Anti-PD-L1 antibodies

Patent metadata

Field	Value
Publication number	US-12570746-B2
Application number	US-202017761127-A
Country	US
Kind code	B2
Filing date	Sep 24, 2020
Priority date	Sep 25, 2019
Publication date	Mar 10, 2026
Grant date	Mar 10, 2026

Abstract

Provided are anti-PD-L1 antibodies. It also provides the nucleic acid molecules encoding the anti-PD-L1 antibodies, expression vectors and host cells used for the expression of the anti-PD-L1 antibodies. It also provides the methods for producing the anti-PD-L1 antibodies and the use thereof.

First claim

The invention claimed is:

1 . A programmed cell death ligand 1 (PD-L1) binding molecule comprising at least one immunoglobulin single variable domain VHH, wherein the VHH comprises CDR1, CDR2 and CDR3, and wherein CDR1 comprises an amino acid sequence as set forth in SEQ ID NO: 1, CDR2 comprises an amino acid sequence as set forth in SEQ ID NO: 2, and CDR3 comprises an amino acid sequence as set forth in SEQ ID NO: 3.

2 . The PD-L1 binding molecule of claim 1 , wherein the VHH comprises;
(A) the amino acid sequence as set forth in SEQ ID NO: 4; or (B) an amino acid sequence which is at least 85%, at least 90%, or at least 95% identical to SEQ ID NO: 4 and binds to PD-L1; or (C) an amino acid sequence with addition, deletion and/or substitution of one or more amino acids compared with SEQ ID NO: 4 and binds to PD-L1.

3 . The PD-L1 binding molecule of claim 1 , wherein the PD-L1 binding molecule is a PD-1 antagonist.

4 . The PD-L1 binding molecule of claim 1 , wherein the PD-L1 binding molecule is an anti-PD-L1 antibody selected from a single-domain antibody, a chimeric antibody, or a humanized antibody.

5 . The PD-L1 binding molecule of claim 1 , wherein the VHH is from a camelid animal, comprising an alpaca or a llama.

6 . The PD-L1 binding molecule of claim 1 , wherein the VHH is fused to another molecule, selected from a group consisting of a Fc domain of an immunoglobin, and a fluorescent protein.

7 . The PD-L1 binding molecule of claim 1 , wherein the VHH is fused to a Fc domain of IgG.

8 . The PD-L1 binding molecule of claim 7 , wherein the PD-L1 binding molecule is a chimeric antibody of VHH from a camelid animal and Fc domain of human IgG1 or IgG4.

9 . An isolated nucleic acid molecule, comprising a nucleic acid sequence encoding the PD-L1 binding molecule according to claim 1 .

10 . The isolated nucleic acid molecule of claim 9 , comprising a nucleic acid sequence as set forth in SEQ ID NO: 5.

11 . An expression vector comprising the isolated nucleic acid molecule of claim 9 .

12 . A host cell comprising the expression vector of claim 11 .

13 . A pharmaceutical composition comprising at least one PD-L1 binding molecule according to claim 1 and a pharmaceutically acceptable carrier.

14 . A method for preparing the PD-L1 binding molecule according to claim 1 , comprising the steps of:
culturing a host cell comprising a nucleic acid sequence encoding the PD-L1 binding molecule according to claim 1 under a condition of expressing the PD-L1 binding molecule in the host cell; and isolating the PD-L1 binding molecule from the host cell.

15 . A method for inhibiting or blocking the binding of PD-L1 to PD-1 in a subject, comprising: administering a therapeutically effective amount of the PD-L1 binding molecule according to claim 1 to the subject.

16 . A method of treating a condition associated with PD-L1 in a subject, comprising: administering a therapeutically effective amount of the PD-L1 binding molecule according to claim 1 to the subject, wherein the condition associated with PD-L1 is a PD-L1-expressing cancer.

17 . The method of claim 16 ,
wherein the cancer is selected from the group consisting of: breast cancer, lung cancer, colon cancer, ovarian cancer, melanoma, bladder cancer, kidney cancer, liver cancer, salivary cancer, stomach cancer, gliomas, thyroid cancer, thymic cancer, epithelial cancer, head and neck cancers, gastric cancer and pancreatic cancer.

18 . A kit for treating or diagnosing a condition associated with PD-L1, wherein the kit comprises a container comprising the PD-L1 binding molecule according to claim 1 , wherein the condition associated with PD-L1 is a PD-L1-expressing cancer.

Assignees

• Wuxi Biologics Ireland Ltd

Inventors

• Chen Yunying
• Li Jing

Classifications

• C12N15/70

  Vectors or expression systems specially adapted for E. coli · CPC title

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K2317/24

  containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered · CPC title

• A61P35/00 Primary

  Antineoplastic agents · CPC title