Immunogenic composition and use thereof

Inventors

Leng, Chih-Hsiang • SU, PO-HSU • CHEN, PO-KANG

Assignees

Adimmune Corp

Abstract

An immunogenic composition, a SARS-CoV-2 vaccine and a vector are introduced. The immunogenic composition has a recombinant protein having a sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, and any polypeptide encoded by a polynucleotide which is at least 80% homologous with SEQ ID NO: 1-4, wherein the recombinant protein contains an IgG1 Fc protein fragment having a length of at least 6 amino acids; or a nucleic acid molecule encoding the recombinant protein. The SARS-CoV-2 vaccine has the above recombinant protein or the nucleic acid molecule encoding the above recombinant protein. The vector has the nucleic acid molecule encoding the above recombinant protein.

Core Innovation

The invention relates to an immunogenic composition and a SARS-CoV-2 vaccine that include either a recombinant protein or a nucleic acid molecule encoding the recombinant protein. The recombinant protein includes a sequence selected from SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, and SEQ ID NO: 4, and may optionally include a secreted signal peptide.

The recombinant protein is described as a recombinant fusion design tied to SARS-CoV-2 antigen sequences, including an IgG1 Fc fragment. The recombinant protein may be fused to SARS-CoV-2 nucleocapsid phosphoprotein, envelope protein, or membrane protein, and the compositions can include immunogenic compounds/adjuvants, pharmaceutically acceptable carriers, and optional stabilizers/preservatives.

The disclosed examples include experimental production using baculovirus/Sf9 and neutralization data using immunized mice. The document reports induction of neutralizing antibodies and improved efficacy with an adjuvant assessed by PRNT, with sera tested for neutralization titers using plaque reduction neutralization testing.

Claims Coverage

The independent claim coverage centers on immunogenic compositions, a SARS-CoV-2 vaccine, and a nucleic-acid vector encoding the recombinant protein. Across the independent claims, there are seven inventive feature patterns: selected recombinant protein sequences, nucleic-acid-encoded recombinant protein, fusion partners, vector platform selection, induction of an immune response, and selected nucleic-acid sequences.

The independent claims collectively cover immunogenic compositions and a SARS-CoV-2 vaccine defined by recombinant protein sequences selected from SEQ ID NO: 1–4, including either the recombinant protein itself or a nucleic acid molecule encoding it. The claims further cover a nucleic-acid vector that encodes such a recombinant protein, with vector platform options and the ability to induce an immune response against SARS-CoV-2 by administration. A separate independent claim covers an immunogenic composition defined by nucleic-acid sequences selected from SEQ ID NO: 6–9.

Stated Advantages

Documented Applications