FDA Clears IND for VIPER-101 in T-Cell Lymphoma


An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.

  • VIPER-101 is a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy being evaluated as a potential treatment for T-cell lymphoma.

  • A first-in-human phase 1 trial will start following this clearance of an investigational new drug application from the FDA for VIPER-101.

  • Data from the phase 1 study are anticipated to be released in early 2025.

The FDA has cleared the investigational new drug application for VIPER-101 for the treatment of patients with T-cell lymphoma. With this clearance, a first-in-human phase 1 trial will be initiated.1

VIPER-101 is a gene-edited, autologous, CAR T-cell therapy for the potential treatment of patients with relapsed or refractory T-cell lymphoma. The CD5-deleted CAR T-cell therapy was made using the proprietary cell therapy engineering and manufacturing platform, Senza5.

VIPER-101 is unique as it is engineered to avoid fratricide and unlock the benefit of circumventing the inhibitory CD5 signaling pathway. As VIPER-101 is made using a proprietary 5-day process to preserve cell stemness, it synergizes to maximize potency, safety, and manufacturing efficiency.

“As a physician-scientist, I have seen first-hand the need for new therapies when treating T-cell lymphoma patients and as such, it is deeply gratifying to advance the first cell therapy candidate from our novel Senza5 technology into first-in-human studies. 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, thus creating the opportunity to deliver a potentially ground-breaking treatment for patients with T-cell lymphoma,” said Marco Ruella, MD, scientific co-founder of Vittoria Biotherapeutics and an assistant professor of medicine in the Perelman School of Medicine at the University of Pennsylvania (Penn), in a press release.

Red blood cells: © vipman4 - stock.adobe.com

Red blood cells: © vipman4 - stock.adobe.com

Across distinct tumor models, VIPER-101 has shown enhanced antitumor efficacy and broad utility of the Senza5 platform. Senza5, a proprietary cell therapy engineering and manufacturing platform, acts on the fundamental biology of T cells and can be used to improve the efficacy of engineered T-cell therapies.

Multiple abstracts will be presented at the upcoming 2023 American Society of Hematology (ASH) Annual Meeting which will demonstrate preclinical data of VIPER-101. Presentations at ASH will highlight recent data generated at Penn, specifically focusing on the Senza5 platform.2

Further, data from the upcoming phase 1 trial of VIPER-101 in patients with relapsed/refractory T-cell lymphoma are expected in early 2025.1

“The FDA clearance of our investigational new drug application for VIPER-101 marks a pivotal milestone for Vittoria Biotherapeutics and our mission to transform therapeutic outcomes for patients battling difficult to treat diseases,” said Nicholas Siciliano, PhD, chief executive officer of Vittoria, in a press release. “With limited advancements in T-cell lymphoma treatment over the last decade, this signifies a crucial step toward bringing an innovative treatment option to T-cell lymphoma patients with the potential to transform patient outcomes—an opportunity enabled by our proprietary Senza5 platform technology, designed to both enhance efficacy and improve safety.”

  1. Vittoria Biotherapeutics announces FDA clearance of IND application for VIPER-101 to treat T-cell lymphoma. News release. Vittoria Biotherapeutics. December 7, 2023. Accessed December 7, 2023. https://tinyurl.com/33k6xh4v
  2. Vittoria Biotherapeutics announces the presentation of new data supporting the company's platform at the 65th American Society of Hematology annual meeting. November 29, 2023. News release. Accessed December 7, 2023. https://tinyurl.com/23uw3nxe
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