TuHURA Biosciences and Kintara Therapeutics Report Positive Results from Phase 1b Trial of IFx-2.0

TuHURA Biosciences, Inc. and Kintara Therapeutics have announced promising results from the Phase 1b trial of IFx-2.0, a personalized cancer vaccine, in advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) which were resistant to checkpoint inhibitors.

IFx-2.0 showed high safety and tolerance at weekly dosing for three weeks. Eighty percent of advanced MCC patients naïve to immune checkpoint inhibitors (ICI) who had not responded to therapies such as pembrolizumab achieved complete or partial responses upon rechallenge with an anti-PD(L)-1 agent after IFx-2.0 treatment.

The trial's positive results, presented at the 2024 ASCO Annual Meeting, support further studies, including a Phase 3 trial set to begin in the second half of 2024. This next phase will evaluate IFx-2.0 combined with Keytruda® for first-line treatment in advanced MCC patients.

The Phase 1b study aimed to establish the safety and feasibility of repeated IFx-2.0 administrations. The study met its primary safety objectives and indicated a 63% durable disease control rate in explored patients following treatment, suggesting IFx-2.0's potential immune-priming effect.