SARS-CoV-2 RNA vaccine compositions and methods of use
Inventors
Reed, Steven Gregory • Carter, Darrick Albert • Khandhar, Amit Praful • Archer, Jacob Freeman • Berglund, Lars Peter Aksel • Erasmus, Jesse • Berube, Bryan • Duthie, Malcolm S.
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Assignees
Member
HDT BioHDT Bio is a clinical-stage biopharmaceutical company based in Seattle, developing novel technologies and products designed to harness and enhance the immune system for the treatment and prevention of cancer and infectious diseases. HDT Bio utilizes advanced immunotherapeutic platforms, including a proprietary nanoparticle delivery system, to provide safe, potent, and durable solutions that enable rapid clinical translation and personalized cancer therapies. The company's multidisciplinary team and international partnerships facilitate robust clinical development, innovative product design, and global distribution with the goal of improving patient outcomes worldwide.
HDT Bio is a clinical-stage biopharmaceutical company based in Seattle, developing novel technologies and products designed to harness and enhance the immune system for the treatment and prevention of cancer and infectious diseases. HDT Bio utilizes advanced immunotherapeutic platforms, including a proprietary nanoparticle delivery system, to provide safe, potent, and durable solutions that enable rapid clinical translation and personalized cancer therapies. The company's multidisciplinary team and international partnerships facilitate robust clinical development, innovative product design, and global distribution with the goal of improving patient outcomes worldwide.
Publication Number
US-12257299-B2
Publication Date
2025-03-25
Expiration Date
Abstract
The disclosure provides compositions, methods of treatment, and methods of making and using compositions to deliver a nucleic acid to a subject. Methods of using the compositions as a COVID-19 vaccine for the treatment of a coronavirus infection are also provided.
Core Innovation
The invention provides a dried composition comprising a lipid carrier that is a nanoemulsion with a hydrophobic core and one or more lipids, and at least one nucleic acid encoding a SARS-CoV-2 spike protein or a functional variant thereof. The nucleic acid comprises a sequence at least 85% identical to any one of SEQ ID NOS: 1-8, and the dried composition further includes at least one sugar in an amount of at least about 50% by weight of the dried composition.
The invention also provides a composition including a lipid carrier comprising liquid oil, surfactants with a hydrophilic surfactant and a hydrophobic surfactant, and a cationic lipid. The composition includes at least one nucleic acid encoding a SARS-CoV-2 spike protein or functional variant thereof, where the nucleic acid comprises a sequence at least 85% identical to any one of SEQ ID NOS: 1 to 7.
The disclosed sequences include SARS-CoV-2 spike protein variant amino acid sequences for delta-preF/Delta variants and Omicron B.1.1.529, together with Wuhan-Hu-1 wild-type spike protein and spike stem helix regions (residues 913-1213). The disclosed nucleotide content further includes a VEEV RNA polymerase and VEEV replicon plus spike antigen vector backbone/antigen RNA sequences for different spike variants, including full-length and stem-helix selections, for expression in the claimed vaccine formulations.
Claims Coverage
The partial content includes two independent claims. Across them, the inventive coverage centers on a lipid-based carrier combined with nucleic acid encoding SARS-CoV-2 spike protein variants with at least 85% sequence identity to specified SEQ ID numbers, with formulation constraints that add either a dried sugar component or a specific lipid carrier structure including surfactants and a cationic lipid.
Dried nanoemulsion carrier with sugar and spike-encoding nucleic acid identity
A dried composition comprising a lipid carrier that is a nanoemulsion comprising a hydrophobic core and one or more lipids; at least one nucleic acid that comprises a sequence encoding a SARS-CoV-2 spike protein or a functional variant thereof, wherein the at least one nucleic acid comprises a sequence at least 85% identical to any one of SEQ ID NOS: 1-8; and at least one sugar present in amount of at least about 50% by weight of the dried composition.
Liquid oil surfactant plus cationic lipid carrier with spike-encoding nucleic acid identity
A composition comprising a lipid carrier, wherein the lipid carrier comprises liquid oil; surfactants, wherein the surfactants comprise a hydrophilic surfactant and a hydrophobic surfactant; and a cationic lipid; and at least one nucleic acid that comprises a sequence encoding a SARS-CoV-2 spike protein or a functional variant thereof, wherein the at least one nucleic acid comprises a sequence that is at least 85% identical to any one of SEQ ID NOS: 1 to 7.
Across the independent claims, the core claim coverage is directed to lipid-carrier compositions (dried nanoemulsion with a high sugar content, or a liquid-oil surfactant system with a cationic lipid) combined with spike-encoding nucleic acids defined by at least 85% sequence identity to specified SEQ ID numbers.
Stated Advantages
Thermally stable composition at about -20 degrees Celsius, about 25 degrees Celsius, about 45 degrees Celsius, and about 2 degrees Celsius to about 8 degrees Celsius (or a combination thereof).
Documented Applications
No documented applications found
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