On June 28, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported that the relapsed or refractory EBV+ peripheral T-cell lymphoma (R/R EBV+ PTCL) cohort of its pivotal NAVAL-1 clinical trial has met the pre-specified efficacy threshold for expansion into Stage 2 of the study (Press release, Viracta Therapeutics, JUN 28, 2023, View Source [SID1234632969]). The efficacy threshold for expansion of NAVAL-1 cohorts from Stage 1 to Stage 2 is based upon a pre-specified minimum number of objective responses achieved within the first 10 patients enrolled.

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"Initial data from the PTCL cohort in NAVAL-1 show a strong signal of efficacy that is in-line with our promising Phase 1b/2 data and sufficient to advance to Stage 2. We now look forward to completing enrollment in Stage 1 and are taking steps to further accelerate enrollment through Stage 2," said Mark Rothera, President and Chief Executive Officer of Viracta. "Given the lack of effective therapies available for patients with PTCL, today’s announcement represents an important step towards addressing a pressing unmet medical need. The advancement of the first cohort into Stage 2 establishes PTCL as the leading indication for the NAVAL-1 clinical trial and provides added momentum to our global clinical program."

NAVAL-1 enrollment continues worldwide with updates on potential additional cohort advancements expected in the second half of 2023.

About NAVAL-1

NAVAL-1 (NCT05011058) is a global, multicenter trial of Nana-val in relapsed or refractory (R/R) EBV+ lymphoma. The trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into six indication cohorts based on EBV+ lymphoma subtype. If a pre-specified activity threshold is reached within a lymphoma subtype in Stage 1 (n=10), additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.