IP Library Granted Patent US 11,207,416
Granted Patent B2
US 11,207,416 · App. 17/192,709 · Granted Dec 28, 2021

Compositions and methods for targeted RNA delivery

Inventors: Kallanthottathil G. Rajeev (Wayland, MA); Souvik Biswas (Stow, MA); Padma Malyala (Burlington, MA); Lisa N. Kasiewicz (Cambridge, MA); Alexandra Chadwick (Somerville, MA); Caroline Reiss (Somerville, MA)
Assignee: Verve Therapeutics, Inc.
A61K47/549A61K47/6929A61P9/10C12N15/113
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Quick Facts
Patent No.
US 11,207,416
App. No.
17/192,709
Granted
Dec 28, 2021
Kind
B2
Abstract

Provided herein are compositions, methods of making the same, and methods for targeted delivery of therapeutic agents for modifying expression and function of target genes, e.g. proteins involved in lipid and cholesterol metabolism such as PCSK9. Further provided herein are compositions and methods of treating conditions related to coronary disease.

Claims (63)

1. A receptor targeting conjugate, comprising a compound of Formula (V):

wherein,

a plurality of the A groups collectively comprising a receptor targeting ligand;

each of L 1 , L 2 , L 3 , L 4 , L 5 , L 6 , L 7 , L 8 , L 9 , L 10 and L 12 is independently substituted or unsubstituted C 1 -C 12 alkylene, substituted or unsubstituted C 1 -C 12 heteroalkylene, substituted or unsubstituted C 2 -C 12 alkenylene, substituted or unsubstituted C 2 -C 12 alkynylene, —(CH 2 CH 2 O) m —, —(OCH 2 CH 2 ) m —, —O—, —S—, —S(═O)—, —S(═O) 2 —, —S(═O)(═NR 1 )—, —C(═O)—, —C(═N—OR 1 )—, —C(═O)O—, —OC(═O)—, —C(═O)C(═O)—, —C(═O)N(R′)—, —N(R′)C(═O)—, —OC(═O)N(R 1 )—, —N(R 1 )C(═O)O—, —N(R 1 )C(═O)N(R 1 )—, —S(═O) 2 N(R 1 )—, —N(R 1 )S(═O) 2 —, —N(R 1 )—, or —N(OR 1 )—;

L 11 is substituted or unsubstituted —(CH 2 CH 2 O) n — or substituted or unsubstituted —(OCH 2 CH 2 ) n —;

each R 1 is independently H or substituted or unsubstituted C 1 -C 6 alkyl;

R comprises a lipid, nucleic acid, amino acid, protein, or lipid nanoparticle;

m is an integer selected from 1 to 10; and

n is an integer selected from 1 to 200,

wherein each of the A groups is a N-acetylgalactosamine moiety

2. The receptor targeting conjugate of claim 1 , wherein

the plurality of the A groups comprises a lectin receptor targeting ligand;

each of L 1 , L 3 , L 4 , and L 7 comprises —(CH 2 ) 4 —;

each of L 2 , L 5 , and L 8 comprises —C(═O)NH—;

each of L 6 and L 9 comprises —(CH 2 ) 3 —;

L 10 is —(CH 2 ) 1-3 —, —CH 2 CH 2 O— or —CH 2 O—;

L 11 is —(CH 2 CH 2 O) n — or —(OCH 2 CH 2 ) n —, where n is an integer selected from 1 to 50;

L 12 is —NH(CO)O— or —NHC(═O)—; and

R is selected from the group consisting of dialkylglycerolyl, diacylglycerolyl, sterol, n-alkyl comprising C 10 -C 30 carbon atoms, branched alkyl comprising C 10 -C 30 carbon atoms or tocopherol.

3. The receptor targeting conjugate of claim 2 , wherein the n is 1-3, 9-15, 33-39 or 41-49.

4. The receptor targeting conjugate of claim 1 , wherein the receptor targeting conjugate is

5. The receptor targeting conjugate of claim 1 , wherein the R comprises one or more of fatty alcohols, fatty acids, glycerolipids, glycerophospholipids, sphingolipids, saccharolipids, polyketides, or sterols or derivatives thereof.

6. The receptor targeting conjugate of claim 1 , wherein the R is a lipid nanoparticle that comprises one or more mRNA encoding one or more gene editor nuclease(s) or base editors and one or more guide RNAs.

7. The receptor targeting conjugate of claim 1 , wherein L 1 , L 4 , and L 7 is independently substituted or unsubstituted C 1 -C 12 alkylene.

8. The receptor targeting conjugate of claim 7 , wherein L 1 , L 4 , and L 7 is independently substituted or unsubstituted C 2 -C 6 alkylene.

