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Last Updated: September 25, 2020

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Claims for Patent: 9,353,164

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Summary for Patent: 9,353,164
Title:Cardiac-specific nucleic acid regulatory elements and methods and use thereof
Abstract: The present invention relates to nucleic acid regulatory elements that are able to enhance cardiac-specific expression of genes, methods employing these regulatory elements and uses of these elements. Expression cassettes and vectors containing these nucleic acid regulatory elements are also disclosed. The present invention is particularly useful for applications using gene therapy.
Inventor(s): Chuah; Lay Khim (Lovenjoel, BE), Vandendriessche; Thierry (Lovenjoel, BE), De Bleser; Pieter (Buggenhout, BE)
Assignee: VIB VZW (Ghent, BE) Life Sciences Research Partners VZW (Leuven, BE) Universiteit Gent (Ghent, BE)
Application Number:13/504,614
Patent Claims:1. A nucleic acid expression cassette comprising at least one nucleic acid regulatory element of 300 nucleotides or less for enhancing cardiac-specific gene expression, wherein the nucleic acid regulatory element is selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 8 and a sequence having 95% identity to any one of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 8, and wherein the nucleic acid regulatory element is operably linked to a promoter and a transgene.

2. The nucleic acid expression cassette of claim 1, wherein the nucleic acid regulatory element is SEQ ID NO: 1 or a sequence having 95% identity thereto.

3. The nucleic acid expression cassette of claim 1, wherein the nucleic acid regulatory element is 250 nucleotides or less.

4. A nucleic acid expression cassette comprising two or more nucleic acid regulatory elements each of 300 nucleotides or less for enhancing cardiac-specific gene expression, wherein the nucleic acid regulatory elements are selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 8 and a sequence having 95% identity to any one of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 8, and wherein each of the nucleic acid regulatory element is operably linked to a promoter and a transgene.

5. The nucleic acid expression cassette of claim 4, wherein the two or more nucleic acid regulatory elements are identical.

6. The nucleic acid expression cassette of claim 1, wherein the promoter is a cardiac-specific promoter.

7. The nucleic acid expression cassette of claim 6, wherein the promoter is from the myosin heavy chain gene.

8. The nucleic acid expression cassette of claim 1, additionally comprising a .beta.-globin intron.

9. The nucleic acid expression cassette of claim 1, wherein the transgene encodes a therapeutic protein.

10. A vector comprising the nucleic acid expression cassette of claim 1.

11. A vector comprising: a nucleic acid regulatory element of 300 nucleotides or less selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 8 and a sequence having 95% identity to any one of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 8, and wherein the nucleic acid regulatory element is operably linked to a promoter and a transgene.

12. The vector according to claim 11, which is a viral vector.

13. The vector according to claim 12, which is an AAV9 vector or an AAV2/9 vector.

14. A method for expressing a protein in a heart cell, the method comprising: introducing into at least one heart cell the nucleic acid expression cassette of claim 1; and expressing the transgene protein product thereof in the heart cell.

15. The method according to claim 14, wherein the protein is expressed in vivo.

16. The nucleic acid expression cassette of claim 7, wherein the promoter is from the myosin heavy chain alpha (.alpha.MHC) gene.

17. The nucleic acid expression cassette of claim 9, wherein the therapeutic protein is selected from the group consisting of an angiogenic factor, VEGF, PlGF, an ATPase, SERCA2a, an ion channel, a cytokine, and a growth factor.

18. The vector of claim 12, wherein the vector is a lentiviral or an AAV vector.

19. A vector comprising: a nucleic acid expression cassette comprising at least one nucleic acid regulatory element of 300 nucleotides or less, wherein the nucleic acid regulatory element is selected from the group consisting of: SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 8 and sequence having 95% identity to any one of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 8, and wherein the nucleic acid regulatory element is operably linked to a promoter and a transgene.

20. An isolated nucleic acid regulatory element of 300 nucleotides or less for enhancing cardiac-specific gene expression, wherein the nucleic acid regulatory element is selected from a sequence having between 95% and 99% identity to any one of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 8, and wherein the nucleic acid regulatory element is operably linked to a promoter and a transgene.

21. A pharmaceutical composition comprising the nucleic acid expression cassette of claim 9, and a pharmaceutically acceptable carrier.

Summary for Patent:   Start Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
09174519Oct 29, 2009
PCT Information
PCT FiledOctober 29, 2010PCT Application Number:PCT/EP2010/066474
PCT Publication Date:May 05, 2011PCT Publication Number:WO2011/051450

Details for Patent 9,353,164

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Schering INTRON A interferon alfa-2b VIAL 103132 001 1986-06-04   Start Trial VIB VZW (Ghent, BE) Life Sciences Research Partners VZW (Leuven, BE) Universiteit Gent (Ghent, BE) 2029-10-29 RX search
Schering INTRON A interferon alfa-2b VIAL 103132 002 1986-06-04   Start Trial VIB VZW (Ghent, BE) Life Sciences Research Partners VZW (Leuven, BE) Universiteit Gent (Ghent, BE) 2029-10-29 RX search
Schering INTRON A interferon alfa-2b VIAL 103132 003 1986-06-04   Start Trial VIB VZW (Ghent, BE) Life Sciences Research Partners VZW (Leuven, BE) Universiteit Gent (Ghent, BE) 2029-10-29 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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