IP Library › Granted Patent US 12,551,550
Granted Patent B2
US 12,551,550 · App. 17/870,536 · Granted Feb 17, 2026

Compositions and vaccines for treating and/or preventing coronavirus variant infections and methods of using the same

Inventors: Himanshu Brahmbhatt (Sydney, AU); Jennifer MacDiarmid (Sydney, AU)
Assignee: EnGeneIC Molecular Delivery Pty Ltd
A61K39/215A61K9/0019A61K31/427A61K31/4706A61K31/513A61K31/519A61K31/53A61K31/635A61K31/675A61K38/19A61K39/001169A61K39/39A61P31/14
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Quick Facts
Patent No.
US 12,551,550
App. No.
17/870,536
Granted
Feb 17, 2026
Kind
B2
Abstract

The present disclosure is directed to compositions and methods useful for treating, as well as vaccinating against, SARS-CoV-2 viral infections, including SARS-CoV-2 variant viral infections.

Claims (80)

1 . A composition comprising:

(a) a vector comprising:

(i) at least one viral antigen protein from a SARS-CoV-2 variant; and

(ii) a plasmid that encodes the least one viral antigen protein; and

(b) a vector comprising α-galactosylceramide (α-GalCer); and

(c) at least one pharmaceutically acceptable carrier,

wherein at least one of vector (a) and vector (b) is an intact, bacterially-derived minicell or killed bacterial cell.

2 . The composition of claim 1 , wherein the SARS-CoV-2 variant is selected from the group consisting of:

(a) UK SARS-CoV-2 variant (B.1.1.7/VOC-202012/01);

(b) B.1.1.7 with E484K variant;

(c) B.1.617.2 (Delta) variant;

(d) B.1.617 variant;

(e) B.1.617.1 (Kappa) variant;

(f) B.1.617.3 variant;

(g) South Africa B.1.351 (Beta) variant;

(h) P.1 (Gamma) variant;

(i) B.1.525 (Eta) variant;

(j) B.1.526 (Iota) variant;

(k) Lambda (lineage C.37) variant;

(l) Epsilon (lineage B.1.429) variant;

(m) Epsilon (lineage B.1.427) variant;

(n) Epsilon (lineage CAL.20C) variant;

(o) Zeta (lineage P.2) variant;

(p) Theta (lineage P.3) variant;

(q) R.1 variant;

(r) Lineage B.1.1.207 variant; and

(s) Lineage B.1.620 variant.

3 . The composition of claim 1 , wherein the SARS-CoV-2 variant is selected from the group consisting of a SARS-CoV-2 variant comprising:

(a) a L452R Spike Protein Substitution;

(b) an E484K Spike Protein Substitution;

(c) K417N Spike Protein Substitution;

(d) E484K Spike Protein Substitution;

(e) N501Y Spike Protein Substitution;

(f) K417T Spike Protein Substitution;

(g) E484K Spike Protein Substitution;

(h) N501Y Spike Protein Substitution; and

(h) SARs-CoV-2 variants having one or more of the following missense mutations: N440, L452R, S477G/N, E484Q, E484K, N501Y, D614G, P681H, P681R, and A701V.

4 . The composition of claim 1 , wherein:

(a) the vector (a) additionally comprises at least one viral antigen from a SARS-CoV-2 strain; and/or

(b) the vector (a) additionally comprises at least one viral antigen from a SARS-CoV-2 strain, and wherein the SARS-CoV-2 strain is selected from the group consisting of the L strain, the S strain, the V strain, the G strain, the GR strain, and the GH strain; and/or

(c) the vector (a) additionally comprises at least one viral antigen from a SARS-CoV-2 strain, wherein the viral antigen is encoded by a polynucleotide comprising the sequence of SARS-CoV-2, or a polynucleotide having at least 80% sequence identity to the polynucleotide comprising the sequence of SARS-CoV-2.

5 . The composition of claim 1 , wherein the plasmid encodes:

(a) at least one of spike(S) protein, nucleocapsid (N) protein, membrane (M) protein, and envelope (E) protein of SARS-CoV-2 or a SARS-CoV-2 variant; and/or

(b) the spike(S) protein, nucleocapsid (N) protein, membrane (M) protein, and the envelope (E) protein; and/or

(c) the spike(S) protein of SARS-CoV-2 or a SARS-CoV-2 variant; and/or

(c) the receptor binding domain (RBD) of a Spike protein of SARS-CoV-2 or a SARS-CoV-2 variant.

