IP Library Granted Patent US 9,809,817
Granted Patent B2
US 9,809,817 · App. 15/089,319 · Granted Nov 7, 2017

Oligonucleotide compounds for targeting huntingtin mRNA

Inventors: Anastasia Khvorova (Westborough, MA); Neil Aronin (Newtonville, MA); Julia Alterman (Worcester, MA)
Assignee: UNIVERSITY OF MASSACHUSETTS
C12N15/113A61K9/0085A61K31/713C12N2310/14C12N2310/315C12N2310/343C12N2310/344C12N2310/346C12N2310/3515C12N2310/3517C12N2310/3519C12N2310/52C12N2320/11C12N2320/30C12N2320/32C12N2320/51
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Quick Facts
Patent No.
US 9,809,817
App. No.
15/089,319
Granted
Nov 7, 2017
Kind
B2
Abstract

This disclosure relates to novel huntingtin targets. Novel oligonucleotides for the treatment of Huntington's disease are also provided.

Claims (45)

1. A vector for inhibiting the expression of HTT gene in a cell, said vector comprising a regulatory sequence operably linked to a nucleotide sequence that encodes a dsRNA molecule substantially complementary to 5′ CAGUAAAGAGAUUAA 3′ (SEQ ID NO:1), 5′ AUAUCAGUAAAGAGA 3′ (SEQ ID NO:2) or 5′ CUCAGGAUUUAAAAU 3′ (SEQ ID NO:3), wherein said dsRNA molecule is between 10 and 35 bases in length.

2. A cell comprising the vector of claim 1 .

3. A dsRNA molecule that is between 15 and 35 base pairs in length, comprising a region of complementarity which is substantially complementary to 5′ CAGUAAAGAGAUUAA 3′ (SEQ ID NO:1), 5′ AUAUCAGUAAAGAGA 3′ (SEQ ID NO:2) or 5′ CUCAGGAUUUAAAAU 3′ (SEQ ID NO:3), wherein the RNA molecule targets an HTT mRNA and comprises at least one modified nucleotide.

4. A pharmaceutical composition for inhibiting the expression of the HTT gene in an organism, comprising the dsRNA of claim 3 and a pharmaceutically acceptable carrier.

5. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ CAGUAAAGAGAUUAA 3′ (SEQ ID NO:1).

6. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ AUAUCAGUAAAGAGA 3′ (SEQ ID NO:2).

7. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ CUCAGGAUUUAAAAU 3′ (SEQ ID NO:3).

8. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand is complementary to at least 10, 11, 12 or 13 contiguous nucleotides of SEQ ID NO:1, 2 or 3.

9. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand contains no more than 3 mismatches with SEQ ID NO:1, 2 or 3.

10. The dsRNA molecule of claim 3 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand is fully complementary to SEQ ID NO:1, 2 or 3.

11. The dsRNA molecule of claim 3 , which is between 30 and 35 base pairs in length.

12. The dsRNA molecule of claim 3 , which is blunt-ended.

13. The dsRNA molecule of claim 3 , which comprises at least one single stranded nucleotide overhang.

14. The dsRNA molecule of claim 3 , wherein the at least one modified nucleotide is selected from the group consisting of a 2′-O-methyl modified nucleotide, a nucleotide comprising a 5′phosphorothioate group, and a terminal nucleotide linked to a cholesteryl derivative or dodecanoic acid bisdecylamide group.

15. The dsRNA molecule of claim 3 , wherein said modified nucleotide is selected from the group consisting of a 2′-deoxy-2′-fluoro modified nucleotide, a 2′-deoxy-modified nucleotide, a locked nucleotide, an abasic nucleotide, 2′-amino-modified nucleotide, 2′-alkyl-modified nucleotide, morpholino nucleotide, a phosphoramidate, a non-natural base comprising nucleotide, at least one 2′-O-methyl modified nucleotide and at least one nucleotide comprising a 5′phosphorothioate group.

16. The dsRNA molecule of claim 3 , wherein the dsRNA molecule comprises alternating 2′-methoxy-ribonucleotides and 2′-fluoro-ribonucleotides.

17. The dsRNA molecule of claim 3 , wherein the nucleotides at positions 2 and 14 from the 5′ end are not 2′-methoxy-ribonucleotides.

18. The dsRNA molecule of claim 3 , wherein the nucleotides are connected via phosphodiester or phosphorothioate linkages.

