IP Library Granted Patent US 12,453,768
Granted Patent B2
US 12,453,768 · App. 18/085,478 · Granted Oct 28, 2025

Vaccines for in vivo expression of nucleic acids and methods of using the same

Inventor: Thomas E. Wagner (Greenville, SC)
Assignee: ORBIS HEALTH SOLUTIONS, LLC
A61K39/385A61K39/215A61P31/14C12N7/00A61K2039/53A61K2039/54A61K2039/6006C12N2770/20034C12N2770/20071
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Quick Facts
Patent No.
US 12,453,768
App. No.
18/085,478
Granted
Oct 28, 2025
Kind
B2
Abstract

The present disclosure provides particles for delivering a nucleic acid that encodes an immunogenic peptide in an antigen presenting cell. The disclosed particles can function as a vaccine and can be used to treat or prevent a viral or bacterial infection in a subject by expressing in vivo an immunogenic peptide, thereby stimulating the subject's immune system to attack the virus or bacteria that naturally express the immunogenic peptide.

Claims (16)

1. A vaccine comprising: (i) a yeast cell wall particle (YCWP) that is surface-modified with polyethyleneimine (PEI), (ii) a lysosome-evading component attached to the YCWP, and (iii) a deoxyribonucleic acid (DNA) sequence encoding an immunogenic peptide from a virus or bacteria, wherein the nucleic acid is attached to the YCWP via a complex formed between the PEI and the nucleic acid, wherein intradermal administration of the vaccine to a human subject elicits an immunogenic response.

2. The vaccine of claim 1 , wherein the lysosome-evading component is a non-infectious virus.

3. The vaccine of claim 2 , wherein the non-infectious virus is an adenovirus.

4. The vaccine of claim 1 , wherein the lysosome-evading component is a quadrivalent influenza vaccine.

5. The vaccine of claim 1 , wherein the lysosome-evading component is a protein.

6. The vaccine of claim 5 , wherein the protein is a hexon protein, a penton protein, melittin, or LL37.

7. The vaccine of claim 1 , wherein the nucleic acid encoding the immunogenic peptide is comprised within an expression vector or plasmid.

8. The vaccine of claim 1 , wherein the immunogenic peptide is derived from a virus or bacteria.

9. The vaccine of claim 1 , wherein the immunogenic peptide is a viral spike protein or an immunogenic fragment thereof.

10. The vaccine of claim 1 , wherein the immunogenic peptide comprises SEQ ID NO: 1 or an immunogenic fragment thereof.

11. The vaccine of claim 1 , wherein the lysosome-evading component is attached to the base particle by an antibody.

12. The vaccine of claim 11 , wherein the lysosome-evading component is an adenovirus and the antibody is an anti-hexon protein antibody.

13. The vaccine of claim 1 , wherein the base particle is a succinimidyl 3-(2-pyridyldithio)propionate (SPDP)-modified YCWP.

14. The vaccine of claim 13 , wherein melittin or LL37 are crosslinked to the YCWP by the SPDP.

15. The vaccine of claim 1 , wherein the vaccine particle is a size that allows it to be phagocytized by a monocytic cell.

