IP Library Granted Patent US 10,426,738
Granted Patent B2
US 10,426,738 · App. 16/002,472 · Granted Oct 1, 2019

Polynucleotides encoding methylmalonyl-CoA mutase

Inventors: Paolo Martini (Boston, MA); Vladimir Presnyak (Cambridge, MA)
Assignee: ModernaTX, Inc.
A61K9/5123A61K9/1272A61K38/52A61K48/005A61P3/00A61P43/00C12N9/90C12N15/52C12Y504/99002A61K38/00
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Quick Facts
Patent No.
US 10,426,738
App. No.
16/002,472
Granted
Oct 1, 2019
Kind
B2
Abstract

The disclosure relates to polynucleotides comprising an open reading frame of linked nucleosides encoding human methylmalonyl-CoA mutase precursor, human methylmalonyl-CoA mutase (MCM) mature form, or functional fragments thereof. In some embodiments, the disclosure includes methods of treating methylmalonic acidemia in a subject in need thereof comprising administering an mRNA encoding an MCM polypeptide.

Claims (30)

1. A messenger RNA (mRNA) comprising

an open reading frame (ORF) encoding the human methylmalonyl-CoA mutase (MCM) polypeptide of SEQ ID NO:213, wherein the ORF is at least 99% identical to the nucleotide sequence of SEQ ID NO:732.

2. The mRNA of claim 1 , wherein the ORF is 100% identical to the nucleotide sequence of SEQ ID NO:732.

3. The mRNA of claim 1 , wherein the mRNA comprises a 5′ untranslated region (UTR) comprising the nucleotide sequence of SEQ ID NO:215.

4. The mRNA of claim 1 , wherein the mRNA comprises a 5′ terminal cap comprising a guanine cap nucleotide containing an N7 methylation and the 5′-terminal nucleotide of the mRNA contains a 2′-O-methyl.

5. The mRNA of claim 1 , wherein the mRNA comprises a poly-A tail 100 residues in length.

6. The mRNA of claim 1 , wherein at least 95% of uridines in the mRNA are 5-methoxyuridines.

7. The mRNA of claim 2 , wherein the mRNA comprises a 5′ UTR comprising the nucleotide sequence of SEQ ID NO:215.

8. The mRNA of claim 2 , wherein the mRNA comprises a 5′ terminal cap comprising a guanine cap nucleotide containing an N7 methylation and the 5′-terminal nucleotide of the mRNA contains a 2′-O-methyl.

9. The mRNA of claim 2 , wherein the mRNA comprises a poly-A tail 100 residues in length.

10. The mRNA of claim 2 , wherein at least 95% of uridines in the mRNA are 5-methoxyuridines.

11. The mRNA of claim 2 , wherein the mRNA comprises a 5′ UTR comprising the nucleotide sequence of SEQ ID NO:215, wherein the mRNA comprises a 5′ terminal cap comprising a guanine cap nucleotide containing an N7 methylation and the 5′-terminal nucleotide of the mRNA contains a 2′-O-methyl, wherein the mRNA comprises a poly-A tail 100 residues in length, and wherein at least 95% of uridines in the mRNA are 5-methoxyuridines.

12. A pharmaceutical composition comprising the mRNA of claim 1 and a pharmaceutically acceptable excipient.

13. A pharmaceutical composition comprising the mRNA of claim 2 and a pharmaceutically acceptable excipient.

14. A pharmaceutical composition comprising the mRNA of claim 11 and a pharmaceutically acceptable excipient.

15. A lipid nanoparticle comprising the mRNA of claim 1 .

16. A lipid nanoparticle comprising the mRNA of claim 2 .

17. A lipid nanoparticle comprising the mRNA of claim 11 .

18. A pharmaceutical composition comprising the lipid nanoparticle of claim 15 .

19. A pharmaceutical composition comprising the lipid nanoparticle of claim 16 .

20. A pharmaceutical composition comprising the lipid nanoparticle of claim 17 .

21. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the mRNA of claim 1 .

22. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the mRNA of claim 2 .

23. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the mRNA of claim 11 .

24. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the pharmaceutical composition of claim 12 .

25. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the pharmaceutical composition of claim 13 .

26. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the pharmaceutical composition of claim 14 .

27. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the lipid nanoparticle of claim 15 .

28. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the lipid nanoparticle of claim 16 .

29. A method of treating methylmalonic acidemia in a human subject in need thereof, the method comprising administering to the human subject an effective amount of the lipid nanoparticle of claim 17 .

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 Jul 12, 2019
From: MARTINI, PAOLO; PRESNYAK, VLADIMIR; BENENATO, KERRY; HOGE, STEPHEN; MCFADYEN, IAIN; KUMARASINGHE, ELLALAHEWAGE SATHYAJITH
To: MODERNATX, INC.
Reel/Frame 049736/0201 →
Cited By (1)
US 12,564,645