LB2501 / Legend Biotech - LARVOL DELTA

FIRST-IN-HUMAN TRIAL OF LB2501, AN IN VIVO CD19/CD20 DUAL TARGETING CAR-T THERAPY, IN RELAPSED/REFRACTORY B-CELL NHL (EHA 2026) - P1 | "Infusion-related reactions occurred in 9 patients (75.0%); all were grade 1 or 2, resolved within a median of 2.0 days, and required no tocilizumab or glucocorticoids. While a longer-follow up is warranted, these data highlight the potential of LB2501 as a scalable, readily accessible "off ‑ the ‑ shelf" immunotherapy for B ‑ cell malignancies. Figure 1: Patient Responses to DL2"

CAR T-Cell Therapy • First-in-human • Late-breaking abstract • P1 data • Preclinical • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma

H.C. Wainwright reiterates Legend Biotech stock rating on strong Carvykti sales (Investing.com) - "The firm noted that Carvykti sales reached $657 million in the second quarter of 2026, representing a 10% increase from $597 million in the prior quarter. The result came 0.3% above consensus estimates of $655.3 million. The company’s overall revenue growth remains robust at 56% over the last twelve months as of Q1 2026, while analysts predict Legend will turn profitable this year...in the second half of 2026 to reach the firm’s forecast of approximately $2.6 billion for the full year...Legend Biotech’s second-quarter 2026 earnings represent the next event, with potential updates on LB2501 durability..."

Pipeline update • Sales • Sales projection • B Cell Non-Hodgkin Lymphoma • Multiple Myeloma

Legend Biotech Establishes Clinical Proof-of-Concept for LB2501, a Potential First-in-Class In Vivo CD19/CD20 Dual-Targeting CAR-T, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (GlobeNewswire) - "Achieved 100% ORR and 83.3% CR rate at dose level 2 following a single infusion in patients with relapsed/refractory B-NHL in an ongoing Phase 1 study. Single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. No dose-limiting toxicities, serious adverse events, ICANS, or deaths were reported; infusion-related reactions and CRS were Grade 1–2, and none required glucocorticoids for CRS management....Proof-of-concept progress demonstrates leadership in next-generation cell therapies, with results presented in a late-breaking session at EHA 2026."

Late-breaking abstract • P1 data • B Cell Non-Hodgkin Lymphoma

Legend Biotech Announces Late-Breaking Oral Presentation at EHA 2026 Showcasing Initial Phase 1 In Vivo CAR-T Data with LB2501 in Non-Hodgkin Lymphoma (NHL) (GlobeNewswire) - "As of April 1, 2026, 12 patients with R/R B-NHL were treated across two dose levels (DL1 and DL2). Additional details will be presented at EHA 2026. Key findings from the abstract include:...At DL2 (median follow-up for DL2 was 2.2 months [range, 2.0 to 3.8]); Objective response rate (ORR): 100% (6/6); Complete response rate (CR): 83.3% (5/6); All responses were ongoing at data cutoff....No dose-limiting toxicities (DLTs), serious adverse events (SAEs), or deaths were observed."

Late-breaking abstract • P1 data • Non-Hodgkin’s Lymphoma

Legend Biotech filed a Form 6-K highlighting early Phase 1 data for LB2501, an investigational in vivo CD19/CD20 dual‑targeting CAR-T therapy for relapsed/refractory B‑cell non-Hodgkin lymphoma. (StockTitan.net) - "As of April 1, 2026, 12 patients were treated across two dose levels. At dose level 2, the objective response rate was 100% (6 of 6 patients), with a complete response rate of 83.3% (5 of 6), and all responses were ongoing at cutoff. Safety data showed no dose-limiting toxicities, serious adverse events, deaths, or immune effector cell-associated neurotoxicity; infusion reactions occurred in 75% of patients and cytokine release syndrome in 66.7%, all Grade 1–2...On June 2, 2026, Legend Biotech Corporation (“Legend Biotech”) announced that promising preliminary clinical data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), will be presented during a late-breaking session at the European Hematology Association ('EHA') 2026 Congress..."

P1 data • B Cell Non-Hodgkin Lymphoma

The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

New P1 trial • Hematological Malignancies • Oncology