NANJING, China, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced that its partner company with Aditum Bio, Oblenio Bio ("Oblenio"), has dosed first patients in the Phase 1a first-in-human clinical trial in Europe of its sole asset LBL-051, a tri-specific T-cell engager targeting BCMA, CD19 and CD3.
LBL-051 is designed to safely induce complete depletion of B cells and plasma cells for a durable immune system reset and the potential for sustained drug-free remission in patients with autoimmune diseases. Preclinical data have shown that LBL-051 achieves complete depletion of both B cells and plasma cells through dual targeting of CD19 and BCMA, with minimal cytokine release.
The open-label, multicenter Phase 1a study is enrolling patients with refractory autoimmune disease across multiple indications. Utilizing a subcutaneous dosing regimen, the trial evaluates safety, tolerability, clinical response, B cell and plasma cell depletion in blood and tissue and select biomarkers. The study design, which received approval from the Paul Ehrlich Institute (PEI), employs a highly innovative first-in-human dose-escalation scheme that enables rapid and thoughtful evaluation of this off-the-shelf therapeutic approach, generating proof-of-concept data while prioritizing patient safety in a range of autoimmune diseases.
This milestone underscores the proven ability of Leads Biolabs' proprietary LeadsBody platform to generate differentiated, globally competitive assets. Following the clinical validation of LBL-034 in hematological malignancies, LBL-051 is now advancing into autoimmune diseases - a broad application area for TCE technology - with the potential for further clinical validation. As the originating innovator, Leads Biolabs continues to provide technical support to Oblenio and remains eligible for significant milestone payments and royalties as LBL-051 advances through global clinical development and commercialization.
Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, commented: "The agreement between Leads Biolabs and Oblenio is progressing as planned, with milestone value steadily materializing. The successful initiation of this Phase 1a study underscores the effectiveness of the NewCo collaboration model, which combines China-based original innovation with world-class clinical development expertise to accelerate the delivery of novel therapies to patients worldwide."
About LBL-051
LBL-051 was discovered and engineered using Leads Biolabs' proprietary LeadsBody platform. By simultaneously targeting BCMA, CD19 and CD3, LBL-051 is uniquely designed to deplete a broader spectrum of pathogenic B-cell and plasma cell populations, offering the potential for deeper and more durable responses compared to single-target or bispecific approaches. This immune reset strategy aims to achieve long-term drug-free remission for patients suffering from a range of refractory autoimmune diseases.
Preclinical data presented by Oblenio at the 2026 European Congress of Rheumatology (EULAR 2026) demonstrated that step-up dosing of LBL-051 resulted in complete depletion of peripheral and tissue B-cells and plasma cells in non-human primates, with consequent emergence of immature, non-memory B-cells in the blood upon recovery - findings consistent with changes described in autoimmune patients achieving long-lasting drug-free remissions in the clinic. Importantly, the study showed that the treatment did not cause cytokine release syndrome (CRS), including at high exposure levels, and demonstrated dose-dependent decreases in peripheral blood immunoglobulins, consistent with plasma cell depletion.
About Leads Biolabs
Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address underserved medical needs in oncology, autoimmune, and other severe diseases both in China and globally.
Leads Biolabs is a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including four clinical-stage drug candidates and one registration-stage asset.
The Company adopts a science-driven R&D approach and has successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. It has also developed multiple proprietary technology platforms, including LeadsBody (a CD3 T-cell engager platform), X-body (a 4-1BB engager platform), TOPiKinectics (an ADC platform) and ImBiTDC (a TDC platform), which serve as the cornerstone for its continued innovation and have been validated by the clinical outcomes of its bispecific antibody portfolios.
Leads Biolabs has established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of its drug candidates, coupled with its global perspectives, proactive strategy, and efficient clinical validation, have made it an attractive partner for leading industry players and investment institutions. For more information, please visit https://en.leadsbiolabs.com/
