Antibodies having specificity for nectin-4 and uses thereof

Patent metadata

Field	Value
Publication number	US-12398206-B2
Application number	US-202017766597-A
Country	US
Kind code	B2
Filing date	Oct 7, 2020
Priority date	Oct 7, 2019
Publication date	Aug 26, 2025
Grant date	Aug 26, 2025

Abstract

The present invention relates to antibodies having specificity for Nectin-4 and uses thereof, in particular for the treatment of cancer.

First claim

The invention claimed is:

1. An antibody having specificity for human Nectin-4 and comprising a HCDR1 comprising SEQ ID NO:2, a HCDR2 comprising SEQ ID NO:3, a HCDR3 comprising SEQ ID NO:4, a LCDR1 comprising SEQ ID NO:5, a LCDR2 comprising SEQ ID NO:6 and a LCDR3 comprising SEQ ID NO:7.

2. The anti-Nectin-4 antibody according to claim 1 , which is a chimeric or humanized antibody.

3. A nucleic acid molecule, which encodes a heavy chain and a light chain of the anti-Nectin-4 antibody of claim 1 .

4. A host cell comprising the nucleic acid molecule according to claim 3 .

5. A method of treating cancer in a subject in need thereof, comprising administering a therapeutically effective amount of an anti-Nectin-4 antibody according to claim 1 .

6. The method according to claim 5 , wherein the cancer is breast cancer, ovarian cancer, bladder cancer, urothelial cancer, pancreatic cancer or lung cancer.

7. The method according to claim 5 , wherein the cancer is metastatic cancer.

8. A pharmaceutical composition comprising an anti-Nectin-4 antibody according to claim 1 , and at least a pharmaceutically acceptable carrier.

9. A method for detecting the presence or expression level of Nectin-4 in a biological sample, wherein the step of detecting is performed by using an anti-Nectin-4 antibody according to claim 1 in an immunohistochemistry (IHC) assay.

10. The method according to claim 9 , wherein the biological sample is a fixed tissue sample.

11. The method according to claim 10 , wherein the biological sample is a formalin-fixed paraffin-embedded (FFPE) tissue.

12. A method of treating a subject suffering from cancer characterized by expression of Nectin-4, the method comprising
1) detecting the expression of Nectin-4 in a tissue sample from the subject in comparison to a reference expression level of Nectin-4 by:
(1a) contacting a tissue sample from the subject with the antibody of claim 1 or an antigen binding fragment thereof; and
(1b) detecting binding of the antibody or antigen binding fragment to the tissue sample; and

2) administering an anti-cancer therapeutic agent to the subject when an increased expression level of Nectin-4 compared to the reference expression level of Nectin-4 is observed.

13. The method according to claim 12 , wherein the expression level of Nectin-4 is detected using an immunohistochemistry (IHC) approach, an immunoblotting assay, a fluorescence activated cell sorting (FACS) assay, or an Enzyme-Linked Immunosorbent Assay (ELISA).

14. The antibody of claim 1 characterized in that it has one of the following functions:
i. the antibody binds to the human Nectin-4 of SEQ ID NO:1 with a K D of less than 10 μg/mL; and
ii. the antibody selectively binds to Nectin-4 in a biological sample in an immunohistochemistry (IHC) assay.

15. The antibody of claim 1 characterized in that it has both of the following functions:
i. the antibody binds to the human Nectin-4 of SEQ ID NO:1 with a K D of less than 10 μg/mL; and
ii. the antibody selectively binds to Nectin-4 in a biological sample in an immunohistochemistry (IHC) assay.

16. The anti-Nectin-4 antibody of claim 1 , which comprises a variable heavy chain (VH) domain and a variable light chain domain having at least 90% identity with the heavy chain and light chain comprising SEQ ID NO:8 and 9 respectively.

17. The anti-Nectin-4 antibody of claim 1 , which comprises a variable heavy chain (VH) domain and a variable light chain comprising SEQ ID NO:8 and 9 respectively.

18. One nucleic acid molecule, which encodes a heavy chain of the anti-Nectin-4 antibody of claim 1 or a light chain of the anti-Nectin-4 antibody of claim 1 .

19. A host cell comprising the nucleic acid molecule according to claim 18 .

20. A method of treating a subject suffering from cancer characterized by expression of Nectin-4, the method comprising administering the antibody of claim 1 to the subject.

Assignees

• Univ Daixmarseille
• Inst Nat Sante Rech Med
• Inst Jean Paoli & Irene Calmettes
• Centre National De La Rech Scientifique—Cnrs

Inventors

• Lopez Marc
• Olive Daniel

Classifications

• C07K2317/565

  Complementarity determining region [CDR] · CPC title

• C07K2317/24

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

• A61P35/00

  Antineoplastic agents · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title

• A61K2039/505

  comprising antibodies · CPC title