Along with reprogramming the immune response to allergies and other inflammatory diseases, innate immune agonists are highly effective at enhancing and directing vaccine-mediated immune responses. Inimmune has developed a number of adjuvants based on innate immune activation and has moved into partnerships to commercialize or distribute these highly effective adjuvants worldwide.
We have partnered with SPI Pharma to commercialize INI-2002 for vaccines as a next-generation synthetic TLR4 agonist. INI-2002 is an effective adjuvant in a number of different formulations and in combination with existing adjuvants such as alum, QS21, and other saponins. INI-2002 has been manufactured GMP and the T4Q adjuvant system (INI-2002+QS21) has been manufactured GMP and is available for licensing. INI-2002 can be readily formulated into an emulsion (squalene, oil in water) as a balanced Th1/Th2 adjuvant system called T4SE. When INI-2002 is adsorbed to alum the adjuvant system is termed T4AH which works well for co-adsorption and delivery of vaccine antigens.
TRAC478 is a new combination adjuvant approach in which INI-2002, a TLR4 adjuvant, and INI-4001, a TLR7/8 adjuvant are used together to generate synergistic immune responses. Pre-clinically, TRAC478 results in strong Th1-biased antibody and T cell responses and is efficacious in influenza challenge models. TRAC478 can be used with a number of different vaccine formulations, each of which influences the adjuvant-mediated immune response to better tailor the response to protect against a particular pathogen. TRAC478 has been produced GMP and the first human use is expected in a NIH-funded influenza vaccine clinical trial as part of the CIVICs (Collaborative Influenza Vaccine Innovation Centers) program.
Deaths among teenagers attributed to synthetic opioids such as fentanyl have tripled over the past two years alone. In response to the growing opioid epidemic, Inimmune is developing anti-opioid vaccines in collaboration with the University of Montana, University of Minnesota, University of Washington, and Columbia University, supported by NIH funding from the HEAL (Helping to End Addiction Long term) initiative. Our lead vaccine candidate uses Inimmune’s adjuvant INI-4001, a TLR7/8 agonist in combination with an antigen that generates heroin-binding antibodies. The inclusion of INI-4001 increases critical antibody titers, increasing the likelihood of protection in patients. A Phase I clinical study using this INI-4001 adjuvanted vaccine is currently ongoing at Columbia University.
We are developing novel synthetic Mincle agonists as Th17-generating adjuvants for bacterial and fungal pathogens in collaboration with the University of Montana. Mincle is a C-type lectin receptor (CLR) that was originally discovered as the ligand for the Mycobacterium tuberculosis (Mtb) cell wall component trehalose dimycolate (TDM). Th17 cells play a key role in the immune system’s defenses against certain bacterial and fungal pathogens, including Mtb. There are no Th17-inducing vaccines in clinical use and we aim to be the first with a synthetic Mincle agonist.
