Preclinical development of A CD8 T-Cell Priming Vaccine Against Chikungunya Virus

The project proposes to advance a CD8 T-cell priming Chikungunya virus (CHIKV) vaccine candidate (PepGNP-ChikV) through preclinical development, cGMP manufacture and and MHRA regulatory submission for a Phase-1 clinical trial in the UK. The overall aim of this project is be ready to move into a Phase-1 clinical trial within 3 to 6 months of completion of this project. CHIKV is a mosquito-transmitted alphavirus that causes epidemics of illness characterized by debilitating arthralgia and arthritis that can endure for months to years following infection. In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact. No licensed vaccine exists. Emergex has developed a unique T-cell priming vaccine platform comprised of two technologies: a library of expressed major histocompatibility complex (MHC) Class 1-restricted viral specific peptides, and a self-adjuvating gold nanoparticle (GNP) carrier system. Emergex believes that T-cell priming vaccines offer an effective means to prevent disease and transmission for a range of pathogens including Chikungunya. T-cell priming vaccines have the advantage that since they target human cells at the stage of initial viral infection, they can clear the viral pathogen before it has the opportunity to replicate (Termed "abortive infection"). This would prevent both clinical disease and transmission. The T-cell prime system also has the capacity for long term protection (\>20 years). Using the Emergex platform, two products (A Dengue vaccine and a Betacoronavirus vaccine) have completed Phase-1 trials in Switzerland (NCT04935801 and NCT04935801). The vaccines were shown to be safe and capable of inducing significant vaccine specific T-cell effector and memory responses. Regulatory approval has been given for a phase 1b trial for the betacoranavirus vaccine due to begin imminently. These vaccines will be advanced in Phase-2 trials. A universal influenza vaccine is due to enter a Phase-1 trial in the USA in Q4 this year. This project will advance upon outputs from the previous competition "SBRI - Vaccines for epidemic diseases: Readiness for clinical development and regulatory submission". In this competition Emergex met all milestones and 1) identified the Chikungunya peptide epitope library using immunoproteomics 2) synthesized an experimental vaccine candidate using those epitope sequences 3) Showed in vitro efficacy of the candidate. Based on these outputs, Emergex believe the candidate is now in a state of readiness to enter formal preclinical development and cGMP manufacture.