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Publication Number
US-12280098-B2
Publication Date
2025-04-22
Expiration Date
Abstract
The present invention provides D39-derived mutant PspA that does not undergo deamination and maintains stability as a molecule even around neutral pH range.Specifically, the present invention relates to a protein of the following (a) or (b): (a) a protein comprising the amino acid sequence as set forth in SEQ ID NO: 2 and having pneumococcal vaccine antigenic activity, and a protein substantially identical to the protein; or(b) a protein being a part of the amino acid sequence as set forth in SEQ ID NO: 2, wherein aspartic acid at position 254 is comprised in the part, and having pneumococcal vaccine antigenic activity, and a protein substantially identical to the protein.
Core Innovation
The invention relates to pneumococcal surface protein A (PspA) proteins derived from D39, in which deamination around neutral pH is avoided by changing Asn254 to Asp (N254D). The described deaminated form and the corresponding Asp254-containing variant are linked to pH-dependent behavior of PspA proteins, as indicated by the reported observations and analysis in the document.
The invention provides PspA proteins defined by SEQ ID NO:2 or SEQ ID NO:3, or parts and variants retaining Asp254, that preserve pneumococcal vaccine antigenic activity. In this framework, the Asp254 retention requirement is a defining molecular feature for the vaccine-relevant antigen while maintaining antigenic activity.
The document further covers encoding nucleic acids and pneumococcal vaccines comprising the PspA protein as an antigen, including vaccine formulations that optionally include nanogel (cCHP). The reported rationale and supporting evidence in the document include identification of deamination corresponding to the N254D change and antigen-specific IgG induction after transnasal immunization using cCHP nanogel formulations.
Claims Coverage
The independent claim covers a protein defined by SEQ ID NO:3 or a high-identity sequence that retains the aspartic acid at position 254 and retains pneumococcal vaccine antigenic activity. Dependent claims further cover narrower protein definitions and pneumococcal vaccine formulations, including inclusion of an adjuvant plus a pharmaceutically acceptable carrier or inclusion of a nanogel (cCHP).
Asp254 retention with vaccine antigenic activity
A protein having an amino acid sequence as set forth in SEQ ID NO: 3, or an amino acid sequence having 90% or more sequence identity to SEQ ID NO: 3, wherein the aspartic acid at position 254 is retained, and wherein the protein has pneumococcal vaccine antigenic activity.
Defined protein by SEQ ID NO: 3
A protein comprising an amino acid sequence as set forth in SEQ ID NO: 3.
90% identity with Asp254 retention
A protein with pneumococcal vaccine antigenic activity that is an amino acid sequence having 90% or more sequence identity to SEQ ID NO: 3 while retaining the aspartic acid at position 254 of SEQ ID NO: 3.
Pneumococcal vaccine with adjuvant and pharmaceutically acceptable carrier
A pneumococcal vaccine formulation that includes an adjuvant, a pharmaceutically acceptable carrier, and the protein according to claim 1.
Pneumococcal vaccine with nanogel
A pneumococcal vaccine that includes a nanogel and the protein defined in claim 1.
Overall, the claim coverage centers on a PspA protein definition requiring retention of Asp at position 254 together with pneumococcal vaccine antigenic activity, with dependent claim coverage extending to vaccine formulations including adjuvant/carrier components and nanogel-containing vaccines.
Stated Advantages
Avoidance of deamination around neutral pH by changing Asn254 to Asp (N254D).
Retention of pneumococcal vaccine antigenic activity for the Asp254-retaining PspA protein.
Induction of antigen-specific IgG after transnasal immunization using cCHP nanogel formulations.
Documented Applications
Pneumococcal vaccines comprising the Asp254-retaining PspA protein as an antigen, including formulations used for transnasal immunization to induce antigen-specific IgG.
Pneumococcal vaccine formulations that include nanogel (cCHP) used in transnasal immunization in mice.
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