Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Abstract Published by WCLC: Extended Follow‑Up Shows Continued Efficacy Improvement

NANJING, China, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the full abstract of the Phase II clinical study evaluating its proprietary drug candidate LBL-024 (Opamtistomig, a PD-L1/4-1BB bispecific antibody) in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (“NSCLC”) has been published on the official website of the World Conference on Lung Cancer (the “WCLC”). Based on data analyzed as of March 6, 2026, LBL-024 in combination with chemotherapy demonstrated an encouraging antitumor activity in the overall population, with robust tumor shrinkage observed in both the squamous and non-squamous NSCLC. The abstract data were based on a median follow‑up of 3.6 months. Updated data with over 7 months of follow‑up will be presented in an oral presentation at WCLC on September 14, 2026.

According to the abstract, among 60 efficacy-evaluable patients with locally advanced or metastatic NSCLC who received LBL-024 in combination with chemotherapy as first-line treatment, the objective response rate (ORR) was 65.0% and the disease control rate (“DCR”) was 95.0%. In the squamous subgroup, the ORR was 77.4% and the DCR was 96.8%, while in the non-squamous subgroup, the ORR was 51.7% and the DCR was 93.1%. The overall safety profile was manageable, with no new safety signals identified.

Importantly, the abstract data reflect only 3.6 months of median follow-up at the time of data cutoff, and updated results based on more than 7 months of follow‑up, to be presented at WCLC are expected to provide further insights into the durability and depth of response. With longer treatment and follow-up, continued tumor shrinkage has been observed in some patients, accompanied by an upward trend in ORR and a favorable trend in progression-free survival (PFS). These findings further support the potential of LBL-024’s differentiated dual-target immune mechanism, designed to both “release the brake and press the accelerator,” and its potential to advance a new-generation “IO 2.0” treatment approach in NSCLC.

LBL‑024 is currently being evaluated in 11 clinical studies across multiple tumor types and has demonstrated encouraging efficacy signals across several indications. Data generated to date across its first seven clinical indications have demonstrated promising therapeutic potential, further supporting the broad development potential of this novel PD-L1/4-1BB bispecific antibody.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: “With extended follow‑up, we have observed continued tumor shrinkage in some patients, accompanied by an upward trend in ORR. This encouraging signal suggests that, with additional treatment cycles and longer follow-up, the updated clinical data may further demonstrate the therapeutic potential of LBL‑024. At the WCLC annual meeting, taking place on September 12–15, we will present updated data from more than 7 months of follow-up in an oral presentation, including the updated ORR, 6-month PFS rate, and subgroup analyses by PD-L1 expression levels in both squamous and non-squamous NSCLC. The encouraging efficacy and manageable safety profile observed to date further supports the potential of LBL-024 as a differentiated IO 2.0 approach with broad applicability across tumor types. We will continue to advance the clinical development and regulatory programs for LBL-024 with the goal of bringing this innovative treatment to patients with significant unmet medical needs as quickly as possible.”

About NSCLC
According to data from the International Agency for Research on Cancer (“IARC”) in 2022, there are approximately 2.48 million new cases of lung cancer and approximately 1.817 million lung cancer-related deaths worldwide each year. According to data published by the National Cancer Center of China, there were approximately 1.176 million new lung cancer cases and approximately 743 thousand lung cancer-related deaths in China in 2024. NSCLC accounts for approximately 85% of all lung cancer cases. Due to the aggressive nature of NSCLC and the lack of effective early screening methods, approximately 70% of patients with NSCLC in China are diagnosed at an advanced stage.

Patients with NSCLC harboring driver gene mutations such as epidermal growth factor receptor (“EGFR”), anaplastic lymphoma kinase (“ALK”) and ROS proto-oncogene 1 (“ROS1”) may benefit from corresponding targeted therapies, while patients without driver gene mutations still rely primarily on immunotherapy in combination with chemotherapy. Further prolonging survival and achieving more durable and deeper responses remain key unmet needs in clinical practice. In squamous NSCLC, driver gene mutations are rare and patients generally cannot benefit from targeted therapies. Commonly used drugs such as pemetrexed and bevacizumab are also generally unsuitable for squamous NSCLC due to efficacy or safety concerns, resulting in limited treatment options. Although PD-1/PD-L1 inhibitors in combination with chemotherapy have expanded treatment options for patients with squamous NSCLC, prognosis remains poorer than in non-squamous NSCLC due to differences in biology, clinical features and treatment responses, with a median progression-free survival (“PFS”) of only 5 to 8 months and a median overall survival (“OS”) of 17 to 27 months, highlighting a significant unmet medical need for more effective treatment options.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across multiple indications, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically “cold” tumors, and has the potential to deliver durable, long-tail survival benefits. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

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 14 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