IP Library Granted Patent US 10,513,710
Granted Patent B2
US 10,513,710 · App. 15/304,943 · Granted Dec 24, 2019

Exosomal loading using hydrophobically modified oligonucleotides

Inventors: Anastasia Khvorova (Westborough, MA); Neil Aronin (Newtonville, MA); Marie Cecile Didiot (Worcester, MA); Reka Haraszti (Tubingen, DE)
Assignee: University of Massachusetts
C12N15/88C12N15/1137A01K2267/0337C12N2310/11C12N2310/14C12N2310/141C12N2310/311C12N2310/313C12N2310/315C12N2310/3181C12N2310/321C12N2310/322C12N2310/3231C12N2310/351C12N2310/3515C12N2310/531
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,513,710
App. No.
15/304,943
Granted
Dec 24, 2019
Kind
B2
Abstract

In one aspect, the invention relates to a method of loading exosomes with oligonucleotide cargo, by incubating an oligonucleotide comprising one or more hydrophobic modifications with a population of exosomes for a period of time sufficient to allow loading of the exosomes with the oligonucleotide. Exosomes loaded with hydrophobic ally modified oligonucleotide cargo, and uses thereof, are also provided.

Claims (46)

1. A method of loading exosomes with a therapeutically effective amount of a hydrophobically modified siRNA cargo by self-assembly, comprising:

providing a hydrophobically modified siRNA at a concentration of 1.25 μM to 20 μM, wherein the hydrophobically modified siRNA is conjugated to a hydrophobic moiety selected from the group consisting of a sterol, GM1, a lipid, a vitamin, a small molecule, a peptide, or a combination thereof, and wherein 65% or more of the nucleotides in the hydrophobically modified siRNA comprise a phosphorothioate modification, a 2′O-Methyl modification, a 2′-Fluoro modification, or a combination thereof, and

incubating the hydrophobically modified siRNA with a population of exosomes, wherein the method takes place at about 4° C.−37° C., without ultracentrifugation, in the absence of electroporation and in the absence of a separately added transfection reagent, thereby loading the exosomes with a therapeutically effective amount of the hydrophobically modified siRNA, wherein the therapeutically effective amount is 1000-3000 molecules of siRNA per exosome.

2. The method of claim 1 , consisting essentially of incubating the hydrophobically modified siRNA with a population of exosomes.

3. The method of claim 1 , wherein loading of the exosomes with the hydrophobically modified siRNA occurs in 30 minutes or less.

4. The method of claim 1 , wherein at least 90% of the exosomes are loaded with the hydrophobically modified siRNA.

5. The method of claim 1 , wherein the hydrophobically modified siRNA has an increased hydrophobicity of at least 2 orders of magnitude relative to unmodified siRNA.

6. The method of claim 1 , wherein at least 70% of the nucleotides in the siRNA are hydrophobically modified.

7. The method of claim 1 , wherein 100% of the nucleotides in the siRNA are hydrophobically modified.

8. The method of claim 1 , wherein the hydrophobic moiety is a sterol.

9. The method of claim 1 , wherein the hydrophobic moiety is a vitamin.

10. The method of claim 8 , wherein the hydrophobic moiety is cholesterol.

11. The method of claim 9 , wherein the hydrophobic moiety is Vitamin E.

12. The method of claim 1 , wherein the exosomes are derived from cultured cells.

13. The method of claim 12 , wherein the exosomes are derived from dendritic cells (DC), immature dendritic cells, B cells, T cells, mast cells, epithelial cells, stem cells, induced pluripotent stem cells (iPS cells), neuronal cells, and tumor cells.

14. The method of claim 1 , wherein the exosomes are synthetic exosomes.

15. The method of claim 1 , wherein the exosomes comprise a targeting peptide.

16. The method of claim 15 , wherein the targeting peptide directs the exosomes to neuronal cells.

17. The method of claim 1 , further comprising purifying the exosomes loaded with the hydrophobically modified siRNA from unloaded siRNA.

