Viracta Therapeutics, Inc. provided a clinical update, including its roadmap for advancing Nana-val?s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company?s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers. Anticipated Key 2024 Milestones: Pivotal NAVAL-1 studyof Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphomas Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.

Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat, with [n=10] or without [n=10] valganciclovir) in the first half of 2024. Meet with the U.S. Food and Drug Administration (FDA) 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 (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024. Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301) Determine the recommended Phase 2 dose (RP2D) by investigating the novel split daily dosing (SDD) 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. Recent Clinical Trial Updates: Pivotal NAVAL-1 study of Nana-val in patients with R/R EBV+ lymphomas Completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort of patients, and enrollment into Stage 2 continues to accelerate, as nearly half of the Stage 2 patients have been enrolled. The protocol was amended to additionally enable enrollment of second-line R/R EBV+ DLBCL patients and R/R EBV+ PTLD patients, including pediatric EBV+ PTLD patients = 12 years of age.

Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301) Initiated enrollment of the sixth dose cohort of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) evaluating the new SDD regimen. In December 2023, the FDA granted an orphan drug designation (ODD) to Nana-val for the treatment of NPC, the fifth ODD granted to Nana-val by the FDA and the seventh ODD for Nana-val globally. Confirmed partial responses without dose-limiting toxicities through the initial five dose cohorts.

Further, new preclinical data presented at ESMO Asia Congress 2023 support continued dose-escalation to enhance Nana-val?s antitumor activity. Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.