Claims for Patent: 9,943,592

Summary for Patent: 9,943,592

Title:	Vaccine adjuvants from self-assembling peptides
Abstract:	Pharmaceutical or veterinary compositions, vaccine systems, methods, and kits for treating or protecting a subject from a condition using peptide-based adjuvants are provided. The peptide adjuvants comprise a peptide having a hydrophobic region, a turning region, and a hydrophilic region. The turning region comprises amino acid residues GSII (SEQ ID NO: 10). The peptide adjuvants can be used to immunopotentiate active agents by improving the immune response to the active agent.
Inventor(s):	Sun; Xiuzhi Susan (Manhattan, KS), Shi; Jishu (Manhattan, KS)
Assignee:	KANSAS STATE UNIVERSITY RESEARCH FOUNDATION (Manhattan, KS)
Application Number:	14/118,700
Patent Claims:	1. A pharmaceutical or veterinary composition comprising a therapeutically effective amount of an amphiphilic peptide adjuvant and an active agent, dispersed in a pharmaceutically acceptable carrier, said peptide adjuvant comprising a peptide having a hydrophobic region, a turning region, and a hydrophilic region, said turning region being between and directly connected to said hydrophobic and hydrophilic regions, said hydrophilic region comprising GPXGDGPXGD (SEQ ID NO:3), KKKKKGPXGD (SEQ ID NO:4), or KKKKKKKKKK (SEQ ID NO:6), where each X is selected from the group consisting of G, R, K, and Q, and said turning region comprising amino acid residues GSII (SEQ ID NO: 10), wherein said peptide is less than 30 amino acid residues in length, and wherein said active agent is selected from the group consisting of killed virus, modified live virus, viral or bacterial proteins, viral or bacterial DNA, toxoids, viral or bacterial protein subunits, and tumor antigens. 2. The composition of claim 1, wherein said hydrophobic regions comprise from about 2 to about 15 amino acid residues, said amino acid residues being selected from the group consisting of F, L, I, V, and combinations thereof. 3. The composition of claim 1, wherein said peptide comprises amino acid residues selected from the group consisting of FLIVIGSIIGPGGDGPGGD (SEQ ID NO:11), FLIVIGSIIKKKKKKKKKK (SEQ ID NO:12), LLLLLGSIIKKKKKKKKKK (SEQ ID NO:13), FLIVIGSIIGPRGDGPRGD (SEQ ID NO:14), FLIVIGSIIGPGGDGPRGD (SEQ ID NO:15), LLLLLGSIIKKKKKGPRGD (SEQ ID NO:16), and fragments or variants thereof having at least about 70% sequence identity thereto. 4. The composition of claim 1, wherein said carrier is selected from the group consisting of normal saline, phosphate buffered saline, sterile water, cell growth medium, aqueous solutions of dimethyl sulfoxide, aqueous solutions of polyethylene glycol, aqueous solutions of dextran, oil-in-water emulsions, and water-in-oil emulsions. 5. The composition of claim 1, said composition further comprising ions or a source of ions, wherein said ions are selected from the group consisting of Ca, Na, Mg, K, and Zn ions. 6. A vaccine system comprising: an active agent selected from the group consisting of killed virus, modified live virus, viral or bacterial proteins, viral or bacterial DNA, toxoids, viral or bacterial protein subunits, and tumor antigens; and a therapeutically effective amount of an amphiphilic peptide adjuvant dispersed in a pharmaceutically acceptable carrier, said peptide adjuvant comprising a peptide having a hydrophobic region, a turning region, and a hydrophilic region, said turning region being between and directly connected to said hydrophobic and hydrophilic regions, said hydrophilic region comprising GPXGDGPXGD (SEQ ID NO:3), KKKKKGPXGD (SEQ ID NO:4), or KKKKKKKKKK (SEQ ID NO:6), where each X is selected from the group consisting of G, R, K, and Q, and said turning region comprising amino acid residues GSII (SEQ ID NO: 10), wherein said peptide is less than 30 amino acid residues in length. 7. The system of claim 6, wherein said active agent and said peptide are mixed together in unit dosage form. 8. The system of claim 6, wherein said active agent is in a first container and said peptide adjuvant is in a second container separate from said active agent. 9. The system of claim 6, further comprising ions or a source of ions dispersed in a carrier with said active agent. 10. A kit for vaccinating a subject comprising: a vaccine system according to claim 6; and instructions for administering said vaccine system to said subject. 