Viracta Therapeutics, Inc. reported preliminary dose-ranging data from the first two dose levels of the dose escalation part of the Phase 1b/2 study of Nana-val in patients with EBV(+) recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). The data are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), which is taking place both virtually and in-person at the Palexpo Exhibition Centre in Geneva, Switzerland, from December 7 -- 9, 2022. The Phase 1b/2 trial's first two dose levels enrolled seven patients with EBV(+) R/M NPC, six of whom were evaluable for response as of the abstract's data cut-off date.

At the time of enrollment, patients had received a median of two prior systemic therapies. All patients were refractory to their last therapy with bone (6/7), liver (5/7), and lung (3/7) metastases. Key data reported in the abstract include: Nana-val was well tolerated with no dose limiting toxicities (DLTs) reported.

Most mmon Grade 1-2 AEs were fatigugue, nausea, and increased creatinine (n=3 each); Two of six evaluable patients achieved stable disease (SD) per RECIST v1.1 criteria; Plasma EBV DNA titers decreased or remained stable in both patients achieving SD, while rising in patients with progressive disease. The company recently amended the trial protocol to include additional dose levels in the Phase 1b dose escalation portion, which is designed to determine the optimal recommended Phase 2 dose (RP2D). The company anticipates initiating the Phase 2 randomized expansion portion of the Phase 1b/2 trial in the second half of 2023.