Pharma Focus Europe

FDA Clears Vittoria Biotherapeutics' IND Application for VIPER-101 to Address T-Cell Lymphoma

Friday, December 08, 2023

Vittoria Biotherapeutics has achieved a significant milestone with the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). This clearance paves the way for the initiation of a groundbreaking Phase 1 clinical trial for VIPER-101, the company's lead candidate. VIPER-101 is a gene-edited, autologous CAR-T cell therapy designed for patients facing relapsed or refractory T-cell lymphoma.

Dr. Nicholas Siciliano, CEO of Vittoria, expressed the importance of this FDA clearance, highlighting the company's commitment to transforming therapeutic outcomes for challenging diseases. The CEO emphasized the lack of substantial advancements in T-cell lymphoma treatment in recent years and sees VIPER-101 as a crucial step toward introducing an innovative treatment option. He credited the proprietary Senza5 platform technology for enhancing efficacy and improving safety.

Scientific co-founder Marco Ruella, MD, underscored the urgent need for new therapies in treating T-cell lymphoma patients. He expressed satisfaction in advancing VIPER-101, the first cell therapy candidate from the Senza5 technology, into human studies. VIPER-101 is unique in targeting CD5, a pan-T cell marker and regulator of an immunosuppressive pathway. The therapy is engineered to overcome challenges associated with conventional CAR-T therapies targeting CD5, such as fratricidal T-cell responses, aiming to provide a groundbreaking treatment for T-cell lymphoma patients.

VIPER-101, produced using the Senza5 platform, undergoes a proprietary five-day process to preserve cell stemness, maximizing potency, safety, and manufacturing efficiency. The upcoming 2023 American Society of Hematology (ASH) Annual Meeting will feature presentations highlighting compelling preclinical data for VIPER-101 and demonstrating the broad utility and enhanced anti-tumor efficacy of the Senza5 platform across various tumor models.

Dr. Siciliano affirmed the company's dedication as they transition from a preclinical to a clinical stage, with Phase 1 initiation expected in early 2024. The company plans to announce Phase 1 trial data in early 2025.

Senza5, the proprietary cell therapy engineering and manufacturing platform, integrates genetic engineering and a unique five-day manufacturing process. By disabling the CD5 signaling pathway on engineered CAR-T cells, Senza5 aims to maximize stemness, durability, and efficacy, overcoming immunosuppressive effects and enhancing antitumor activity. The platform's focus on T cell biology positions Senza5 as a versatile tool for improving the efficacy of engineered T-cell therapies.



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