NANJING, China, Nov. 4, 2025 -- Leads Biolabs (Stock Code: 9887.HK) today announced that five research abstracts from its hematological oncology portfolio—including programs LBL–034 and LBL–076—have been accepted for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH), taking place December 6 to 9, 2025, in Orlando, Florida. These include one oral presentation, three poster presentations, and one online publication.
LBL-034: Multiple Studies Featured, Clinical Data Highlighted in Oral Presentation
Oral Presentation
- Title: A first-in-human, phase I/II, open-label, multicenter, dose-escalation and expansion study of LBL-034, a conditionally activated bispecific antibody targeting GPRC5D and CD3 with a 2:1 format, in patients with relapsed/refractory multiple myeloma
- Publication Number: 91
- Date & Time: December 6, 2025 | 9:30–9:45 AM EST
- Location: OCCC – West Hall D2
- Session: First oral presentation of the first session on the opening day
The Phase I/II trial (NCT06049290), led by Professor Jin Lu of Peking University People's Hospital, is being conducted across 17 hospitals in China. LBL-034 demonstrated favorable safety and promising anti-tumor activity in patients with relapsed/refractory multiple myeloma (RRMM), including those with high-risk, refractory disease, particularly at doses of 800–1200 µg/kg.
Updated efficacy and safety results will be presented in this highly anticipated oral session on the opening day of the ASH 2025 Annual Meeting.
Poster Presentation 1
- Title: Pharmacokinetics, pharmacodynamics, and biomarkers of LBL-034, a GPRC5D-targeted T-cell engager, in a first-in-human phase I/II study in relapsed/refractory multiple myeloma
- Publication Number: 4070
- Date & Time: December 7, 2025 | 6:00–8:00 PM EST
- Location: OCCC – West Halls B3–B4
Poster Presentation 2
- Title: Proof of concept and mechanistic evaluation of LBL-034, a potent GPRC5D-targeting T-cell engager with an affinity-optimized, sterically engineered anti-CD3 arm, in a multiple myeloma xenograft mouse model
- Publication Number: 2155
- Date & Time: December 6, 2025 | 5:30–7:30 PM EST
- Location: OCCC – West Halls B3–B4
Online Publication
- Title: Population pharmacokinetics (popPK) and exposure–response (ER) analyses of LBL-034, a potent GPRC5D T-cell engager, in patients with relapsed/refractory multiple myeloma
- Publication Number: 6824
LBL-076: A Strong Debut and International Recognition for Preclinical Innovation
Poster Presentation
- Title: LBL-076, a first-in-class GPRC5D×CD38×CD3 trispecific T-cell engager (TCE) for the treatment of relapsed/refractory multiple myeloma
- Publication Number: 3302
- Date & Time: December 7, 2025 | 6:00–8:00 PM EST
- Location: OCCC – West Halls B3–B4
LBL-076 is a first-in-class trispecific T-cell engager designed to simultaneously target CD38, GPRC5D, and CD3.
Its innovative molecular architecture aims to overcome immune escape and antigen loss driven by tumor heterogeneity, achieving potent and durable anti-tumor activity in relapsed/refractory multiple myeloma.
Preclinical data demonstrate robust efficacy, supporting LBL-076 as a potential next-generation therapy for heavily pretreated MM patients.
Executive Commentary
"The inclusion of multiple Leads Biolabs studies at the 2025 ASH Annual Meeting highlights our scientific depth and leadership in tumor immunotherapy," said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs.
"We are especially honored that our key program, LBL-034, was selected for an oral presentation—a recognition of its unique mechanism and groundbreaking clinical data. This achievement reflects not only the scientific value of LBL-034, but also the global recognition of our innovation capabilities."
About LBL-034
LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using Leads Biolabs' proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 effectively redirects and activates T cells to eliminate GPRC5D-positive cancer cells. This configuration enhances GPRC5D binding affinity and anti-tumor potency while minimizing immune exhaustion and reducing potential off-target effects on healthy tissues.
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, LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engager globally, following TALVEY® (talquetamab) by Janssen Biotech, which has been approved in the U.S. for MM. In October 2024, LBL-034 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of multiple myeloma.
About LBL-076
LBL-076 is a potential first-in-class trispecific T-cell engager (TCE) targeting CD38 × GPRC5D × CD3, also developed using Leads Biolabs' LeadsBody platform. This innovative molecule simultaneously binds to GPRC5D and CD38, two validated multiple myeloma (MM) targets, while conditionally activating T cells.
LBL-076 demonstrates potent T cell–dependent cellular cytotoxicity (TDCC) against myeloma cells expressing various levels of GPRC5D and CD38, accompanied by efficient T-cell activation and only mild cytokine release. Structural optimization further reduces potential cytotoxicity against CD38-expressing immune cells. In multiple murine xenograft models with heterogeneous antigen expression, LBL-076 has shown robust and durable anti-tumor activity, supporting its potential as a next-generation therapy for patients with relapsed or refractory MM.
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/
