Tragically, from 1999 to 2018 over 450,000 people died from an opioid overdose. 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 an anti-fentanyl vaccine in collaboration with the University of Montana, University of Minnesota, and Columbia University, supported by NIH funding from the HEAL (Helping to End Addition Long term) initiative.
This $34 million contract advances two vaccine candidates through phase I clinical trials over period of five years.. The vaccine’s primary goal is to prevent opioid overdose deaths due to the presence of fentanyl 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). To date, the vaccine has demonstrated pre-clinical proof of concept in mouse, rat, and pig fentanyl challenge models and has advanced to IND preparations and cGMP manufacturing with the first Phase I trial expected to begin in 2023.
Sweere JM, Van Belleghem JD, Ishak H, et al. Bacteriophage trigger antiviral immunity and prevent clearance of bacterial infection. Science 2019;363
Infections caused by multidrug-resistant (MDR) bacteria such as Pseudomonas aeruginosa (Pa) are a growing threat to human life. The World Health Organization (WHO) recently categorized Pa as a priority pathogen of the greatest risk to human health. PA opportunistically infects diabetic wounds, cystic fibrosis airways, and medical materials (such as ventilators, bandages, and catheters), resulting in hospital acquired infections. Each year, fewer viable options are available to treat Pa infections due to drug resistance. No effective vaccine is available to prevent infection. A major hurdle to developing an effective Pa vaccine is identifying well conserved molecular targets from the wide range of Pa strains that infect humans which are amenable to immunization.
Breakthrough research led by Dr. Pat Secor at the University of Montana and colleagues have found that approximately 84% of Pa isolates are infected by a filamentous bacteriophage (a virus that infects bacteria) called Pf. Vaccinating against the major coat protein (CoaB) of Pf virions prevents Pa from establishing an infection in a mouse wound model (Sweere, Science 2019). Using our proprietary vaccine adjuvant INI-2002, we, in collaboration with Dr. Secor, have developed a series of conjugate vaccines that target the well-conserved CoaB antigen found on the strains of Pf phage that infect diverse Pa isolates, including drug resistant strains.
Vaccines are one of the most successful medical interventions in human history, saving 2.5 million lives per year and protecting millions more from severe illness and hospitalization, according to the WHO. Despite this incredible success, there are many infectious diseases for which effective vaccines do not currently exist. One strategy to developing new or more protective vaccines is through the addition of adjuvants, which help activate the immune system.
Inimmune is a leader in the discovery and development of vaccine adjuvants with over 20 years of expertise in their safe and effective use. Inimmune’s novel small molecule adjuvants can activate the immune system in specific ways to drive the right immune response to deliver protection against pathogens of interest.
Our lead vaccine adjuvants target innate immune receptors TLR4, TLR7/8, and Mincle and are focused on generating Th1 and Th17 responses. We are also working on discovery of new adjuvants that target STING as well as inflammasome-activating adjuvants. In addition, our formulations team has extensive expertise in tailoring vaccine delivery systems for these innate immune agonists, to match the route of administration and dosing required for a given indication.
TLR-7/8 (INI-4001), TLR-4 (INI-2002), CTLR (UM-1098), STING
Inimmune is advancing a novel TLR7/8 agonist nanoparticle formulation to the clinic to treat cancer by harnessing the patient’s immune system and synergizing with existing immune checkpoint inhibitor therapies. Further, we’re leveraging our expertise in innate immune activation to develop novel compounds and technology to target other immune receptors to develop the next generation of disruptive therapies in oncology.
Professional doctor or nurse giving flu or COVID-19 injection to patient. Woman in medical face mask getting antiviral vaccine at hospital or health center during vaccination and immunization campaign.