# US 11,440,953 B2 · Anti-abeta antibodies

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- Number: US 11,440,953 B2
- Document ID: US11440953B2
- Status: Granted
- Kind: B2
- Application number: 17/725,363
- Filed: 2022-04-20
- Published: 2022-08-04
- Granted: 2022-09-13
- Earliest claimed: 2020-07-23
- Assignees: Othair Prothena Limited
- Applicants: Othair Prothena Limited
- Inventors: Michael Skov; Tarlochan S. Nijjar; Frédérique Bard; Robin Barbour; Wagner Zago
- Web page: https://patentgrep.com/patent/US11440953B2

## CPC

- C07K 16/18: against material from animals or humans
- C07K 16/2887: {against CD20}
- C07K 16/2896: {against molecules with a "CD"-designation, not provided for elsewhere}
- C07K 16/462: {Igs containing a variable region (Fv) from one specie and a constant region (Fc) from another}
- A61K 2039/505: {comprising antibodies}
- C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/55: Fab or Fab'
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC]
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- C07K 2319/02: containing a signal sequence
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/40: containing a tag for immunodetection, or an epitope for immunisation
- 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)

## Abstract

Antibodies that bind human beta-amyloid peptide, methods of detecting, measuring and treating amyloidogenic disorders with said antibodies, pharmaceutical compositions comprising the antibodies and methods of manufacture are provided.

## Claims

### Claim 1

An antibody or an antigen binding fragment thereof that specifically binds to Aβ peptide, comprising a heavy chain variable region comprising heavy chain CDR1, CDR2, and CDR3 and a light chain variable region comprising light chain CDR1, CDR2, and CDR3, wherein
heavy chain CDR1 comprises the amino acid sequence of SEQ ID NO: 16,
heavy chain CDR2 comprises the amino acid sequence of SEQ ID NO: 20,
heavy chain CDR3 comprises the amino acid sequence of SEQ ID NO: 18,
light chain CDR1 comprises the amino acid sequence of SEQ ID NO: 29,
light chain CDR2 comprises the amino acid sequence of SEQ ID NO: 34, and
light chain CDR3 comprises the amino acid sequence of SEQ ID NO: 38.

### Claim 2 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein the heavy chain variable region, excluding the CDRs, is at least 95% identical to the amino acid sequence of SEQ ID NO: 3, and wherein the light chain variable region, excluding the CDRs, is at least 95% identical to the amino acid sequence of SEQ ID NO: 9.

### Claim 3 (depends on 2)

The antibody or antigen binding fragment thereof of claim 2, wherein the heavy chain variable region, excluding the CDRs, is at least 98% identical to the amino acid sequence of SEQ ID NO: 3, and wherein the light chain variable region, excluding the CDRs, is at least 98% identical to the amino acid sequence of SEQ ID NO: 9.

### Claim 4 (depends on 3)

The antibody or antigen binding fragment thereof of claim 3, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 3, and wherein the light chain variable region comprises the amino acid sequence of SEQ ID NO: 9.

### Claim 5 (depends on 4)

The antibody or antigen binding fragment thereof of claim 4 further comprising a heavy chain constant region comprising an amino acid sequence at least 95% identical to SEQ ID NO: 40.

### Claim 6 (depends on 4)

The antibody or antigen binding fragment thereof of claim 4 further comprising a light chain constant region comprising an amino acid sequence at least 95% identical to SEQ ID NO: 41.

### Claim 7 (depends on 5)

The antibody or antigen binding fragment thereof of claim 5 further comprising a light chain constant region comprising an amino acid sequence at least 95% identical to SEQ ID NO: 41.

### Claim 8 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein the antibody is a humanized IgG1.

### Claim 9 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein the antibody is a full antibody, a chimeric antibody, a CDR-grafted antibody, or a recombinant antibody.

### Claim 10 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein the antigen binding fragment is a Fab, Fab′, F(ab′)2, Fabc, or Fv.

### Claim 11 (depends on 1)

The antibody or antigen binding fragment thereof of claim 1, wherein the antibody or antigen binding fragment thereof specifically binds to an epitope having an amino acid sequence including three or more amino acid positions from amino acids 1-7 of Aβ (SEQ ID NO: 84).

### Claim 12 (depends on 1)

A pharmaceutical composition, comprising:
a pharmaceutically effect amount of the antibody or antigen binding fragment thereof of claim 1; and
a pharmaceutically acceptable carrier or diluent.

### Claim 13

A humanized IgG1 antibody or an antigen binding fragment thereof that specifically binds to Aβ peptide, comprising:
a) a heavy chain comprising a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 3; and
b) a light chain comprising a light chain variable region comprising the amino acid sequence of SEQ ID NO: 9.

### Claim 14 (depends on 13)

The humanized IgG1 antibody or antigen binding fragment thereof of claim 13, wherein the antibody is a full antibody, a chimeric antibody, a CDR-grafted antibody, or a recombinant antibody.

### Claim 15 (depends on 13)

The humanized IgG1 antibody or antigen binding fragment thereof of claim 13, wherein the antigen binding fragment is a Fab, Fab′, F(ab′)2, Fabc, or Fv.

### Claim 16 (depends on 13)

A pharmaceutical composition, comprising:
a pharmaceutically effective amount of the humanized IgG1 antibody or antigen binding fragment thereof of claim 13; and
a pharmaceutically acceptable carrier or diluent.

### Claim 17

A humanized IgG1 antibody that specifically binds to Aβ peptide, comprising:
a) a heavy chain comprising
a variable region comprising the amino acid sequence of SEQ ID NO: 3, and
a constant region comprising the amino acid sequence of SEQ ID NO: 40 with or without the C-terminal lysine; and
b) a light chain comprising
a variable region comprising the amino acid sequence of SEQ ID NO: 9, and
a constant region comprising the amino acid sequence of SEQ ID NO: 41.

### Claim 18 (depends on 17)

The humanized IgG1 antibody of claim 17, wherein the antibody is a full antibody, a chimeric antibody, a CDR-grafted antibody, or a recombinant antibody.

### Claim 19 (depends on 17)

A pharmaceutical composition, comprising:
a pharmaceutically effective amount of the humanized IgG1 antibody of claim 17; and
a pharmaceutically acceptable carrier or diluent.