IP Library Granted Patent US 10,704,046
Granted Patent B2
US 10,704,046 · App. 16/118,297 · Granted Jul 7, 2020

Multimeric oligonucleotide compounds

Inventors: Eugen Uhlmann (Glashutten, DE); Markus Weber (Langenfeld, DE); Romesh R. Subramanian (Framingham, MA); Thomas Dino Rockel (Dusseldorf, DE); Arthur M. Krieg (Cambridge, MA)
Assignee: Translate Bio MA, Inc.
C12N15/113C12N2310/11C12N2310/113C12N2310/315C12N2310/3231C12N2310/341C12N2310/346C12N2310/51C12N2310/52
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Quick Facts
Patent No.
US 10,704,046
App. No.
16/118,297
Granted
Jul 7, 2020
Kind
B2
Abstract

The disclosure provides multimeric oligonucleotide compounds, comprising two or more target-specific oligonucleotides (e.g., antisense oligonucleotides (ASOs)), each being resistant to cleavage, and linked together by a cleavable linker. In particular, two or more linked target-specific oligonucleotides, each to a different target, allows concomitant inhibition of multiple genes' expression levels, while exhibiting favorable pharmacokinetic and pharmacodynamic properties. Methods of making and uses of the described compounds are also provided.

Claims (38)

1. A single-stranded nucleic acid compound comprising the general formula: 5′X3′-L-5′X3′,

wherein each X is independently a single-stranded targeting oligonucleotide of 8 to 16 nucleotides in length having a region of complementarity comprising at least 7 contiguous nucleotides complementary to a target region of an mRNA, wherein adjacent nucleotides of the region of complementarity of each X comprise phosphorothioate linkages, and

wherein L is a linker consisting of 1 to 10 pyrimidine nucleotides linked through phosphodiester linkages that links at least two Xs and that is i) more susceptible to cleavage in a liver mammalian extract than each X and ii) more susceptible to cleavage in liver mammalian extract than mammalian serum or plasma, and

wherein when the target regions complementary to the first X and second X do not overlap in the mRNA, the 5′-end of the target region complementary to the first X and the 3′-end of the target region complementary to the second X are not within a distance of 0 to 4 nucleotides in the mRNA, and

wherein at least one targeting oligonucleotide is a mixmer or gapmer.

2. The single-stranded nucleic acid compound of claim 1 , wherein the pyrimidine nucleotides are thymidines or uridines.

3. A composition comprising a single-stranded nucleic acid compound of claim 1 and a carrier.

4. A composition comprising a single-stranded nucleic acid compound of claim 1 in a buffered solution.

5. A pharmaceutical composition comprising a single-stranded nucleic acid compound of claim 1 and a pharmaceutically acceptable carrier.

6. A kit comprising a container housing the composition of claim 3 .

7. The single-stranded nucleic acid compound of claim 2 , wherein the pyrimidine nucleotides are thymidines.

8. The single-stranded nucleic acid compound of claim 2 , wherein the pyrimidine nucleotides are uridines.

9. The single-stranded nucleic acid compound of claim 1 , wherein at least one targeting oligonucleotide is a gapmer.

10. The single-stranded nucleic acid compound of claim 1 , wherein at least one targeting oligonucleotide is a mixmer.

11. The single-stranded nucleic acid compound of claim 1 , wherein each targeting oligonucleotide is a gapmer.

12. The single-stranded nucleic acid compound of claim 1 , wherein each targeting oligonucleotide is a mixmer.

13. The single-stranded nucleic acid compound of claim 1 , wherein at least one targeting oligonucleotide is a mixmer that comprises alternating deoxyribonucleotides and 2′-fluoro-deoxyribonucleotides, alternating deoxyribonucleotides and 2′-O-methyl nucleotides, alternating deoxyribonucleotides and ENA nucleotide analogues, alternating deoxyribonucleotides and LNA nucleotides, or alternating LNA nucleotides and 2′-O-methyl nucleotides.

14. The single-stranded nucleic acid compound of claim 13 , wherein each targeting oligonucleotide is a mixmer that comprises alternating deoxyribonucleotides and 2′-fluoro-deoxyribonucleotides, alternating deoxyribonucleotides and 2′-O-methyl nucleotides, alternating deoxyribonucleotides and ENA nucleotide analogues, alternating deoxyribonucleotides and LNA nucleotides, or alternating LNA nucleotides and 2′-O-methyl nucleotides.

