An AS01-like adjuvant system
We partnered with SPI Pharma, to commercialize an AS01-like adjuvant system.
Synthetic adjuvant system (SAS) is an AS01-like adjuvant system combining Inimmune’s novel synthetic TLR4 adjuvant INI-2002 with saponin alternatives. These saponin alternatives are supplied by various partners and range from synthetic to natural products. All of these saponins and combinations with INI-2002 offer advantages over current clinical adjuvants. Some of those advantages include 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.
In pre-clinical models, SAS demonstrates comparable or improved immunogenicity compared to current clinical TLR4 + saponin adjuvant combinations with comparable or improved injection site pain depending on the formulation of SAS that is being investigated. Further, SAS adjuvanted vaccines are efficacious in pre-clinical influenza challenge models.
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 is in progress with completion expected Q1 2025.
