IL-5 antibody, antigen binding fragment thereof, and medical application therefor

Patent metadata

Field	Value
Publication number	US-12258394-B2
Application number	US-202217747627-A
Country	US
Kind code	B2
Filing date	May 18, 2022
Priority date	Sep 29, 2017
Publication date	Mar 25, 2025
Grant date	Mar 25, 2025

Abstract

Provided are an IL-5 antibody, an antigen binding fragment thereof, and a medical application therefor. The present invention comprises a mouse-derived antibody containing an IL-5 antibody CDR region, a chimeric antibody, a humanized antibody, and a pharmaceutical composition comprising said IL-5 antibody and said antigen binding fragment thereof, as well as the use of the pharmaceutical composition as a drug.

First claim

The invention claimed is:

1. A method for inhibiting human IL-5 in a human subject in need thereof, wherein the human IL-5 is associated with a disease selected from the group consisting of asthma, malignant attack of asthma, eosinophilia, Churg-Strauss syndrome, atopic dermatitis, nasal polyps and eosinophilic esophagitis, the method comprising administering to the subject a therapeutically effective amount of an anti-IL-5 antibody or antigen-binding fragment thereof, wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region and a light chain variable region, wherein:
the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 region as set forth in amino acid sequences of SEQ ID NO: 16, 17 and 18, respectively; and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 region as set forth in amino acid sequences of SEQ ID NO: 19, 20 and 21, respectively.

2. The method according to claim 1 , wherein the monoclonal antibody is selected from the group consisting of murine antibody, chimeric antibody, and humanized antibody.

3. The method according to claim 2 , wherein the humanized antibody comprises a heavy chain variable region of SEQ ID NO: 49.

4. The method according to claim 3 , wherein the humanized antibody comprises a heavy chain variable region of SEQ ID NO:50 or 51.

5. The method according to claim 2 , wherein the humanized antibody comprises a light chain variable region of SEQ ID NO: 46.

6. The method according to claim 4 , wherein the humanized antibody comprises a light chain variable region of SEQ ID NO: 47 or 48.

7. The method according to claim 1 , wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises:
a heavy chain variable region selected from any one of SEQ ID NO: 49, 50 and 51 and a light chain variable region selected from any one of SEQ ID NO: 46, 47 and 48.

8. The method according to claim 1 , wherein the anti-IL-5 antibody is a full-length antibody, and further comprises a human antibody constant region.

9. The method according to claim 8 , wherein the full-length antibody comprises a human antibody heavy chain constant region as set forth in SEQ ID NO: 52 and a human light chain constant region as set forth in SEQ ID NO:53.

10. The method according to claim 1 , wherein the antigen-binding fragment is selected from the group consisting of Fab, Fab′, F (ab′) 2, single-chain antibody (scFv), dimerized V region (diabody), and disulfide-stabilized V region (dsFv).

11. A method for inhibiting human IL-5 in a human subject in need thereof, wherein the human IL-5 is associated with a disease selected from the group consisting of asthma, malignant attack of asthma, eosinophilia, Churg-Strauss syndrome, atopic dermatitis, nasal polyps and eosinophilic esophagitis, the method comprising administering to the subject a therapeutically effective amount of an anti-IL-5 antibody or antigen-binding fragment thereof, wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region and a light chain variable region, wherein,
the heavy chain variable region comprises HCDR1, HCDR2 and HCDR3 region as set forth in amino acid sequences of SEQ ID NO: 16, 17 and 18, respectively; and the light chain variable region comprises LCDR1, LCDR2 and LCDR3 region as set forth in amino acid sequences of SEQ ID NO: 19, 20 and 21, respectively.

12. The method according to claim 11 , wherein the disease is asthma.

13. The method according to claim 11 , wherein the anti-IL-5 antibody or antigen-binding fragment thereof comprises a heavy chain variable region of SEQ ID NO: 51 and a light chain variable region of SEQ ID NO: 47.

Assignees

• Jiangsu Hengrui Medicine Co
• Shanghai hengrui pharmaceutical co ltd

Inventors

• Ying Hua
• Shi Jinping
• Wang Yifang
• Hu Qiyue
• Ge Hu
• Tao Weikang

Classifications

• C07K14/7155

  for interleukins [IL] · CPC title

• C07K2319/30

  Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto · CPC title

• C07K2319/21

  containing a His-tag · CPC title

• C07K2317/92

  Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value · CPC title

• C07K2317/569

  Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody® · CPC title