ON January 19, 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 European Commission (EC) has granted an orphan drug designation (ODD) to Viracta’s all-oral combination product candidate, Nana-val (nanatinostat and valganciclovir), for the treatment of diffuse large B-cell lymphoma (DLBCL). The EC previously granted ODD to Nana-val for the treatment of peripheral T-cell lymphoma (Press release, Viracta Therapeutics, JAN 19, 2023, View Source [SID1234626397]). In addition, Nana-val was previously granted ODD by the U.S. Food and Drug Administration for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV+) DLBCL, not otherwise specified.
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"Nana-val’s sixth orphan drug designation across the U.S. and Europe underscores the high unmet medical need for EBV-positive lymphoma patients worldwide, the broad therapeutic potential of its novel mechanism of action, and the global nature of our clinical and regulatory strategy," said Mark Rothera, President and Chief Executive Officer of Viracta. "This strategy is embodied by our pivotal trial, NAVAL-1, which has more than 60 sites open globally, and cohorts dedicated to multiple subtypes of EBV-positive lymphoma, including DLBCL. Emerging data have shown that EBV-positive DLBCL is a differentiated disease with a significantly lower survival outcome compared to EBV-negative disease. Nana-val has displayed promising preliminary efficacy in EBV-positive DLBCL, leaving it uniquely positioned to treat this underserved patient population."
ODD in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medical Products. To qualify for ODD from the EC, a product candidate must be intended to treat, prevent, or diagnose a life-threatening or chronically debilitating disease that does not affect more than 5 in 10,000 people across the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products.
Receiving an ODD from the EC provides companies with certain benefits and incentives including clinical protocol assistance, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees, and ten years of market exclusivity upon receipt of marketing authorization in the EU. The availability of market exclusivity is intended to encourage the development of medicines for rare diseases by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period.
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/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.