US2023201337A1PendingUtilityA1
Vaccine compositions comprising endogenous gag polypeptides
Est. expiryMay 18, 2040(~13.8 yrs left)· nominal 20-yr term from priority
A61K 2039/57C07K 2319/00A61K 39/12A61K 2039/64C12N 2770/20071A61K 39/385A61K 39/145A61K 39/215A61P 31/14A61K 2039/5258A61K 2039/6031C12N 2770/20034
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Claims
Abstract
Described herein is a composition comprising: 1) an ARC polypeptide or an endogenous gag (endo-gag) polypeptide; 2) a pathogen-associated antigen; and 3) an adjuvant. Also described herein are vaccines and methods of vaccination using compositions comprising: 1) an ARC polypeptide or an endogenous gag (endo-gag) polypeptide; 2) a pathogen-associated antigen; and 3) an adjuvant.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1 . A composition comprising: 1) an ARC polypeptide or an endogenous gag (endo-gag) polypeptide; 2) a pathogen-associated antigen; and 3) an adjuvant.
2 . The composition of claim 1 , wherein the arc polypeptide comprises:
a) an amino acid sequence that is SEQ ID NO: 1 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 1;.
3 . The composition of claim 1 or 2 , wherein the endo-gag polypeptide comprises:
a) an amino acid sequence that is SEQ ID NO: 16 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 16;
b) an amino acid sequence that is SEQ ID NO: 17 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 17;
c) an amino acid sequence that is SEQ ID NO: 18 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 18;
d) an amino acid sequence that is SEQ ID NO: 19 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 19;
e) an amino acid sequence that is SEQ ID NO: 20 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 20;
f) an amino acid sequence that is SEQ ID NO: 21 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 21;
g) an amino acid sequence that is SEQ ID NO: 22 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 22; or
h) an amino acid sequence that is SEQ ID NO: 23 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 23; or
i) an amino acid sequence that is SEQ ID NO: 24 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 24; or
j an amino acid sequence that is SEQ ID NO: 25 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 25; or
k) an amino acid sequence that is SEQ ID NO: 26 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 26; or
1) an amino acid sequence that is SEQ ID NO: 27 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 27; or
m) an amino acid sequence that is SEQ ID NO: 28 or an amino acid sequence that is at least 90% identical to the SEQ ID NO: 28;
n) or any combination thereof.
4 . The composition of claim 1 or 3 , wherein the pathogen-associated antigen and the adjuvant are different compounds or polypeptides.
5 . The composition of any one of claims 1 to 4 , wherein the pathogen-associated antigen comprises a polypeptide.
6 . The composition of any one of claims 1 to 5 , wherein the pathogen-associated antigen is a bacterial antigen, a fungal antigen, a parasitic antigen or a viral antigen.
7 . The composition of any one of claims 1 to 5 , wherein the pathogen-associated antigen is a bacterial antigen.
8 . The composition of any one of claims 1 to 5 , wherein the pathogen-associated antigen is a fungal antigen.
9 . The composition of any one of claims 1 to 5 , wherein the pathogen-associated antigen is a parasitic antigen.
10 . The composition of any one of claims 1 to 5 , wherein the pathogen-associated antigen is a viral antigen.
11 . The composition of claim 10 , wherein the viral antigen is a respiratory virus antigen.
12 . The composition of claim 10 , wherein the viral antigen is a Coronaviridae antigen.
13 . The composition of claim 12 , wherein the Coronaviridae exhibits human tropism.
14 . The composition of claim 12 or 13 , wherein the Coronaviridae is selected from a list consisting of SARS Coronavirus (SARS-CoV-1), COVID-19 (SARS-CoV-2), MERS-coronavirus (MERS-CoV), or any combination thereof.
15 . The composition of any one of claims 10 to 14 , wherein the viral antigen comprises a spike protein, an envelope protein, a nucleocapsid protein, a membrane protein, a membrane glycoprotein, or a non-structural protein.
