Viracta Therapeutics is advancing Nana-Val, an all-oral combination therapy, as a potential treatment for post-transplant lymphoproliferative disorder (PTLD) and other Epstein-Barr virus (EBV)-associated malignancies. The therapy is currently under evaluation in a pivotal Phase 2 basket trial. This development addresses a critical need for novel treatments in PTLD, a condition with limited therapeutic options.
Nana-Val: A Novel Approach to Targeting EBV+ Malignancies
Nana-Val combines nanatinostat (VRx-3996), an orally available histone deacetylase (HDAC) inhibitor, with valganciclovir, an antiviral agent. Nanatinostat selectively inhibits specific isoforms of Class I HDACs, which is key to inducing viral genes epigenetically silenced in EBV-associated malignancies. By targeting EBV-infected cells, Nana-Val aims to provide a more specific and effective treatment approach.
Clinical Development and Ongoing Trials
Viracta Therapeutics is currently investigating Nana-Val in a pivotal global, multicenter, open-label Phase 2 basket trial (NAVAL-1) in multiple subtypes of relapsed/refractory EBV+ lymphoma. Additionally, a multinational Phase 1b/2 trial is underway in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. These trials are designed to assess the safety and efficacy of Nana-Val across a range of EBV-associated malignancies.
Addressing Unmet Needs in PTLD
Post-transplant lymphoproliferative disorder (PTLD) represents a significant challenge in transplant medicine. The disorder arises from immunosuppression following organ transplantation, leading to uncontrolled proliferation of lymphocytes, often driven by EBV. Current treatment strategies have limitations, highlighting the need for innovative therapies like Nana-Val that can specifically target EBV-infected cells and improve patient outcomes.
Competitive Landscape
While the competitive landscape includes companies like Moderna Therapeutics exploring mRNA-based therapies (e.g., mRNA-1189), Viracta Therapeutics is currently the most advanced with Nana-Val in Phase 2 clinical trials. The oral route of administration and the targeted mechanism of action of Nana-Val offer potential advantages over existing treatments.
