PHILADELPHIA, PA — Vittoria Biotherapeutics has hit a significant milestone with the U.S. Food and Drug Administration (FDA) clearing its Investigational New Drug (IND) application for VIPER-101, the company’s leading gene-edited CAR-T cell therapy candidate. This clearance paves the way for a first-in-human Phase 1 clinical trial to treat patients with relapsed or refractory T-cell lymphoma.
Dr. Nicholas Siciliano, CEO of Vittoria, hailed the FDA clearance as a pivotal moment for the company. “This signifies a crucial step toward bringing an innovative treatment option to T-cell lymphoma patients with the potential to transform patient outcomes, enabled by our proprietary Senza5 platform technology,” he said.
Vittoria’s scientific co-founder, Marco Ruella, emphasized the need for new therapies in treating T-cell lymphoma. “VIPER-101 is the first autologous CD5-targeting therapy designed to circumvent fratricide, improve anti-tumor efficacy, and mitigate inherent safety challenges associated with targeting T-cell malignancies with CAR-T therapies,” he stated.
VIPER-101 is a unique autologous, CD5-deleted CAR-T therapy. It is produced using Vittoria’s proprietary cell therapy engineering and manufacturing platform, Senza5TM. The therapy is engineered to avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. These features synergize to maximize potency, safety, and manufacturing efficiency.
Vittoria plans to present multiple abstracts that highlight the compelling preclinical data generated with the VIPER-101 cell therapy candidate at the upcoming 2023 American Society of Hematology (ASH) Annual Meeting.
“We will continue our vigorous dedication as we advance VIPER-101 through clinical trials with phase 1 initiation expected in early 2024,” added Dr. Siciliano. The company anticipates announcing data from its Phase 1 trial in early 2025.
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