IP Library › Granted Patent US 12,383,508
Granted Patent B2
US 12,383,508 · App. 17/277,423 · Granted Aug 12, 2025

High-purity peg lipids and uses thereof

Inventors: Örn Almarsson (Cambridge, MA); Jin Lim (Lexington, MA); Eugene Cheung (Sharon, MA); Jaclyn Milton (Somerville, MA)
Assignee: ModernaTX, Inc.
A61K9/5153A61K8/86A61K9/5123C08G65/3322
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Quick Facts
Patent No.
US 12,383,508
App. No.
17/277,423
Granted
Aug 12, 2025
Kind
B2
Abstract

The present disclosure is based, at least in part, on the discovery that high-purity PEG lipids exhibit superior physical and biological properties, particularly when used in lipid nanoparticle (LNP) formulations. Therefore, the present disclosure provides PEG lipids at a recommended purity, e.g., for use in formulations, such as LNP formulations. The present disclosure also provides LNPs comprising the high-purity PEG lipids, and methods for delivering therapeutic agents to a subject using the same.

Claims (36)

1. A lipid nanoparticle (LNP) comprising a plurality of PEG lipids of Formula (I):

or salts thereof;

wherein r is independently an integer from 35-55, inclusive; and

wherein the plurality of PEG lipids has a purity of 87% or greater with respect to the PEG lipid component of the LNP.

2. The LNP of claim 1 further comprising an ionizable amino lipid.

3. The LNP of claim 1 further comprising a helper lipid.

4. The LNP of claim 1 further comprising a structural lipid.

5. The LNP of claim 1 comprising the plurality of PEG lipids, an ionizable amino lipid, a helper lipid, and a structural lipid.

6. The lipid nanoparticle (LNP) of claim 1 comprising Compound (A):

the plurality of PEG lipids of Formula (I), 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine (DOPE), and cholesterol.

7. The lipid nanoparticle (LNP) of claim 1 comprising Compound (B):

the plurality of PEG lipids of Formula (I), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol.

8. The lipid nanoparticle (LNP) of claim 1 comprising Compound (C):

the plurality of PEG lipids of Formula (I), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol.

9. The LNP of claim 1 further comprising a therapeutic agent.

10. The LNP of claim 9 , wherein the therapeutic agent is a nucleic acid.

11. The LNP of claim 9 , wherein the therapeutic agent is an mRNA.

12. The LNP of claim 1 , wherein the LNP formulation exhibits lower IgM binding as compared to an LNP formulation comprising a plurality of PEG lipids with a purity of less than 87%.

13. The LNP of claim 1 , wherein the LNP formulation exhibits higher ApoE binding as compared to an LNP formulation comprising a plurality of PEG lipids with a purity of less than 87%.

14. The LNP of claim 1 , wherein the LNP formulation is less sensitive to accelerated blood clearance (ABC) as compared to an LNP formulation comprising a plurality of PEG lipids with a purity of less than 87%.

15. A method of delivering a therapeutic agent to a subject, the method comprising administering to the subject an LNP of claim 1 ; wherein the LNP further comprises the therapeutic agent, and wherein the LNP encapsulates the therapeutic agent.

16. The LNP of claim 1 , wherein r is independently an integer from 40-50, inclusive.

17. The LNP of claim 1 , wherein r is independently an integer from 42-48, inclusive.

18. The LNP of claim 1 , wherein r is 45.

19. The LNP of claim 1 , wherein the purity of the plurality of PEG lipids is greater than 90%.

20. The LNP of claim 1 , wherein the purity of the plurality of PEG lipids is greater than 95%.

21. The LNP of claim 1 , wherein the purity of the plurality of PEG lipids is greater than 98%.

22. The LNP of claim 1 , wherein the PEG lipid component of the LNP is substantially free of impurities.

23. The LNP of claim 5 comprising a molar ratio of 0.15-15% of the plurality of PEG lipids of Formula (I), 25-65% of the ionizable amino lipid, 30-50% of the structural lipid, and 10-40% of the helper lipid.

24. The LNP of claim 2 , wherein the ionizable amino lipid is Compound (B):

or a pharmaceutically acceptable salt thereof.

25. The LNP of claim 7 comprising a molar ratio of 40% or less of Compound (B), 0.15-15% of the plurality of PEG lipids of Formula (I), 20-40% of DSPC, and 30-50% of cholesterol.

26. The LNP of claim 7 comprising a molar ratio of 25-35% of Compound (B), 1-2% of the plurality of PEG lipids of Formula (I), 25-35% of DSPC, and 35-42% of cholesterol.

27. The LNP of 7 further comprising a therapeutic agent.

28. The LNP of claim 27 , wherein the therapeutic agent is an mRNA.

29. A method of delivering a therapeutic agent to a subject, the method comprising administering to the subject an LNP of claim 7 ; wherein the LNP further comprises the therapeutic agent, and wherein the LNP encapsulates the therapeutic agent.

Assignments (2)
SECURITY INTEREST Recorded Nov 19, 2025
From: MODERNATX, INC.
To: ARES CAPITAL CORPORATION, AS AGENT
Reel/Frame 073634/0354 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 19, 2021
From: ALMARSSON, ORN; LIM, JIN; CHEUNG, EUGENE; MILTON, JACLYN
To: MODERNATX, INC.
Reel/Frame 055647/0457 →
Continuity (3)
Provisional Application 62745164 · Oct 12, 2018
Provisional Application 62733456 · Sep 19, 2018
Related Publication 20220031631A1 · Feb 3, 2022
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