Viracta Therapeutics, Inc. (Nasdaq: VIRX) has announced the closure of its pivotal Phase 2 NAVAL-1 clinical trial evaluating Nana-val for the treatment of relapsed/refractory Epstein-Barr virus-positive (EBV+) lymphomas. The decision, effective immediately, comes as the company initiates a process to explore strategic alternatives to maximize shareholder value amid growing financial constraints.
The NAVAL-1 trial was a global, multicenter, open-label Phase 2 basket trial designed to assess the efficacy and safety of Nana-val, an all-oral combination therapy consisting of nanatinostat and valganciclovir, in patients with various subtypes of relapsed or refractory EBV+ lymphoma. The trial's closure was not prompted by any new safety findings, according to Viracta.
Strategic Review and Resource Conservation
Mark Rothera, President and Chief Executive Officer of Viracta, stated, "As we continue to look for ways to conserve resources and maximize value for the company, we made the very difficult decision to close the NAVAL-1 study while the Board undertakes its strategic review." Rothera expressed gratitude to the patients and physicians involved in the trial and reiterated his belief in Nana-val's potential to improve outcomes for patients with relapsed/refractory EBV+ lymphomas.
To maximize its cash runway, Viracta's Board of Directors has initiated a comprehensive review of strategic alternatives, which may include a merger, licensing agreement, sale, or other strategic transaction. However, the company cautioned that there is no guarantee that this exploration will result in any agreements or transactions, nor is there a specific timeline for the process.
Nana-val: A "Kick and Kill" Approach
Nana-val combines nanatinostat, a proprietary investigational drug, with valganciclovir, an antiviral agent. This combination represents Viracta's "Kick and Kill" approach, designed to target virus-associated cancers. While the NAVAL-1 trial is discontinued, Viracta is continuing to evaluate Nana-val in a multinational, open-label Phase 1b/2 clinical trial for patients with recurrent or metastatic EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors.
Financial Context and Future Outlook
The decision to halt the NAVAL-1 trial reflects the financial pressures facing Viracta. The company's leadership has emphasized the need to conserve resources while exploring strategic options. The closure of the trial raises questions about the future development of Nana-val and the company's overall direction.
Viracta does not intend to disclose further developments regarding the exploration of strategic alternatives unless and until its Board of Directors has approved a specific action or otherwise determined that further disclosure is appropriate or required by law.
