Viracta Therapeutics Announces Completion of Second-Stage Enrollment into the Peripheral T-Cell Lymphoma Cohort of the NAVAL-1 Trial

Accelerated pace of enrollment supports speed to market strategy

Topline results from Stage 1 expected to be presented in the second quarter of 2024 followed by Stage 2 data in the third quarter of 2024

SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that its lead development program, Nana-val (nanatinostat in combination with valganciclovir), a first-in-class, all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, has completed Stage 2 enrollment into the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV⁺) peripheral T-cell lymphoma (PTCL) cohort of the NAVAL-1 trial.

“Given the nature of this serious life-threatening condition and absence of EBV-targeted treatments today, our goal is to bring Nana-val to patients with relapsed or refractory EBV-positive PTCL as quickly as possible,” said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta. “The completion of Stage 2 enrollment of the PTCL cohort in NAVAL-1 is a major milestone for the Nana-val clinical development program. We would like to acknowledge the dedication of our study execution team and the commitment of our investigators for this achievement. We look forward to building upon our previously published positive data from the Phase 1b/2 clinical trial and reporting topline PTCL cohort data from Stage 1 of the NAVAL-1 trial in the second quarter of 2024. Additionally, we plan to meet with FDA in mid-2024 to align on requirements for accelerated approval of Nana-val in this orphan indication.”

Upcoming Anticipated Milestones for the NAVAL-1 Trial of Nana-val in Patients with R/R EBV⁺ PTCL

• Present topline Stage 1 data from both arms (in patients treated with nanatinostat with [n=10] or without [n=10] valganciclovir) in the second quarter of 2024, with an aim to clearly delineate the differentiation of Nana-val’s ‘kick and kill’ mechanism of action.
• Present Stage 1 + Stage 2 data (n=21) from the R/R EBV⁺ PTCL cohort in patients treated with Nana-val in the third quarter of 2024.
• Engage with the U.S. Food and Drug Administration (FDA) in mid-2024, to align on requirements for accelerated approval.
• Enroll patients into the post-Phase 2 expansion cohort to support potential accelerated approval.

About the NAVAL-1 Trial