VIPER-101 / viTToria Biotherap - LARVOL DELTA

Title first‑in‑human Phase 1 dose‑finding study (VIPER 101) of dual‑population autologous CD5‑deleted anti-CD5 CAR‑T (Senza5 CART5) cells in Relapsed/Refractory T‑cell lymphomas (ASH 2025) - P1 | "In this open‑label, dose‑finding Phase1 trial, adults with histologically confirmedrelapsed/refractory (r/r) CD5+ T‑cell lymphoma after ≥1 prior therapy receive lymphodepletion(fludarabine 25mg/m² + cyclophosphamide 250mg/m² x 3 days or bendamustine 90mg/m² x 2 days)followed by a single IV infusion of Senza5 CART5 at doses ranging from 3x106 to 1.25x108 CAR+ cells.Primary endpoints are safety and recommended Phase2 dose (RP2D); secondary/exploratory endpointsinclude manufacturing feasibility, invivo expansion, tissue trafficking, T‑cell aplasia mitigation, overallresponse rate (ORR), and complete response (CR) rate per Lugano criteria. While follow-up is limited, these data support further development of Senza5 CART5 for r/rT‑cell lymphomas. Moreover, these results underscore the potential for CD5 deletion as a platform tobroadly enhance the efficacy of engineered T-cell therapies for additional indications."

Clinical • First-in-human • P1 data • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Lymphoma • Rare Diseases • T Cell Non-Hodgkin Lymphoma • CD4 • CD5 • CD8

Senza5TM CART5: An Autologous CD5-Deleted Anti-CD5 CART Product with Enhanced Anti-T-Cell Lymphoma Activity (ASH 2023) - "This novel CD5 KO anti-CD5 CART product manufactured in a 5-day GMP process shows high specificity and significantly enhanced antitumor efficacy resulting from the synergistic effect of improved early T-cell activation due to CD5 deletion and preservation of T-cell memory phenotypes conferred by a novel, 5-day manufacturing processes. Autologous Senza5TM CART5 for the treatment of CD5+ nodal T-cell lymphomas is expected to enter the clinic in a Phase I study later this year."

IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Cell Non-Hodgkin Lymphoma • CD4 • CD8 • TRB

CD5-Deleted Chimeric Antigen Receptor Cells (Senza5™ CART5) to Enhance Immunotherapy Against T-Cell Non-Hodgkin Lymphoma: A First-in-Human Phase I Clinical Trial (ASH 2024) - P1 | "Participants will receive 3x106 (DL -1) to 1.25x108 (DL4) CART5+ cells based on the assigned DL, preceded by lymphodepletion with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 (Flu/Cy) IV daily on days -5 to -3 (or bendamustine 90mg/m2 IV daily on days -5 and -4 if contraindications to or unavailability of Flu/Cy). We will also assess the impact of treatment on normal T cells, and the persistence of CD5KO untransduced T cells that are infused as part of the Senza5™ CART5 product by multicolor flow cytometry, qPCR, and single-cell RNA/TCR sequencing.The trial is registered at clinicaltrials.gov as NCT06420089 and open to accrual. Enrollment is ongoing."

Clinical • First-in-human • IO biomarker • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD5

VIPER-101: CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Vittoria Biotherapeutics | Trial completion date: Jun 2027 ➔ Aug 2029 | Trial primary completion date: Aug 2026 ➔ Aug 2028

First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Vittoria Biotherapeutics…announced it will share interim clinical data from its Phase 1 first-in-human study of VIPER-101, a CD5-modulated autologous CAR-T therapy for patients with relapsed or refractory (r/r) T-cell lymphoma (TCL), in a poster presentation at the American Society of Hematology Annual Meeting (GlobeNewswire)

First-in-human • P1 data • T Cell Non-Hodgkin Lymphoma

CD5-deleted chimeric antigen receptor cells (Senza5 CART5) to enhance immunotherapy against T-cell non-Hodgkin lymphoma: A first-in-human phase I clinical trial (NCT06420089). (ASCO 2025) - P1 | "The trial is sponsored by Vittoria Biotherapeutics and is registered at clinicaltrials.gov as NCT06420089. Enrollment in this trial has begun."

Clinical • IO biomarker • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD5

Vittoria Biotherapeutics to Share Trials-in-Progress Presentation from Phase 1 Study of VIPER-101 at ASCO 2025 Annual Meeting (GlobeNewswire) - "Vittoria Biotherapeutics...announced it will present a trials-in-progress poster highlighting the ongoing Phase 1 clinical trial of VIPER-101, the Company’s lead investigational CD5-targeted CAR-T therapy for relapsed/refractory T-cell lymphoma, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....The presentation will feature the design and objectives of the Phase 1 study, which marks the first clinical application of Vittoria’s proprietary Senza5 platform....The open-label Phase 1 study is designed to assess safety and preliminary efficacy, and to determine the recommended Phase 2 dose (RP2D) of VIPER-101 in patients with relapsed or refractory CD5 positive T-cell non-Hodgkin lymphoma (NHL)."