18. The method of claim 17 , wherein the exosomes are purified after loading using ultracentrifugation.

19. The method of claim 1 , wherein the hydrophobically modified siRNA directs the silencing of a mutant huntingtin gene or a mutant SOD1 gene.

20. The method of claim 1 , wherein the hydrophobically modified oligonucleotide contains a detectable label.

21. The method of claim 20 , wherein the detectable label is a fluorescent label or a radioactive label.

22. The method of claim 1 , wherein the hydrophobically modified siRNA is provided at a concentration of 5 μM.

23. The method of claim 1 , wherein the hydrophobically modified siRNA is provided at a concentration of 10 μM.

24. The method of claim 1 , wherein the hydrophobically modified siRNA is provided at a concentration of 20 μM.

25. The method of claim 1 , wherein the siRNA contains a duplex region of 19 base pairs.

26. The method of claim 1 , wherein the siRNA contains a duplex region of 14-16 base pairs.

27. The method of claim 26 , wherein the siRNA contains a duplex region of 15 base pairs.

28. The method of claim 1 , wherein the method takes place at about 4° C.

29. The method of claim 1 , wherein the method takes place at about 37° C.

30. The method of claim 1 , wherein the method takes place at room temperature.

31. A composition comprising exosomes loaded with hydrophobically modified siRNA, produced by a method according to claim 1 .

32. The method of claim 1 , wherein the hydrophobically modified siRNA is provided at a concentration of 1.25 μM to 5 μM.

33. The method of claim 1 , wherein the hydrophobically modified siRNA is provided at a concentration of 1.25 μM to 10 μM.

34. A method of loading exosomes with a therapeutically effective amount of hydrophobically modified siRNA cargo by self-assembly, comprising:

providing a hydrophobically modified siRNA at a concentration of 1.25 μM to 20 μM, wherein the hydrophobically modified siRNA is conjugated to cholesterol or Vitamin E, and wherein 65% or more of the nucleotides in the hydrophobically modified siRNA comprise a phosphorothioate modification, a 2′-O-Methyl modification, a 2′-Fluoro modification, or a combination thereof, and

incubating the hydrophobically modified siRNA with a population of exosomes, wherein the method takes place at about 4° C. to 37° C. without ultracentrifugation, in the absence of electroporation and in the absence of a separately added transfection reagent, thereby loading the exosomes with a therapeutically effective amount of the hydrophobically modified siRNA.

35. The method of claim 34 , wherein the hydrophobically modified siRNA is provided at a concentration of 5 μM.

36. The method of claim 34 , wherein the hydrophobically modified siRNA is provided at a concentration of 10 μM.

37. The method of claim 34 , wherein the hydrophobically modified siRNA is provided at a concentration of 20 μM.

38. The method of claim 34 , wherein the therapeutically effective amount is 1000-3000 oligonucleotides per exosome.

39. The method of claim 34 , wherein the exosomes are purified after loading.

40. The method of claim 39 , wherein the exosomes are purified after loading using ultracentrifugation.

41. The method of claim 34 , wherein the hydrophobically modified siRNA is provided at a concentration of 1.25 μM to 5 μM.

42. The method of claim 34 , wherein the hydrophobically modified siRNA is provided at a concentration of 1.25 μM to 10 μM.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 9, 2019
From: HARASZTI, REKA
To: UNIVERSITY OF MASSACHUSETTS
Reel/Frame 050669/0592 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 7, 2017
From: KHVOROVA, ANASTASIA; ARONIN, NEIL; DIDIOT, MARIE CECILE
To: UNIVERSITY OF MASSACHUSETTS
Reel/Frame 042634/0281 →
Continuity (2)
Provisional Application 61981722 · Apr 18, 2014
Related Publication 20170183686A1 · Jun 29, 2017
Cited By (1)
US 12,571,004