6 . The composition of claim 1 , wherein:

(a) vector (a) is a first intact, bacterially derived minicell or killed bacterial cell, and vector (b) is a second intact, bacterially derived minicell or killed bacterial cell; and/or

(b) vector (a) and vector (b) are the same intact, bacterially derived minicell or killed bacterial cell, comprising the α-GalCer and the plasmid that encodes at least one viral antigen protein from a SARS-CoV-2 variant; and/or

(c) one of vector (a) and vector (b) is not an intact, bacterially derived minicell or killed bacterial cell and the other of vector (a) and vector (b) is an intact, bacterially derived minicell or killed bacterial cell.

7 . The composition of claim 1 , wherein the composition is formulated for oral administration, injection, nasal administration, pulmonary administration, or topical administration.

8 . A method of treating and/or vaccinating against a viral infection, comprising administering to a subject in need a composition comprising administering to a subject in need a composition according to claim 1 .

9 . The method of claim 8 , wherein the subject:

(a) is suffering from or at risk of developing lymphopenia; and/or

(b) is deemed at risk for severe illness and/or serious complications from the viral infection; and/or

(c) is about age 50 or older, about age 55 or older, about age 60 or older, or about age 65 or older; and/or

(d) suffers from one or more pre-existing conditions selected from the group consisting of diabetes, asthma, a respiratory disorder, high blood pressure, and heart disease; and/or

(e) is immunocompromised; and/or

(f) is immunocompromised due to AIDS, cancer, a cancer treatment, hepatitis, an auto-immune disease, steroid receiving, immunosenescence, or any combination thereof.

10 . The method of claim 8 , wherein administration:

(a) increases the chance of survival following exposure to a coronavirus; and/or

(b) reduces the risk of transmission of coronavirus.

11 . The method of claim 10 , wherein:

(a) the chance of survival is increased by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100%, as measured using any clinically recognized technique; and/or

(b) the reduction in risk of transmission is by about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or about 100%, as measured using any clinically recognized technique.

12 . The method of claim 8 , wherein administering is via any pharmaceutically acceptable methods.

13 . The method of claim 8 , wherein the subject is exposed to or is anticipated to be exposed to an individual who is contagious for a coronavirus.

14 . The method of claim 13 , wherein the individual who is contagious for a coronavirus has one or more symptoms selected from the group consisting of fever, cough, shortness of breath, diarrhea, sneezing, runny nose, and sore throat.

15 . The method of claim 8 , wherein the subject is a healthcare worker, aged 60 years or older, frequent traveler, military personnel, caregiver, or a subject with a preexisting condition that results in increased risk of mortality with infection.

16 . The method of claim 8 :

(a) further comprising administering one or more antiviral drugs; and/or

(b) further comprising administering one or more antiviral drugs, wherein the one or more antiviral drugs are selected from the group consisting of chloroquine, darunavir, galidesivir, interferon beta, lopinavir, ritonavir, remdesivir, and triazavirin.

17 . The method of claim 8 , wherein the α-GalCer induces a Th1 cytokine response in the subject, and optionally wherein the cytokine comprises IFNγ.

18 . The method of claim 8 , wherein:

(a) a first minicell comprising the α-GalCer and a second minicell comprising the plasmid encoding at least one viral antigen are administered to the subject simultaneously; and/or

(b) a first minicell comprising the α-GalCer and a second minicell comprising the plasmid encoding at least one viral antigen are administered to the subject sequentially; and/or

(c) a first minicell comprising the α-GalCer and second minicells comprising the plasmid encoding at least one viral antigen are administered to the subject repeatedly; and/or

(d) a first minicell comprising the α-GalCer and second minicells comprising the plasmid encoding at least one viral antigen are administered to the subject at least once a week, twice a week, three times per week, or four times per week.

19 . The composition of claim 1 , wherein the plasmid encodes a Spike protein from at least one of SARS-CoV-2 variant Alpha (B.1.1.7.UK), SARS-CoV-2 variant Beta (B.1.351. SA), SARS-CoV-2 variant Delta (B.1.617.2 India), and/or SARS-CoV-2 variant Gamma (P.1 Brazil).