16 . The composition of claim 15 , wherein the viral antigen comprises a SARS Coronavirus (SARS-CoV-1) antigen, a COVID-19 (SARS-CoV-2) antigen, a MERS-coronavirus (MERS-CoV) antigen, or any combination thereof.
17 . The composition of claim 16 , wherein the viral antigen comprises a spike protein, an envelope small membrane protein, a membrane protein, a non-structural protein 6 (NSP6), a nucleoprotein, an ORF10 protein, Protein 3a, Protein7a, Protein 9b, structural protein 8, uncharacterized protein 4, or any combination thereof.
18 . The composition of claim 16 , wherein the viral antigen comprises an amino acid residue sequence as set forth in any one of SEQ ID NOs: 30 to 42, and combinations thereof.
19 . The composition of claim 16 , wherein the viral antigen consists of an amino acid residue sequence as set forth in any one of SEQ ID NOs: 30 to 42, and combinations thereof.
20 . The composition of claim 10 , wherein the viral antigen is an Influenza antigen.
21 . The composition of claim 20 , wherein the Influenza antigen is an M1 matrix protein or a fragment thereof.
22 . The composition of any one or claims 1 to 21 , wherein the ARC polypeptide or the endo-gag-polypeptide is coupled to the pathogen-associated antigen.
23 . The composition of claim 22 , wherein the ARC polypeptide or the endo-gag-polypeptide is coupled to the pathogen-associated antigen by a peptide bond.
24 . The composition of claim 23 , wherein the pathogen-associated antigen is N-terminal to the ARC polypeptide or the endo-gag-polypeptide.
25 . The composition of claim 23 , wherein the pathogen-associated antigen is C-terminal to the ARC polypeptide or the endo-gag-polypeptide.
26 . The composition of any one of claims 23 to 25 , comprising a flexible peptide linker separating the pathogen-associated antigen and the ARC polypeptide or the endo-gag-polypeptide.
27 . The composition of claim 22 , wherein the ARC polypeptide or the endo-gag-polypeptide is coupled to the pathogen by a bond formed from the reaction of an NHS-ester and a primary amine of the ARC polypeptide.
28 . The composition of any one of claims 1 to 27 , wherein the adjuvant comprises an immune stimulatory compound.
29 . The composition of claim 27 , wherein the immune stimulatory compound comprises a lipid, a nucleic acid, an aluminum compound, an water-in-oil emulsion, a polypeptide, or any combination thereof.
30 . The composition of claim 29 , wherein the immune stimulatory compound comprises a lipid.
31 . The composition of claim 29 , wherein the immune stimulatory compound comprises a nucleic acid.
32 . The composition of claim 31 , wherein the nucleic acid is a DNA.
33 . The composition of claim 32 , wherein the DNA comprises CPG-1018, CPG-1826, CPG-2007, CPG-2006, or any combination thereof.
34 . The composition of claim 31 , wherein the nucleic acid is an RNA.
35 . The composition of claim 32 , wherein the RNA comprises CV1802, Poly(U), Poly(I:C), ssRNA40, GFP RNA, RNA41, RNA42, RNA33, RNA35, 5′-phosphorylated blunt-ended viral genomic dsRNA <300bp, long dsRNA >1000bp, genomic ssRNA, ssRNA40, or any combination thereof.
36 . The composition of claim 29 , wherein the immune stimulatory compound comprises an aluminum compound.
37 . The composition of claim 36 , wherein the aluminum compound comprises alum.
38 . The composition of claim 29 , wherein the wherein the immune stimulatory compound comprises an water-in-oil emulsion.
39 . The composition of claim 29 , wherein the immune stimulatory compound comprises an agonist for a toll-like receptor, a NOD-like receptor, a RIG-1 or MDA-5 receptor, a C-type lectin receptor, a costimulatory molecule, a cytokine receptor, a STING pathway, or any combination thereof.
