Viracta announces first clinical response in EBV+ solid tumor setting

Viracta Therapeutics announced new clinical data from the Phase 1b/2 trial of Nana-val in patients with EBV+ R/M NPC and other EBV+ solid tumors and outlined its key 2023 clinical objectives. New Phase 1b data on Nana-val in patients with EBV+ R/M NPC, include: One PR and one disease progression were reported in evaluable patients in the third dose level; Preliminary safety data from the first three dose levels was previously presented at the European Society for Medical Oncology Immuno-Oncology Congress in December 2022, showing Nana-val was well-tolerated with no dose limiting toxicities; Enrollment in the fourth dose level is ongoing. Key 2023 clinical objectives include: Nana-val in patients with EBV+ R/R lymphoma; Pivotal NAVAL-1 study open for enrollment at more than 60 sites globally; the study footprint is expected to expand further in 2023; Anticipate providing an update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 in the first half of 2023; Expect to provide additional updates from other lymphoma subtype(s) throughout 2023. Regarding Nana-val in patients with advanced EBV+ solid tumors, the company anticipates completion of the Phase 1b dose escalation portion of the trial and selection of the recommended Phase 2 dose in 2023; anticipates initiating the Phase 2 randomized expansion portion of the trial, designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with EBV+ R/M NPC, in the second half of 2023; anticipates initiating the exploratory Phase 1b cohort designed to evaluate Nana-val at the RP2D in other EBV+ solid tumors in the second half of 2023. Viracta strengthened its balance sheet by exercising its option to draw the $20 million tranche from its non-dilutive $50 million credit facility with Silicon Valley Bank and Oxford Finance. Viracta intends to use this additional capital to support Nana-val’s development in EBV+ R/M NPC and to explore its potential in other advanced EBV+ solid tumor indications. As a result, Viracta ended 2022 with over $90 million in cash, cash equivalents, and investments, and has an anticipated cash runway into late 2024.