Viracta Therapeutics Gets FDA Clearance of IND Application for Phase 1b/2 Trial

  Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors. The global Phase 1b/2 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. Initiation of the trial is expected in the second half of 2021.

https://www.prnewswire.com/news-releases/viracta-therapeutics-announces-fda-clearance-of-ind-application-for-phase-1b2-trial-in-epstein-barr-virus-positive-ebv-solid-tumors-301338482.html