For ongoing clinical trial information: NCT06302426
Every year, cancer claims the lives of more than half a million Americans and is the second leading cause of death in the United States. While checkpoint inhibitors and other novel immunotherapies have resulted in increased life expectancy for some people, current immunotherapies still fail in nearly 80% of cancer patients.
Our clinical-stage cancer therapeutic is INI-4001, a potent TLR7/8 agonist that has been engineered for nanoparticle delivery. INI-4001 demonstrates efficacy as monotherapy and in combination with immune checkpoint therapy (ICT), such as anti-PD-1, in multiple pre-clinical murine cancer models. Our optimized nanoparticle formulation for INI-4001 enhances anti-tumor efficacy, maintaining high IFNα production while reducing pro-inflammatory TNFα. Mechanistically, INI-4001 increases the number of antigen presenting cells and enhances CD8 T cell responses in the tumor microenvironment. We are currently concluding an open-label, all solid tumor Phase 1 trial investigating the safety of INI-4001. With our Phase 1 study expected to close in Q4 2026, INI-4001 has demonstrated safety, tolerability, and on-target innate immune activation. We are currently seeking partnering and out-licensing opportunities for INI-4001 to continue clinical development. To learn more about our Phase 1 clinical trial, please visit www.clinicaltrials.gov.
