Vittoria Biotherapeutics, Inc. has dosed the first patient in its phase 1 clinical trial of VIPER-101, an autologous cell therapy designed to treat relapsed and/or refractory (r/r) T-cell lymphoma. This marks a significant step forward in addressing a severe disease with limited treatment options. The trial aims to evaluate the safety and preliminary efficacy of VIPER-101, with initial data expected in 2025.
VIPER-101: A Novel Approach to T-Cell Lymphoma Treatment
VIPER-101 incorporates Vittoria’s proprietary Senza5 platform, which integrates CD5 gene-editing technology with a rapid, 5-day manufacturing process. This innovative approach is intended to enhance the efficacy and safety profile of conventional autologous cell therapies. The Senza5 platform aims to maximize stemness, durability, and efficacy of its produced cell therapies by disabling the CD5 signaling pathway on engineered CAR T-cells and bypassing CD5’s immunosuppressive effects to amplify the therapy’s antitumor activity.
"This milestone represents a pivotal step forward in our mission to develop transformative therapies for patients with difficult-to-treat diseases," said Nicholas Siciliano, Chief Executive Officer of Vittoria Biotherapeutics. "By addressing the key limitations of existing CAR-T therapies, VIPER-101 is uniquely engineered to enhance the potency, durability, and safety of treatment. We are eager to evaluate its therapeutic potential and look forward to generating meaningful data that could redefine the treatment paradigm for patients battling T cell lymphoma."
Trial Design and Objectives
The open-label phase 1 study is designed to assess the safety and preliminary efficacy of VIPER-101, as well as to determine the recommended phase 2 dose (RP2D) in patients with r/r CD5 positive nodal T-cell non-Hodgkin lymphoma (NHL). VIPER-101 is a gene-edited, autologous, dual-population cell therapy designed to target CD5, which is present on cancer cells in more than 85% of patients with T-cell lymphoma. In preclinical studies, VIPER-101 has demonstrated superior efficacy compared to classical CD5-targeted CAR T-cells.
Addressing Unmet Needs in T-Cell Lymphoma
Marco Ruella, Scientific Founder of Vittoria Biotherapeutics and a Physician-Scientist at the University of Pennsylvania's Perelman School of Medicine, emphasized the importance of this clinical advancement: "Despite advances in cell therapy, patients with T cell lymphoma continue to have limited treatment options. Bringing this innovative approach into the clinic represents the culmination of years of dedicated research aimed at addressing the need for new treatment options for these patients."