19. The dsRNA molecule of claim 3 , wherein the nucleotides at positions 1-6 from the 3′ end, or positions 1-7 from the 3′ end, are connected to adjacent nucleotides via phosphorothioate linkages.

20. A di-branched RNA compound comprising a dsRNA of claim 3 connected to another dsRNA by one or more moieties independently selected from a linker, a spacer and a branching point.

21. A method for inhibiting expression of HTT gene in a cell, the method comprising:

(a) introducing into the cell a double-stranded ribonucleic acid (dsRNA) of claim 3 ; and

(b) maintaining the cell produced in step (a) for a time sufficient to obtain degradation of the mRNA transcript of the HTT gene, thereby inhibiting expression of the HTT gene in the cell.

22. A method of treating or managing Huntington's disease comprising administering to a patient in need of such treatment or management a therapeutically effective amount of said dsRNA of claim 3 .

23. The method of claim 21 , wherein said dsRNA is administered to the brain of the patient.

24. The method of claim 21 , wherein said dsRNA is administered by intrastriatal infusion.

25. The method of claim 21 , wherein the dsRNA causes a decrease in HTT gene mRNA in the striatum.

26. The method of claim 21 , where the dsRNA causes a decrease in HTT gene mRNA in the cortex.

27. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ CAGUAAAGAGAUUAA 3′ (SEQ ID NO:1).

28. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ AUAUCAGUAAAGAGA 3′ (SEQ ID NO:2).

29. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand comprises the region of complementarity which is substantially complementary to 5′ CUCAGGAUUUAAAAU 3′ (SEQ ID NO:3).

30. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand is complementary to at least 10, 11, 12 or 13 contiguous nucleotides of SEQ ID NO:1, 2 or 3.

31. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand contains no more than 3 mismatches with SEQ ID NO:1, 2 or 3.

32. The vector of claim 1 , wherein the dsRNA comprises a sense strand and an antisense strand, wherein the antisense strand is fully complementary to SEQ ID NO:1, 2 or 3.

33. The vector of claim 1 , wherein the dsRNA is between 30 and 35 base pairs in length.

34. The vector of claim 1 , wherein the dsRNA blunt-ended.

35. The vector of claim 1 , wherein the dsRNA comprises at least one single stranded nucleotide overhang.

36. A method for inhibiting expression of HTT gene in a cell, the method comprising:

(a) introducing into the cell the vector of claim 1 ; and

(b) maintaining the cell produced in step (a) for a time sufficient to obtain degradation of the mRNA transcript of the HTT gene, thereby inhibiting expression of the HTT gene in the cell.

37. A method of treating or managing Huntington's disease comprising administering to a patient in need of such treatment or management a therapeutically effective amount of the vector of claim 1 .

38. The method of claim 37 , wherein said vector is administered to the brain of the patient.

39. The method of claim 37 , wherein said vector is administered by intrastriatal infusion.

40. The method of claim 37 , wherein the dsRNA causes a decrease in HTT gene mRNA in the striatum.

41. The method of claim 37 , where the dsRNA causes a decrease in HTT gene mRNA in the cortex.

Assignments (5)
INVENTION OWNERSHIP AGREEMENT AND CONSENT JUDGEMENT Recorded Jun 2, 2021
From: PHIO PHARMACEUTICALS CORP.
To: UNIVERSITY OF MASSACHUSETTS
Reel/Frame 056450/0417 →
CORRECTION BY DECLARATION OF ASSIGNEE FOR APPLICATION NO. 15/089,319, INCORRECT ASSIGNMENT RECORDED AT REEL/FRAME 042906/0799 Recorded Aug 23, 2017
From: UNIVERSITY OF MASSACHUSETTS
To: UNIVERSITY OF MASSACHUSETTS
Reel/Frame 043660/0071 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 5, 2017
From: KHVOROVA, ANASTASIA
To: RXI PHARMACEUTICALS CORPORATION
Reel/Frame 042906/0799 →
CONFIRMATORY LICENSE Recorded Apr 6, 2017
From: UNIVERSITY OF MASSACHUSETTS MEDICAL SCH
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 042171/0998 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2016
From: KHVOROVA, ANASTASIA; ARONIN, NEIL; ALTERMAN, JULIA
To: UNIVERSITY OF MASSACHUSETTS
Reel/Frame 039335/0341 →
Continuity (3)
Provisional Application 62289274 · Jan 31, 2016
Provisional Application 62142731 · Apr 3, 2015
Related Publication 20160355808A1 · Dec 8, 2016