Recombinant polypeptides containing at least one immunogenic fragment and uses thereof

Inventors

Schomburg, Fritz M. • Rancour, David M.

Assignees

Boost Biopharma Inc

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 recombinant polypeptides that include immunogenic fragments of the SARS-CoV-2 spike glycoprotein. The recombinant polypeptide comprises an amino acid sequence having at least 93% sequence identity to an amino acid sequence selected from SEQ ID NOs: 245-254. The immunogenic fragment framework is described for spike glycoprotein regions including S1 N-terminal domain (NTD) and S1 C-terminal domain (CTD), including constructs based on full spike or spike fragment types as described.

In some embodiments, the recombinant polypeptide comprises modular architectures in which immunogenic fragments are connected to one another and/or to an antibody Fc region. The modular architecture includes defined fragment combinations, optional polypeptide linkers connecting fragments, and orientations for Fc connection. Optional Fc removal after expression and purification is described as part of the recombinant polypeptide designs, together with linker sequences and linker rules described in the document.

The sequence space is defined by allowed fragment sequences and by defined spike mutation, substitution, and deletion positions relative to a Wuhan reference, including specific example mutation positions. The document further describes combinations of immunogenic fragments as identical or non-identical fragment combinations and describes sequence-identity thresholds including 93% and 97% contexts. The recombinant constructs are presented with pharmaceutical compositions and vaccine uses, including claims that specify adjuvants as formulation components.

Claims Coverage

The partial set includes two independent claims: one directed to a recombinant polypeptide with at least 93% sequence identity to specified reference sequences, and a second directed to a pharmaceutical composition including a recombinant polypeptide with at least two immunogenic fragments where at least one fragment has at least 97% sequence identity to specified reference sequences.

Across the independent claims, the core inventive coverage is the recombinant polypeptide and immunogenic-fragment framework tied to explicit sequence-identity thresholds to SEQ ID NOs: 245-254, with the second independent claim strengthening the identity constraint for a pharmaceutical composition containing at least two immunogenic fragments.

Stated Advantages

Documented Applications

No documented applications found