US2023157969A1PendingUtilityA1

POLYMERIC NANOPARTICLES PROVIDING NUCLEIC ACIDS ENCODING TNF-a

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Assignee: HILLSTREAM BIOPHARMA INCPriority: Nov 2, 2016Filed: Oct 6, 2022Published: May 25, 2023
Est. expiryNov 2, 2036(~10.3 yrs left)· nominal 20-yr term from priority
Inventors:Surender KharbandaVasundhara ShuklaDonald W. KufeHarpal Singh
C07K 14/7151C07K 14/525A61K 45/06A61K 38/191A61P 35/00A61P 3/00A61P 37/02A61K 47/6937A61K 47/6835A61P 25/00A61P 29/00A61K 9/5153A61K 31/7068A61K 31/337A61P 1/16A61K 31/395A61K 47/6455A61P 1/04A61K 31/519A61K 2300/00A61K 48/00A61K 31/365A61K 9/5146A61K 31/706A61P 37/06A61K 31/4745A61P 9/00A61K 31/704A61K 31/555A61K 38/10A61P 5/00A61K 38/1709A61K 38/08A61K 47/6935A61P 31/04
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Claims

Abstract

The present invention relates to polymeric nanoparticles comprising a cytokine or a nucleic acid encoding for a cytokine, pharma-ceutical compositions comprising the same, and methods for treating certain diseases comprising administering these polymeric nanoparticles to a subject in need thereof.

Claims

exact text as granted — not AI-modified
1 - 35 . (canceled) 
     
     
         36 . A method for inducing TNF expression in a cell comprising contacting the cell with a composition comprising:
 a) a polymeric nanoparticle comprising a block copolymer comprising poly(lactic acid) (PLA) and poly(ethylene glycol) (PEG); and   b) an isolated nucleic acid that encodes a protein comprising an amino acid sequence at least 70% identical to the sequence of SEQ ID NO:9, or a portion thereof.   
     
     
         37 . The method of  claim 36 , wherein the polymeric nanoparticle comprises a poly(lactic acid)-poly(ethylene glycol) (PLA-PEG) di-block copolymer. 
     
     
         38 . The method of  claim 36 , wherein the polymeric nanoparticle comprises a poly(lactic acid)-poly(ethylene glycol)-poly(propylene glycol)-poly(ethylene glycol)-poly(lactic acid) (PLA-PEG-PPG-PEG-PLA) block copolymer. 
     
     
         39 . The method of  claim 36 , wherein the molecular weight of PLA is between about 10,000 and about 100,000 daltons. 
     
     
         40 . The method of  claim 36 , wherein the composition further comprises a chemotherapeutic agent or a targeted anti-cancer agent selected from the group consisting of doxorubicin, daunorubicin, decitabine, irinotecan, SN-38, cytarabine, docetaxel, triptolide, geldanamycin, 17-AAG, 5-FU, oxaliplatin, carboplatin, methotrexate, paclitaxel, indenoisoquinolines, and bortezomib. 
     
     
         41 . The method of  claim 36 , wherein the polymeric nanoparticles further comprise a targeting moiety attached to the outside of the polymeric nanoparticles, and wherein the targeting moiety is an antibody, peptide, or aptamer. 
     
     
         42 . The method of  claim 36 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to nucleotides 404-874 of SEQ ID NO:11. 
     
     
         43 . The method of  claim 36 , wherein the isolated nucleic acid comprises nucleotides 404-874 of SEQ ID NO:11. 
     
     
         44 . The method of  claim 36 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to nucleotides 176-874 of SEQ ID NO:11. 
     
     
         45 . The method of  claim 36 , wherein the isolated nucleic acid comprises nucleotides 176-874 of SEQ ID NO:11. 
     
     
         46 . The method of  claim 36 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to the nucleotide sequence of SEQ ID NO:11. 
     
     
         47 . The method of  claim 36 , wherein the isolated nucleic acid comprises the nucleotide sequence of SEQ ID NO:11. 
     
     
         48 . The method of  claim 36 , wherein the isolated nucleic acid encodes an amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO:9. 
     
     
         49 . The method of  claim 36 , wherein the isolated nucleic acid encodes the amino acid sequence of SEQ ID NO:9. 
     
     
         50 . The method of  claim 36 , wherein the isolated nucleic acid encodes an amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO:10. 
     
     
         51 . The method of  claim 36 , wherein the isolated nucleic acid encodes the amino acid sequence of SEQ ID NO:10. 
     
