On June 2, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that the Safety Monitoring Committee for the ongoing Phase 1b/2 study of Nana-val in patients with EBV+ solid tumors (VT3996-301) has reviewed safety data from the first dose cohort of patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC) and has approved advancing to the next dose level. Newly enrolled patients will enter the trial’s second cohort and receive nanatinostat 30 mg orally, 4 days per week, in combination with valganciclovir 900 mg orally daily (Press release, Viracta Therapeutics, JUN 2, 2022, View Source [SID1234615444]). Preliminary safety and efficacy data from the trial are expected in the second half of this year.
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"Treatment options are limited for patients with RM-NPC, and we are very pleased with the progress thus far in this trial," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "We look forward to enrolling the next cohort which moves us closer to determining the recommended dose of Nana-val for evaluation in additional patients with RM-NPC and other EBV-positive solid tumors."
In addition, the company also announced an upcoming poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will summarize the design of the Phase 1b/2 trial in patients with EBV+ RM-NPC and other EBV+ solid tumors.
Presentation Details:
Poster Title: A Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma (RM-NPC)
Session Title: Head and Neck Cancer
Session Date and Time: Monday June 6, 2022, 1:15 – 4:15 pm CDT
Poster Number: 93b
Presenter: A. Dimitrios Colevas, M.D., Stanford Cancer Institute
A copy of the ASCO (Free ASCO Whitepaper) poster will be available by visiting the Events and Webcasts page of the Viracta website following the conference’s conclusion. The poster’s corresponding abstract is currently available on the ASCO (Free ASCO Whitepaper) Annual Meeting Website.
About the Phase 1b/2 Trial
The Phase 1b/2 trial (NCT05166577) is an open-label, multinational 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 advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.
About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat 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. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.