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AssigneeImunon, Inc.
InventorsMajed Mohd MATAR, Brian Jeffrey SPARKS, Alanna SMITH, Jennifer RICE, Khursheed ANWER
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Certain aspects of the invention are directed to methods of making a concentrated nucleic acid composition comprising: (a) combining (i) a DNA plasmid comprising a nucleic acid encoding a human IL-12 polypeptide, (ii) a cationic lipopolymer comprising polyethylene glycol (PEG)-polyethylenimine (PEI)-cholesterol (PPC), and (iii) a filler excipient in an aqueous medium, wherein the nucleic acid complexes with the cationic lipopolymer, thereby forming a nucleic acid mixture having a concentration of at least 0.15 mg/mL; and (b) concentrating the nucleic acid mixture of (a) by tangential flow filtration to form a concentrated nucleic acid composition having a concentration of at least 0.75 mg/mL, wherein the concentrated nucleic acid composition is suitable for pharmaceutical use, storage at −20° C. or less, 4° C. or less, and/or lyophilization. The invention further relates to pharmaceutical compositions prepared using the disclosed methods and methods of using the same.
A method of making a concentrated nucleic acid composition comprising:
A kit comprising a first vial comprising a nucleic acid mixture comprising (i) a DNA plasmid comprising a nucleic acid encoding a human IL-12 polypeptide, (ii) a cationic lipopolymer comprising polyethylene glycol (PEG)-polyethylenimine (PEI)-cholesterol (PPC), and (iii) a filler excipient in an aqueous medium, wherein the nucleic acid is complexed with the cationic lipopolymer and the nucleic acid mixture comprises at least 25 mg to 50 mg of the DNA plasmid, and optionally further comprising a second vial comprising a diluent.
A kit comprising a vial comprising a nucleic acid mixture comprising (i) a DNA plasmid comprising a nucleic acid encoding a human IL-12 polypeptide, (ii) a cationic lipopolymer comprising polyethylene glycol (PEG)-polyethylenimine (PEI)-cholesterol (PPC), and (iii) a filler excipient in an aqueous medium, wherein the nucleic acid is complexed with the cationic lipopolymer;
Dependencies are inferred from the claim text.