VIRX - Viracta Therapeutics gets FDA clearance for early stage carcinoma study

Viracta Therapeutics (VIRX) announces that the U.S. FDA has cleared Viracta's Investigational New Drug ((IND)) application to proceed into an early stage trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma ((RM-NPC)) and other EBV+ solid tumors.The company said that it expects to initiate the study in the second half of 2021.The trial is designed to evaluate the safety and preliminary efficacy of Viracta's all-oral combination regimen in advanced EBV+ solid tumors (including EBV+ RM-NPC), and in combination with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC.The Phase 1b dose escalation portion of the trial is designed to evaluate safety, pharmacokinetics, and determine the recommended Phase 2 dosing regimen of nanatinostat and valganciclovir for expansion in patients with EBV+ solid tumors.In Phase 2, the safety, preliminary efficacy and potential pharmacodynamic markers of nanatinostat and valganciclovir together and in combination with pembrolizumab will be evaluated.

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Viracta Therapeutics gets FDA clearance for early stage carcinoma study