16. The vaccine of claim 15 , wherein the monocytic cell is an antigen presenting cell.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 20, 2026
From: ORBIS HEALTH SOLUTIONS, LLC
To: ELIOS HOLDINGS, LLC
Reel/Frame 074417/0948 →
Continuity (2)
Continuation 16909311 · Jun 23, 2020
Related Publication 20250009875A1 · Jan 9, 2025
References Cited (33)
US 5591601A · Wagner et al. · 1997 [cited by applicant]
US 5635380A · Naftilan et al. · 1997 [cited by applicant]
US 11529414B2 · Wagner · 2022 [cited by examiner]
US 20090117658A1 · Wagner et al. · 2009 [cited by applicant]
US 20100068808A1 · Bangera et al. · 2010 [cited by applicant]
US 20100111985A1 · Schwamberger et al. · 2010 [cited by applicant]
US 20100260797A1 · Hanon · 2010 [cited by applicant]
WO WO9711605A1 · 1997 [cited by applicant]
WO WO0011202A1 · 2000 [cited by applicant]
Alignment of SEQ 1 with Issued_Patents db SEQ 1 in U.S. Appl. No. 11/529,414. [cited by examiner]
Underhill. (Journal of endotoxin research. Jun. 2003; 9 (3):176-80). [cited by examiner]
Argiolas et al., “Bombolitins, a New Class of Mast Cell Degranulating Peptides from the Venom of the Bumblebee Megabombus pennsylvanicus,” The Journal of Biological Chemistry, Feb. 10, 1985, 260(3):1437-1444. [cited by applicant]
Baklaushev et al., “Luciferase Expression Allows Bioluminescence Imaging But Imposes Limitations on the Orthotopic Mouse (4T1) Model of Breast Cancer”, Scientific Reports, 7:7715, 2017 (17 pages). [cited by applicant]
Bal et al., “Adenovirus type 7 penton, Purification of soluble pentamers from [cited by applicant]
Chen et al., “Disease severity dictates SARS-CoV-2-specific neutralizing antibody responses in COVID-19”, Signal Transduction and Targeted Therapy, (2020)5:180 (6 pages). [cited by applicant]
Curiel et al., “High-Efficiency Gene Transfer Mediated by Adenovirus Coupled to DNA-Polylysine Complexes”, Human Gene Therapy, 3:147-154 (1992). [cited by applicant]
Feng et al., “An adenovirus-vectored COVID-19 vaccine confers protetion from SARS-COV-2 challenge in rhesus macaques”, Nature Communications, (2020)11:4207 (11 pages). [cited by applicant]
Garofalo et al., “Prospects of Replication-Deficient Adenovirus Based Vaccine Development against SARS-CoV-2”, Vaccines, vol. 8, No. 293, 2020 (10 pages). [cited by applicant]
Hammond et al., “A Particulate Viral Protein Vaccine Reduces Viral Load and Delays Progression to Disease in Immunized Ponies Challenged with Equine Infectious Anemia Virus,” Virology, 1999, 254:37-49. [cited by applicant]
Jaimes et al., “Phylogenetic Analysis and Structural Modeling of SARS-CoV-2 Spike Protein Reveals an Evolutionary Distinct and Proteolytically Sensitive Activation Loop”, Journal of Molecular Biology, vol. 432, 2020, pp… [cited by applicant]
Lackey et al., “Enhancement of Cell Transfection Efficiency by a Biomimetic Membrane-disruptive Polymer in a Model Nonviral Targeted Delivery System,” Abstracts of Scientific Presentations: The Third Annual Meeting of t… [cited by applicant]
Mizuguchi et al., “A simplified system for constructing recombinant adenoviral vectors containing heterologous peptides in the HI loop of their fiber knob”, Gene Therapy (2001) 8, pp. 730-735. [cited by applicant]
Pollet et al., “SARS-CoV-2 RBD219-N1C1: A Yeast-Expressed SARS-CoV-2 Recombinant Receptor-Binding Domain Candidate Vaccine Stimulates Virus Neutralizing Antibodies and T-cell Immunity in Mice”, bioRxiv.Jan. 1, 2020 (not… [cited by applicant]
Redding et al., “DNA vaccines in veterinary use”, Expert Rev. Vaccines 8(9), 2009 (26 pages). [cited by applicant]
Sequence alignment SEQ ID No 1 with Geneseq db acc No. BHT59643 by Qin et al May 1, 2020 (4 pages). [cited by applicant]
Shen et al., “Polyethylenimine-based micro/nanoparticles as vaccine adjuvants”, International Journal of Nanomedicine, 2017:12, pp. 5443-5460. [cited by applicant]
Shim et al., “Intranasal immunization with plasmid DNA encoding spike protein of SARS-coronavirus/polyethylenimine nanoparticles elicits antigen-specific humoral and cellular immune responses”, BMC Immunology 11(65), 20… [cited by applicant]
Sit et al., “Infection of dogs with SARS-CoV-2”, Nature, vol. 586, Oct. 29, 2020 (9 pages). [cited by applicant]
Stayton et al., “Molecular engineering of proteins and polymers for targeting and intracellular delivery of therapeutics,” Journal of Controlled Release, 2000, 65:203-220. [cited by applicant]
Turunen et al., “Peptide-Retargeted Adenovirus Encoding a Tissue Inhibitor of Metalloproteinase-1 Decreases Restenosis after Intravascular Gene Transfer”, Molecular Therapy, vol. 6, No. 3, 2002 (7 pages). [cited by applicant]
Wagner et al,. “Influenza virus hemagglutinin HA-2 N-terminal fusogenic peptides augment gene transfer by transferrin-polylysine-DNA complexes: Toward a synthetic virus-like gene-transfer vehicle,” Proc. Nat. Acad. Sci.… [cited by applicant]
Wagner et al., “Coupling of adenovirus to transferrin-polylysine/DNA complexes greatly enhances receptor-mediated gene delivery and expression of transfected genes”, Proc. Natl. Acad. Sci. vol. 89, pp. 6099-6103, Jul. 1… [cited by applicant]
Werkmeister et al., “The effect of sequence variations and structure on the cytolytic activity of melittin peptides,” Biochimica et Biophysica Acta, 1993, 1157:50-54. [cited by applicant]