Trial is evaluating VIPER-101, a novel, gene edited, autologous dual-population CAR-T therapy in patients with T cell lymphoma
VIPER-101 was developed with Vittoria’s proprietary Senza5 platform that features CD5 modulation and a proprietary 5-day manufacturing process
Dec. 19, 2024 -- Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options.
VIPER-101 incorporates Vittoria’s proprietary Senza5™ platform which integrates CD5 gene-editing technology with a rapid, 5-day manufacturing process to deliver a potent and targeted therapy for r/r T cell lymphoma. This innovative approach is intended to enhance the efficacy and safety profile of conventional autologous cell therapies, offering new hope to patients whose cancers have not responded to traditional lines of treatment.
“This milestone represents a pivotal step forward in our mission to develop transformative therapies for patients with difficult-to-treat diseases,” said Nicholas Siciliano, Ph.D., 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.”
Marco Ruella, M.D., Scientific Founder of Vittoria Biotherapeutics and a Physician-Scientist in the Perelman School of Medicine at the University of Pennsylvania added, “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.”
The open-label Phase 1 study is designed to assess safety and preliminary efficacy, and to determine the recommended Phase 2 dose (RP2D) of VIPER-101 in patients with r/r CD5 positive nodal T cell non-Hodgkin lymphoma (NHL). The study is currently recruiting patients and additional information can be found at ClinicalTrials.gov (NCT06420089).
The Company anticipates preliminary data from the trial in 2025.
VIPER-101 is a gene-edited, autologous, dual-population cell therapy being evaluated as a potential treatment for patients with T cell lymphoma. VIPER-101 is designed to target CD5, which is present on cancer cells in more than 85% of patients with T cell lymphoma. VIPER-101 leverages the company’s proprietary Senza5 platform technology, which enhances T cell effector function by abrogating CD5-mediated immunosuppression through gene editing. In preclinical studies, VIPER-101 has shown superior efficacy compared to classical CD5-targeted CAR T.
Senza5™ is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering and a proprietary five-day manufacturing process 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. The expedited five-day manufacturing process further enhances stemness, which promotes greater in vivo expansion and durability and the potential for longer-lasting responses. Senza5 can be widely utilized to improve the efficacy of engineered T cell therapies by acting on the fundamental biology of T cells.
Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company, is developing novel CAR T cell therapies that transcend the limitations of current cell therapies. Based on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5™ platform unlocks the cytotoxic potential of engineered T cells and utilizes a five-day manufacturing process to maximize stemness, durability, and potency. By acting on the fundamental biology of T cells, Senza5 can be used to improve the efficacy of engineered T cell therapies with pipeline applications in solid tumors and autoimmune diseases. To learn more, visit vittoriabio.com and follow us on LinkedIn.
Editor’s Note: Dr. Ruella is the scientific founder of, a paid consultant for, and an equity holder in, Vittoria Biotherapeutics. The University of Pennsylvania holds equity in ViTToria Biotherapeutics, has received sponsored research funding from Vittoria, has licensed certain intellectual property to Vittoria, and may receive future funding and financial consideration based on development and commercialization of certain products by Vittoria.
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