Advanced Adjuvant Systems - Development and Commercialization

Next generation adjuvant systems using Inimmune’s novel synthetic TLR4 agonist (INI-2002)

We have partnered with SPI Pharma to commercialize two advanced adjuvant systems: T4Q, made up of INI-2002 and QS21, and T4AH, which consists of INI-2002 absorbed to alum.

TLR4 agonists are well established to synergize with other adjuvant components, such as the natural saponin QS21 and alum. These adjuvant systems enhance the immune response against viral and bacterial pathogens. For example, TLR4 agonist MPL is combined with QS21 to make GSK’s well-known adjuvant system AS01®. Inimmune’s T4Q adjuvant system combines our novel synthetic TLR4 adjuvant, INI-2002, with QS21. In addition, we are working on combining INI-2002 with semi-synthetic saponin alternatives supplied by various partners. All of these saponins and combinations with INI-2002 offer advantages over current clinical adjuvants, including improved availability, stability, and production sustainability. INI-2002 alone offers greatly improved stability compared to current clinical TLR4 adjuvants. Additionally, we have developed an innovative formulation approach that avoids the cold chain requirement of current clinical TLR4 + saponin adjuvant combinations. In July 2024, we announced that we partnered with SPI Pharma to develop and commercialize this adjuvant system.

Efficacy in Pre-Clinical Models

In pre-clinical models, T4Q demonstrates comparable or improved immunogenicity compared to current clinical TLR4 + saponin adjuvant combinations. Further, T4Q adjuvanted vaccines are efficacious in pre-clinical influenza challenge models. T4AH, INI-2002 adsorbed to alum, enhances antibody and T cell responses when combined with recombinant antigens.

cGMP Manufacturing

INI-2002 has been manufactured under cGMP conditions and our partners have either completed cGMP manufacturing of saponin alternatives or cGMP manufacturing campaigns are underway. cGMP manufacturing of both T4Q and T4AH is in progress with completion expected Q1/Q2 2025.

AS01® is a registered trademark of GSK Biologicals S.A.