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Last Updated: November 23, 2020

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Claims for Patent: 10,028,993

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Summary for Patent: 10,028,993
Title:Method of reducing titers of antibodies specific for a therapeutic agent
Abstract: The present invention relates, in general, to a method of treating patients undergoing enzyme replacement therapy (ERT) or other therapy involving the administration of a proteinaceous therapeutic agent as well gene replacement therapy with non-viral or viral vectors, or other therapeutic modality or modalities, used alone or in combination, which involve the administration of exogenous substances for potential therapeutic benefit, including, but not limited to DNA vaccines, siRNA, splice-site switching oligomers (SSOs) as well as RNA-based nanoparticles (RNPs) and nanovaccines. The invention further relates to compounds and compositions suitable for use in such methods.
Inventor(s): Kishnani; Priya S. (Durham, NC), Banugaria; Suhrad G. (Durham, NC), Koeberl; Dwight D. (Durham, NC), Prater; Sean N. (Durham, NC)
Assignee: Duke University (Durham, NC)
Application Number:15/438,375
Patent Claims:1. A method of reducing titers of antibodies specific for a therapeutic agent, wherein said therapeutic agent is a proteinaceous replacement for alpha-galactosidase A, in a patient suffering from Fabry disease treated with said therapeutic agent, said method comprising administering to said patient a proteasome inhibitor in an amount and under conditions such that said antibody titers are reduced.

2. A method of reducing the incidence of the formation in a patient suffering from Fabry disease of antibodies specific for a therapeutic agent, wherein said therapeutic agent is a proteinaceous replacement for alpha-galactosidase A, comprising administering to said patient, prior to administration of said therapeutic agent, an amount of a proteasome inhibitor sufficient to effect said reduction.

3. The method according to claim 1, wherein said therapeutic agent is administered directly to said patient.

4. The method according to claim 2, wherein said therapeutic agent is administered directly to said patient.

5. The method according to claim 1, wherein said proteinaceous replacement is recombinant human alpha-galactosidase A.

6. The method according to claim 2, wherein said proteinaceous replacement is recombinant human alpha-galactosidase A.

7. The method according to claim 1, wherein said proteasome inhibitor is bortezomib.

8. The method according to claim 2, wherein said proteasome inhibitor is bortezomib.

9. The method according to claim 1, wherein said method further comprises administering to said patient a compound that targets or alters antigen presentation or humoral or cell mediated immune response.

10. The method according to claim 2, wherein said method further comprises administering to said patient a compound that targets or alters antigen presentation or humoral or cell mediated immune response.

11. The method according to claim 1, wherein said method further comprises administering to said patient a compound that exerts a therapeutic effect against B cells and a compound that targets or alters antigen presentation or humoral or cell mediated immune response.

12. The method according to claim 2, wherein said method further comprises administering to said patient a compound that exerts a therapeutic effect against B cells and a compound that targets or alters antigen presentation or humoral or cell mediated immune response.

13. The method according to claim 11, wherein said method comprises administering to said patient rituximab, methotrexate and intravenous gamma globulin.

14. The method according to claim 12, wherein said method comprises administering to said patient rituximab, methotrexate and intravenous gamma globulin.

Details for Patent 10,028,993

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Genentech RITUXAN rituximab SOLUTION;INTRAVENOUS 103705 001 1997-11-26   Start Trial Duke University (Durham, NC) 2030-05-06 RX search
Genentech RITUXAN rituximab SOLUTION;INTRAVENOUS 103705 002 1997-11-26   Start Trial Duke University (Durham, NC) 2030-05-06 RX search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 001 2017-06-22   Start Trial Duke University (Durham, NC) 2030-05-06 RX Orphan search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 002 2017-06-22   Start Trial Duke University (Durham, NC) 2030-05-06 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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