SAN DIEGO, April 8, 2020 /PRNewswire/ - Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, today announced that the Company recently held a collaborative and productive guidance (Type C) Meeting with the United States Food and Drug Administration (FDA). The Type C Meeting was held on March 31, 2020 regarding the Company's lead program, nanatinostat in combination with the antiviral valganciclovir, for the treatment of Epstein-Barr virus (EBV)-associated lymphoma. The purpose of the meeting was to obtain the FDA's input on patient selection and clinical data needed to ensure readiness for the development of a registrational trial in patients with relapsed or refractory EBV-associated lymphoma. Viracta intends to request an end-of-Phase 2 (EOP2) meeting later in 2020.
"We are pleased with our recent regulatory interactions and collaboration with the FDA," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "Our discussions were very constructive and demonstrated a high level of engagement and support from the Agency, giving us further conviction to rapidly advance our program towards registration and ultimately deliver this therapy to address the unmet need of patients across EBV-associated lymphoma subtypes."
Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class 1 HDACs which is key to inducing latent viral genes in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV-associated lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].
Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in relapsed/refractory lymphomas, as well as Orphan Drug Designation for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and angioimmunoblastic T-cell lymphoma.
Approximately 95% of the world's adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient's life. Under certain circumstances, such cells may undergo malignant transformation and become lymphoma. In addition to lymphomas, EBV is associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.
Viracta is a precision oncology company targeting virus-associated malignancies. The Company's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in a Phase 2 clinical trial for Epstein-Barr virus positive lymphomas. Viracta is pursuing application of this Kick and Kill platform approach in other EBV associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma and other viral related cancers.
For additional information please visit www.viracta.com.