40 . The composition of claim 39 , wherein the toll-like receptor agonist is selected from a list consisting of CpG oligonucleotide, SD-101, LFX453, imiquimod, Bacillus Calmette-Guerin (BCG), monophosphoryl lipid A, Poly ICLC, GSK1795091, or any combination thereof.
41 . The composition of claim 39 , wherein the NOD-like receptor agonist is selected from a list consisting of bacterial peptidoglycan, an acylated derivative of iE-DAP (C12-iE-DAP), D-gamma-Glu-mDAP (iE-DAP), L-Ala-gamma-D-Glu-mDAP (Tri-DAP), muramyl dipeptide (MDP), muramyl tripeptide, L18-MDP, M-TriDAP, murabutide, PGN-ECndi, PGN-ECndss, PGN-SAndi, N-glycolylated muramyl dipeptide, murabutide, or any combination thereof.
42 . The composition of claim 39 , wherein the RIG-1 or MDA-5 receptor agonist is selected from a list consisting of poly(I:C), Poly(dA:dT), Poly(dG:dC), 3p-hpRNA, 5′ppp-dsRNA, or any combination thereof.
43 . The composition of claim 39 , wherein the C-type lectin receptor agonist is selected from a list consisting of Beta-1,3-glucan, zymosan, Heat-killed C. albicans , cord factor, and Trehalose-6,6-dibehenate, or any combination thereof.
44 . The composition of claim 29 , wherein the immune stimulatory compound comprises a polypeptide.
45 . The composition of claim 44 , wherein the polypeptide is a polypeptide from Brucella abortus , Bordetella pertussis , Chlamydia trachomatis , Fusobacterium nucleatum , Mycobacterium tuberculosis , Neisseria meningitidis , Staphylococcus aureus , Shigella dysenteriae , Shigella flexneri , Streptococcus pneumoniae , Vibrio cholerae , Brucella abortus , Mycobacterium paratuberculosis , Neisseria meningitidis , Streptococcus pneumoniae , or any combination thereof.
46 . The composition of claim 45 , wherein the polypeptide is from BCSP31, FHA, MOMP, PorB, PVL, Porin, OmpA, 34 kDa MOMP, PepO, OmpU, Lumazine synthase, Omp16, Omp19, BCSP31, CobT, RpfE, Rv0652, HBHA, NhhA, DnaJ, Pneumolysin, ΔA146 Pneumolysin, or any combination thereof.
47 . The composition of claim 44 , wherein the polypeptide is polypeptide from bacterial flagellin.
48 . The composition of claim 44 , wherein the polypeptide is polypeptide from human heat shock protein 70.
49 . The composition of any one or claims 1 to 48 , wherein the adjuvant is coupled to the ARC polypeptide or the endo-gag-polypeptide.
50 . The composition of claim 49 , wherein the adjuvant is coupled to the ARC polypeptide or the endo-gag-polypeptide by a bond formed from the reaction of an NHS-ester and a primary amine of the ARC polypeptide.
51 . The composition of claim 49 , wherein the adjuvant is coupled to the ARC polypeptide or the endo-gag-polypeptide by a peptide bond.
52 . The composition of claim 51 , wherein the adjuvant is N-terminal to the ARC polypeptide or the endo-gag-polypeptide.
53 . The composition of claim 51 , wherein the adjuvant is C-terminal to the ARC polypeptide or the endo-gag-polypeptide.
54 . The composition of any one of claims 51 to 53 , comprising a flexible peptide linker separating the adjuvant and the ARC polypeptide or the endo-gag-polypeptide.
55 . The composition of any one of claims 1 to 54 , wherein the composition comprises a virus-like particle.
56 . The composition of claim 55 , wherein the virus-like particle comprises a mixture of the ARC or the endo-gag-polypeptide polypeptide coupled to the pathogen-associated antigen and the ARC polypeptide or the endo-gag-polypeptide coupled to the adjuvant.
57 . The composition of claim 55 or 56 , wherein the virus-like particle comprises ARC polypeptide or the endo-gag-polypeptide not coupled to adjuvant or pathogen-associated antigen.
