Viracta Therapeutics Inc. (NASDAQ: VIRX) stock decline during pre-market by 2.32%. Viracta is a precision oncology firm that focuses on virus-related cancers. In two Phase 2 clinical trials for EBV-positive lymphoma, Viracta’s patented investigational medication, nanatinostat, is now being tested in conjunction with the antiviral treatment valganciclovir as an oral combination therapy.
VIRX stock, Recent Development
The US Food and Drug Administration approved Viracta Therapeutics’ Investigational New Drug (IND) request to move on with a Phase 1b/2 study in individuals with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid malignancies. The purpose of the worldwide Phase 1b/2 study is to assess the tolerability and preliminary effectiveness of Viracta’s all-oral combination regimen in progressive EBV+ solid tumors (including EBV+ RM-NPC), as well as in conjunction with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC. The study is anticipated to begin in the second half of 2021.
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The purpose of the Phase 1b dose escalation phase of the study is to assess safety, pharmacokinetics, and identify the appropriate Phase 2 dosing regimen of nanatinostat and valganciclovir for expansion in EBV+ solid tumor patients. In Phase 2, nanatinostat and valganciclovir, alone and in conjunction with pembrolizumab, will be tested for safety, preliminary effectiveness, and possible pharmacodynamic indicators in EBV+ RM-NPC patients.
Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta stated,
The approval of this IND application is a significant step forward in demonstrating the therapeutic approach’s wider relevance in the treatment of EBV-related cancers. EBV is the major cause of NPC, which is among the most prevalent head and neck malignancies in the world. With no conventional medicine choices for second or later lines of therapy and a median overall survival of fewer than 20 months, patients with RM-NPC have a dismal prognosis. NPC has been shown to express PD-L1, and initial response rates of 20% to 30% have been observed with PD-1 inhibitors for RM-NPC. They are currently studying this combination in patients with additional EBV+ malignancies and exploring possible synergies with checkpoint inhibition, based on the positive activity shown in their Phase 1b/2 trial with nanatinostat and valganciclovir in patients with EBV+ recurrent lymphomas.