IP Library Granted Patent US 12,121,592
Granted Patent B2
US 12,121,592 · App. 17/832,196 · Granted Oct 22, 2024

Lipid nanoparticle compositions and methods for mRNA delivery

Inventors: Frank DeRosa (Cambridge, MA); Braydon Charles Guild (Cambridge, MA); Michael Heartlein (Cambridge, MA)
Assignee: Translate Bio, Inc.
A61K48/0008A61K9/0019A61K9/0073A61K9/1271A61K9/1272A61K9/5123A61K31/713A61K38/1816A61K38/47A61K38/4846A61K38/57A61K48/0075A61K48/0091C07K14/505C07K14/8125C12N9/2465C12N9/644C12N15/52C12N15/85C12Y302/01022C12Y304/21022A61K48/00
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Quick Facts
Patent No.
US 12,121,592
App. No.
17/832,196
Granted
Oct 22, 2024
Kind
B2
Abstract

Disclosed herein are compositions and methods for modulating the production of a protein in a target cell. The compositions and methods disclosed herein are capable of ameliorating diseases associated with protein or enzyme deficiencies.

Claims (32)

1. A composition comprising: a first messenger RNA (mRNA) encoding a protein or peptide and a second mRNA encoding a protein or peptide, wherein the first mRNA and the second mRNA are encapsulated within a lipid nanoparticle,

wherein the lipid nanoparticle has a size less than 150 nm and comprises:

(i) a PEG-modified lipids at a molar ratio of greater than 1% of the total lipids in the lipid nanoparticle,

(ii) a cationic lipids at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle,

(iii) a non-cationic lipids at a molar ratio of greater than 5% of the total lipids in the lipid nanoparticle, and

(iv) cholesterol at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle.

2. The composition of claim 1 , wherein the lipid nanoparticle comprises PEG-modified lipids at a molar ratio of 0.5% to 20% of the total lipids.

3. The composition of claim 2 , wherein PEG-modified lipids comprise DMG-PEG-2000.

4. The composition of claim 1 , wherein the lipid nanoparticle comprises cationic lipids at a molar ratio of 20% to 70% of the total lipids.

5. The composition of claim 1 , wherein the lipid nanoparticle comprises non-cationic lipids at a molar ratio of greater than 5% to less than 90% of the total lipids.

6. The composition of claim 5 , wherein non-cationic lipids comprise DSPC.

7. The composition of claim 5 , wherein non-cationic lipids comprise DOPE.

8. The composition of claim 1 , wherein the first mRNA comprises:

(i) a 5′-UTR,

(ii) a 3′-UTR,

(iii) a 5′ cap structure, and

(iv) a poly A tail.

9. The composition of claim 8 , wherein the poly A tail comprises at least 90 nucleotides.

10. The composition of claim 8 , wherein the poly A tail comprises at least 200 nucleotides.

11. The composition of claim 1 , wherein the first mRNA is modified.

12. The composition of claim 11 , wherein the first mRNA comprises pseudouridine.

13. The composition of claim 1 , wherein the lipid nanoparticle has a size less than 125 nm.

14. The composition of claim 1 , wherein the lipid nanoparticle has a size less than 100 nm.

15. The composition of claim 8 , wherein the second mRNA comprises:

(i) a 5′-UTR,

(ii) a 3′-UTR,

(iii) a 5′ cap structure, and

(iv) a poly A tail.

16. The composition of claim 15 , wherein the poly A tail comprises at least 90 nucleotides.

17. The composition of claim 15 , wherein the poly A tail comprises at least 200 nucleotides.

18. The composition of claim 8 , wherein the second mRNA is modified.

19. The composition of claim 18 , wherein the second mRNA comprises pseudouridine.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2023
From: GUILD, BRAYDON CHARLES; DEROSA, FRANK; HEARTLEIN, MICHAEL
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 064112/0527 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2023
From: SHIRE HUMAN GENETIC THERAPIES, INC.
To: RANA THERAPEUTICS, INC.
Reel/Frame 064163/0849 →
CHANGE OF NAME Recorded Jun 29, 2023
From: RANA THERAPEUTICS, INC.
To: TRANSLATE BIO, INC.
Reel/Frame 064164/0055 →