MDNA - Medicenna on go with pivotal trial with MDNA55 in brain cancer

Following End of Phase 2 meeting with the FDA, Medicenna Therapeutics ([[MDNA]] +1.8%) has been advised to proceed with a hybrid control design for a Phase 3 trial of MDNA55 in recurrent glioblastoma (rGBM) with no mutation in 1DH1/1DH2 genes. The FDA may also consider an interim analysis of the trial if certain criteria are met.The hybrid design allows robust overall survival ((OS)) analysis and reduces enrollment requirements in the control arm.The company says that lower number of trial participants can help cut down on trial costs and expedite timelines for regulatory approval.The proposed Phase 3 trial design includes a concurrent 3:1 randomized cohort and an additional matched external control arm. The primary endpoint of OS will be determined by a 1:1 analysis of the MDNA55 arm versus the pooled control arm.MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/European Medical Agency, respectivelyMedicenna also has MDNA11, IL-2 with CD122 binding

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Medicenna on go with pivotal trial with MDNA55 in brain cancer