Recombinant polypeptides containing at least one immunogenic fragment and antibody fc region and uses thereof
Inventors
Schomburg, Fritz M. • Rancour, David M.
Assignees
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Publication Number
US-11358990-B2
Publication Date
2022-06-14
Expiration Date
Abstract
Provided is a recombinant polypeptide containing at least one immunogenic fragment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike glycoprotein, and pharmaceutical compositions containing the same.
Core Innovation
The invention relates to a recombinant polypeptide comprising at least one immunogenic fragment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike glycoprotein. The immunogenic fragment is defined by an amino acid sequence having at least 93% sequence identity to an amino acid sequence selected from SEQ ID NO: 29, SEQ ID NO: 37, and SEQ ID NO: 39, and the recombinant polypeptide further comprises an antibody Fc region.
The document describes immunogenic-fragment constructs that can incorporate variant-associated amino acid substitutions while maintaining the specified sequence identity thresholds. It further describes combinations of spike amino-acid substitutions on immunogenic fragments, multi-fragment constructs in which immunogenic fragments are linked together, and structural linking of immunogenic fragments to the antibody Fc region using peptide linkers and specified linker SEQ ID NO amino acid sequences.
The document also describes pharmaceutical compositions and vaccines that include the recombinant polypeptides, including formulations with or without adjuvant. Adjuvants discussed include AS03, alum, and TLR agonists.
Claims Coverage
The document includes two independent claims. Across these claims, the coverage is centered on Fc-fused SARS-CoV-2 spike immunogenic fragments defined by sequence identity to specific SEQ ID NOs, and pharmaceutical compositions containing multi-immunogenic-fragment recombinant polypeptides with an elevated sequence-identity threshold.
Fc-containing recombinant polypeptide with defined immunogenic fragment sequence identity
A recombinant polypeptide comprising at least one immunogenic fragment of SARS-CoV-2 spike glycoprotein, the immunogenic fragment comprising an amino acid sequence with at least 93% sequence identity to an amino acid sequence selected from SEQ ID NO: 29, SEQ ID NO: 37, and SEQ ID NO: 39, and an antibody Fc region.
Pharmaceutical composition with recombinant polypeptide having multiple high-identity immunogenic fragments
A pharmaceutical composition comprising a recombinant polypeptide, the recombinant polypeptide comprising at least two immunogenic fragments of SARS-CoV-2 spike glycoprotein, and wherein at least one of the at least two immunogenic fragments comprises an amino acid sequence with at least 97% sequence identity to an amino acid sequence selected from SEQ ID NO: 29, SEQ ID NO: 37, and SEQ ID NO: 39.
Overall, the claims cover Fc-fused recombinant polypeptides built from SARS-CoV-2 spike immunogenic fragments selected by high sequence identity to specific SEQ ID NOs, and pharmaceutical compositions containing such polypeptides, including configurations requiring multiple fragments meeting a higher 97% identity threshold.
Stated Advantages
Modular platform enabling rapid incorporation of emerging variant mutations.
Robust expression/protease resistance and strong, durable immune responses in non-human primates.
Elicits anti-S1 binding and pseudovirus neutralization responses as described.
Documented Applications
Vaccines/pharmaceutical compositions comprising recombinant polypeptides containing SARS-CoV-2 spike immunogenic-fragment–Fc fusions, including formulations with adjuvant (e.g., AS03, alum) and adjuvant-free compositions.
Non-human primate immunization and measurement of ELISA anti-S1 binding and pseudovirus neutralization outcomes (e.g., NT50) as discussed.
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