Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12234263-B2
Publication Date
2025-02-25
Expiration Date
Abstract
Provided herein are compositions related to vaccines, e.g., influenza vaccines, including, peptide based vaccines, nucleic acid based vaccines, recombinant virus based vaccines, antibody based vaccines, and virus based vaccines. Also provided herein are methods related to vaccines, e.g., influenza vaccines, including methods of identifying epitopes for the vaccines, producing, formulating, and administering the vaccines.
Core Innovation
The disclosure describes engineered influenza vaccine polypeptides that are non-naturally-occurring and include multiple influenza epitope sequences selected from defined SEQ ID NO sets. In particular, a polypeptide includes at least a first epitope, a second epitope, and a third epitope, where the epitopes differ from each other and are selected from specified SEQ ID NOs, including a variant of SEQ ID NO: 88 that lacks the N-terminus V residue.
The disclosure further provides polypeptides comprising epitopes set forth as SEQ ID NOs: 2, 3, 8, 11, 12, 17, 21, 22, 24, 32-34, 40, 41, 43, 49, 51, 58, 59, 61, 62, 70, 73-78, 82, 84-86, 92-94, and a variant of SEQ ID NO: 88 that lacks the N-terminus V residue. In some constructs, consecutive epitopes are connected using a linker sequence, including RVKR (SEQ ID NO: 110), with options for direct linkage or linker-mediated connections in the epitope assembly.
In addition to polypeptides, the disclosure provides vaccine compositions and pharmaceutical formulations that include polypeptides described herein, including influenza antigen-based formats. The disclosure also includes nucleic acid and vector constructs, as well as viral particles, configured around the defined influenza epitope sequences, and describes APC-based and virus-based influenza vaccine approaches.
Claims Coverage
The independent claim set covers two main non-overlapping polypeptide claim structures: a three-epitope non-naturally-occurring polypeptide with mutually different epitopes selected from a specified SEQ ID NO group, and a multi-epitope polypeptide comprising a large defined set of SEQ ID NO epitope sequences plus the SEQ ID NO: 88 variant lacking the N-terminus V residue. Dependent claims additionally constrain linker usage and extend coverage to nucleic acids, vectors, viral particles, pharmaceutical compositions, and administration-related subject use where those dependent claim topics appear in the provided claim text.
Differing first, second, and third selected epitopes
A non-naturally-occurring polypeptide comprising at least a first epitope, a second epitope, and a third epitope, wherein the first epitope, the second epitope, and the third epitope differ from each other, and wherein the first epitope, the second epitope, and the third epitope are selected from the group consisting of SEQ ID NOs: 40, 58, 61, 43, 51, 93, 22, 49, 82, 88, 34, and a variant of SEQ ID NO: 88 that lacks the N-terminus V residue.
Comprising a defined multi-epitope set including SEQ ID NO: 88 variant lacking N-terminal V
A polypeptide comprising epitopes set forth as SEQ ID NOs: 2, 3, 8, 11, 12, 17, 21, 22, 24, 32-34, 40, 41, 43, 49, 51, 58, 59, 61, 62, 70, 73-78, 82, 84-86, 92-94, and a variant of SEQ ID NO: 88 that lacks the N-terminus V residue.
Linker sequence between consecutive epitopes
The polypeptide includes one or more copies of a linker connecting consecutive epitopes, where the linker sequence is RVKR (SEQ ID NO: 110).
Vector and/or virus-based pharmaceutical composition
A pharmaceutical composition includes the polynucleotide provided as part of a vector and/or a virus, together with a pharmaceutically acceptable carrier or excipient.
Across the independent claims, coverage is directed to engineered influenza vaccine polypeptides defined by specific epitope SEQ ID NO sets, including an SEQ ID NO: 88 variant lacking the N-terminus V residue, with dependent claim refinements specifying epitope linkage using RVKR (SEQ ID NO: 110) and extending to nucleic-acid encoding forms and vaccine composition formats that include vector/virus and pharmaceutically acceptable carrier or excipient.
Stated Advantages
Protection outcomes are reported in mouse challenge models.
Immunogenicity is assessed by IFN-γ ELISPOT in a Phase 1 human trial for AdFlu51pep.
Documented Applications
APC-based influenza vaccine formats, including dendritic cell (DC) loading ex vivo or in vivo.
Virus-based influenza vaccine strategies, including live or inactivated influenza vaccine strategies and recombinant viral vaccines carrying specified influenza epitopes.
Recombinant adenovirus vaccines carrying multiple influenza epitopes, including tandem-transgene formats separated by RVKR (SEQ ID NO:110).
Peptide/adjuvant-associated influenza vaccination approaches.
Phase 1 human trial for AdFlu51pep.
Interested in licensing this patent?