58 . The composition of any one of claims 55 to 56 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the adjuvant comprises from about 5% to about 20% of the virus-like particle.
59 . The composition of any one of claims 55 to 56 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the adjuvant comprises from about 5% to about 15% of the virus-like particle.
60 . The composition of any one of claims 55 to 56 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the adjuvant comprises about 10% of the virus-like particle.
61 . The composition of any one of claims 55 to 59 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the pathogen-associated antigen comprises from about 5% to about 20% of the virus-like particle.
62 . The composition of any one of claims 55 to 59 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the pathogen-associated antigen comprises from about 5% to about 15% of the virus-like particle.
63 . The composition of any one of claims 54 to 59 , wherein the ARC polypeptide or the endo-gag-polypeptide coupled to the pathogen-associated antigen comprises about 10% of the virus-like particle.
64 . The composition of any one of claims 54 to 63 , wherein the ARC polypeptide or the endo-gag-polypeptide not coupled to adjuvant or pathogen-associated antigen comprises from about 90% to about 60% of the virus-like particle.
65 . The composition of any one of claims 54 to 63 , wherein the ARC polypeptide or the endo-gag-polypeptide not coupled to adjuvant or pathogen-associated antigen comprises from about 90% to about 70% of the virus-like particle.
66 . The composition of any one of claims 54 to 63 , wherein the ARC polypeptide or the endo-gag-polypeptide not coupled to adjuvant or pathogen-associated antigen comprises about 80% of the virus-like particle.
67 . The composition of any one of claims 1 to 65 , comprising a pharmaceutically acceptable excipient, carrier, or diluent.
68 . The composition of any one of claims 1 to 67 , for use in priming or boosting an adaptive immune response to the pathogen-associated antigen.
69 . The use of claim 68 , wherein the adaptive immune response is an antibody response to the pathogen-associated antigen.
70 . The use of claim 69 , wherein the antibody response produces IgG antibodies that specifically bind the pathogen-associated antigen.
71 . The use of claim 68 , wherein the adaptive immune response is a cellular immune response to the pathogen-associated antigen.
72 . The composition of any one of claims 1 to 67 , for use as a vaccine.
73 . A method of priming an adaptive immune response to a pathogen-associated antigen in an individual comprising administering the composition of any one of claims 1 to 67 to the individual thereby priming an adaptive immune response to the pathogen-associated antigen.
74 . The method of claim 73 , wherein the individual is a human individual.
75 . The method of claim 73 , wherein the adaptive immune response is an antibody response to the pathogen-associated antigen.
76 . The method of claim 73 , wherein the antibody response produces IgG antibodies that specifically bind the pathogen-associated antigen.
77 . The method of claim 73 , wherein the adaptive immune response is a cellular immune response to the pathogen-associated antigen.
78 . A method of vaccinating an individual comprising administering the composition of any one of claims 1 to 68 to the individual thereby vaccinating the individual.
79 . The method of claim 78 , wherein the method of vaccinating protects from Coronaviridae infection or symptoms.
80 . The method of claim 79 , wherein the Coronaviridae comprises SARS Coronavirus (SARS-CoV-1), COVID-19 (SARS-CoV-2), MERS-coronavirus (MERS-CoV), or any combination thereof.
81 . A nucleic acid encoding the ARC polypeptide or the endo-gag-polypeptide of any one of claims 21 to 24 or 49 to 53 .
82 . A vector comprising the nucleic acid of claim 81 .
83 . The vector of claim 82 comprising a promoter operatively coupled to the nucleic acid encoding the ARC polypeptide.
84 . A host cell comprising the vector of claim 82 or 83 .
85 . A method of manufacturing a vaccine comprising isolating the ARC polypeptide or the endo-gag polypeptide from the host cell of claim 84 and contacting the polypeptide to a solution comprising a salt concentration of 100 mM to 1000 mM.
86 . The method of claim 85 , wherein the salt is NaCl or NaPO 4 .Join the waitlist — get patent alerts
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