Median PFS Trending Beyond One Year: Leads Biolabs' LBL-034 Showcases Breakthrough Clinical Data in Oral Presentation at the 2025 ASH Annual Meeting

NANJING, China, Dec. 8, 2025 /PRNewswire/ -- From December 6 to 9, 2025, the 67th Annual Meeting of the American Society of Hematology ("ASH") was held in Orlando, Florida, USA. Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company", Stock Code: 9887.HK) delivered an oral presentation on the opening day of the conference featuring the Phase I/II clinical results of LBL-034, a GPRC5D/CD3 bispecific antibody with a unique 2:1 structure and conditional activation, independently developed using the proprietary LeadsBody platform, for the treatment of relapsed/refractory multiple myeloma (RRMM).

The study, led by Professor Jin Lu of Peking University People's Hospital and conducted across 17 centers in China, demonstrated that LBL-034 achieved favorable safety and highly encouraging anti-tumor activity, including in high-risk refractory subgroups, highlighting its potential as a best-in-class therapeutic candidate.

The key clinical highlights of LBL-034

• Safe escalation to 1200 μg/kg with no DLTs or MTD reached.
  Adverse events impacting quality of life were predominantly Grade 1–2 and occurred mainly during Cycle 1, with markedly lower incidence thereafter. Taste, skin, and nail toxicities were infrequent and generally self-resolving.
• Strong efficacy across dose levels 400–1200 μg/kg (n=40).
  ORR reached 82.5%, with ≥CR at 52.5%, ≥VGPR at 72.5%, and MRD negativity at 80.0%.
  At 800 μg/kg, ORR and ≥CR were 90.9% and 63.6%, respectively.
• Robust activity in difficult-to-treat RRMM subgroups.
  • Extramedullary disease (EMD): ORR 75.0%, including two sCRs. At 1200 μg/kg, ORR in EMD patients reached 100%, with rapid EMD lesion regression observed.
  • Prior BCMA-treated patients: ORR 85.7%, with CR/sCR 57.1%.
• Durable clinical benefit.
  Across the 400–1200 μg/kg range, the 12-month PFS rate was 61.2% (median follow-up: 9.6 months). At 400 μg/kg (n=11), median follow-up reached 13.1 months, with a 12-month PFS rate of 56.8%.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"We are delighted that the strong efficacy and clinical potential of LBL-034 have been recognized by the international scientific community. A Phase II trial evaluating the safety and efficacy of LBL-034 with a RP2D at 1200 μg/kg in 4 populations, including 4L+RRMM, 2L+RRMM with EMD, 4L+RRMM with prior BCMA therapy, and R/R Plasma Cell Leukopenia (PCL) is currently ongoing. With our focused and efficient clinical development strategy, we aim to deliver new treatment options to patients with multiple myeloma, particularly those who are refractory or have extramedullary disease, as quickly as possible."

About LBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company's proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner.

In preclinical studies, LBL-034 has demonstrated strong efficacy signals, comparable to or exceeding those of leading competitors. The molecule is currently being evaluated in a Phase I/II clinical trial for relapsed or refractory multiple myeloma (RRMM) in China. According to Frost & Sullivan, as of November 2024, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally. In October 2024, LBL-034 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of multiple myeloma.

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.

We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.

We adopt a science-driven R&D approach and have successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. We have also developed multiple proprietary technology platforms, including LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), TOPiKinectics (ADC platform), which serve as the cornerstone for our continued innovation and have been validated by the clinical outcomes of our bispecific antibody portfolios.

We have established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of our drug candidates, coupled with our global perspectives, proactive strategy, and efficient clinical validation, have made us an attractive partner for leading industry players and investment institutions. For more information, please visit https://en.leadsbiolabs.com/