PHILADELPHIA, Dec. 07, 2023 - 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.
VIPER-101 is an autologous, CD5 deleted CAR-T therapy for the treatment of T-cell lymphoma produced using Vittoria’s proprietary cell therapy engineering and manufacturing platform, Senza5TM. CD5 is a pan-T cell marker that also regulates an immunosuppressive signaling pathway, however, conventional CAR-T cell therapies targeting CD5 for T cell malignancies can elicit fratricidal T-cell responses, diminishing treatment efficacy. VIPER-101 is uniquely engineered to both avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. Engineered using a proprietary five-day process to preserve cell stemness, the features of VIPER-101 synergize to maximize potency, safety, and manufacturing efficiency.