TuHURA Biosciences Initiates Its Phase 3 Accelerated Approval Trial of IFx-2.0 as an Adjunctive Therapy to Keytruda® (Pembrolizumab) in First Line Treatment for Advanced or Metastatic Merkel Cell Carcinoma

TuHURA Biosciences, formed by CohBar and Morphogenesis, a UF startup, has announced the initiation of 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 (MCC).

IFx-2.0 is designed to overcome primary resistance to checkpoint inhibitors (CPIs), such as Keytruda^® (pembrolizumab), and has demonstrated systemic anti-tumor specific immune responses (an abscopal effect) 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. In the Phase 1b trial, patients with advanced or metastatic MCC who progressed on either pembrolizumab or avelumab (anti-PD(L)-1) therapy, received weekly administration of IFx-2.0 for up to three doses followed by rechallenge with anti-PD(L)-1 therapy. Results demonstrated an overall response rate of 63% (2 CR, 5 PR) with two responses lasting 23 and 33 months and five ongoing responses (6, 11, 13, 19 and 23 months) as of the last follow-up.  

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