Method of treatment comprising purified recombinant IL-13 antibody

Patent metadata

Field	Value
Publication number	US-10597446-B2
Application number	US-201815886277-A
Country	US
Kind code	B2
Filing date	Feb 1, 2018
Priority date	Sep 13, 2013
Publication date	Mar 24, 2020
Grant date	Mar 24, 2020

Abstract

Purified recombinant polypeptides isolated from Chinese hamster ovary host cells, including antibodies, such as therapeutic antibodies, and methods of making and using such polypeptides are provided.

First claim

What is claimed is:

1. A method of treating an IL13 mediated disorder selected from asthma, idiopathic pulmonary fibrosis, and atopic dermatitis in a patient comprising administering a treatment composition to the patient, wherein the treatment composition comprises a composition comprising an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells, wherein the composition comprises the anti-IL13 antibody and a residual amount of hamster phospholipase B-like 2 (PLBL2) of less than 20 ng/mg, wherein the anti-IL13 antibody comprises three heavy chain CDRs, CDR-H1 having the amino acid sequence of SEQ ID NO.: 1, CDR-H2 having the amino acid sequence of SEQ ID NO.: 2, and CDR-H3 having the amino acid sequence of SEQ ID NO.: 3, and three light chain CDRs, CDR-L1 having the amino acid sequence of SEQ ID NO.: 4, CDR-L2 having the amino acid sequence of SEQ ID NO.: 5, and CDR-L3 having the amino acid sequence of SEQ ID NO.: 6.

2. The method of claim 1 , wherein administration of the treatment composition is less immunogenic for hamster PLBL2 compared to administration of a reference composition, wherein the reference composition comprises an anti-IL13 monoclonal antibody purified from Chinese hamster ovary host cells and a residual amount of hamster PLBL2 of greater than 100 ng/mg.

3. The method of claim 1 , wherein the treatment composition is administered subcutaneously once every four weeks, once every eight weeks, or once every 12 weeks.

4. The method of claim 3 , wherein the patient is treated once every four weeks for at least one month.

5. The method of claim 1 , wherein the asthma is allergic asthma or non-allergic asthma.

6. The method of claim 1 , wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7.

7. The method of claim 1 , wherein the anti-IL13 antibody comprises a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.

8. The method of claim 6 , wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10.

9. The method of claim 7 , wherein the anti-IL13 antibody comprises a light chain having the amino acid sequence of SEQ ID NO.: 14.

10. The method of claim 1 , wherein the anti-IL13 antibody comprises a heavy chain variable region having the amino acid sequence of SEQ ID NO.: 7 and a light chain variable region having the amino acid sequence of SEQ ID NO.: 9.

11. The method of claim 10 , wherein the anti-IL13 antibody comprises a heavy chain having the amino acid sequence of SEQ ID NO.: 10 and a light chain having the amino acid sequence of SEQ ID NO.: 14.

12. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 15 ng/mg.

13. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 10 ng/mg.

14. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 8 ng/mg.

15. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 5 ng/mg.

16. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 3 ng/mg.

17. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 2 ng/mg.

18. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 1 ng/mg.

19. The method of claim 1 , wherein the residual amount of hamster PLBL2 is less than 0.5 ng/mg.

20. The method of claim 2 , wherein the residual amount of hamster PLBL2 in the reference composition is greater than 200 ng/mg.

21. The method of claim 2 , wherein the residual amount of hamster PLBL2 in the reference composition is greater than 300 ng/mg.

Assignees

• Genentech Inc

Inventors

• Yu X Christopher
• Fischer Saloumeh Kadkhodayan
• Fisher Susan C
• Lowe John
• Sanchez Ailen M
• Vanderlaan Martin

Classifications

• A61P37/08

  Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) · CPC title

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P11/06

  Antiasthmatics · CPC title

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61K2039/505

  comprising antibodies · CPC title