Viracta Therapeutics, Inc. announced that additional data from the Phase 1b/2 clinical trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) showed two ongoing confirmed partial responses (PRs) at higher dose levels. Planning for success, company incorporated FDA's Project Optimus initiative into the Phase 2 study design, which is intended to confirm the recommended Phase 2 dose of Nana-val that maximizes efficacy as well as safety and tolerability in patients with advanced EBV-positive solid tumors. This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab.

Along with the U.S. Food and Drug Administration's Project Optimus initiative at the start of Phase 2, up to 40 patients with R/M EBV+ NPC will be randomized to receive either the RP2D or a dose level below the RP2D in a dose-optimization cohort. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trials in patients with recurrent or metastatics (R/M) EBV+ NPC and other EBV+ solid tumors. Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multic enter-label, open-label Phase 1b/2 basket trial for the treatment of multiple sub types of relapsed or refractories (R/R) Epstein-Barr virus -positive (EBV+) lymphoma (NAval-1), as well as a multinational, open-label Phase 2 clinical trial for the treatment of patients with recurrent or metastatic ("R/M) EBV+) lymphoma (NAVAL- 1), as well as a multinational Phase 2 basket trial in patients with recurrent or metastatic (R/M") EBV+ NPC and other EBV+ solid tumors.

NANA-val is currently being evaluated In multiple ongoing clinical trials, including an pivotal, global, multicenter.