Vittoria Biotherapeutics has announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human Phase 1 clinical trial to evaluate the Company’s lead candidate, VIPER-101, a gene-edited, autologous, CAR-T cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
“The FDA clearance of our investigational new drug application for VIPER-101 marks a pivotal milestone for Vittoria Biotherapeutics and our mission to transform therapeutic outcomes for patients battling difficult to treat diseases,” said Dr. Nicholas Siciliano, Ph.D., chief executive officer of Vittoria. “With limited advancements in T-cell lymphoma treatment over the last decade, this signifies a crucial step toward bringing an innovative treatment option to T-cell lymphoma patients with the potential to transform patient outcomes – an opportunity enabled by our proprietary Senza5 platform technology, designed to both enhance efficacy and improve safety.”
Marco Ruella, MD, scientific co-founder of Vittoria and an assistant professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania commented, “As a physician-scientist, I have seen first-hand the need for new therapies when treating T-cell lymphoma patients and as such, it is deeply gratifying to advance the first cell therapy candidate from our novel Senza5 technology into first-in-human studies. VIPER-101 is the first autologous CD5-targeting therapy designed to circumvent fratricide, improve anti-tumor efficacy, and mitigate inherent safety challenges associated with targeting T-cell malignancies with CAR-T therapies, thus creating the opportunity to deliver a potentially ground-breaking treatment for patients with T-cell lymphoma.”