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Last Updated: September 21, 2021

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Claims for Patent: 9,364,435


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Summary for Patent: 9,364,435
Title:Lipid formulations for nucleic acid delivery
Abstract: The present invention provides novel, stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.
Inventor(s): Yaworski; Edward (Maple Ridge, CA), Lam; Kieu (Surrey, CA), Jeffs; Lloyd (Delta, CA), Palmer; Lorne (Vancouver, CA), MacLachlan; Ian (Mission, CA)
Assignee: PROTIVA BIOTHERAPEUTICS, INC. (Burnaby, BC, CA)
Application Number:14/462,441
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,364,435
Patent Claims: 1. A nucleic acid-lipid particle comprising: (a) a nucleic acid; (b) a cationic lipid comprising from 50 mol % to 85 mol % of the total lipid present in the particle; (c) a non-cationic lipid comprising from 13 mol % to 49.5 mol % of the total lipid present in the particle; and (d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 mol % to 2 mol % of the total lipid present in the particle.

2. The nucleic acid-lipid particle of claim 1, wherein the nucleic acid comprises an interfering RNA, mRNA, an antisense oligonucleotide, a ribozyme, a plasmid, an immunostimulatory oligonucleotide, or mixtures thereof.

3. The nucleic acid-lipid particle of claim 2, wherein the interfering RNA comprises a small interfering RNA (siRNA), an asymmetrical interfering RNA (aiRNA), a microRNA (miRNA), or mixtures thereof.

4. The nucleic acid-lipid particle of claim 1, wherein the cationic lipid comprises from 50 mol % to 65 mol % of the total lipid present in the particle.

5. The nucleic acid-lipid particle of claim 1, wherein the non-cationic lipid comprises a mixture of a phospholipid and cholesterol or a derivative thereof.

6. The nucleic acid-lipid particle of claim 5, wherein the phospholipid comprises dipalmitoylphosphatidylcholine (DPPC), distearoylphosphatidylcholine (DSPC), or a mixture thereof.

7. The nucleic acid-lipid particle of claim 5, wherein the phospholipid comprises from 3 mol % to 15 mol % of the total lipid present in the particle.

8. The nucleic acid-lipid particle of claim 5, wherein the cholesterol or derivative thereof comprises from 30 mol % to 40 mol % of the total lipid present in the particle.

9. The nucleic acid-lipid particle of claim 1, wherein the conjugated lipid that inhibits aggregation of particles comprises a polyethyleneglycol (PEG)-lipid conjugate.

10. The nucleic acid-lipid particle of claim 9, wherein the PEG-lipid conjugate comprises a PEG-diacylglycerol (PEG-DAG) conjugate, a PEG-dialkyloxypropyl (PEG-DAA) conjugate, or a mixture thereof.

11. The nucleic acid-lipid particle of claim 10, wherein the PEG-DAA conjugate comprises a PEG-dimyristyloxypropyl (PEG-DMA) conjugate, a PEG-distearyloxypropyl (PEG-DSA) conjugate, or a mixture thereof.

12. The nucleic acid-lipid particle of claim 1, wherein the conjugated lipid that inhibits aggregation of particles comprises from 1 mol % to 2 mol % of the total lipid present in the particle.

13. The nucleic acid-lipid particle of claim 1, wherein the nucleic acid is fully encapsulated in the nucleic acid-lipid particle.

14. A pharmaceutical composition comprising a nucleic acid-lipid particle of claim 1 and a pharmaceutically acceptable carrier.

15. A method for introducing a nucleic acid into a cell, the method comprising: contacting the cell with a nucleic acid-lipid particle of claim 1.

16. A method for the in vivo delivery of a nucleic acid, the method comprising: administering to a mammalian subject a nucleic acid-lipid particle of claim 1.

17. A method for treating a disease or disorder in a mammalian subject in need thereof, the method comprising: administering to the mammalian subject a therapeutically effective amount of a nucleic acid-lipid particle of claim 1.

18. The method of claim 17, wherein the disease or disorder is a viral infection.

19. The method of claim 17, wherein the disease or disorder is a liver disease or disorder.

20. The method of claim 17, wherein the disease or disorder is cancer.

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