LEU-011 / Leucid Bio - LARVOL DELTA

Leucid Bio Provides Update on Phase I/IIa AERIAL Trial Evaluating Lateral CAR-T LEU011 for the Treatment of Solid Tumours (PRNewswire) - "Proof-of-concept established for LEU011 in the treatment of relapsed/refractory solid tumours. LEU011 has been well tolerated, with disease control observed in multiple patients at lowest dose evaluated to date. Enrolment continues in dose-escalation segment of the AERIAL trial with additional data for LEU011 anticipated during the first half of 2026. Poster presentation of AERIAL trial presented at SITC 2025 Annual Meeting."

P1/2 data • Solid Tumor

A First-in-human Phase I/IIa dose escalation trial evaluating the safety and preliminary efficacy of LEU011, a novel CAR-T, in subjects with relapsed/refractory solid tumors (AERIAL) (SITC 2025) - "Key eligibility includes good performance status (ECOG 0-1), adequate organ function, a washout period ≥28 days from prior anti-cancer therapies (except LDC), no active infections or major co-morbidities.Endpoints: The primary endpoints for this trial are the incidence and nature of dose-limiting toxicities and the incidence, nature, and severity of adverse events.Trial Registration This trial 'LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours' is registered at ClinicalTrials.gov with the unique reference number NCT06193902Ethics Approval Ethical approval for this clinical trial was granted by the North East - York Research Ethics Committee under REC reference 23/NE/0097. All participants provided informed consent prior to enrollment onto the trial.Abstract 578 Figure 1Request permissionsTrial schematic"

Clinical • First-in-human • IO biomarker • P1/2 data • Oncology • Solid Tumor • CXCR2 • NKG2D

AERIAL: LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. (clinicaltrials.gov) - P1/2 | N=17 | Recruiting | Sponsor: Leucid Bio | Trial completion date: Jun 2027 ➔ May 2029 | Trial primary completion date: Jul 2025 ➔ May 2029

Trial completion date • Trial primary completion date • Solid Tumor

Leucid Bio Announces Treatment of First Patient in AERIAL Trial of NKG2D CAR-T Therapy LEU011 for Solid Tumours (PRNewswire) - "Leucid Bio...today announced that the first patient has been dosed in the Phase 1 AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with refractory solid tumours....Initiation of the AERIAL trial follows the successful first close of the Series A1 financing of £7.2 million in February 2025, co-led by Epidarex Capital and 2invest AG, bringing the Series A to £18.7 million to date....Initial proof-of-concept data for LEU011 is expected in the second half of 2025."

Commercial • P1 data • Trial status • Solid Tumor

Updates on LEU011: An Adaptor CAR Platform (IO-SUMMIT EUROPE 2024) - "Leucid Bio has recently secured regulatory approval to undertake a Phase 1 clinical trial in which LEU011 will be evaluated in patients with a range of NKG2D ligand solid tumours. An update on the LEU011 programme will be provided."

Oncology • Solid Tumor • CXCR2 • NKG2D

Updates on LEU011: An Adaptor CAR Platform (IO-SUMMIT EUROPE 2024) - "Leucid Bio has recently secured regulatory approval to undertake a Phase 1 clinical trial in which LEU011 will be evaluated in patients with a range of NKG2D ligand solid tumours. An update on the LEU011 programme will be provided."

Oncology • Solid Tumor • CXCR2 • NKG2D

AERIAL: LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours. (clinicaltrials.gov) - P1/2 | N=17 | Recruiting | Sponsor: Leucid Bio

New P1/2 trial • Oncology • Solid Tumor

Leucid Bio Granted MHRA Clinical Trial Authorisation for Lateral NKG2D CAR-T Cell Therapy LEU011 (PRNewswire) - "Leucid Bio...announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorisation (CTA) to commence the Phase 1/2 AERIAL clinical trial evaluating the safety and tolerability of LEU011 for the treatment of adults with relapsed or refractory solid tumours....'We look forward to initiating the AERIAL study over the next few months and providing preliminary first-in-human data for LEU011 in 2024'."

New P1/2 trial • Solid Tumor

ImaginAb Executes New License and Supply Agreement for CD8 ImmunoPET Technology with Leucid Bio (PRNewswire) - "ImaginAb Inc...is pleased to announce the execution of a new non-exclusive License and Supply Agreement with Leucid Bio (Leucid), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company's proprietary Lateral CAR Platform. Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb's investigational CD8 ImmunoPET tracer, 89Zr crefmirlimab berdoxam, to Leucid for use in its basket study in solid tumors, with LEU011 targeting NKG2DL, Autologous CAR T-cells."

Licensing / partnership • Oncology • Solid Tumor

Leucid Bio and Great Ormond Street Hospital enter commercial agreement at new gene therapy manufacturing centre (PRNewswire) - "Leucid Bio...announces a first-of-its-kind commercial manufacturing master services agreement with Great Ormond Street Hospital NHS Foundation Trust (GOSH) to manufacture lead asset, LEU011 a lateral CAR targeting NKG2D ligands, for use in human clinical studies. Leucid Bio expects to file its Clinical Trial Application (CTA) to initiate the clinical trial in H1 2023 and to be dosing patients suffering from solid tumours and haematological malignancies, by H2 2023, subject to regulatory approval....Under the terms of the agreement GOSH will work with Leucid at the state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children and provide quality assurance services required for manufacture of clinical product for the LEU011 first-in-man study, and potentially, other Leucid clinical programmes."

Licensing / partnership • New trial • Hematological Malignancies • Oncology • Solid Tumor