Viracta Therapeutics announces ODD granted by U.S. FDA to nana-val

Viracta Therapeutics announced that the U.S. Food and Drug Administration has granted an orphan drug designation, ODD, to Nana-val, the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers, for the treatment of nasopharyngeal carcinoma. “This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We are encouraged by the interim data from the Phase 1b/2 study of Nana-val in patients with recurrent or metastatic EBV-positive nasopharyngeal carcinoma, supporting the continued advancement of the study with a new split daily dosing regimen at higher doses. With sites open and enrolling the sixth dose cohort of the study, we are on track to expand into the Phase 2 portion in 2024. The growing clinical data in both the lymphoma and solid tumor settings, further validates the therapeutic potential of Nana-val to treat EBV-positive cancers, an underserved area of high unmet medical need.”