Viracta Therapeutics (VIRX) Announces Orphan Drug Designation Granted by FDA for its All-Oral Combination of Nanatinostat and Valganciclovir for Treatment of Epstein Barr Virus-Positive Diffuse Large

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 granted its all-oral combination product candidate, nanatinostat and valganciclovir (Nana-val), orphan drug designation (ODD) for the treatment of Epstein Barr virus-positive diffuse large B-cell lymphoma, not otherwise specified (EBV+ DLBCL, NOS). DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL) in the U.S. and worldwide, accounting for approximately 25% of newly diagnosed cases of NHL in the U.S, of which a subset are EBV+. Viracta has previously received ODD from the FDA for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder (PTLD) and plasmablastic lymphoma.

"This latest orphan drug designation underscores the potential benefits of our all-oral kick and kill approach to targeting EBV-positive cancers," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "Nana-val has shown promising preliminary efficacy across multiple subtypes of relapsed/refractory EBV-positive lymphoma, including DLBCL. We are dosing patients in the pivotal NAVAL-1 trial, which includes patients with EBV-positive DLBCL, and look forward to its continued momentum with sites now open for enrollment in the U.S., Europe, and Asia. Through NAVAL-1's progress, we aim to further develop Nana-val as a new and actionable therapy in indications where many patients recur from the standard of care and have particularly poor prognoses."

The FDA grants orphan drug designations to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits toward qualified clinical trial costs, assistance with clinical study design and drug development, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory approval for the disease or condition for which the drug has the orphan drug designation. In 2020, 31 of the 53 novel drug approvals, or 58%, in the FDA's Center for Drug Evaluation and Research, were orphan designated products.

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