Vittoria Biotherapeutics Announces FDA Clearance for VIPER-101 IND in T-Cell Lymphoma

Vittoria Biotherapeutics has disclosed the approval of their Investigational New Drug (IND) submission by the FDA, paving the way for the commencement of a pioneering Phase 1 clinical trial in humans. This trial aims to assess the efficacy of VIPER-101, the leading therapeutic candidate from the company, which consists of a gene-edited, autologous CAR-T cell therapy, designed specifically for the treatment of individuals suffering from T-cell lymphoma that has either resisted previous treatment or recurred.

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The authorization by the FDA of our experimental drug proposal for VIPER-101 signifies a significant breakthrough for our company, Vittoria Biotherapeutics, in our quest to improve treatment outcomes for those suffering from hard-to-treat illnesses,” stated Dr. Nicholas Siciliano, Ph.D., the CEO of Vittoria. 

“Considering the few developments in the area of T-cell lymphoma therapies over the past years, this represents an essential progression in introducing a novel therapeutic approach to individuals with T-cell lymphoma, potentially revolutionizing their treatment results. This is made possible through our exclusive technology platform, Senza5, developed to augment effectiveness and enhance safety.” Dr. Siciliano elaborated further.

VIPER-101 is a personalized CAR-T therapy targeting CD5, designed for T-cell lymphoma, and is developed on Vittoria’s unique cell therapy engineering and production platform, Senza5TM. While CD5 serves as a general marker for T-cells and plays a role in an immune-downregulating pathway, conventional CAR-T treatments directed at CD5 for malignant T-cell conditions may induce self-targeting immune responses, reducing the treatment's potency.

VIPER-101 is innovatively constructed to prevent such self-targeting and to fully leverage the advantage of bypassing the suppressive CD5 pathway. Using a specialized five-day refining technique to maintain cellular youthfulness, VIPER-101's attributes are harmonized to optimize power, safety, and production process efficiency.

At the forthcoming ASH Annual Meeting in 2023, a series of abstracts are slated to be presented that display the significant preclinical outcomes obtained with VIPER-101, and that highlight the Senza5 platform's extensive promise and increased tumor-fighting capabilities in various cancer models.

Dr. Siciliano declared: “Our team’s intense commitment, which has been instrumental in our swift and cost-effective shift from the research stage to clinical phase, will remain our cornerstone as we usher VIPER-101 into clinical trials, with the start of phase 1 slated for the start of 2024.”

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According to the data provided by the Synapse Database, As of December 15, 2023, there are 19 investigational drugs for the CD5 target, including 18 indications, 22 R&D institutions involved, with related clinical trials reaching 8, and as many as 9577 patents.

VIPER-101 targets CD5 and is intended for the treatment of T-cell lymphoma. The drug has received IND approval, indicating its potential as a therapeutic option for patients with this specific type of cancer.