Clinical protocol • T Cell Non-Hodgkin Lymphoma

Vittoria Biotherapeutics Announces Dosing of First Patient in Phase 1 Clinical Trial of VIPER-101 (GlobeNewswire) - "Vittoria Biotherapeutics...announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options....The open-label Phase 1 study is designed to assess safety and preliminary efficacy, and to determine the recommended Phase 2 dose (RP2D) of VIPER-101 in patients with r/r CD5 positive nodal T cell non-Hodgkin lymphoma (NHL). The study is currently recruiting patients....The Company anticipates preliminary data from the trial in 2025."

P1 data • Trial status • T Cell Non-Hodgkin Lymphoma

Vittoria Biotherapeutics Completes $25 Million in Private Financing to Propel Groundbreaking Cell Therapy Candidates (GlobeNewswire) - "This funding is a $10 million extension to its previous $15 million financing secured in November 2023. The latest round was led by Valley Forge Investment Corporation, with new investments from the Global BioAccess Fund and Hatch Biofund, alongside ongoing support from existing investors Agent Capital, Tellus BioVentures, NYBC Ventures, and the University of Pennsylvania. The funds will primarily support the company’s Phase 1 clinical trial of its lead oncology candidate, VIPER-101, an autologous, dual-population T cell therapy, as a potential treatment of T-cell Lymphoma."

Financing • Non-Hodgkin’s Lymphoma

VIPER-101: CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Vittoria Biotherapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Vittoria Biotherapeutics Announces Peer-Reviewed Publication in Science Immunology (GlobeNewswire) - "The preclinical study...describes the benefits of the approach of modulating the CD5 signaling pathway and utilizing a proprietary five-day manufacturing process to enhance CAR T potency, durability, and accessibility. These features may address existing challenges with current CAR T-cell treatments including CAR T exhaustion, suboptimal efficacy, and manufacturing inefficiencies....Vittoria's VIPER-101 clinical trial is now open for enrollment for the treatment of T-cell lymphoma....Initial clinical data is expected in early 2025..."

P1 data • Preclinical • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

VIPER101: CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Vittoria Biotherapeutics

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Vittoria Biotherapeutics Announces Keith Westby as Chief Operating Officer (GlobeNewswire) - "Vittoria Biotherapeutics, a clinical-stage cell therapy company, has announced that Keith Westby has joined the company as its inaugural Chief Operating Officer. Mr. Westby brings over two decades of biotechnology entrepreneurial experience and a proven track record of building successful organizations. In his role, Mr. Westby will manage the advancement of Vittoria’s novel therapeutics into the clinic, including Vittoria’s lead program, VIPER-101, for the treatment of T-cell lymphoma."

Clinical • Hematological Malignancies • Lymphoma • Oncology

Vittoria Biotherapeutics Announces FDA Clearance of IND Application for VIPER-101 to Treat T-Cell Lymphoma (GlobeNewswire) - "Vittoria Biotherapeutics has announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human Phase 1 clinical trial to evaluate the Company’s lead candidate, VIPER-101, a gene-edited, autologous, CAR-T cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma....At the upcoming 2023 American Society of Hematology (ASH) Annual Meeting, multiple abstracts will be presented that highlight the compelling preclinical data generated with the VIPER-101 cell therapy candidate, and that showcase the broad utility and enhanced anti-tumor efficacy of the Senza5 platform across distinct tumor models....as we advance VIPER-101 through clinical trials with phase 1 initiation expected in early 2024.'...The Company anticipates announcing data from its Phase 1 trial in early 2025."

IND • New P1 trial • P1 data • Preclinical • Hematological Malignancies • Lymphoma • Oncology

Vittoria Biotherapeutics Secures Over $15 Million in Private Financing Round to Support the Development of Novel CAR-T Cell Therapies (GlobeNewswire) - "Vittoria Biotherapeutics today announced it has secured over $15 million in a private financing round. The funds will be used to continue advancing Vittoria’s lead candidate, VIPER-101, an autologous, dual population CD5-knockout CAR-T cell therapy for T-cell Lymphoma, into the clinic. VIPER-101 features the Company’s novel Senza5Ô platform technology...'we plan to use this capital to advance our lead program, VIPER-101 - for the treatment of T-cell lymphoma - into the clinic in early 2024.'"

Financing • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

MaxCyte and Vittoria Biotherapeutics Sign Strategic Platform License to Advance Next Generation Cellular Therapies (GlobeNewswire) - "MaxCyte, Inc...and Vittoria Biotherapeutics...announced the signing of a strategic platform license (SPL) of MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform to Vittoria Biotherapeutics. Under the terms of the agreement, Vittoria will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue. Vittoria’s technology and clinical programs are designed to address current gaps with contemporary cell therapies and the Company is planning to file an investigational new drug application (IND) for their lead program, Viper 101, later this year."

IND • Licensing / partnership • Hematological Malignancies • Lymphoma • Oncology