Ph 3 Accelerated Approval Trial of IFx-2.0 as an Adjunctive Therapy to Keytruda in 1L Treatment for Advanced or Metastatic MCC initiated
“The initiation of IFx-2.0’s Phase 3 accelerated approval trial is a significant milestone for TuHURA and for the 40% to 50% of patients with advanced or metastatic MCC who may not respond to first line treatment with Keytruda® (pembrolizumab),” stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. “IFx-2.0’s potential ability to harness the power of a patient’s innate immune response leading to the activation and proliferation of tumor specific B cells and T cells represents a novel mechanism to overcome primary resistance to checkpoint inhibitors. As we start initiating study sites, we are grateful for the interest among investigators from leading cancer centers across the US in participating in this Phase 3 trial. We anticipate having more than half of the 22 participating sites open over the next 3-4 weeks, with the balance activated by the end of summer.”
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