# US 2023/0406933 A1 · Immune checkpoint inhibitor

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- Number: US 2023/0406933 A1
- Document ID: US20230406933A1
- Status: Published application
- Kind: A1
- Application number: 18/035,070
- Filed: 2021-11-02
- Published: 2023-12-21
- Earliest claimed: 2020-11-03
- Assignees: Randox Laboratories Limited
- Applicants: Randox Laboratories Ltd.
- Inventors: Marshall Dunlop; Shirley Schon; John Lamont; Peter Fitzgerald
- Web page: https://patentgrep.com/patent/US20230406933A1

## CPC

- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 2317/22: from camelids, e.g. camel, llama or dromedary
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/622: Single chain antibody (scFv)
- 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 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- 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)

## Abstract

The present invention relates to therapeutic antibodies, or antigen-binding portions thereof, for use in the treatment of cancer and infectious disease. Specifically, the present invention relates to therapeutic antibodies, or antigen-binding portions thereof, that target the programmed death-ligand 1 polypeptide. The present invention also relates to pharmaceutical compositions comprising said therapeutic antibody, or antigen-binding portions thereof.

## Claims

### Claim 1

An antibody or antigen-binding portion thereof, wherein the antibody or antigen-binding portion thereof has at least 80% sequence identity to SEQ ID NO: 7, and wherein the antibody or antigen-binding portion thereof can specifically bind a programmed death-ligand 1 (PD-L1) polypeptide, and wherein the antibody or antigen-binding portion thereof comprises one or more heavy chain CDRs, wherein (i) a heavy chain CDR1 has at least 70% sequence identity to SEQ ID NO: 1, (ii) a heavy chain CDR2 has at least 70% sequence identity to SEQ ID NO: 2 and (iii) a heavy chain CDR3 has at least 70% sequence identity to SEQ ID NO: 3.

### Claim 2 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the heavy chain CDR3 has the amino acid sequence according to SEQ ID NO: 36.

### Claim at position 3

3-8. (canceled)

### Claim 9 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the antibody or antigen-binding portion thereof has a Kd value of between 0.3 and 0.6 nM, preferably between 0.4 and nM, even more preferably between 0.4 and 0.5 nM.

### Claim 10 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the antibody or antigen-binding portion thereof is a single domain antibody, preferably wherein the antibody or antigen-binding portion thereof is a single heavy-chain variable domain antibody.

### Claim 11 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the antibody or antigen-binding portion thereof is a human or humanized antibody or antigen-binding portion thereof.

### Claim 12 (depends on 1)

The antibody or antigen-binding portion thereof of claim 1, wherein the antibody or antigen-binding portion thereof forms part of a fusion protein or a bispecific antibody.

### Claim 13 (depends on 1)

A nucleic acid encoding the antibody or antigen-binding portion thereof of claim 1, or a complementary sequence thereof.

### Claim 14 (depends on 1)

A method of treatment comprising administering the antibody or antigen-binding portion or nucleic acid thereof of claim 1 to a subject in need thereof.

### Claim 15 (depends on 14)

The method of claim 14, wherein the treatment is a treatment of cancer, and wherein the cancer is a tumour present within the central nervous system (CNS) or wherein the cancer is a solid tumour.

### Claim 16 (depends on 12)

The method of claim 12, wherein the treatment is a treatment of an infectious disease.

### Claim 17 (depends on 1)

A pharmaceutical composition comprising the antibody or antigen-binding portion thereof or the nucleic acid of claim 1, wherein the composition additionally includes a pharmaceutically acceptable carrier and/or a known therapeutic agent.

### Claim 18 (depends on 1)

The antibody or antigen-binding portion thereof according to claim 1, wherein the antibody or antigen-binding portion thereof has at least 85% sequence identity to SEQ ID NO: 7, more preferably at least 90% sequence identity to SEQ ID NO: 7, more preferably at least 95% sequence identity to SEQ ID NO: 7.

### Claim 19 (depends on 1)

The antibody or antigen-binding portion thereof according to claim 1, wherein the heavy chain CDR1 has at least 75% sequence identity to SEQ ID NO: 1, more preferably at least 80% sequence identity to SEQ ID NO: 1, more preferably at least 85% sequence identity to SEQ ID NO: 1, more preferably at least 90% sequence identity to SEQ ID NO: 1, more preferably at least 95% sequence identity to SEQ ID NO: 1.

### Claim 20 (depends on 1)

The antibody or antigen-binding portion thereof according to claim 1, wherein the heavy chain CDR2 has at least 75% sequence identity to SEQ ID NO: 2, more preferably at least 80% sequence identity to SEQ ID NO: 2, more preferably at least 85% sequence identity to SEQ ID NO: 2, more preferably at least 90% sequence identity to SEQ ID NO: 2, more preferably at least 95% sequence identity to SEQ ID NO: 2.

### Claim 21 (depends on 1)

The antibody or antigen-binding portion thereof according to claim 1, wherein the heavy chain CDR3 has at least 75% sequence identity to SEQ ID NO: 3, more preferably at least 80% sequence identity to SEQ ID NO: 3, more preferably at least 85% sequence identity to SEQ ID NO: 3, more preferably at least 90% sequence identity to SEQ ID NO: 3, more preferably at least 95% sequence identity to SEQ ID NO: 3.
