IP Library Granted Patent US 10,683,504
Granted Patent B2
US 10,683,504 · App. 16/679,691 · Granted Jun 16, 2020

Serpina1 iRNA compositions and methods of use thereof

Inventors: Alfica Sehgal (Medford, MA); Klaus Charisse (Acton, MA); Brian Bettencourt (Groton, MA); Martin A. Maier (Belmont, MA); Kallanthottathil G. Rajeev (Wayland, MA); Gregory Hinkle (Plymouth, MA); Muthiah Manoharan (Weston, MA)
Assignee: Alnylam Pharmaceuticals, Inc.
C12N15/113A61K31/712A61K31/713C12N2310/11C12N2310/14C12N2310/315C12N2310/32C12N2310/321C12N2310/331C12N2310/332C12N2310/343C12N2310/344C12N2310/346C12N2310/351C12N2320/32C12N2320/34C12N2320/51C12N2330/30
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Quick Facts
Patent No.
US 10,683,504
App. No.
16/679,691
Granted
Jun 16, 2020
Kind
B2
Abstract

The invention relates to RNAi agents, e.g., double-stranded RNAi agents, targeting the Serpina1 gene, and methods of using such RNAi agents to inhibit expression of Serpina1 and methods of treating subjects having a Serpina1 associated disease, such as a liver disorder.

Claims (27)

1. A double stranded ribonucleic acid (dsRNA) agent for inhibiting expression of a serine peptidase inhibitor, clade A, member 1 (Serpina1) in a cell,

wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region, the antisense strand comprising a region of complementarity to an mRNA encoding Serpina1, wherein the region of complementarity comprises at least 15 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of 5′-AUUAAGAAGACAAAGGGUUUGUU-3′ (SEQ ID NO:139),

wherein the sense strand is 19-40 nucleotides in length and the antisense strand is 19-30 nucleotides in length,

wherein at least one nucleotide of the sense strand and at least one nucleotide of the antisense strand are modified nucleotides.

2. The dsRNA agent of claim 1 , wherein the region of complementarity comprises at least 17 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of 5′-AUUAAGAAGACAAAGGGUUUGUU-3′ (SEQ ID NO:139).

3. The dsRNA agent of claim 2 , wherein the region of complementarity comprises at least 17 contiguous nucleotides from the nucleotide sequence of 5′-AUUAAGAAGACAAAGGGUUUGUU-3′ (SEQ ID NO:139).

4. The dsRNA agent of claim 1 , wherein the region of complementarity comprises at least 19 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of 5′-AUUAAGAAGACAAAGGGUUUGUU-3′ (SEQ ID NO:139).

5. The dsRNA agent of claim 1 , further comprising a ligand.

6. The dsRNA agent of claim 5 , wherein the ligand is one or more GalNAc derivatives.

7. The dsRNA agent of claim 1 , wherein the agent further comprises at least one phosphorothioate or methylphosphonate internucleotide linkage.

8. The dsRNA agent of claim 1 , wherein at least one of the modified nucleotides is selected from the group consisting of a 3′-terminal deoxy-thymine (dT) nucleotide, a 2′-O-methyl modified nucleotide, a 2′-fluoro modified nucleotide, a 2′-deoxy-modified nucleotide, a locked nucleotide, an abasic nucleotide, a 2′-amino-modified nucleotide, a 2′-alkyl-modified nucleotide, a morpholino nucleotide, a phosphoramidate, a non-natural base comprising nucleotide, a nucleotide comprising a 5′-phosphorothioate group, and a terminal nucleotide linked to a cholesteryl derivative and a dodecanoic acid bisdecylamide group.

9. The dsRNA agent of claim 1 , wherein at least one of the modified nucleotides is selected from the group consisting of a 2′-O-methyl modified nucleotide and a 2′-fluoro modified nucleotide.

10. The dsRNA agent of claim 1 , wherein at least one strand comprises a 3′ overhang of at least 1 nucleotide.

11. The dsRNA agent of claim 10 , wherein the strand is the antisense strand.

12. The dsRNA agent of claim 1 , wherein the double stranded region is 15 to 30 base pairs in length.

13. A double stranded ribonucleic acid (dsRNA) agent for inhibiting expression of a serine peptidase inhibitor, clade A, member 1 (Serpina1) in a cell,

wherein the dsRNA agent comprises a sense strand and an antisense strand forming a double stranded region 15 to 30 base pairs in length, the antisense strand comprising a region of complementarity to an mRNA encoding Serpina1, wherein the region of complementarity comprises at least 17 contiguous nucleotides differing by no more than 3 nucleotides from the nucleotide sequence of 5′-AUUAAGAAGACAAAGGGUUUGUU-3′ (SEQ ID NO:139),

wherein the sense strand is 19-40 nucleotides in length and the antisense strand is 19-30 nucleotides in length,

wherein at least one nucleotide of the sense strand and at least one nucleotide of the antisense strand is a modified nucleotide independently selected from the group consisting of a 2′-O-methyl modified nucleotide and a 2′-fluoro modified nucleotide,

wherein at least one strand comprises a phosphorothioate or methylphosphonate internucleotide linkage, and

wherein the dsRNA agent comprises a ligand.

14. A cell comprising the dsRNA agent of claim 1 .

15. A cell comprising the dsRNA agent of claim 13 .

16. A pharmaceutical composition comprising the dsRNA agent of claim 1 .

17. A pharmaceutical composition comprising the dsRNA agent of claim 13 .

18. A kit comprising the dsRNA agent of claim 1 and instructions for use.

19. A kit comprising the dsRNA agent of claim 13 and instructions for use.

Assignments (2)
SECURITY INTEREST Recorded Oct 1, 2025
From: ALNYLAM PHARMACEUTICALS, INC.; SIRNA THERAPEUTICS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 072996/0337 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2019
From: SEHGAL, ALFICA; CHARISSE, KLAUS; BETTENCOURT, BRIAN; MAIER, MARTIN; RAJEEV, KALLANTHOTTATHIL G.; HINKLE, GREGORY; MANOHARAN, MUTHIAH
To: ALNYLAM PHARMACEUTICALS, INC.
Reel/Frame 051246/0422 →