Vittoria Biotherapeutics Announces FDA RMAT and Orphan Drug Designations for Senza5 CART5 (VIPER-101) in T-Cell Lymphoma
RMAT designation provides early and frequent FDA engagement to support planned pivotal development of Senza5 CART5
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RMAT designation provides early and frequent FDA engagement to support planned pivotal development of Senza5 CART5
Therapy may be eligible for priority review and accelerated approval if applicable criteria are met
Orphan Drug Designation, granted in July 2026, provides development incentives to support Senza5 CART5 in T-cell lymphoma
PHILADELPHIA, Nov. 10, 2026 (GLOBE NEWSWIRE) — Vittoria Biotherapeutics, Inc. (“Vittoria” or the “Company”), a clinical-stage immunotherapy company developing engineered T-cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation to Senza5 CART5 (VIPER-101), its investigational CD5-edited autologous CAR-T cell therapy, for the treatment of relapsed or refractory CD5-positive peripheral T-cell lymphoma.
RMAT designation is intended for regenerative medicine therapies addressing serious or life-threatening conditions for which preliminary clinical evidence indicates the potential to address unmet medical needs. The designation provides opportunities for enhanced interaction with FDA to facilitate efficient clinical development and review. The RMAT designation was based on clinical data from the Phase 1 VIPER-101 study. Orphan Drug Designation is intended to encourage treatments for rare diseases and offers development incentives, including tax credits for qualifying clinical trials, exemption from certain FDA user fees, and the potential for seven years of U.S. market exclusivity if the therapy is subsequently approved for the designated use.
“These designations represent significant milestones for Senza5 CART5 and reinforce the therapy’s potential to address a critical unmet need in T-cell lymphoma,” said Nicholas A. Siciliano, Ph.D., Chief Executive Officer of Vittoria Biotherapeutics. “The encouraging clinical activity observed to date, combined with our differentiated approach to T-cell engineering, provides a compelling foundation for the program’s continued advancement. We look forward to working closely with FDA under the RMAT designation to advance Senza5 CART5 into a pivotal study for relapsed or refractory T-cell lymphoma.”
Results from the Phase 1 VIPER-101 clinical trial will be presented in an oral session at the 68th American Society of Hematology (ASH) Annual Meeting on December 14, 2026. The trial (NCT06420089) is evaluating VIPER-101 in patients with relapsed or refractory CD5-positive peripheral T-cell lymphoma. VIPER-101 uses Vittoria’s proprietary Senza5® platform to produce a dual-population CAR-T therapy: CD5-edited, CD5-directed CAR-T cells designed for antitumor activity and companion CD5-negative, CAR-negative T cells designed to support immune reconstitution. The therapy is manufactured using Vittoria’s rapid, five-day process.
About Vittoria Biotherapeutics
Vittoria Biotherapeutics, Inc. is a clinical-stage immunotherapy company developing engineered T-cell therapies that address key limitations of current approaches. Built on technology exclusively licensed from the University of Pennsylvania, the Company’s proprietary Senza5 platform unlocks the cytotoxic potential of engineered T cells and uses a five-day manufacturing process to maximize stemness, durability, and potency. By acting on the fundamental biology of T cells, Senza5 is designed to improve the efficacy of engineered T-cell therapies, with pipeline applications in hematologic malignancies, solid tumors, and autoimmune diseases. Building on its expertise in T-cell biology and CD5 modulation, Vittoria is also developing LampTAC, a modular, cell-intrinsic protein degradation platform that enables genome-editing-free engineering of next-generation cell therapies. To learn more, visit vittoriabio.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the potential benefits of RMAT and Orphan Drug Designations, the clinical development of Senza5 CART5, planned interactions with FDA, and the design and timing of any pivotal study. These statements are based on current expectations and are subject to risks and uncertainties, including that results from early studies may not be predictive of results in later studies, that FDA may not agree with the Company’s proposed development plan, and that designations do not guarantee expedited development, review, or approval. Vittoria undertakes no obligation to update these statements except as required by law.
Investor Contact
Vittoria Biotherapeutics, Inc.
Nicholas A. Siciliano, Ph.D.
Chief Executive Officer
+1 215-600-1380
NSiciliano@vittoriabio.com
Media Contact
LifeSci Communications
Mike Tattory
mtattory@lifescicomms.com
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