Opioid Vaccine

From 1999 to today, more than one million people have died from a drug overdose.

Tragically, from 1999 to today, more than one million people have died from a drug overdose. Opioids, particularly synthetic opioids such as fentanyl, are involved in the majority of drug overdose deaths.

INI-4001 Adjuvanted Opioid Vaccine

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, and Columbia University, supported by NIH funding from the HEAL (Helping to End Addiction Long term) initiative. A second anti-fentanyl vaccine is being developed in collaboration with Boston Children’s Hospital and the University of Houston. This $34 million contract advances two vaccine candidates through phase I clinical trials over a period of five years. The vaccine’s primary goal is to prevent opioid overdose deaths due to the presence of fentanyl or heroin and morphine in drugs of abuse.

Our lead vaccine candidate utilizes Inimmune’s adjuvant INI-4001 in combination with a fentanyl hapten conjugated to a carrier protein (CRM-197). The inclusion of INI-4001 increases critical antibody titers , increasing the likelihood of protection in patients. To date, our vaccine has demonstrated pre-clinical efficacy in fentanyl challenge models in a number of different species and has advanced to IND preparations and cGMP manufacturing with the first Phase I trial expected to begin in 2025.