein the light chain constant region has the amino acid sequence of SEQ ID NO: 49.

### Claim 7 (depends on 5)

The pharmaceutical composition of claim 5, wherein the heavy chain constant region has the amino acid sequence of SEQ ID NO: 52 provided the C terminal lysine residue may be omitted.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the mature heavy chain variable region is fused to a heavy chain constant region having the amino acid sequence of SEQ ID NO: 52 provided the C terminal lysine residue may be omitted and the mature light chain variable region is fused to a light chain constant region having the amino acid sequence of SEQ ID NO: 49.

### Claim 9 (depends on 1)

The antibody of claim 1, wherein position H11 (Kabat numbering) is occupied by V, position H28 (Kabat numbering) is occupied by T, position H38 (Kabat numbering) is occupied by R, position H48 (Kabat numbering) is occupied by M, position H69 (Kabat numbering) is occupied by M, position H91 (Kabat numbering) is occupied by Y or a combination thereof.

### Claim 10 (depends on 9)

The antibody of claim 9, wherein position H11 (Kabat numbering) is occupied by V.

### Claim 11 (depends on 9)

The antibody of claim 9, wherein position H28 (Kabat numbering) is occupied by T.

### Claim 12 (depends on 9)

The antibody of claim 9, wherein position H38 (Kabat numbering) is occupied by R.

### Claim 13 (depends on 9)

The antibody of claim 9, wherein position H48 (Kabat numbering) is occupied by M.

### Claim 14 (depends on 9)

The antibody of claim 9, wherein position H69 (Kabat numbering) is occupied by M.

### Claim 15 (depends on 9)

The antibody of claim 9, wherein position H91 (Kabat numbering) is occupied by Y.

### Claim 16 (depends on 1)

The antibody of claim 1, wherein position L46 (Kabat numbering) is occupied by F, position L49 (Kabat numbering) is occupied by C and position L83 (Kabat numbering) is occupied by A.

### Claim 17 (depends on 16)

The antibody of claim 16, wherein position H67 (Kabat numbering) is occupied by A and position H71 (Kabat numbering) is occupied by A.

### Claim 18 (depends on 17)

The antibody of claim 17, wherein the mature heavy chain variable region has an amino acid sequence comprising SEQ ID NO: 23 and the mature light chain variable region has an amino acid sequence comprising SEQ ID NO: 33.

### Claim 19 (depends on 18)

The antibody of claim 18, wherein the mature heavy chain variable region is fused to a heavy chain constant region having the amino acid sequence of SEQ ID NO: 52 provided the C-terminal lysine residue may be omitted and the mature light chain variable region is fused to a light chain constant region having the amino acid sequence of SEQ ID NO: 49.

### Claim 20 (depends on 18)

The antibody of claim 18, wherein the mature heavy chain variable region is fused to a heavy chain constant region and the mature light chain variable region is fused to a light chain constant region.

### Claim 21 (depends on 20)

The antibody of claim 20, wherein the heavy chain constant region has the amino acid sequence of SEQ ID NO: 52 provided the C-terminal lysine residue may be omitted.

### Claim 22 (depends on 20)

The antibody of claim 20, wherein the light chain constant region has the amino acid sequence of SEQ ID NO: 49.