IP Library Granted Patent US 11,547,764
Granted Patent B2
US 11,547,764 · App. 17/556,573 · Granted Jan 10, 2023

Lipid nanoparticle compositions and methods for MRNA delivery

Inventors: Braydon Charles Guild (Lexington, MA); Frank DeRosa (Lexington, MA); Michael Heartlein (Lexington, 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 11,547,764
App. No.
17/556,573
Granted
Jan 10, 2023
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 (13)

1. A composition comprising an mRNA encoding a protein or a peptide, encapsulated within a lipid nanoparticle, wherein the lipid nanoparticle has a size less than 150 nm and comprises (i) a PEG-modified lipid at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle, (ii) a cationic lipid at a molar ratio of greater than 10% of the total lipids in the lipid nanoparticle, (iii) a non-cationic lipid at a molar ratio of greater than 5% of total lipids in the lipid nanoparticle, and (iv) cholesterol at a molar ratio greater than 10% of the total lipids in the lipid nanoparticle, and wherein the mRNA comprises (i) a 5′-UTR, (ii) a 3′-UTR, (iii) a 5′ cap structure, and (iv) a poly A tail.

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

3. The composition of claim 2 , wherein the lipid nanoparticle comprises PEG-modified lipids at a molar ratio of 1% to 15% of the total lipids.

4. The composition of claim 3 , wherein the lipid nanoparticle comprises non-cationic lipids at a molar ratio of 5% to 90% of the total lipids.

5. The composition of claim 4 , wherein one or more non-cationic lipids comprise DSPC.

6. The composition of claim 4 , wherein one or more non-cationic lipids comprise DOPE.

7. The composition of claim 4 , wherein one or more PEG-modified lipids comprise DMG-PEG-2000.

8. The composition of claim 1 , wherein the poly A tail comprises at least 90 nucleotides.

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

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

11. The composition of claim 10 , wherein the lipid nanoparticle has a size less than 100 nm.

12. The method of claim 1 , wherein the mRNA is modified.

13. The method of claim 12 , wherein the mRNA comprises pseudouridines.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2022
From: GUILD, BRAYDON CHARLES; DEROSA, FRANK; HEARTLEIN, MICHAEL
To: SHIRE HUMAN GENETIC THERAPIES, INC.
Reel/Frame 059829/0444 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 5, 2022
From: SHIRE HUMAN GENETIC THERAPIES, INC.
To: RANA THERAPEUTICS, INC.
Reel/Frame 059857/0537 →
CHANGE OF NAME Recorded May 5, 2022
From: RANA THERAPEUTICS, INC.
To: TRANSLATE BIO, INC.
Reel/Frame 059857/0624 →
Continuity (12)
Division 17509674 · Oct 25, 2021
Division 17341016 · Jun 7, 2021
Division 17099462 · Nov 16, 2020
Division 16931231 · Jul 16, 2020
Division 16681565 · Nov 12, 2019
Division 16502672 · Jul 3, 2019
Division 16286400 · Feb 26, 2019
Division 16233031 · Dec 26, 2018
Division 15482117 · Apr 7, 2017
Division 14124608
Provisional Application 61494881 · Jun 8, 2011
Related Publication 20220111070A1 · Apr 14, 2022