TuHURA Biosciences initiates Phase 3 approval trial of IFx-2.0 in carcinoma

TuHURA Biosciences (HURA) initiated its Phase 3 accelerated approval trial of IFx-2.0, TuHURA’s lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma, or MCC. IFx-2.0 is designed to overcome primary resistance to checkpoint inhibitors, such as Keytruda, and has demonstrated systemic anti-tumor specific immune responses when administered intratumorally into cutaneous, subcutaneous, or accessible nodal lesions in the company’s Phase 1b trial of IFx-2.0 in patients with advanced or metastatic MCC. The company’s Phase 3 accelerated approval trial of IFx-2.0, conducted under an SPA Agreement with the U.S. FDA, will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda vs. Keytruda plus placebo in the first line treatment for patients with advanced or metastatic MCC. Keytruda is currently approved in MCC under accelerated approval based on ORR. The primary endpoint for the trial is ORR with a key secondary endpoint of PFS. Other secondary endpoints are safety, duration of response, and overall survival. The key secondary endpoint of PFS, if successfully achieved without a detrimental effect on overall survival, could satisfy the requirement for regular approval without the requirement for a post approval confirmatory trial. The initiation of the Phase 3 trial represents the achievement of a milestone for the third tranche of funding under the company’s private placement, thereby trigging the purchase from the company of an additional $2.23M under the private placement financing.