PRODUCTION OF SYNTHETIC ADJUVANT SYSTEM (SAS): A SYNERGISTIC COMBINATION OF SYNTHETIC ADJUVANT COMPONENTS

There are very few FDA approved adjuvants available, limiting the discovery and development of vaccines to combat new pathogens that threaten public health. Inimmune Corp has developed a fully synthetic TLR4 agonist, INI-2002, with superior potency and stability versus other licensed TLR4 adjuvants. Simultaneously, Adjuvance Technologies has developed TQL-1055, a semi-synthetic and less toxic form of QS-21. Herein, Inimmune will develop a synthetic adjuvant system containing INI-2002 in combination with TQL-1055 (Synthetic Adjuvant System, SAS) in which both components synergize to elicit a Th1-biased immune response and perform the development, preclinical efficacy and safety testing necessary to advance SAS to IND. Aim 1 will include scale-up production of INI-2002 and optimization SAS formulations to provide improved stability. Aim 2, closely coordinated with Aim 1, will test lead formulated SAS candidates in both in vitro and in vivo models to determine innate and adaptive immune responses to SAS, specifically seeking an improved Th1 bias. In Aim 3, in vitro and in vivo toxicology studies will evaluate the safety of lead, optimized SAS formulations. Completion of this SBIR will result in a synthetic adjuvant system with chemically defined components, superior stability, which elicits a strongly Th1-biased immune response, and is widely available.