9. The receptor targeting conjugate of claim 7 , wherein L 1 , L 4 , and L 7 is C 4 alkylene.

10. The receptor targeting conjugate of claim 1 , wherein each L 2 , L 5 , and L 8 is independently —C(═O)N(R 1 )—, —N(R 1 )C(═O)—, —OC(═O)N(R 1 )—, —N(R 1 )C(═O)O—, or —N(R 1 )C(═O)N(R 1 )—.

11. The receptor targeting conjugate of claim 1 , wherein each L 2 , L 5 , and L 8 is independently —C(═O)N(R 1 )— or —N(R 1 )C(═O)—, wherein R 1 is H or —CH 3 .

12. The receptor targeting conjugate of claim 1 , wherein each L 3 , L 6 , and L 9 is independently substituted or unsubstituted C 1 -C 12 alkylene.

13. The receptor targeting conjugate of claim 12 , wherein each L 3 is substituted or unsubstituted C 2 -C 6 alkylene.

14. The receptor targeting conjugate of claim 1 , wherein each L 6 and L 9 is independently substituted or unsubstituted C 2 -C 10 alkylene.

15. The receptor targeting conjugate of claim 14 , wherein each L 6 and L 9 is independently substituted or unsubstituted C 2 -C 6 alkylene.

16. The receptor targeting conjugate of claim 1 , wherein L 10 is substituted or unsubstituted C 1 -C 12 alkylene.

17. The receptor targeting conjugate of claim 1 , wherein L 11 is —(OCH 2 CH 2 ) n —.

18. The receptor targeting conjugate of claim 17 , wherein n is an integer between 30 and 50.

19. The receptor targeting conjugate of claim 17 , wherein n is 33, 34, 35, 36, 37, 38, or 39.

20. The receptor targeting conjugate of claim 1 , wherein L 12 is —O—, —C(═O)O—, —C(═O)N(R 1 ), —N(R 1 )C(═O)—, or —N(R 1 )C(═O)O—, wherein R 1 is H or —CH 3 .

21. The receptor targeting conjugate of claim 1 , wherein R is a lipid.

22. The receptor targeting conjugate of claim 1 , wherein R is dialkylglycerolyl.

23. The receptor targeting conjugate of claim 1 , wherein A binds to a lectin.

24. The receptor targeting conjugate of claim 1 , wherein

each of L 1 , L 3 , L 4 , and L 7 is —(CH 2 ) 4 —;

each of L 2 , L 5 , and L 8 is —C(═O)NH—;

each of L 6 and L 9 is —(CH 2 ) 3 —;

L 10 : —(CH 2 ) 2 —;

L 11 : —(OCH 2 CH 2 ) n ;

n is 33, 34, 35, 36, 37, 38, or 39;

R is 1,2-O-dioctadecylglycerolyl;

each of the A groups is a N-acetylgalactosamine moiety

and

L 12 is —NH(CO)—.

25. A nanoparticle composition comprising one or more nucleic acid molecular entities and the receptor targeting conjugate of claim 24 .

26. The nanoparticle composition of claim 25 , wherein the one or more nucleic acid molecular entities comprise an mRNA molecule, a guide RNA molecule, or both, wherein the mRNA molecule encodes a gene editor nuclease, a base editor nuclease, or both.

27. A pharmaceutical composition comprising the nanoparticle composition of claim 26 and an excipient or carrier.

28. A receptor targeting conjugate selected from the following:

wherein each of the p and q is independently an integer from 1 to 5, and n is an integer from 1 to 50;

wherein n is an integer from 1 to 50;

wherein each of the p and q is independently an integer from 1 to 5, and n is an integer from 1 to 50;

wherein n is an integer from 1 to 50;

wherein each of the p and q is independently an integer from 1 to 5, and n is an integer from 1 to 50:

wherein each of the p and q is independently an integer from 1 to 5, and n is an integer from 1 to 50;

wherein each of the p and q is independently an integer from 1 to 5, and n is an integer from 1 to 50;

wherein n is an integer from 1-50;

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 29, 2021
From: RAJEEV, KALLANTHOTTATHIL G.; BISWAS, SOUVIK; MALYALA, PADMA; KASIEWICZ, LISA N.; CHADWICK, ALEXANDRA; REISS, CAROLINE
To: VERVE THERAPEUTICS, INC.
Reel/Frame 055747/0968 →
Continuity (3)
Provisional Application 62984866 · Mar 4, 2020
Provisional Application 63078982 · Sep 16, 2020
Related Publication 20210299261A1 · Sep 30, 2021
Cited By (4)
US 12,264,175 US 12,274,753 US 12,569,570 US 12,649,921