Nanatinostat Gets Orphan Drug Designation for EBV-Associated Cancers

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.

“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.