20 . The composition of claim 1 , wherein vector (a) and vector (b) are the same intact, bacterially derived minicell or killed bacterial cell, comprising the α-GalCer, the plasmid that encodes at least one SARS-CoV-2 viral antigen protein, wherein at least some of the SARS-CoV-2 variant antigen protein is present in the membrane of the intact bacterially derived minicell or killed bacterial cell.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2022
From: BRAHMBHATT, HIMANSHU; MACDIARMID, JENNIFER
To: ENGENEIC MOLECULAR DELIVERY PTY LTD
Reel/Frame 060584/0410 →
Continuity (3)
Continuation In Part 17480073 · Sep 20, 2021
Provisional Application 63224838 · Jul 22, 2021
Related Publication 20230041309A1 · Feb 9, 2023
References Cited (68)
US 8524484B2 · Sabbadini · 2013 [cited by examiner]
US 10973908B1 · Bermudes · 2021 [cited by applicant]
US 20060002956A1 · Surber et al. · 2006 [cited by applicant]
US 20080038296A1 · Brahmbhatt et al. · 2008 [cited by applicant]
US 20080051469A1 · Brahmbhatt et al. · 2008 [cited by applicant]
US 20090011490A1 · Sabbadini et al. · 2009 [cited by applicant]
US 20100028380A1 · Kang et al. · 2010 [cited by applicant]
US 20120252099A1 · Sabbadini et al. · 2012 [cited by applicant]
US 20170165345A1 · Leadbetter · 2017 [cited by examiner]
US 20170326235A1 · Brahmbhatt et al. · 2017 [cited by applicant]
US 20200054689A1 · Brahmbhatt et al. · 2020 [cited by applicant]
US 20210283244A1 · Chen et al. · 2021 [cited by applicant]
JP 2009530264A · 2009 [cited by applicant]
JP 2012505174A1 · 2012 [cited by applicant]
WO WO0067776A1 · 2000 [cited by applicant]
WO WO200067776 · 2000 [cited by applicant]
WO WO03033519A2 · 2003 [cited by applicant]
WO WO2003033519A2 · 2003 [cited by applicant]
WO WO2004113507A1 · 2004 [cited by applicant]
WO WO2006107097A1 · 2006 [cited by applicant]
WO WO2020021437A1 · 2020 [cited by applicant]
WO WO2021191796A1 · 2021 [cited by applicant]
WO WO2021243974A1 · 2021 [cited by applicant]
GENBANK “Severe acute respiratory syndrome coronavirus 2 isolate Wuhan-Hu-1, complete genome,” GenBank, URL: https://www.ncbi.nlm.nih.gov/nuccore/MN908947.3, 2020, Accession No. MN908947, Version MN908947.3 (10 pages). [cited by applicant]
Giacalone et al, “Immunization with non-replicating [cited by applicant]
Notice of Allowance issued in U.S. Appl. No. 17/480,073 dated Mar. 7, 2025. [cited by applicant]
Notice of Reasons for Refusal on Japanese Appl. No. 2022-557099, dated Mar. 11, 2025 (14 pages with English language translation). [cited by applicant]
Agnihothram et al., “Evaluation of serologic and antigenic relationships between Middle Eastern respiratory syndrome coronavirus and other coronaviruses to develop vaccine platforms for the rapid response to emerging co… [cited by applicant]
Bolles et al., “A double-inactivated severe acute respiratory syndrome coronavirus vaccine provides incomplete protection in mice and induces increased eosinophilic proinflammatory pulmonary response upon challenge,” J.… [cited by applicant]
Bungener et al., “Delivery of protein antigens to the immune system by fusion-active virosomes: a comparison with liposomes and ISCOMs),” Biosci. Rep., 22(2):323-38 (2002). [cited by applicant]
Chan, et al., “Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan,” Emerg. Microbes Infect. 9, 221-236 (2020). [cited by applicant]
Chen et al., “Antigen Delivery to Macrophages Using Liposomal Nanoparticles Targeting Sialoadhesin/CD169,” PLoS ONE 7(6): e39039 (2012), 9 pages. [cited by applicant]
Daemen et al., “Virosomes for antigen and DNA delivery,” Adv Drug Deliv Rev., Jan. 10, 2005;57(3):451-463. [cited by applicant]
Drosten, et al., “Identification of a novel coronavirus in patients with severe acute respiratory syndrome,” N Engl J Med. 2003; 348(20):1967-1976. [cited by applicant]
Duan, et al., “Pre- and post-treatment chest CT findings: 2019 novel coronavirus (2019-nCOV) pneumonia,” Radiology 2020, 1 page. [cited by applicant]
Grohskopf, et al., “Prevention and control of seasonal influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018-19 influenza season. MMWR,” Recomm. Rep. 67, 1-20 (… [cited by applicant]
Guan, et al., “Clinical characteristics of 2019 novel coronavirus infection in China,” medRxiv. (2020), 30 pages. [cited by applicant]
Huang, et al., “Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China,” Lancet. 395, 497-506 (2020). [cited by applicant]
Jiang, et al., “SARS vaccine development,” Emerg. Infect. Dis. 11, 1016-1020 (2005). [cited by applicant]
