MISSOULA, Montana, July 24, 2024 – Inimmune, a clinical stage biotech company focused on the development of novel immunotherapies, vaccines, and vaccine adjuvants announced today the dosing of the first patient in its Phase 1 single ascending dose study of INI-4001 in patients with advanced solid tumors.
This is an open-label, multiple-ascending dose, two-part dose ranging and cohort expansion study of INI-4001 in patients with advanced solid tumors. This first-in-human trial of INI-4001, Inimmune’s proprietary TLR7/8 agonist in a nanoparticle delivery system, will consist of two parts. In Phase 1a, single dose escalation cohorts receiving monotherapy INI-4001 will determine PK, safety, and tolerability. This is followed by Phase 1b where patients who have progressed or have stable disease after 3 cycles of INI-4001 will be allowed to receive concurrent administration of an anti-PD-1 or anti-PD-L1 immunotherapy plus INI-4001.
In pre-clinical studies, INI-4001 was efficacious both as a monotherapy and in combination with anti-PD-1 checkpoint therapy in syngeneic murine tumors (LLC, MC38 and B16F10). Additionally, INI-4001 has been shown to induce production of the cytokine IFNα and activation of antigen presenting cells, leading to downstream T cell activation in vivo. INI-4001 may prove to be an ideal combination agent with checkpoint inhibitors given that a minority of patients currently benefit from checkpoint inhibitor monotherapy.
Inimmune’s CEO, Alan Joslyn, said “We are very excited that INI-4001 clinical trials have commenced, as this marks an important milestone for our company and oncology patients. INI-4001 either as monotherapy or in combination with checkpoint therapy can potentially provide physicians a new therapeutic option in their treatment toolbox.”
Inimmune’s trial of INI-4001 is being conducted in Australia and is expected to be complete by the end of 2025. Additional information can be found at clinicaltrials.gov (NCT06302426).
