LEADS BIOLABS-B(09887): Partner OBLENIO completes the first administration of LBL-051 in the Phase IA clinical trial for treatment-resistant autoimmune diseases.

LEADS BIOLABS-B (09887) announced that its NewCo Oblenio Bio (Oblenio), jointly established with Aditum Bio, has completed the initial dosing of the first batch of patients in the Phase Ia first-in-human clinical trial of LBL-051 (its sole asset, a tri-specific T cell engager (TCE) targeting BCMA, CD19, and CD3) conducted in Europe. LBL-051 aims to safely achieve the complete elimination of B cells and plasma cells to achieve a durable reset of the immune system, with the potential to bring sustained drug-free remission to patients with autoimmune diseases. Preclinical data demonstrate that LBL-051 can achieve complete clearance of B cells and plasma cells by simultaneously targeting CD19 and BCMA, with very low levels of cytokine release. This open-label, multi-center Phase Ia study is enrolling patients with various refractory autoimmune disease indications. The trial employs a subcutaneous administration method to assess safety, tolerability, clinical response, clearance of B cells and plasma cells in blood and tissue, and related biomarkers. The study design has received approval from the Paul Ehrlich Institute (PEI) in Germany and utilizes a highly innovative first-in-human dose escalation scheme, enabling rapid and prudent evaluation of this therapy's efficacy while prioritizing patient safety, and obtaining proof of concept data across multiple autoimmune diseases. This milestone progress fully reflects the companys capability to develop differentiated and globally competitive assets through its proprietary LeadsBodyTM platform. Following the clinical validation of LBL-034 in the hematological tumor field, LBL-051 is expected to achieve clinical validation once again in the broad application scenarios of this TCE technology in autoimmune diseases. As the original developer, the company will continue to provide technical support to Oblenio and will remain eligible for milestone payments and sales revenue sharing as LBL-051 advances in global clinical development and commercialization.