11. The composition of claim 1, wherein said hydrophilic region is derived from spider flagelliform silk protein and wherein said hydrophobic and turning regions are derived from human muscle L-type calcium channel protein. 12. The system of claim 6, wherein said hydrophilic region is derived from spider flagelliform silk protein and wherein said hydrophobic and turning regions are derived from human muscle L-type calcium channel protein. 13. The system of claim 6, wherein said carrier is selected from the group consisting of normal saline, phosphate buffered saline, sterile water, cell growth medium, aqueous solutions of dimethyl sulfoxide, aqueous solutions of polyethylene glycol, aqueous solutions of dextran, oil-in-water emulsions, and water-in-oil emulsions. 14. The composition of claim 1, wherein said amphiphilic peptide adjuvant forms a hydrogel in said carrier. 15. The system of claim 6, wherein said amphiphilic peptide adjuvant forms a hydrogel in said carrier. 16. A pharmaceutical or veterinary composition comprising a therapeutically effective amount of an amphiphilic peptide adjuvant and an active agent, dispersed in a pharmaceutically acceptable carrier, said peptide adjuvant comprising a peptide having a hydrophobic region, a turning region, and a hydrophilic region, said turning region being between and directly connected to said hydrophobic and hydrophilic regions, wherein said peptide comprises amino acid residues selected from the group consisting of FLIVIGSIIGPGGDGPGGD (SEQ ID NO:11), FLIVIGSIIKKKKKKKKKK (SEQ ID NO:12), LLLLLGSIIKKKKKKKKKK (SEQ ID NO:13), FLIVIGSIIGPRGDGPRGD (SEQ ID NO:14), FLIVIGSIIGPGGDGPRGD (SEQ ID NO:15), LLLLLGSIIKKKKKGPRGD (SEQ ID NO:16), and fragments or variants thereof having at least about 70% sequence identity thereto, and wherein said active agent is selected from the group consisting of killed virus, modified live virus, viral or bacterial proteins, viral or bacterial DNA, toxoids, viral or bacterial protein subunits, and tumor antigens. 17. A pharmaceutical or veterinary composition comprising a therapeutically effective amount of an amphiphilic peptide adjuvant and an active agent, dispersed in a pharmaceutically acceptable carrier, wherein said amphiphilic peptide adjuvant forms a hydrogel in said carrier, said peptide adjuvant comprising a peptide having a hydrophobic region, a turning region, and a hydrophilic region, said turning region being between and directly connected to said hydrophobic and hydrophilic regions, said turning region comprising amino acid residues GSII (SEQ ID NO: 10), wherein said peptide is less than 30 amino acid residues in length, and wherein said active agent is selected from the group consisting of killed virus, modified live virus, viral or bacterial proteins, viral or bacterial DNA, toxoids, viral or bacterial protein subunits, and tumor antigens. 18. The composition of claim 17, wherein said carrier is selected from the group consisting of normal saline, phosphate buffered saline, sterile water, cell growth medium, aqueous solutions of dimethyl sulfoxide, aqueous solutions of polyethylene glycol, aqueous solutions of dextran, oil-in-water emulsions, and water-in-oil emulsions. 19. The composition of claim 17, said composition further comprising ions or a source of ions, wherein said ions are selected from the group consisting of Ca, Na, Mg, K, and Zn ions. 20. A vaccine system comprising: an active agent selected from the group consisting of killed virus, modified live virus, viral or bacterial proteins, viral or bacterial DNA, toxoids, viral or bacterial protein subunits, and tumor antigens; and a therapeutically effective amount of an amphiphilic peptide adjuvant dispersed in a pharmaceutically acceptable carrier, said peptide adjuvant comprising a peptide having a hydrophobic region, a turning region, and a hydrophilic region, said turning region being between and directly connected to said hydrophobic and hydrophilic regions, said turning region comprising amino acid residues GSII (SEQ ID NO: 10), wherein said peptide is less than 30 amino acid residues in length, wherein said amphiphilic peptide adjuvant forms a hydrogel in said carrier.

Details for Patent 9,943,592

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2031-05-26