Recombinant bovine immunodeficiency virus gag virus-like particles containing influenza immunogens

Inventors

Pushko, Peter • Tretyakova, Irina

Assignees

Medigen Inc

Abstract

Described herein, are Bovine immunodeficiency virus gag protein (“Bgag”) recombinant virus like particles (“VLPs”) including one or more different types of target pathogen proteins. Also described, are compositions including the Bgag VLPs and the methods of making and using the novel Bgag VLP.

Core Innovation

The invention relates to bovine immunodeficiency virus Gag (Bgag) virus-like particles (VLPs) comprising one or more different Influenza virus hemagglutinin (HA) and/or neuraminidase (NA) transmembrane proteins, with the proteins integrated into the lipid bilayer of the VLP. In this way, the Influenza antigens are presented on Bgag VLP particles in combination with the Bgag VLP platform. The disclosed VLP format supports inclusion of different HA and/or NA transmembrane proteins and their integration into the VLP membrane context.

The disclosure describes Bgag VLPs that co-express and display Influenza HA and/or NA transmembrane proteins, including different HA/NA sets for multi-target and multi-subtype presentation. It reports functional characterization in which HA mediates hemagglutination and NA retains enzymatic activity. The disclosure further reports evidence consistent with VLP morphology/size and antigen co-localization within the VLP context.

The invention further relates to pharmaceutical compositions that comprise the Bgag VLPs together with suitable pharmaceutical excipients, including use as vaccines. The disclosure states vaccine utility through elicited immune responses, including neutralizing HI antibody titers, and protection in challenge models. Additionally, the disclosure describes genetic modifications of influenza target proteins and discusses diagnostic/DIVA potential and incorporation of RNA as an immune modulator.

Claims Coverage

The patent includes three independent claims for the Bgag VLP, a pharmaceutical composition, and methods for making the VLP and the composition. Across these claims, the core inventive features center on a Bgag VLP with integrated Influenza HA/NA transmembrane proteins in the lipid bilayer, and on producing and formulating those VLPs for immunogenic and vaccine use.

Across the independent claims, the coverage centers on Bgag VLPs that display Influenza HA and/or NA transmembrane proteins with integration into the VLP lipid bilayer, a corresponding pharmaceutical composition with a suitable excipient, and methods that make the VLPs and formulate the pharmaceutical composition by mixing the Bgag VLP with excipients.

Stated Advantages

Documented Applications