Viracta Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to nanatinostat (VRx-3996), in combination with valganciclovir, for the treatment of post-transplant lymphoproliferative disorder (PTLD), plasmablastic lymphoma, and angioimmunoblastic T cell lymphoma.

Nanatinostat, an oral Class I histone deacetylase (HDAC) inhibitor, is being evaluated in a phase 1b/2 trial Epstein Barr Virus (EBV)-associated lymphomas. The drug candidate works by affecting the coiling of DNA around histones to change epigenetically-controlled expression patterns.

As part of the Company’s “Kick & Kill” approach, nanatinostat is designed to activate EBV genes that have been epigenetically suppressed, whereas valganciclovir, an antiviral, kills virus-harboring cancer cells. The combination therapy has the potential to be the first targeted, oral epigenetic therapy for EBV-associated cancers.


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“We are pleased that the FDA has granted Orphan Drug status to nanatinostat, further validating our therapeutic approach and expediting the development of novel treatments for virally-driven cancers.  Importantly, the Orphan Drug designation includes both T cell and B cell lymphomas, which highlights our ability to target cancer cells that contain the EBV genome regardless of tumor type,” said Ivor Royston, MD, Viracta’s CEO.

For more information visit Viracta.com.

This article originally appeared on MPR