LB2501

iStock, designer491 All six non-Hodgkin lymphoma patients on Legend Biotech’s CAR T therapy responded to treatment—findings that could make the biotech an attractive takeover target, according to analysts at Oppenheimer. Legend Biotech’s CAR T candidate hit a 100% response rate in a Phase 1 study of non-Hodgkin lymphoma, positioning the biotech as an attractive takeover target in a space that has seen recent big-ticket deals from pharma powerhouses Eli Lilly, AstraZeneca and Gilead. Phase 1 data disclosed Tuesday showed that all six patients given Legend’s CAR T asset, dubbed LB2501, responded to treatment, resulting in a 100% objective response rate. The cell therapy totally removed signs of disease in five patients, yielding a complete response rate of 83.3%. These data “point to a potentially best-in-class pro the in vivo CART space and best-in-disease pro NHL [non-Hodgkin lymphoma],” Oppenheimer wrote to investors on Tuesday. Conceding that they would need longer-term data for a more comprehensive analysis, the analysts nevertheless said that LB2501’s efficacy and safety look “superior” or at least comparable to other therapies in this indication, including ex vivo CAR Ts and T cell engagers. Indeed, Legend reported no dose-limiting toxicities, deaths or serious adverse events in its press announcement, nor did it detect any case of immune effector cell–associated neurotoxicity syndrome (ICANS). The biotech closed Tuesday’s trading session at $36.28 apiece, up 42% from the day prior. LB2501’s Phase 1 assessment is currently ongoing, with 12 patients treated so far across two dose cohorts, Legend said, noting that the trial focused on patients with relapsed or refractory B cell NHL. Only six patients were able to make the biotech’s data cutoff for its Tuesday readout. The study has an expected primary completion date in mid-2027. Mergers & acquisitions Eli Lilly Enters CAR T Realm With $2.4B Orna Buy, Starting With Autoimmune The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases. February 9, 2026 · 2 min read · Dan Samorodnitsky Read more “Positive in vivo CART data strengthens chances of LEGN acquisition in our view,” Oppenheimer wrote, pointing out that the CAR T market has of late been “a very active M&A space.” In February, for instance, Lilly dropped $2.4 billion to acquire Orna Therapeutics and its pipeline of in vivo CAR T candidates. The pharma followed that up in April by acquiring Kelonia Therapeutics for up to $7 billion —a decision that quickly paid off with the biotech on Sunday touting a 100% objective response rate for its own in vivo CAR T asset KLN-1010 in a Phase 1 study of patients with relapsed or refractory multiple myeloma. All patients also hit minimal residual disease after KLN-1010 treatment, suggesting they had no signs of cancer in their bone marrow at the one-month follow-up, Kelonia said at the time. Other recent CAR T deals include Gilead’s $7.8 billion buyout of Arcellx in February and AstraZeneca’s $630 million licensing bet for AbelZeta’s cancer therapy in January.

Legend Biotech (Nasdaq: LEGN) reported a 100% objective response rate in six evaluable patients treated at the higher dose level with LB2501, its investigational in vivo CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma, with complete responses in five of six. LB2501 is a CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion, with Legend hoping to challenge the manufacturing and logistical constraints that have limited conventional CAR-T access. The data will be presented in a late-breaking oral presentation at the European Hematology Association (EHA) 2026 Congress in Stockholm on June 14. The NCT07002112 study is an open-label, dose-escalation Phase I trial enrolling patients with relapsed/refractory B-cell malignancies. As of an April 1, 2026 data cutoff, 12 patients with R/R B-cell NHL had been treated across two dose levels; the efficacy headline derives from the six patients at dose level 2, with a median follow-up of 2.2 months (range 2.0–3.8). All six responses were ongoing at cutoff. Pharmacokinetic data showed dose-dependent in vivo CAR-T expansion, with CAR-T cells detectable in peripheral blood for up to 116 days — notable given that no lymphodepleting chemotherapy was administered prior to infusion. Safety across all 12 patients was characterized by infusion-related reactions in 75% (all Grade 2 or lower) and cytokine release syndrome in 66.7% (all Grade 2 or lower), with no dose-limiting toxicities, no serious adverse events, no deaths, and no immune effector cell-associated neurotoxicity syndrome. Grade 3 or higher events were limited to decreased lymphocyte and neutrophil counts. Competitive context The readout for LB2501 CAR-T in NHL readout matters principally because of what LB2501 does not require: ex vivo cell manufacturing, a REMS-certified treatment center, or lymphodepletion chemotherapy. Approved autologous CD19-targeting CAR-T therapies — Kite/Gilead’s Yescarta (axicabtagene ciloleucel), Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), and Novartis’ Kymriah (tisagenlecleucel) — demand weeks of manufacturing, specialized infusion infrastructure, and inpatient monitoring for CRS and neurotoxicity, barriers that exclude a meaningful proportion of eligible patients. LB2501 instead uses Legend’s proprietary TaVec lentiviral vector platform, engineered to transduce T-cells selectively in vivo following a single intravenous infusion, generating CAR-T cells directly within the patient. The dual CD19/CD20 targeting is designed to reduce the antigen-loss escape that has contributed to relapse after single-target CAR-T therapies. The competitive field for R/R B-NHL is crowded. CD3×CD20 bispecific antibodies — AbbVie/Genmab’s Epkinly (epcoritamab) and Roche’s Columvi (glofitamab) — have demonstrated durable responses in late-line DLBCL and follicular lymphoma without the manufacturing burden of CAR-T, and their outpatient or fixed-duration profiles have made them a practical alternative for many centers. ADCs including Genentech/Roche’s Polivy (polatuzumab vedotin) and ADC Therapeutics’ Zynlonta (loncastuximab tesirine) occupy the third-line DLBCL space. Against this backdrop, an in vivo CAR-T approach that could be administered like a standard infusion — without prior lymphodepletion and without apheresis — would represent a meaningfully different operational profile, though cross-trial comparisons are limited by differences in patient populations, prior lines of therapy, and follow-up duration. The reported 83% complete response rate compares favorably with outcomes reported for approved therapies in heavily pretreated B-cell lymphomas, although meaningful comparisons are limited by the very small sample size, short follow-up, and potential differences in patient populations. For Legend, LB2501 represents a strategic extension beyond its established partnership with Johnson & Johnson on conventional ex vivo BCMA-targeted CAR-T Carvykti (ciltacabtagene autoleucel) in multiple myeloma. The broader in vivo CAR-T field remains early. While several in vivo CAR-T programs remain preclinical or in early clinical development, Legend is among the first companies to report objective responses from an in vivo CAR-T approach in a hematologic malignancy. AstraZeneca has also disclosed early clinical data from its BCMA-targeted in vivo CAR-T program in multiple myeloma, suggesting the field is beginning to transition from proof-of-concept to clinical validation. The dual-targeting strategy — simultaneously engaging CD19 and CD20 — also differentiates LB2501 from most investigational in vivo programs, which have focused on single antigens. Whether dual targeting translates into reduced antigen-loss relapse rates will require longer follow-up and larger cohorts to determine. Full data from both dose levels, including the DL1 cohort not detailed in the press release, are expected at the EHA 2026 presentation on June 14. Dose escalation appears to be ongoing, and the trial’s primary endpoints of safety and tolerability will continue to be assessed as enrollment expands. The next meaningful milestone for LB2501 will be response durability data and any signal from higher dose levels or expanded patient numbers that could support a decision on Phase II dose and design. 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