Enzyvant, a biopharmaceutical company focused on developing innovative treatments for patients with rare diseases, formed a partnership with Visikol, a contract research organization focused on digital pathology and drug discovery.
Under the terms of the agreement, Visikol will collaborate with Enzyvant and Duke University (Darem, North Carolina, USA) to develop a novel assay for thymic histology samples. The purpose of this investigational assay is to provide a quantitative technique for assessment of RVT-802 and is an important step in ongoing efforts to support an FDA filing.
RVT-802 is an investigational, thymic-tissue based regenerative therapy designed to treat the primary immune deficiency resulting from congenital athymia associated with complete DiGeorge Anomaly.
Ezyvant has offices in Basel, Swizerland and Cambridge, USA. The company plans to initiate the rolling Biologics License Application submission for RVT-802 to the U.S. Food and Drug Administration (FDA) later this year. RVT-802 has received Breakthrough Therapy designation, Regenerative Medicine Advanced Therapy designation, rare pediatric disease designation, and orphan drug designation from the FDA.