- TuHURA Biosciences (HURA, Financial) initiates Phase 3 trial for IFx-2.0 with FDA Special Protocol Assessment.
- The trial targets a 63% overall response rate in patients with advanced or metastatic Merkel cell carcinoma.
- Phase 3 trial triggering $2.23 million tranche from $12.5 million PIPE financing.
TuHURA Biosciences (HURA) has officially commenced its Phase 3 accelerated approval trial for IFx-2.0, an innovative innate immune agonist aimed at overcoming resistance to checkpoint inhibitors. The trial, which has been granted a Special Protocol Assessment (SPA) by the FDA, is designed to evaluate IFx-2.0 as an adjunctive therapy to Keytruda® in the first-line treatment of advanced or metastatic Merkel cell carcinoma (MCC).
This pivotal study will enroll 118 participants across 22 to 25 sites in the United States. The trial's primary endpoint is the Overall Response Rate (ORR), with a key secondary endpoint being Progression Free Survival (PFS). The success of these endpoints could lead to an accelerated approval, potentially eliminating the need for additional confirmatory trials.
The Phase 1b trial of IFx-2.0 demonstrated a promising 63% overall response rate, with responses lasting up to 33 months. This innovative approach aims to unlock the innate immune system to combat checkpoint inhibitor resistance in up to 40-50% of non-responding MCC patients.
The initiation of the Phase 3 trial has triggered a significant $2.23 million funding tranche from TuHURA's recent $12.5 million PIPE financing. Moreover, the rapid activation of trial sites, with more than half expected to open within 3-4 weeks, underscores strong interest and efficient trial execution.
IFx-2.0 will be administered weekly for three weeks, alongside the approved dose and schedule of Keytruda®, in a randomized placebo-controlled format. Patients will continue receiving Keytruda for up to two years or until disease progression, ensuring a robust evaluation of the combined treatment's efficacy and safety.
