IP Library Granted Patent US 9,822,355
Granted Patent B2
US 9,822,355 · App. 14/647,547 · Granted Nov 21, 2017

Targeting BCL11A distal regulatory elements for fetal hemoglobin reinduction

Inventors: Stuart H. Orkin (Brookline, MA); Daniel E. Bauer (Cambridge, MA); Jian Xu (Plano, TX)
Assignee: Children's Medical Center Corporation
C12N15/01A61K35/12A61K38/465C07K14/4702C07K14/805C12N9/22C12N15/102C12N15/63
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Quick Facts
Patent No.
US 9,822,355
App. No.
14/647,547
Granted
Nov 21, 2017
Kind
B2
Abstract

Provided herein are methods and compositions for increasing fetal hemoglobin levels in a cell by disrupting BCL11A expression at the genomic level. Also provided herein are methods and compositions relating to the treatment of hemoglobinopathies by reinduction of fetal hemoglobin levels.

Claims (14)

1. A method for producing a genetically modified human hematopoietic progenitor cell having decreased BCL11A mRNA and protein expression, the method comprising introducing into an isolated human hematopoietic progenitor cell, in vitro or ex vivo, a vector comprising a regulatory element operably linked to the coding sequence of a DNA-targeting endonuclease, wherein the DNA-targeting endonuclease comprises a TAL DNA binding domain and whereby the DNA-targeting endonuclease binds to and cleaves the genomic DNA of the cell within chromosome 2 between positions 60,716,189-60,728,61 (according to UCSC Genome Browser hg 1.9 human genome assembly) thereby disrupting the DNAse hypersensitive sites +62, +58, or +55 therein, thereby genetically modifying the human hematopoietic progenitor cell and reducing the mRNA and the protein expression of BCL11A.

2. The method of claim 1 wherein the vector is introduced into the isolated human hematopoietic progenitor cell ex vivo.

3. A method for producing a genetically modified human hematopoietic progenitor cell having decreased BCL11A mRNA and protein expression, the method comprising introducing at least an RNA encoding a DNA-targeting endonuclease into an isolated hematopoietic progenitor cell in vitro or ex vivo, wherein the DNA-targeting, endonuclease comprises a TAL DNA binding domain, and whereby the DNA-targeting endonuclease binds to and cleaves the genomic DNA of the cell within chromosome 2 between positions 60,716,189-60,728,612 (according to UCSC Genome Browser hg 19 human genome assembly) thereby disrupting the DNAse hypersensitive sites +62, +58, or +55 therein, thereby genetically modifying the human hematopoietic progenitor cell and reducing the mRNA and the protein expression of BCL11A.

4. The method of claim 3 , wherein the DNA-targeting endonuclease is introduced into the isolated human hematopoietic progenitor cell ex vivo.

5. The method of claim 1 or claim 3 , wherein the isolated human hematopoietic progenitor is a cell of the erythroid lineage.

6. The method of claim 1 or claim 3 , wherein the isolated human hematopoietic progenitor cell comprises at least one genetic modification.

7. A method of increasing fetal hemoglobin levels in an isolated hematopoietic progenitor cell, the method comprising introducing into the isolated hematopoietic progenitor cell ex vivo a vector comprising a regulatory element operably linked to the coding sequence of a DNA-targeting endonuclease, wherein the DNA-targeting endonucleases comprises a TAL DNA binding domain and whereby the DNA-targeting endonuclease binds to and cleaves the genomic DNA of the hematopoietic progenitor cell within chromosome 2 between positions 60,716,189-60,728,61 causing at least one genetic modification in the DNAse hypersensitive sites +62, +58, or +55 therein, Whereby fetal hemoglobin expression is increased in the hematopoietic progenitor or erythroid progeny of the hematopoietic progenitor cell, compared to a hematopoietic progenitor cell or erythroid cell without the at least one genetic modification wherein the genetic modification is an insertion or a deletion.

8. A method of increasing fetal hemoglobin levels in an isolated hematopoietic progenitor cell, the method comprising introducing at least an RNA encoding a DNA-targeting endonuclease into an isolated hematopoietic progenitor cell ex vivo, wherein the DNA-targeting endonuclease comprises a TAL DNA binding domain, and whereby the DNA-targeting endonuclease binds and cleaves the genomic DNA of the hematopoietic progenitor cell within on chromosome 2 between positions 60,716,189-60,728,612 causing at least one genetic modification in the DNAse hypersensitive sites +62, +58, or +55 therein, whereby fetal hemoglobin expression is increased in the hematopoietic progenitor or erythroid progeny of the hematopoietic progenitor cell, compared to a hematopoietic progenitor cell or erythroid cell without the at least one genetic modification wherein the genetic modification is an insertion or a deletion.

9. The method of claim 6 , claim 7 or claim 8 , wherein the at least one genetic modification is a deletion.

10. The method of claim 9 , wherein the deletion removes the entire region between chromosome 2 location 60,716,189-60,728,612 or removes one or more DHSs in the region.

11. The method of claim 9 , wherein the deletion removes the entire region between chromosome 2 location 60,716,189-60,728,612.

12. The method of claim 9 , wherein the deletion disrupts DHS +62.

13. The method of claim 9 , wherein the deletion disrupts DHS +58.

14. The method of claim 9 , wherein the deletion disrupts DHS +55.

Assignments (3)
CONFIRMATORY LICENSE Recorded May 15, 2017
From: BOSTON CHILDREN'S HOSPITAL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 042459/0285 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2015
From: BAUER, DANIEL E.
To: CHILDREN'S MEDICAL CENTER CORPORATION
Reel/Frame 035728/0810 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2015
From: HOWARD HUGHES MEDICAL INSTITUTE
To: CHILDREN'S MEDICAL CENTER CORPORATION
Reel/Frame 035728/0833 →
Continuity (5)
Provisional Application 61730323 · Nov 27, 2012
Provisional Application 61730369 · Nov 27, 2012
Provisional Application 61776144 · Mar 11, 2013
Provisional Application 61889174 · Oct 10, 2013
Related Publication 20150307867A1 · Oct 29, 2015