Challenge: As the global SARS-CoV-2 situation continues to evolve, the strategy of focusing vaccine development on the currently dominant variant of concern (eg. BA.4 and BA.5 in 2022, XBB.1.5 in 2023) should be complemented by approaches that provide more durable and wider protection against future, emerging variants that can be quickly manufactured for urgent deployment.
Solution: The project will support development of COVID-19 vaccine booster antigens that induce an optimal pan-variant antibody response. A diverse set of recombinant zoonotic spike proteins, chimeric and stabilized constructs will be designed de novo based on well established protein engineering approaches and screened. In subsequent stages of the project, iterative protein engineering, CHO cell line development (used for spike antigen production) and in vivo testing steps will narrow down the number of candidates and refine dosing and antigen combination strategies. In parallel, this project will include activities to (i) decrease the risk of the manufacturing platform for antigens, (ii) study the combination of the antigens for formulation, and (iii) create a master cell bank (MCB) for the selected antigen(s).
Expected Achievements /Impacts: This project will deliver (i) two to four well-characterized stable CHO pools expressing vaccine antigens with well-established preclinical efficacy (using the Inspirevax intranasal adjuvant), (ii) a MCB for the selected antigen(s), (iii) a viral clearance study on the platform purification process for the selected antigen(s), and (iv) an optimized formulation for the new antigen(s) or antigen mix. The novel antigens will be rapidly deployable by Oragenics using a de-risked, scaled manufacturing platform (developed for reference strain and Variant “X”) for clinical trials, enabling an efficient, informed response to future variants of concern. The emergence of a successful vaccine developed locally in Quebec will help reinforce Quebec’s reputation as a leader in biopharmaceutical research, both within Canada and internationally.
