PHILADELPHIA, PA — Vittoria Biotherapeutics, Inc. has announced the launch of its Phase 1 clinical trial for VIPER-101, a cutting-edge gene-edited cell therapy aimed at treating relapsed and refractory (r/r) T cell lymphoma. This severe form of cancer has limited treatment options, making the advancement a significant leap forward in oncology.
VIPER-101 is built on Vittoria’s proprietary Senza5™ platform, which integrates CD5 gene-editing technology with a rapid five-day manufacturing process. This platform is designed to enhance the therapy’s potency, durability, and safety, offering promise for patients who have not responded to conventional treatments.
“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., CEO of Vittoria Biotherapeutics. “By addressing the key limitations of existing CAR-T therapies, VIPER-101 is uniquely engineered to redefine the treatment paradigm for patients battling T cell lymphoma.”
The Phase 1 study will assess the safety, preliminary efficacy, and recommended Phase 2 dose of VIPER-101 in patients with CD5-positive nodal T cell non-Hodgkin lymphoma. The company plans to release preliminary trial data in 2025.
“Despite advances in cell therapy, patients with T cell lymphoma continue to have limited treatment options,” noted Marco Ruella, M.D., Scientific Founder of Vittoria Biotherapeutics. “Bringing this innovative approach into the clinic represents the culmination of years of dedicated research.”
VIPER-101 will specifically target CD5, a protein expressed in more than 85% of patients with T cell lymphoma. Preclinical studies suggest the therapy delivers superior efficacy compared to traditional CD5-targeted CAR T-cell approaches. The Senza5 platform also demonstrates breakthrough capabilities by enhancing antitumor activity and improving cell therapy durability through genetic engineering.
This trial represents new hope for patients with r/r T cell lymphoma, combining advanced technology with years of scientific innovation.
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