Vittoria Biotherapeutics to Present First-in-Human CAR-T Data for T-Cell Lymphoma at ASH 2025
核心洞察
Vittoria Biotherapeutics (搜索) will present interim Phase 1 data for VIPER-101, a CD5 (搜索)-modulated autologous CAR-T therapy targeting relapsed or refractory T-cell lymphoma (搜索), at the American Society of Hematology annual meeting in December.
VIPER-101 utilizes the company's proprietary Senza5 platform technology, which combines gene editing with a five-day manufacturing process to enhance T-cell stemness, durability, and efficacy by disabling CD5 (搜索)-mediated immunosuppression.
The therapy targets CD5 (搜索), which is present on cancer cells in more than 85% of patients with T-cell lymphoma (搜索), and has demonstrated superior efficacy compared to classical CD5-targeted CAR-T therapies in preclinical studies.
Vittoria Biotherapeutics (搜索) announced it will present interim clinical data from its first-in-human Phase 1 study of VIPER-101, a CD5 (搜索)-modulated autologous CAR-T therapy for patients with relapsed or refractory T-cell lymphoma (搜索) (TCL), at the American Society of Hematology annual meeting in Orlando, Florida from December 6-9, 2025. The poster presentation, scheduled for December 7, will mark the first public release of clinical findings for the company's lead program.
"T-cell lymphoma (搜索) has remained an exceptionally challenging disease with limited therapeutic advances for far too long," said Nicholas Siciliano, Ph.D., Chief Executive Officer of Vittoria Biotherapeutics (搜索). "Vittoria's interim clinical data, being presented for the first time, provide clear evidence of the translatability and therapeutic benefits of our Senza5 platform technology and demonstrate the potential of our CD5 (搜索)-targeted, dual-population CAR-T candidate to meaningfully shift the treatment paradigm for patients living with T-cell lymphoma."
Novel Dual-Population CAR-T Design
VIPER-101 is a gene-edited, autologous, dual-population cell therapy being evaluated as a potential treatment for patients with T-cell lymphoma (搜索). The therapy is designed to target CD5 (搜索), which is present on cancer cells in more than 85% of patients with T-cell lymphoma. Unlike classical CD5-directed CAR-T therapies, VIPER-101 incorporates a dual-population design and uses gene editing to disable CD5 signaling, aiming to counteract the immunosuppressive pathway that typically limits T-cell activity.
In preclinical studies, VIPER-101 has shown superior efficacy compared to classical CD5 (搜索)-targeted CAR-T therapies, setting high expectations for the interim human data to be presented at ASH.
Senza5 Platform Technology
VIPER-101 leverages Vittoria's proprietary Senza5 platform technology, which enhances T-cell effector function by abrogating CD5 (搜索)-mediated immunosuppression through gene editing. The Senza5 platform is a proprietary cell therapy engineering and manufacturing platform that combines the power of genetic engineering with a proprietary five-day manufacturing process to maximize stemness, durability, and efficacy of its produced cell therapies.
The platform works by disabling the CD5 (搜索) signaling pathway on engineered CAR-T cells and bypassing CD5's immunosuppressive effects to amplify the therapy's antitumor activity. The expedited five-day manufacturing process further enhances stemness, which promotes greater in vivo expansion and durability and the potential for longer-lasting responses. According to the company, Senza5 can be widely utilized to improve the efficacy of engineered T-cell therapies by acting on the fundamental biology of T-cells.
ASH Presentation Details
The presentation will take place on December 7 from 6:00 PM to 8:00 PM ET during Session 704: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II, located at OCCC - West Halls B3-B4. The presentation is titled "First in human Phase 1 dose finding study (VIPER 101) of dual population autologous CD5 (搜索) deleted anti-CD5 CAR T (Senza5 CART5) cells in Relapsed/Refractory T cell lymphomas" and has been assigned Publication Number 4174.
An electronic version of the poster will be made available on Vittoria's website at the conclusion of the presentation. The ASH presentation will be closely watched for early signs of efficacy, safety, and manufacturing scalability — all critical benchmarks for advancing an engineered T-cell therapy in one of the most treatment-resistant hematologic cancers.