15. The single-stranded nucleic acid compound of claim 1 , wherein at least one targeting oligonucleotide is an X—N-Y gapmer, wherein X and Y each independently contain 1, 2, 3, 4, 5 or more modified nucleotides and N is 3, 4, 5, 6, 7, 8, 9, or 10 deoxynucleotides with non-modified sugars.

16. The single-stranded nucleic acid compound of claim 15 , wherein each targeting oligonucleotide is an X—N-Y gapmer, wherein X and Y each independently contain 1, 2, 3, 4, 5 or more modified nucleotides and N is 3, 4, 5, 6, 7, 8, 9, or 10 deoxynucleotides with non-modified sugars.

17. The single-stranded nucleic acid compound of claim 1 , wherein each targeting oligonucleotide comprises phosphorothioate internucleotide linkages between all nucleotides.

18. The single-stranded nucleic acid compound of claim 1 , wherein each targeting oligonucleotide comprises a locked nucleic acid (LNA) nucleotide, ethylene bridged nucleic acid (ENA) nucleotide, 2′-O-methyl nucleotide, or 2′-fluoro-deoxyribonucleotide.

19. The single-stranded nucleic acid compound of claim 1 , wherein the linker consists of 2 to 4 pyrimidine nucleotides linked through phosphodiester linkages.

20. A method of delivering multiple targeting oligonucleotides to a cell, the method comprising:

contacting a cell with a single-stranded nucleic acid compound of claim 1 under conditions in which the compound enters into the cell.

21. The method of claim 20 , wherein the cell is in vitro.

22. The method of claim 20 , wherein the cell is in vivo.

23. The method of claim 20 , wherein the single-stranded nucleic acid compound is delivered systemically to a subject comprising the cell.

24. A method of delivering multiple targeting oligonucleotides to a cell, the method comprising:

contacting a cell with a single-stranded nucleic acid compound of claim 11 under conditions in which the compound enters into the cell.

25. The method of claim 24 , wherein the cell is in vitro.

26. The method of claim 24 , wherein the cell is in vivo.

27. The method of claim 24 , wherein the single-stranded nucleic acid compound is delivered systemically to a subject comprising the cell.

28. A method of delivering multiple targeting oligonucleotides to a cell, the method comprising:

contacting a cell with a single-stranded nucleic acid compound of claim 12 under conditions in which the compound enters into the cell.

29. The method of claim 28 , wherein the cell is in vitro.

30. The method of claim 28 , wherein the cell is in vivo.

31. The method of claim 28 , wherein the single-stranded nucleic acid compound is delivered systemically to a subject comprising the cell.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 27, 2020
From: SUBRAMANIAN, ROMESH R.
To: PFIZER INC.
Reel/Frame 051628/0444 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 27, 2020
From: ROCKEL, THOMAS DINO; UHLMANN, EUGEN; WEBER, MARKUS
To: COLEY PHARMACEUTICAL GMBH
Reel/Frame 051628/0542 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 27, 2020
From: PFIZER INC.; COLEY PHARMACEUTICAL GMBH
To: RANA THERAPEUTICS, INC.
Reel/Frame 051628/0574 →
CHANGE OF NAME Recorded Jan 27, 2020
From: RANA DEVELOPMENT, INC.
To: TRANSLATE BIO MA, INC.
Reel/Frame 051708/0623 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 27, 2020
From: UHLMANN, EUGEN; SUBRAMANIAN, ROMESH; KRIEG, ARTHUR M.
To: RANA THERAPEUTICS, INC.
Reel/Frame 051708/0682 →
CHANGE OF NAME Recorded Jan 27, 2020
From: RANA THERAPEUTICS, INC.
To: RANA DEVELOPMENT, INC.
Reel/Frame 051708/0688 →
Continuity (4)
Continuation 15416100 · Jan 26, 2017
Continuation 14344523
Provisional Application 61534561 · Sep 14, 2011
Related Publication 20190062743A1 · Feb 28, 2019