Humanized anti-IL-1R3 antibody and methods of use

Patent metadata

Field	Value
Publication number	US-12054552-B2
Application number	US-202318471388-A
Country	US
Kind code	B2
Filing date	Sep 21, 2023
Priority date	Sep 21, 2022
Publication date	Aug 6, 2024
Grant date	Aug 6, 2024

Abstract

An antibody that specifically binds to IL-1R3, comprising an antibody heavy chain amino acid sequence of SEQ ID NO: 1 and a light chain amino acid sequence of SEQ ID NO: 2. A pharmaceutical composition is provided comprising the said antibody and a pharmaceutically acceptable diluent, carrier or excipient. Also said antibody for use in treating a disease or disorder in a subject in need thereof. The disease or disorder may be an autoimmune or autoinflammatory disease or disorder.

First claim

What is claimed is:

1. An antibody that specifically binds to IL-1R3, comprising an antibody heavy chain comprising SEQ ID NO: 1 and a light chain comprising SEQ ID NO: 2.

2. A pharmaceutical composition comprising the antibody of claim 1 and a pharmaceutically acceptable diluent, carrier or excipient.

3. An isolated nucleic acid molecule encoding an antibody that specifically binds to IL-1R3,
wherein the antibody comprises a heavy chain comprising SEQ ID NO: 1 and a light chain comprising SEQ ID NO: 2.

4. An expression vector comprising the nucleic acid molecule of claim 3 .

5. A host cell comprising the expression vector of claim 4 .

6. The host cell of claim 5 , which is a Chinese hamster ovary (CHO) cell.

7. A method of manufacturing an antibody that specifically binds to IL-1R3, comprising the steps of:
(i) transfecting a host cell using an isolated nucleic acid molecule encoding said antibody or an expression vector comprising a nucleic acid molecule encoding said antibody;
(ii) cultivating the host cell under conditions allowing expression of the antibody;
(iii) recovering the antibody; and
(iv) optionally further purifying and/or modifying and/or formulating the antibody;
wherein the antibody comprises a heavy chain comprising SEQ ID NO: 1 and a light chain comprising SEQ ID NO: 2.

8. The method of claim 7 , wherein the host cell is a Chinese hamster ovary (CHO) cell.

9. The method of claim 7 , wherein the method comprises: (v) further formulating the antibody,
wherein the formulating comprises combining the antibody with a pharmaceutically acceptable diluent, carrier or excipient.

10. The method of claim 7 , wherein an expression level of the antibody is greater than an expression level of an anti-IL-1R3 antibody comprising a human IgG1 Fc region,
wherein the human IgG1 Fc region comprises amino acid substitutions L234A and L235A, according to EU numbering.

11. An antibody produced by the method of claim 7 .

12. A method of treating a disease or disorder in a subject in need thereof comprising administering to the subject an effective amount of an antibody that specifically binds to IL-1R3,
wherein the antibody comprises a heavy chain comprising SEQ ID NO: 1 and a light chain comprising SEQ ID NO: 2,
wherein the disease or disorder is an autoimmune, autoinflammatory, neoplastic, inflammatory, and/or fibrotic disease or disorder.

13. The method of claim 12 wherein the disease or disorder is a neoplastic disease or disorder.

14. The method of claim 12 , wherein the disease or disorder is an inflammatory skin disease.

15. The method of claim 8 , wherein the host cell is a CHO DXB11 cell.

16. The method of claim 8 , wherein the method comprises:
(v) further formulating the antibody,
wherein the formulating comprises combining the antibody with a pharmaceutically acceptable diluent, carrier or excipient.

17. The method of claim 15 , wherein the method comprises:
(v) further formulating the antibody,
wherein the formulating comprises combining the antibody with a pharmaceutically acceptable diluent, carrier or excipient.

18. The method of claim 8 , wherein an expression level of the antibody is greater than an expression level of an anti-IL-1R3 antibody comprising a human IgG1 Fc region,
wherein the human IgG1 Fc region comprises amino acid substitutions L234A and L235A, according to EU numbering.

19. The method of claim 15 , wherein an expression level of the antibody is greater than an expression level of an anti-IL-1R3 antibody comprising a human IgG1 Fc region,
wherein the human IgG1 Fc region comprises amino acid substitutions L234A and L235A, according to EU numbering.

20. An antibody produced by the method of claim 8 .

21. An antibody produced by the method of claim 15 .

22. The host cell of claim 5 , wherein the host cell is a CHO DXB11 cell.

Assignees

• Sanofi Biotechnology

Inventors

• Lange Christian
• Li Ziyu
• Steinmann Björn
• Sjuts Hanno
• Weil Sandra

Classifications

• A61K2039/505

  comprising antibodies · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K2317/71

  Decreased effector function due to an Fc-modification · CPC title

• C07K2317/76

  Antagonist effect on antigen, e.g. neutralization or inhibition of binding · CPC title

• C07K2317/24

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