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Last Updated: March 28, 2024

Claims for Patent: 8,865,417


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Summary for Patent: 8,865,417
Title:Assays for the detection of anti-TNF drugs and autoantibodies
Abstract: The present invention provides assays for detecting and measuring the presence or level of anti-TNF.alpha. drug therapeutics and autoantibodies in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNF.alpha. drug therapeutics to detect the presence or level of autoantibodies (e.g., HACA and/or HAHA) against the drug.
Inventor(s): Singh; Sharat (Rancho Santa Fe, CA), Wang; Shui Long (San Diego, CA), Ohrmund; Linda (San Diego, CA)
Assignee: Nestec S.A. (Vevey, CH)
Application Number:14/046,863
Patent Claims:1. A method for detecting the presence or level of an autoantibody to an anti-TNF.alpha. drug in a sample, the method comprising: (a) contacting a labeled anti-TNF.alpha. drug and labeled TNF.alpha. with the sample to form a first labeled complex between the labeled anti-TNF.alpha. drug, the labeled TNF.alpha., and the autoantibody and a second labeled complex between the labeled anti-TNF.alpha. drug and the autoantibody, wherein the labeled anti-TNF.alpha. drug and the labeled TNF.alpha. comprise different labels; (b) subjecting the first labeled complex and the second labeled complex to size exclusion chromatography to separate the first labeled complex and the second labeled complex; and (c) detecting the first labeled complex and the second labeled complex, thereby detecting the presence or level of a non-neutralizing form of the autoantibody when both the first labeled complex and the second labeled complex are present, and detecting the presence or level of a neutralizing form of the autoantibody when only the second labeled complex is present.

2. The method of claim 1, wherein the sample is serum.

3. The method of claim 1, wherein the anti-TNF.alpha. drug is a member selected from the group consisting of infliximab, etanercept, adalimumab, certolizumab pegol, and combinations thereof.

4. The method of claim 1, wherein the autoantibody is a member selected from the group consisting of a human anti-mouse antibody (HAMA), a human anti-chimeric antibody (HACA), a human anti-humanized antibody (HAHA) and combinations thereof.

5. The method of claim 1, wherein the size exclusion chromatography is size exclusion-high performance liquid chromatography (SE-HPLC).

6. The method of claim 1, wherein the labeled anti-TNF.alpha. drug is a fluorophore-labeled anti-TNF.alpha. drug.

7. The method of claim 6, wherein the fluorophore is selected from the group consisting of a polymethine dye, a pthalocyanine dye, a cyanine dye, a xanthene dye, a fluorene dye, a rhodamine dye, a coumarin dye, and a fluorescein dye.

8. The method of claim 1, wherein the labeled TNF.alpha. is a fluorophore-labeled TNF.alpha..

9. The method of claim 8, wherein the fluorophore is selected from the group consisting of a polymethine dye, a pthalocyanine dye, a cyanine dye, a xanthene dye, a fluorene dye, a rhodamine dye, a coumarin dye, and a fluorescein dye.

10. The method of claim 1, wherein the sample is obtained from a subject receiving therapy with the anti-TNF.alpha. drug.

11. A method for detecting the presence or level of an autoantibody to an anti-TNF.alpha. drug in a sample, the method comprising: (a) contacting a labeled anti-TNF.alpha. drug with the sample to firm a first labeled complex between the labeled anti-TNF.alpha. drug and the autoantibody; (b) subjecting the first labeled complex to a first size exclusion chromatography to separate the first labeled complex from free labeled anti-TNF.alpha. drug; (c) detecting the first labeled complex, thereby detecting the presence or level of the autoantibody; (d) contacting labeled TNF.alpha. with the first labeled complex from step (c) to form a second labeled complex between the labeled anti-TNF.alpha. drug and the labeled TNF.alpha., wherein the labeled anti-TNF.alpha. drug and the labeled TNF.alpha. comprise different labels, and wherein the second labeled complex does not include the autoantibody; (e) subjecting the second labeled complex to a second size exclusion chromatography to separate the second labeled complex from free labeled TNF.alpha.; and (f) detecting the second labeled complex, thereby detecting the presence or level of a neutralizing form of the autoantibody.

12. The method of claim 11, wherein the sample is serum.

13. The method of claim 11, wherein the anti-TNF.alpha. drug is a member selected from the group consisting of infliximab, etanercept, adalimunab, certolizumab pegol, and combinations thereof.

14. The method of claim 11, wherein the autoantibody is a member selected from the group consisting of a human anti-mouse antibody (HAMA), a human anti-chimeric antibody (HACA), a human anti-humanized antibody (HAHA), and combinations thereof.

15. The method of claim 11, wherein the first and/or the second size exclusion chromatography is size exclusion-high performance liquid chromatography (SE-HPLC).

16. The method of claim 11, wherein the labeled anti-TNF.alpha. drug is a fluorophore-labeled anti-TNF.alpha. drug.

17. The method of claim 16, wherein the fluorophore is selected from the group consisting of a polymethine dye, a pthalocyanine dye, a cyanine dye, a xanthene dye, a fluorene dye, a rhodamine dye, a coumarin dye, and a fluorescein dye.

18. The method of claim 11, wherein the labeled TNF.alpha. is a fluorophore-labeled TNF.alpha..

19. The method of claim 18, wherein the fluorophore is selected from the group consisting of a polymethine dye, a pthalocyanine dye, a cyanine dye, a xanthene dye, a fluorene dye, a rhodamine dye, a coumarin dye, and a fluorescein dye.

20. The method of claim 11, wherein the sample is obtained from a subject receiving therapy with the anti-TNF.alpha. drug.

Details for Patent 8,865,417

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 08/24/1998 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept Injection 103795 09/27/2004 ⤷  Try a Trial 2029-10-26
Immunex Corporation ENBREL etanercept Injection 103795 02/01/2007 ⤷  Try a Trial 2029-10-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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