2025 ASCO: Encouraging Clinical Data from Leads Biolabs' Innovative Bispecific Antibody LBL-024 against PD-L1 and 4-1BB Selected for Oral Presentation

Nanjing, China — April 24, 2025 — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”) today announced that two of its innovative oncology assets, LBL-024 and LBL-007, have been selected for oral and poster presentations, respectively, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago from May 30 to June 3. The selection highlights the strong clinical potential and innovation of Leads Biolabs’ immuno-oncology pipeline.

LBL-024

[Abstract Title] Assessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial.

[Abstract Number] 2500

[Session Type] Oral Abstract Session

[Session Title] Developmental Therapeutics—Immunotherapy

[Session Date and Time] 5/31/2025 3:00 PM-6:00 PM CDT

[Presentation Date and Time] 5/31/2025 3:00 PM-3:12 PM CDT

LBL-007

[Abstract Title] Updated efficacy, safety and biomarker analysis of a phase 2 study of LBL-007 (alcestobart, an anti-LAG-3 mAb) combined with tislelizumab (an anti–PD-1 mAb) and chemotherapy in previously untreated recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

[Abstract Number] 6097

[Session Type] Poster Session

[Session Title] Head and Neck Cancer

[Poster Board] 505

[Session Date and Time] 6/2/2025 9:00 AM-12:00 PM CDT

Leadership Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented:
“We are truly honored to have LBL-024 selected for oral presentation at ASCO for a second consecutive year. This recognition affirms the growing global acknowledgment of our clinical research and innovation. Notably, this year we will present first-line treatment data in advanced EP-NEC, a step forward from last year’s later-line findings. This progress marks a meaningful milestone in expanding LBL-024’s clinical potential and reflects our vision to transform care for patients with this challenging cancer type. We look forward to engaging with global oncology leaders to advance the frontier of immunotherapy together.”

About LBL-024

LBL-024 is a potential first-in-class bispecific antibody simultaneously targeting PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to reach the single arm pivotal trial stage as a monotherapy and holds promise to become the first approved treatment specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC), a malignancy with significant unmet medical need.

Developed using Leads Biolabs’ proprietary X-Body™ bispecific platform, LBL-024 features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows LBL-024 to both reverse PD-L1–mediated immune suppression and selectively enhance T cell activation, resulting in potent, synergistic anti-tumor effects.

In Phase I/II clinical trials in China, LBL-024 has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. The lack of a standard of care in EP-NEC supports the pursuit of accelerated approval through a single-arm pivotal study.

In recognition of its clinical potential, LBL-024 received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China (October 2024), and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for neuroendocrine carcinoma (November 2024).

Beyond NEC, LBL-024 has shown encouraging early activity in other tumor types, including small cell lung cancer (SCLC), biliary tract cancer (BTC), and with strong potential for expansion into broader indications such as non-small cell lung cancer (NSCLC), ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC).

About LBL-007

LBL-007 is a fully human IgG4 monoclonal antibody targeting LAG3. It ranks among the top three LAG3-targeted clinical-stage monoclonal antibodies globally in terms of clinical development (other than the only one marketed LAG3-targeted drug), according to Frost & Sullivan, as of November 2024. We have granted BeiGene an exclusive license to develop, manufacture and commercialize LBL-007 outside Greater China.

Configured to target unique epitopes of LAG3, LBL-007 can bind to LAG3 with high affinity and block LAG3’s engagement with all four identified immune inhibitory ligands. Upon binding to LAG3, LBL-007 induces potent endocytosis, reducing LAG3 expression on the cell surface, which further blocks ligand interaction and enhances immune responses. LBL-007 has exhibited stronger inhibition of tumor growth and superior efficacy compared to the analog of relatlimab, the LAG3 antibody component in Opdualag™, in our preclinical studies.

Through our collaboration with BeiGene, LBL-007 is currently being investigated under Phase II clinical trials in China and globally for multiple cancer indications.. The combination therapy integrating LBL-007 and PD-1 inhibitors has demonstrated promising synergistic antitumor effects and favorable safety across various tumor types in our clinical studies. LBL-007 is the first LAG3 antibody to show robust efficacy in NPC. It also potentially offers a more effective treatment option than current standard of care for NPC.