Leads Biolabs Unveils Promising Clinical Data for LBL-034 at 2025 ASH Annual Meeting

Groundbreaking Results for LBL-034 at the 2025 ASH Annual Meeting

From December 6 to 9, 2025, the American Society of Hematology (ASH) held its 67th Annual Meeting in Orlando, Florida, where Leads Biolabs presented its innovative findings regarding LBL-034, a highly anticipated bispecific antibody designed for patients with relapsed or refractory multiple myeloma (RRMM). This therapeutic candidate, developed using the proprietary LeadsBody platform, aims to target cancer cells effectively while minimizing side effects, marking a potential leap forward in treatment options for patients struggling with this aggressive form of cancer.

Overview of the Presentation

The presentation was delivered on the opening day of the conference and highlighted the Phase I/II clinical results of LBL-034, which uniquely targets GPRC5D/CD3 structures. The trial, led by Professor Jin Lu of Peking University People’s Hospital, involved 17 medical centers throughout China. Participants in the study showed promising safety profiles and solid anti-tumor efficacy, providing hope for those classified in high-risk subgroups of RRMM.

Key Clinical Highlights:

1. Safety Profile: The drug was administered in escalating doses up to 1200 μg/kg without encountering dose-limiting toxicities (DLTs) or reaching a maximum tolerated dose (MTD). Notably, adverse events impacting patient quality of life were primarily Grade 1-2, occurring mostly during the first cycle of treatment with a decrease in occurrence in subsequent cycles.

2. Efficacy Results: Across the varied dosing regimens between 400 to 1200 μg/kg, an overall response rate (ORR) of 82.5% was recorded, including a complete response (CR) rate of 52.5% and a very good partial response (VGPR) rate of 72.5%. Remarkably, at the 800 μg/kg dosage, the ORR escalated to 90.9% with a CR of 63.6%.

3. Performance in Challenging Subgroups: Patients with extramedullary disease (EMD) saw an ORR of 75%, and astonishingly, at the maximum dose of 1200 μg/kg, ORR in this subset reached a perfect 100% with rapid regression of EMD lesions observed. In patients previously treated with BCMA therapies, an ORR of 85.7% was achieved, showcasing LBL-034's significant potential.

4. Durability of Response: Among participants across various dosing levels, the 12-month progression-free survival (PFS) rate was 61.2%, reflecting a median follow-up duration of 9.6 months. In patients receiving the lowest dose of 400 μg/kg, the median follow-up extended to 13.1 months, yielding a PFS of 56.8%.

Executive Insights

Dr. Charles Cai, Chief Medical Officer at Leads Biolabs, expressed his enthusiasm regarding the outcome of the trials, remarking, "The recognition of LBL-034's efficacy and therapeutic promise at an international platform like ASH is truly rewarding. Our ongoing Phase II trial aims to further evaluate the drug’s safety and efficacy in various RRMM populations at a refined dose of 1200 μg/kg. Our intent is to expedite delivering these new treatment strategies to patients with difficult-to-treat conditions as swiftly as possible."

About LBL-034

LBL-034 functions as a bispecific T-cell engager (TCE) targeting both GPRC5D and CD3, utilizing the Company’s innovative LeadsBody platform. Designed with a unique 21 binding format, it allows selective targeting of GPRC5D+ cancer cells while optimizing T cell activation, thereby reducing the risk of cytokine storms, toxic systemic effects, and T cell exhaustion.

In preclinical tests, LBL-034 has showcased formidable efficacy results rivaling leading industry competitors. As of November 2024, it stands out as the second most advanced GPRC5D-targeted CD3 T-cell engager globally, having received Orphan Drug Designation from the U.S. FDA for treating multiple myeloma in October 2024.

About Leads Biolabs

Founded in 2012, Leads Biolabs has established itself as a clinical-stage biotech company dedicated to innovating therapies targeting unmet medical needs in oncology and autoimmune diseases, both domestically and globally. With a portfolio of 14 innovative drug candidates, including multiple clinically advanced products, Leads Biolabs remains at the forefront of next-generation immuno-oncology treatments. Their comprehensive research and development approach has successfully yielded proprietary technologies such as the LeadsBody platform, enhancing their capability for continual innovation. For further information, visit Leads Biolabs.