Viracta Therapeutics Announces Notice of Allowance for U.S. Patent Application Covering its Combination Product Candidate for the Treatment of Viral or Virally-Induced Conditions
Resulting patent to extend Viracta's intellectual property protection

SAN DIEGO, July 9, 2020 /PRNewswire/ - Viracta Therapeutics, Inc., a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 15/959,482. The allowed application, titled "Methods and Compositions for Treating Viral or Virally-induced Conditions," protects the use of Viracta's all-oral combination product candidate of nanatinostat, Viracta's proprietary investigational drug, and valganciclovir for the treatment of Epstein-Barr virus (EBV)-associated cancers. Upon its grant, the resulting patent will provide protection into at least 2031, with claims broadly covering the treatment of viral or virally-induced conditions using a combination of nanatinostat and certain antiviral agents listed in the claims, including valganciclovir.

"This Notice of Allowance represents an important addition to our intellectual property portfolio and strategy, as the resulting patent provides additional protection to our all-oral combination therapy as we advance our program towards registration," said Ivor Royston, MD, President and Chief Executive Officer of Viracta. "Notably, the comprehensive nature of the allowed claims offers protection not only for Viracta's program for EBV-associated lymphoma, but also for the treatment of other EBV-associated malignancies, such as nasopharyngeal carcinoma and gastric carcinoma, which will be important as we plan to initiate our EBV-associated solid tumor clinical program in the near future."

In addition to the recently allowed method of treatment application, Viracta's U.S. intellectual property portfolio includes a granted composition of matter patent, potential market exclusivities based on its granted orphan drug designations, and additional patent applications that could provide patent protection into 2040.

A Notice of Allowance is issued after the USPTO makes the determination that a patent should be granted from an application. A patent from the recently allowed application is expected to be issued in the coming months. Based on its current development and commercialization plans, Viracta expects this patent to be Orange Book eligible.

About Nanatinostat

Nanatinostat (VRx-3996) 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 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 EBV-positive lymphomas, as well as orphan drug designations for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and T-cell lymphomas, including angioimmunoblastic T-cell lymphoma and extranodal NK/T-cell lymphoma.

About EBV-Associated Cancers

Approximately 95% of the world's adult population is infected with 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.

About Viracta Therapeutics, Inc.

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 EBV-positive lymphomas. Viracta is pursuing application of this Kick and Kill platform approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma and gastric carcinoma, and other viral-related cancers.

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