Inimmune

Missoula – November 06, 2026 -- Inimmune's TLR7/8 agonist INI-4001 produced no dose-limiting toxicities in a 10-patient Phase 1 study of heavily pretreated advanced solid tumor patients, and the company is weighing a Phase 2a start as early as 2027, subject to funding or partnership support.

INI-4001 tolerated up to 7.2 μg/kg across five dose levels

The trial (NCT06302426) tested the investigational small molecule for safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity. Patients received INI-4001 intravenously once weekly across five escalating dose levels. Adverse events were primarily transient, consistent with innate immune activation, and generally resolved within 24 hours. No concerning pharmacokinetic findings were reported.