IP Library Granted Patent US 10,655,128
Granted Patent B2
US 10,655,128 · App. 15/787,876 · Granted May 19, 2020

Compositions and methods for modulating MECP2 expression

Inventors: Arthur M. Krieg (Cambridge, MA); Romesh Subramanian (Framingham, MA); James McSwiggen (Arlington, MA); Jeannie T. Lee (Boston, MA)
Assignees: Translate Bio MA, Inc.; The General Hospital Corporation
C12N15/113A61K31/712A61K31/7115A61K31/7125A61K47/555A61K47/61A61K47/64A61K47/6455C07H21/00C07H21/02C07H21/04C12N2310/11C12N2310/315C12N2310/321C12N2310/3231
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Quick Facts
Patent No.
US 10,655,128
App. No.
15/787,876
Granted
May 19, 2020
Kind
B2
Abstract

Aspects of the invention provide single stranded oligonucleotides for activating or enhancing expression of MECP2. Further aspects provide compositions and kits comprising single stranded oligonucleotides for activating or enhancing expression of MECP2. Methods for modulating expression of MECP2 using the single stranded oligonucleotides are also provided. Further aspects of the invention provide methods for selecting a candidate oligonucleotide for activating or enhancing expression of MECP2.

Claims (28)

1. A single stranded oligonucleotide produced by a process comprising:

synthesizing a single stranded oligonucleotide that:

(a) has a sequence 5′-X-Y-Z, wherein X is any nucleotide, Y is a nucleotide sequence of 6 nucleotides in length that is not a seed sequence of a human microRNA, and Z is a nucleotide sequence of 3-23 nucleotides in length,

(b) is complementary with at least 10 consecutive nucleotides of a PRC2-associated region of a MECP2 gene, wherein the PRC2-associated region is a region of the MECP2 gene that has a sequence that occurs at a higher frequency in a sequencing reaction of products of an RNA-immunoprecipitation assay that employs an antibody that targets Ezh2 to immunoprecipitate RNA-associated PRC2 complexes from cells comprising the MECP2 gene compared to a control sequencing reaction of products of a control RNA-immunoprecipitation assay that employs a control antibody; and and

wherein, during the synthesis, at least one nucleotide incorporated into the oligonucleotide is a nucleotide analogue.

2. The single stranded oligonucleotide of claim 1 , wherein the oligonucleotide does not comprise three or more consecutive guanosine nucleotides.

3. The single stranded oligonucleotide of claim 1 , wherein the oligonucleotide is 8 to 30 nucleotides in length.

4. The single stranded oligonucleotide of claim 1 , wherein the at least one nucleotide analogue results in an increase in Tm of the oligonucleotide in a range of 1 to 5° C. compared with an oligonucleotide that does not have the at least one nucleotide analogue.

5. The single stranded oligonucleotide of claim 1 , wherein at least one nucleotide of the oligonucleotide comprises a 2′ O-methyl.

6. The single stranded oligonucleotide of claim 1 , wherein the oligonucleotide comprises at least one ribonucleotide, at least one deoxyribonucleotide, or at least one bridged nucleotide.

7. The single strand oligonucleotide of claim 6 , wherein the bridged nucleotide is a LNA nucleotide, a cEt nucleotide or a ENA modified nucleotide.

8. The single stranded oligonucleotide of claim 1 , further comprising phosphorothioate internucleotide linkages between at least two nucleotides.

9. The single stranded oligonucleotide of claim 8 , further comprising phosphorothioate internucleotide linkages between all nucleotides.

10. The single stranded oligonucleotide of claim 1 , wherein the nucleotide at the 3′ position of the oligonucleotide has a 3′ hydroxyl group.

11. A single stranded oligonucleotide produced by a process comprising:

synthesizing a single stranded oligonucleotide that:

(a) comprises a region of complementarity that is complementary with at least 10 consecutive nucleotides of a PRC2-associated region of a MECP2 gene, wherein the PRC2-associated region is a region of the MECP2 gene that has a sequence that occurs at a higher frequency in a sequencing reaction of products of an RNA-immunoprecipitation assay that employs an antibody that targets Ezh2 to immunoprecipitate RNA-associated PRC2 complexes from cells comprising the MECP2 gene compared to a control sequencing reaction of products of a control RNA-immunoprecipitation assay that employs a control antibody;

(b) has at least one of:

(i) a sequence that is 5′X-Y-Z, wherein X is any nucleotide and wherein X is anchored at the 5′ end of the oligonucleotide, Y is a nucleotide sequence of 6 nucleotides in length that is not a human seed sequence of a microRNA, and Z is a nucleotide sequence of 3 to 23 nucleotides in length;

(ii) a sequence that does not comprise three or more consecutive guanosine nucleotides;

(iii) a sequence that is complementary to a PRC2-associated region that encodes an RNA that forms a secondary structure comprising at least two single stranded loops; and/or

(iv) a sequence that has greater than 60% G-C content,

wherein, during the synthesis, at least one nucleotide incorporated into the oligonucleotide is a nucleotide analogue.

12. A composition comprising a single stranded oligonucleotide of claim 1 and a carrier.

13. A composition comprising a single stranded oligonucleotide of claim 1 in a buffered solution.

14. A pharmaceutical composition comprising a composition of claim 12 and a pharmaceutically acceptable carrier.

15. A kit comprising a container housing the composition of claim 12 .

16. A method for preparing a pharmaceutical composition comprising providing the single stranded oligonucleotide of claim 1 and a pharmaceutically acceptable carrier.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2021
From: TRANSLATE BIO MA, INC
To: THE GENERAL HOSPITAL CORPORATION
Reel/Frame 055419/0935 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2020
From: KRIEG, ARTHUR M.; SUBRAMANIAN, ROMESH; MCSWIGGEN, JAMES
To: RANA THERAPEUTICS, INC.
Reel/Frame 051545/0773 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2020
From: LEE, JEANNIE T.
To: HOWARD HUGHES MEDICAL INSTITUTE
Reel/Frame 051545/0826 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 17, 2020
From: HOWARD HUGHES MEDICAL INSTITUTE
To: THE GENERAL HOSPITAL CORPORATION D/B/A/ MASSACHUSETTS GENERAL HOSPITAL
Reel/Frame 051545/0844 →
CHANGE OF NAME Recorded Jul 18, 2018
From: RANA DEVELOPMENT, INC.
To: TRANSLATE BIO MA, INC.
Reel/Frame 046570/0123 →
CHANGE OF NAME Recorded Jul 18, 2018
From: RANA THERAPEUTICS, INC.
To: RANA DEVELOPMENT, INC.
Reel/Frame 046570/0137 →
Continuity (3)
Continuation 14401237
Provisional Application 61648051 · May 16, 2012
Related Publication 20180223282A1 · Aug 9, 2018
Cited By (1)
US 12,343,357