Vittoria Biotherapeutics Begins Phase 1 Trial Dosing for VIPER-101

Vittoria Biotherapeutics, Inc., a clinical-stage company focused on developing advanced cell therapies for challenging diseases, has recently commenced a Phase 1 clinical trial of its innovative therapy, VIPER-101. This novel treatment targets relapsed and/or refractory (r/r) T cell lymphoma, a condition with few viable treatment alternatives.

VIPER-101 is an autologous cell therapy that utilizes Vittoria's proprietary Senza5™ platform. This platform integrates CD5 gene-editing technology with an accelerated 5-day manufacturing process, aiming to deliver a potent and specifically-targeted treatment for r/r T cell lymphoma. The approach seeks to improve upon existing autologous cell therapies by offering a more effective and safer option for patients who have not responded to conventional treatments.

Nicholas Siciliano, Ph.D., the CEO of Vittoria Biotherapeutics, emphasized the significance of this development, noting that VIPER-101 is engineered to improve the potency, durability, and safety of CAR-T therapies. He expressed anticipation for the potential of this therapy to change the treatment landscape for patients with T cell lymphoma.

Dr. Marco Ruella, a key scientific figure at Vittoria Biotherapeutics and a faculty member at the University of Pennsylvania, emphasized the need for new treatment approaches in T cell lymphoma. He highlighted the innovative nature of VIPER-101 as the result of extensive research aimed at expanding treatment options for these patients.

The ongoing open-label Phase 1 trial is set to evaluate the safety and preliminary efficacy of VIPER-101, with the objective of determining the recommended Phase 2 dose (RP2D) for patients with r/r CD5-positive nodal T cell non-Hodgkin lymphoma (NHL). Patient recruitment is underway, and more details are accessible on ClinicalTrials.gov under the identifier NCT06420089. Preliminary results from the study are anticipated in 2025.

VIPER-101 is a gene-edited, dual-population cell therapy designed to treat T cell lymphoma by targeting the CD5 molecule, present on cancer cells in over 85% of these patients. The therapy uses the Senza5 platform to enhance T cell function by disrupting CD5-mediated immunosuppression via gene editing. Preclinical studies have indicated that VIPER-101 may offer superior efficacy compared to conventional CD5-targeted CAR T therapies.

The Senza5™ platform stands out by combining genetic engineering with a swift five-day manufacturing process. This combination maximizes the stemness, durability, and efficacy of its cell therapies by interfering with the CD5 signaling pathway in engineered CAR T cells, thus boosting antitumor activity. The quick manufacturing process promotes greater in vivo expansion and durability, potentially leading to more enduring treatment responses. Senza5 can be adapted to enhance the effectiveness of engineered T cell therapies by addressing key aspects of T cell biology.

Vittoria Biotherapeutics is leveraging exclusive technology from the University of Pennsylvania to develop CAR T cell therapies that surpass the limitations of current options. The Senza5™ platform is designed to unlock the cytotoxic potential of engineered T cells, aiming to maximize their stemness, durability, and potency through expedited production processes. Applications of this technology extend to solid tumors and autoimmune diseases, showcasing its versatile potential in advancing cell therapy efficacy.