NANJING, China, Oct. 25, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”, Stock Code: 9887.HK) today announced updated first‑in‑human clinical data for LBL‑034, its GPRC5D/CD3 bispecific T‑cell engager (TCE). The updated results were delivered in an oral presentation at the 2026 Annual Meeting of the European Society for Medical Oncology (ESMO), showcasing compelling efficacy and safety outcomes in patients with relapsed/refractory multiple myeloma (RRMM). In the effective dose range of 400–1,200 μg/kg, median progression-free survival (mPFS) reached 21.8 months, approximately twice the level reported in the pivotal studies of approved therapies against the same target.
LBL-034 demonstrated deep and durable antitumor activity across multiple difficult-to-treat patient subgroups, including those with extramedullary disease (EMD), prior exposure to BCMA-directed therapies, and extensive prior treatment. Its safety profile was characterized by predominantly low-grade cytokine release syndrome (CRS) and manageable treatment-related adverse events. These findings provide important clinical validation of the conditional T-cell redirection and activation mechanism underpinning Leads Biolabs’ proprietary LeadsBody TCE platform, supporting its continued development and potential application beyond hematologic malignancies, including autoimmune diseases and solid tumors.
Key Clinical Findings
Patient Baseline Characteristics
As of the data cutoff date of July 16, 2026, 56 patients with RRMM had been enrolled. Patients were heavily pretreated, with a median of 4.5 prior lines of therapy (range: 3–12).
- Extensive prior treatment: 73.2% of patients were triple-class exposed, 57.1% were penta-drug exposed, and 60.7% were triple-class refractory.
- Prior advanced therapies: 28.6% had received autologous stem-cell transplantation (ASCT), and 16.1% had received BCMA-directed CAR-T therapy.
- High-risk disease features: 23.2% had EMD, and 64.3% had high-risk cytogenetic abnormalities.
Overall Efficacy
Among the 41 patients treated within the effective dose range of 400–1,200 μg/kg, with a median follow-up of 17.8 months, LBL-034 demonstrated encouraging long-term disease control.
- Durable disease control: The mPFS was 21.8 months, although the PFS data remained immature at the cutoff. Median duration of response (mDoR) had not been reached.
- Sustained PFS: The 15-month and 18-month PFS rates were 62.0% and 54.8%, respectively.
- Durable responses: The 12-month and 18-month duration-of-response (DoR) rates were 77.0% and 68.4%, respectively.
- Dose-dependent depth of response: Median time to achieving complete response (CR) or better decreased with increasing dose, from 5.60 months at 400 μg/kg to 3.45 months at 800 μg/kg and 3.06 months at 1,200 μg/kg. This trend provides pharmacodynamic support for the selection of the recommended Phase 2 dose (RP2D).
Encouraging Efficacy in High‑Risk, Hard‑to‑Treat Subgroups
LBL-034 demonstrated promising antitumor activity in several patient populations with substantial unmet medical needs.
- Patients with EMD: The overall response rate (ORR) was 75.0%, with two patients achieving stringent complete response (sCR). In the 1,200 μg/kg cohort, all patients with EMD responded (ORR: 100%), accompanied by rapid and substantial reductions in extramedullary lesions.
- Patients with prior BCMA-targeted therapy failure: ORR was 85.7%, with an sCR rate of 57.1%.
- Penta-drug-exposed patients: ORR was 73.9%, with an sCR rate of 34.8%.
These results highlight the potential of LBL-034 to deliver deep clinical responses in heavily pretreated patients, including those whose disease has become resistant to established treatment approaches.
Favorable and Manageable Safety Profile
LBL-034 continued to demonstrate a favorable safety profile across the evaluated dose range.
- No dose-limiting toxicities: No dose-limiting toxicities (DLTs) were observed during dose escalation up to 1,200 μg/kg, and the maximum tolerated dose (MTD) was not reached.
- Predominantly low-grade CRS: Nearly all CRS events were low-grade, with only one Grade 3 or higher event reported.
- Manageable neurotoxicity: Two cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were reported; both patients recovered fully. No movement disorders or ataxia-related neurotoxic events were observed.
- Manageable treatment-emergent adverse events: Adverse events affecting quality of life were predominantly Grade 1–2. Most treatment-emergent adverse events occurred during step-up dosing and the first treatment cycle, with event rates declining substantially in subsequent cycles.
- Sustained treatment exposure: Median treatment exposure was 11.3 months, supporting the feasibility of prolonged treatment with LBL-034.
Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: “The updated results presented at ESMO 2026 are highly encouraging. LBL-034 has demonstrated deep and durable clinical responses in heavily pretreated patients with RRMM, including those with high-risk features such as extramedullary disease, prior failure of BCMA-targeted therapies, and penta-drug exposure. These findings underscore the potential of LBL-034 to become a differentiated treatment option for patients with substantial unmet medical needs and support its best-in-class potential.
“We are also encouraged by the dose-dependent trend toward a shorter time to complete response or better, which provides important pharmacodynamic support for RP2D selection. The safety findings are equally meaningful: adverse events were predominantly low-grade and concentrated in the early treatment period, while treatment exposure extended to a median of 11.3 months. Together, these results support the potential for sustained treatment with LBL-034.
“Importantly, LBL-034 represents the first clinical validation of our TCE platform. The findings demonstrate the potential of our proprietary LeadsBody platform to generate TCE molecules that combine deep anti-improve responses with a manageable safety profile. Building on this milestone, we aim to advance our TCE pipeline and explore its potential across broader therapeutic areas, including autoimmune diseases and solid tumors.”
About LBL‑034
LBL‑034 is a humanized GPRC5D × CD3 bispecific T‑cell engager (TCE) generated from Leads Biolabs’ proprietary LeadsBody™ platform. It adopts a 2:1 molecular architecture: two high‑affinity GPRC5D‑targeting Fab domains paired with one CD3‑binding single‑chain variable fragment (scFv).
The molecule is engineered to selectively engage GPRC5D‑positive tumor cells and conditionally activate T‑cells. This design aims to lower risks of cytokine release, systemic toxicity and T‑cell exhaustion while delivering potent, sustained anti‑myeloma activity.
Preclinical and clinical programs have yielded promising efficacy signals for LBL‑034. Preliminary monotherapy data for RRMM were featured as an opening oral presentation at ASH 2025, and this updated dataset was selected for a proffered paper oral session at ESMO 2026. LBL‑034 secured FDA Orphan Drug Designation (ODD) in October 2024 and FDA Fast Track Designation in January 2026. Preparation work for its Phase III clinical trial is now underway.
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 15 innovative drug candidates, including five 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/
Contact: yizi@leadsbiolabs.com