     
         52 . The method of  claim 36 , wherein the composition further comprises a cationic peptide. 
     
     
         53 . The method of  claim 36 , wherein the composition further comprises a cell-penetrating peptide. 
     
     
         54 . The method of  claim 36 , wherein the composition further comprises a cationic cell-penetrating peptide. 
     
     
         55 . The method of  claim 54 , wherein the isolated nucleic acid and the cationic cell-penetrating peptide form a complex. 
     
     
         56 . The method of  claim 54 , wherein the cationic cell-penetrating peptide is selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 6, 7, 8, and polyarginine. 
     
     
         57 . A method for treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising:
 a) a polymeric nanoparticle comprising a block copolymer comprising poly(lactic acid) (PLA) and poly(ethylene glycol) (PEG); and   b) an isolated nucleic acid that encodes a protein comprising an amino acid sequence at least 70% identical to the sequence of SEQ ID NO:9, or a portion thereof.   
     
     
         58 . The method of  claim 57 , wherein the polymeric nanoparticle comprises a PLA-PEG di-block copolymer. 
     
     
         59 . The method of  claim 57 , wherein the polymeric nanoparticle comprises a PLA-PEG-PPG-PEG-PLA block copolymer. 
     
     
         60 . The method of  claim 57 , wherein the molecular weight of PLA is between about 10,000 and about 100,000 daltons. 
     
     
         61 . The method of  claim 57 , wherein the pharmaceutical composition further comprises a chemotherapeutic agent or a targeted anti-cancer agent selected from the group consisting of doxorubicin, daunorubicin, decitabine, irinotecan, SN-38, cytarabine, docetaxel, triptolide, geldanamycin, 17-AAG, 5-FU, oxaliplatin, carboplatin, methotrexate, paclitaxel, indenoisoquinolines, and bortezomib. 
     
     
         62 . The method of  claim 57 , wherein the polymeric nanoparticles further comprise a targeting moiety attached to the outside of the polymeric nanoparticles, and wherein the targeting moiety is an antibody, peptide, or aptamer. 
     
     
         63 . The method of  claim 57 , wherein the cancer is breast cancer, prostate cancer, non-small cell lung cancer, metastatic colon cancer, pancreatic cancer, or a hematological malignancy. 
     
     
         64 . The method of  claim 57 , wherein the cancer comprises a PD-1 refractory tumor. 
     
     
         65 . The method of  claim 57 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to nucleotides 404-874 of SEQ ID NO:11. 
     
     
         66 . The method of  claim 57 , wherein the isolated nucleic acid comprises nucleotides 404-874 of SEQ ID NO:11. 
     
     
         67 . The method of  claim 57 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to nucleotides 176-874 of SEQ ID NO:11. 
     
     
         68 . The method of  claim 57 , wherein the isolated nucleic acid comprises nucleotides 176-874 of SEQ ID NO:11. 
     
     
         69 . The method of  claim 57 , wherein the isolated nucleic acid comprises a nucleotide sequence at least 95% identical to the nucleotide sequence of SEQ ID NO:11. 
     
     
         70 . The method of  claim 57 , wherein the isolated nucleic acid comprises the nucleotide sequence of SEQ ID NO:11. 
     
     
         71 . The method of  claim 57 , wherein the isolated nucleic acid encodes an amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO:9. 
     
     
         72 . The method of  claim 57 , wherein the isolated nucleic acid encodes the amino acid sequence of SEQ ID NO:9. 
     
     
         73 . The method of  claim 57 , wherein the isolated nucleic acid encodes an amino acid sequence at least 95% identical to the amino acid sequence of SEQ ID NO:10. 
     
     
         74 . The method of  claim 57 , wherein the isolated nucleic acid encodes the amino acid sequence of SEQ ID NO:10. 
     
     
         75 . The method of  claim 57 , wherein the pharmaceutical composition further comprises a cationic peptide. 
     
     
         76 . The method of  claim 57 , wherein the pharmaceutical composition further comprises a cell-penetrating peptide. 
     
     
         77 . The method of  claim 57 , wherein the pharmaceutical composition further comprises a cationic cell-penetrating peptide. 
     
     
         78 . The method of  claim 77 , wherein the isolated nucleic acid and the cationic cell-penetrating peptide form a complex. 
     
     
         79 . The method of  claim 77 , wherein the cationic cell-penetrating peptide is selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 6, 7, 8, and polyarginine.

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