An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.
The FDA has cleared the investigational new drug application for VIPER-101 for the treatment of patients with T-cell lymphoma. With this clearance, a first-in-human phase 1 trial will be initiated.1
VIPER-101 is a gene-edited, autologous, CAR T-cell therapy for the potential treatment of patients with relapsed or refractory T-cell lymphoma. The CD5-deleted CAR T-cell therapy was made using the proprietary cell therapy engineering and manufacturing platform, Senza5.
VIPER-101 is unique as it is engineered to avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. As VIPER-101 is made using a proprietary 5-day process to preserve cell stemness, it synergizes to maximize potency, safety, and manufacturing efficiency.
“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,” said Marco Ruella, MD, scientific co-founder of Vittoria Biotherapeutics and an assistant professor of medicine in the Perelman School of Medicine at the University of Pennsylvania (Penn), in a press release.
Across distinct tumor models, VIPER-101 has shown enhanced antitumor efficacy and broad utility of the Senza5 platform. Senza5, a proprietary cell therapy engineering and manufacturing platform, acts on the fundamental biology of T cells and can be used to improve the efficacy of engineered T-cell therapies.
Multiple abstracts will be presented at the upcoming 2023 American Society of Hematology (ASH) Annual Meeting which will demonstrate preclinical data of VIPER-101. Presentations at ASH will highlight recent data generated at Penn, specifically focusing on the Senza5 platform.2
Further, data from the upcoming phase 1 trial of VIPER-101 in patients with relapsed/refractory T-cell lymphoma are expected in early 2025.1
“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 Nicholas Siciliano, PhD, chief executive officer of Vittoria, in a press release. “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.”