Viracta Therapeutics provides anticipated 2024 milestones

Viracta Therapeutics provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val, is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers. Anticipated Key 2024 Milestones: Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory Epstein-Barr virus-positive lymphomas: Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma cohort of patients treated with Nana-val in the first quarter of 2024. Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort in the first half of 2024. Meet with the U.S. Food and Drug Administration to discuss additional requirements for accelerated approval by mid-2024. Enroll patients with R/R EBV+ PTCL into the post-Phase 2 expansion cohort to support potential accelerated approval. Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024. Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma and R/R EBV+ post-transplant lymphoproliferative disorder by year-end 2024. Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors: Determine the recommended Phase 2 dose by investigating the novel split daily dosing regimen at higher dose levels of Nana-val in the second half of 2024. Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024. “Our primary focus in 2024 is the speed to market strategy for Nana-val in patients with relapsed or refractory EBV-positive PTCL, supported by its accelerating pace of enrollment into Stage 2 and plans to engage with the FDA to discuss Nana-val’s potential accelerated approval pathway in mid-2024,” said Mark Rothera, President and Chief Executive Officer of Viracta. “Additionally, we are encouraged by the progress of the Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors, which is now enrolling and treating patients with the novel split daily dosing regimen, and we remain on track to expand the study into Phase 2 in 2024. The growing clinical data together with the recent orphan drug designation granted by FDA for the treatment of nasopharyngeal carcinoma further positions Nana-val as a tumor-agnostic approach to address the high unmet medical need for patients with EBV-associated cancers, including both lymphomas and solid tumors. With an anticipated cash runway into 2025, we are well-positioned for a successful 2024.”