On October 6, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the initiation of a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors (Press release, Sunesis, OCT 6, 2021, View Source [SID1234590868]). The trial is designed to evaluate the safety and preliminary efficacy of nanatinostat in combination with valganciclovir (Nana-val) alone and in combination with the PD-1 checkpoint inhibitor pembrolizumab.
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"The initiation of this Phase 1b/2 trial is a key step towards expanding the development of our unique therapeutic approach beyond EBV+ lymphoproliferative disorders. Nasopharyngeal carcinoma is highly associated with EBV, and treatment options for patients with advanced or recurrent EBV+ solid tumors are limited," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "We are encouraged by the preliminary data that Nana-val has demonstrated in relapsed/refractory EBV+ lymphoma and look forward to evaluating the activity of our novel oral combination regimen in patients with EBV+ solid tumors."
The Phase 1b/2 trial is an open-label, multicenter trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ RM-NPC. In Phase 2, up to sixty patients with EBV+ RM-NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.
About Nanatinostat
Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three ongoing trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1).