IP Library Granted Patent US 10,125,092
Granted Patent B2
US 10,125,092 · App. 15/505,282 · Granted Nov 13, 2018

Lipids and lipid compositions for the delivery of active agents

Inventors: Rohan Eric John Beckwith (Cambridge, MA); Luis Brito (Cambridge, MA); Brian Addison Dechristopher (Cambridge, MA); Gabriel Grant Gamber (Cambridge, MA); Andrew Geall (Cambridge, MA); Thomas Zabawa (Cambridge, MA)
Assignee: Novartis AG
C07C219/06A61K9/1272A61K9/5123A61K31/711A61K31/713A61K31/7105A61K47/18A61K47/22C07C217/58C07C219/16C07C229/12C07D207/08C07D211/34C07D211/62C07D295/15
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Quick Facts
Patent No.
US 10,125,092
App. No.
15/505,282
Granted
Nov 13, 2018
Kind
B2
Abstract

This invention provides for a compound of formula (I), or a pharmaceutically acceptable salt thereof, wherein R A , R B , R 2 and R 4 are defined herein. The compounds of formula (I) and pharmaceutically acceptable salts thereof are cationic lipids useful in the delivery of biologically active agents to cells and tissues.

Claims (52)

1. A compound of formula (II) or a pharmaceutically acceptable salt thereof:

wherein

R 1 is selected from

R 2 and R 3 are each, independently, C 12-22 alkyl, C 12-22 alkenyl,

and

R 4 is selected from hydrogen, halo and C 1-4 alkyl.

2. The compound according to claim 1 or a pharmaceutically acceptable salt thereof, wherein R 2 is selected from:

3. The compound according to claim 1 or a pharmaceutically acceptable salt thereof, wherein R 3 is selected from:

4. The compound according to claim 1 or a pharmaceutically acceptable salt thereof, wherein the compound is selected from:

2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl 4-(dimethylamino)butanoate;

((2-(((4-(dimethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-(((3-(dimethylamino)propanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-(((1-methylpiperidine-4-carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-((((3-(dimethylamino)propoxy)carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-((((3-(diethylamino)propoxy)carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

3-(dimethylamino)propyl 4-methyl-2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl carbonate;

4-methyl-2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl 4-(dimethylamino)butanoate;

(9Z,9′Z,12Z,12′Z)-((2-(((4-(dimethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(butane-4,1-diyl) bis(octadeca-9,12-dienoate);

4-(dimethylamino)butyl 4-methyl-2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl carbonate;

((2-(((1-ethylpiperidine-4-carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-(((1-isopropylpiperidine-4-carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-((2-(1-methylpiperidin-4-yl)acetoxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

((2-(((4-(pyrrolidin-1-yl)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(octane-8,1-diyl) bis(decanoate);

2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl (3-(dimethylamino)propyl) carbonate;

(9Z,9′Z,12Z,12′Z)-((2-(((4-(dimethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(ethane-2,1-diyl) bis(octadeca-9,12-dienoate);

2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl 3-(dimethylamino)propanoate;

2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl (3-(diethylamino)propyl) carbonate;

((2-(((4-(diethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(pentane-5,1-diyl) bis(4,4-bis(octyloxy)butanoate);

8-(4-((5-((4,4-bis(octyloxy)butanoyl)oxy)pentyl)oxy)-3-(((4-(dimethylamino)butanoyl)oxy)methyl)phenoxy)octyl decanoate;

8-(4-((5-((4,4-bis(octyloxy)butanoyl)oxy)pentyl)oxy)-2-(((4-(dimethylamino)butanoyl)oxy)methyl)phenoxy)octyl decanoate;

((2-(((4-(dimethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(propane-3,1-diyl) bis(4,4-bis(octyloxy)butanoate);

((2-(((4-(dimethylamino)butanoyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(pentane-5,1-diyl) bis(4,4-bis(octyloxy)butanoate); and

((2-(((1,4-dimethylpiperidine-4-carbonyl)oxy)methyl)-1,4-phenylene)bis(oxy))bis(pentane-5,1-diyl) bis(4,4-bis(octyloxy)butanoate).

5. A lipid composition comprising a compound according to claim 1 or a pharmaceutically acceptable salt thereof.

6. The lipid composition according to claim 5 , further comprising a biologically active agent.

7. The lipid composition according to claim 6 , wherein the biologically active agent is a DNA, siRNA or mRNA.

8. The lipid composition according to claim 5 , further comprising a helper lipid.

9. The lipid composition according to claim 8 , further comprising a neutral lipid.

10. The lipid composition according to claim 9 , further comprising a stealth lipid.

11. The lipid composition according to claim 10 , wherein the helper lipid is cholesterol, the neutral lipid is DSPC, and the stealth lipid is S010, S024, S027, S031, or S033.

12. The lipid composition according to claim 5 , wherein the lipid composition is in the form of a lipid nanoparticle.

13. The lipid composition according to claim 6 , wherein the biologically active agent is a mRNA.

14. A compound 2,5-bis((9Z,12Z)-octadeca-9,12-dien-1-yloxy)benzyl 4(dimethylamino)butanoate or a pharmaceutically acceptable salt thereof.

15. A lipid composition comprising a compound according to claim 14 .

16. The lipid composition according to claim 15 , further comprising a biologically active agent.

17. The lipid composition according to claim 16 , wherein the biologically active agent is a DNA, siRNA or mRNA.

18. The lipid composition according to claim 16 , wherein the biologically active agent is a mRNA.

19. The lipid composition according to claim 15 , further comprising a helper lipid.

20. The lipid composition according to claim 19 , further comprising a neutral lipid.

21. The lipid composition according to claim 20 , further comprising a stealth lipid.

22. The lipid composition according to claim 21 , wherein the helper lipid is cholesterol, the neutral lipid is DSPC, and the stealth lipid is S010, S024, S027, S031, or S033.

23. The lipid composition according to claim 15 , wherein the lipid composition is in the form of a lipid nanoparticle.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: BECKWITH, ROHAN ERIC JOHN; DECHRISTOPHER, BRIAN ADDISON; GAMBER, GABRIEL GRANT; ZABAWA, THOMAS
To: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH INC.
Reel/Frame 045351/0201 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: BRITO, LUIS
To: NOVARTIS VACCINES AND DIAGNOSTICS, INC.
Reel/Frame 045351/0273 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: GEALL, ANDREW
To: NOVARTIS VACCINES AND DIAGNOSTICS, INC.
Reel/Frame 045351/0351 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH INC.
To: NOVARTIS AG
Reel/Frame 045351/0406 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: NOVARTIS VACCINES AND DIAGNOSTICS, INC.
To: NOVARTIS AG
Reel/Frame 045351/0449 →
Continuity (2)
Provisional Application 62046487 · Sep 5, 2014
Related Publication 20170275243A1 · Sep 28, 2017
Cited By (1)
US 12,311,033