A more durable and universal adjuvanted influenza vaccine through synthetic biology

Technology to develop and produce vaccines that offer broader protection against constantly mutating pathogens has been a continuing challenge. Formulating adjuvants with new antigens can result in elevated immune responses, leading to better and longer protection. Yet, despite the advantages of delivering vaccines with adjuvants, such deployment has been hindered. This is because of limited availability of cGMP adjuvants for clinical trials and overarching intellectual property (IP) and freedom-to-operate (FTO) constraints. Now that the IP/FTO landscape for proven adjuvants has opened, innovations in adjuvant formulations and antigen design have emerged as important strategies in addressing worldwide seasonal influenza outbreaks. Enepret Inc. has developed mimics of widely used oil-in-water emulsion adjuvants (EVAX emulsions) which can be manufactured sustainably and limitlessly under cGMP conditions. These emulsions will be preclinically evaluated with innovative toll-like receptor agonists (TLR4: BECC470 and TLR9: CpG55.2) and novel universal and commercially available seasonal influenza antigens for immune response breadth and efficacy. These evaluations will lead to selection of the most promising combination of adjuvants/influenza antigen to take forward, which can proceed without impediments from FTO constraints. Critically, these adjuvants combination can be available as cGMP-grade products, advanced in clinical trials, and deployed for more efficacious and durable vaccinations. Project Number: 75N93025C00020-0-9999-1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator: CHASE KEMPINSKI | Institution: ENEPRET, INC., LEXINGTON, KY | Award Amount: $599,526 | Activity Code: N43 View on NIH RePORTER: https://reporter.nih.gov/project-details/75N93025C00020099991