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Last Updated: March 29, 2024

Claims for Patent: 8,921,526


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Summary for Patent: 8,921,526
Title:Mutated anti-TNF.alpha. antibodies and methods of their use
Abstract: The present invention is directed to modified antibodies, including anti-TNF.alpha. antibodies, in which C-terminal amino acids of heavy chain sequences are modified from a native sequence of proline-glycine-lysine (\"PGK\") to one that includes a proline positioned between the glycine and lysine, resulting in a C-terminal sequence of proline-glycine-proline-lycine (\"PGPK\"). The invention further provides methods of producing and using such antibodies.
Inventor(s): Chumsae; Chris M. (North Andover, MA), Kaymakcalan; Zehra (Westborough, MA)
Assignee: AbbVie, Inc. (North Chicago, IL)
Application Number:14/206,296
Patent Claims:1. An antibody, or antigen-binding portion thereof, comprising a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9).

2. The antibody, or antigen-binding portion thereof, of claim 1, wherein the antibody, or antigen-binding portion thereof, is an anti-TNF.alpha. antibody, or antigen-binding portion thereof.

3. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering a therapeutically effective amount of the antibody, or antigen-binding portion thereof, of claim 2 to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

4. The method of claim 3, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

5. The antibody, or antigen-binding portion thereof, of claim 2, wherein the antibody, or antigen-binding portion thereof, comprises the heavy and light chain variable regions of adalimumab.

6. A pharmaceutical composition comprising the antibody, or antigen-binding portion thereof, of claim 5 and a pharmaceutically acceptable carrier.

7. A pharmaceutical composition comprising the antibody, or antigen-binding portion thereof, of claim 2 and a pharmaceutically acceptable carrier.

8. A pharmaceutical composition comprising the antibody, or antigen-binding portion thereof, of claim 1 and a pharmaceutically acceptable carrier.

9. An anti-TNF.alpha. antibody, or antigen-binding portion thereof, comprising a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9).

10. A pharmaceutical composition comprising the antibody, or antigen-binding portion thereof, of claim 9 and a pharmaceutically acceptable carrier.

11. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering a therapeutically effective amount of the antibody, or antigen-binding portion thereof, of claim 9 to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

12. The method of claim 11, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

13. An antibody, or antigen-binding portion thereof, comprising the heavy and light chain variable regions of adalimumab and a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9).

14. A pharmaceutical composition comprising the antibody, or antigen-binding portion thereof, of claim 13 and a pharmaceutically acceptable carrier.

15. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering a therapeutically effective amount of the antibody, or antigen-binding portion thereof, of claim 13 to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

16. The method of claim 15, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

17. A pharmaceutical composition comprising an antibody, or antigen-binding portion thereof, comprising a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9) and a pharmaceutically acceptable carrier.

18. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering a therapeutically effective amount of an antibody, or antigen-binding portion thereof, comprising the heavy and light chain variable regions of adalimumab and a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9) to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

19. The method of claim 18, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

20. A pharmaceutical composition comprising an anti-TNF.alpha. antibody, or antigen-binding portion thereof, comprising a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9) and a pharmaceutically acceptable carrier.

21. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering the pharmaceutical composition of claim 20 to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

22. The method of claim 21, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

23. A pharmaceutical composition comprising an antibody, or antigen-binding portion thereof, comprising the heavy and light chain variable regions of adalimumab and a C-terminal heavy chain sequence of proline-glycine-proline-lysine (PGPK) (SEQ ID NO:9), and a pharmaceutically acceptable carrier.

24. A method of treating a subject having a disorder in which TNF.alpha. activity is detrimental, the method comprising administering the pharmaceutical composition of claim 23 to the subject, thereby treating the TNF.alpha.-associated disease or disorder.

25. The method of claim 24, wherein the disorder in which TNF.alpha. activity is detrimental is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's Disease, plaque psoriasis, active axial spondyloarthritis and non-radiographic axial spondyloarthritis.

Details for Patent 8,921,526

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 12/31/2002 ⤷  Try a Trial 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 02/21/2008 ⤷  Try a Trial 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 04/24/2013 ⤷  Try a Trial 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 09/23/2014 ⤷  Try a Trial 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 11/23/2015 ⤷  Try a Trial 2033-03-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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