Kersten, et al., “Liposomes and ISCOMs,” Vaccine, 21(9-10):915-920 (2003). [cited by applicant]
Ksiazek, et al., “A novel coronavirus associated with severe acute respiratory syndrome,” [cited by applicant]
Lew, et al., “Acute respiratory distress syndrome in critically Ill patients with severe acute respiratory syndrome,” [cited by applicant]
Menachery et al., “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence,” Nat Med. 2015; 21:1508-1513. [cited by applicant]
Regla-Nava, et al., “Severe acute respiratory syndrome coronaviruses with mutations in the E protein are attenuated and promising vaccine candidates,” J. Virol. 89, 3870-3887 (2015). [cited by applicant]
Schoggins, et al, “A diverse range of gene products are effectors of the type I interferon antiviral response,” Nature. 2011;472(7344):481-485. [cited by applicant]
Shang, et al., “The outbreak of SARS-CoV-2 pneumonia calls for viral Vaccines,” Vaccines (2020) 5:18, 3 pages. [cited by applicant]
Sheahan et al., “Successful vaccination strategies that protect aged mice from lethal challenge from influenza virus and heterologous severe acute respiratory syndrome coronavirus,” J Virol. 2011, 85(1): 217-230. [cited by applicant]
Su, et al., “Construction of Stable LamB-Shiga Toxin B Sununit Hybrids: Analysis of Expression in [cited by applicant]
Wu, F. et al., “A new coronavirus associated with human respiratory disease in China,” Nature, 20 pages, (2020). [cited by applicant]
Yue, et al., “Progress and perspectives in developing polymeric vectors for in vitro gene delivery,” Biomater. Sci., 1:152-170 (2013). [cited by applicant]
Zaki, et al., “Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia,” N Engl J Med. 2012;367(19):1814-1820. [cited by applicant]
International Preliminary Report on Patentability issued in International Patent Application No. PCT/IB2021/052402, dated Oct. 6, 2022. [cited by applicant]
International Search Report that issued in International Patent Application No. PCT/IB2021/052402, dated Jun. 23, 2021. [cited by applicant]
Fotouhi, et al., “Adjuvant use of the NKT cell agonist alpha-galactosylceramide leads to enhancement of M2-based DNA vaccine immunogenicity and protective immunity against influenza A virus,” [cited by applicant]
Gao, et al., “Nanocell COVID-19 Vaccine elicits iNKT-licensed dendritic cells to produce high affinity antibodies neutralizing variants of concern,” Research Square, (Apr. 2022), pp. 1-36. [cited by applicant]
International Search Report and Written Opinion issued in International Patent Application No. PCT/IB2022/056759, dated Nov. 1, 2022. [cited by applicant]
Search Report issued in European Patent Application No. 22845545.7, dated May 13, 2025 (9 pages). [cited by applicant]
Hosseini et al., “Potential SARS-CoV-2 vaccines: Concept, progress, and challenges”, International Immunopharmacology, 2021, vol. 97 (15 pages). [cited by applicant]
European Search Report for EP Appl. Ser. No. 21774470 dated Feb. 26, 2024 (7 pages). [cited by applicant]
Fotouhi et al., “Adjuvant use of the NKT cell agonist alpha-galactosylceramide leads to enhancement of M2-based DNA vaccine immunogenicity and protective immunity against influenza A virus,” Archives of Virology, 2017, … [cited by applicant]
International Preliminary Report on Patentability for PCT Appl. Ser. No. PCT/IB2022/056759 dated Feb. 1, 2024 (7 pages). [cited by applicant]
International Search Report and Written Opinion for Appl. Ser. No. PCT/IB2021/052402 dated Jun. 23, 2021 (15 pages). [cited by applicant]
International Search Report and Written Opinion for PCT Appl. Ser. No. PCT/IB2022/056759 dated Nov. 1, 2022 (12 pages). [cited by applicant]
Kemp et al., “Recurrent emergence and transmission of a SARS-Co V-2 spike deletion H69N70” Posted on BioRxiv, Mar. 8, 2020 (41 pages). [cited by applicant]
King et al. “CD1d-Invariant Natural Killer T Cell-Based Cancer Immunotherapy: Alpha-B1-Galactosylceramide and Beyond” Front. Immunol. 9:1519. Jul. 2, 2018 (7 pages). [cited by applicant]
US Non-Final Office Action on U.S. Appl. No. 17/480,073 Dated Nov. 7, 2024 (10 pages). [cited by applicant]
Office Action issued in Chinese Patent Application No. 202180035730.3 dated Dec. 3, 2025 (16 pages with English language translation). [cited by applicant]
Zhang et al., “Research and development of coronavirus vaccine and prospect of 2019 novel coronavirus vaccines,” Journal of Nanjing Medical University (Natural Sciences), 2020, vol. 40, No. 2 (5 pages with English langu… [cited by applicant]