TuHURA Biosciences Says FDA Lifts Partial Hold On TuHURA's IFx-2.0 Phase 3 Trial For Metastatic MCC

(RTTNews) - TuHURA Biosciences, Inc. (HURA), a Phase 3 immune-oncology company, announced Monday that the U.S. Food and Drug Administration (FDA) has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0.

This will allow the company's Phase 3 trial to proceed as agreed to under the previously announced Special Protocol Assessment (SPA) Agreement with the FDA.

The Company's Phase 3 accelerated approval trial of IFx-2.0, will now be conducted under an SPA Agreement with the FDA later in June 2025.

The trial will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda compared to Keytruda plus placebo in the first line treatment of patients with advanced or metastatic Merkel cell carcinoma (MCC).

The resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025

Keytruda is currently approved in MCC under accelerated approval based on Overall Response Rate (ORR). The pivotal trial for IFx-2.0 is expected to enroll 118 across approximately 22 to 25 U.S. sites.

Trial participants will be randomized on a 1:1 basis and receive Keytruda in both arms, for up to two years, or until disease progression or Keytruda related toxicities.

The primary endpoint for the trial is ORR with a key secondary endpoint of Progression Free Survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival. The accelerated approval is based on the successful achievement of the ORR primary endpoint.