NANJING, China, May 28, 2026 /PRNewswire/ — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the Phase II clinical study of its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), in combination with chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC), has been selected for an oral presentation at the 2026 World Conference on Lung Cancer (WCLC), the world’s most influential scientific meeting in the lung cancer field, taking place September 12–15, where Leads Biolabs will present breakthrough efficacy data based on an expanded patient cohort compared to the previously reported 18-patient dataset.
Previously reported early-stage NSCLC data showed that Opamtistomig combined with chemotherapy achieved a compelling objective response rate (ORR). With extended follow-up, deepening tumor responses and durable tumor shrinkage were observed across multiple subgroups, including immunotherapy-pretreated non-squamous NSCLC, first-line non-squamous NSCLC, and first-line squamous NSCLC.
At WCLC 2026, the Company will present updated data demonstrating high response rates and continuously deepening tumor shrinkage of Opamtistomig in an expanded patient population, along with a safety profile consistent with previous findings. These results further validate the safety breakthrough enabled by conditional 4-1BB activation via the X-body platform and highlight Opamtistomig’s differentiated clinical advantages in first-line NSCLC.
Opamtistomig’s potential as an IO 2.0 pan-tumor backbone therapy is being validated in three key dimensions—broad antitumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 inhibitors: its clinical development spans 13 solid tumor indications, demonstrating first- or best-in-class potential in multiple tumor types, including NSCLC, extrapulmonary neuroendocrine carcinoma (EP-NEC), small cell lung cancer (SCLC), and biliary tract cancer (BTC); clear survival benefit trends have been observed in multiple indications, with potential to translate into long-term efficacy benefits with continued follow-up; and with over 600 patients enrolled, Opamtistomig demonstrated a favorable safety profile as monotherapy and in combination with chemotherapy, with no dose-limiting toxicities observed and the maximum tolerated dose not reached at doses up to 25.0 mg/kg.
Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: “The selection for an oral presentation at WCLC represents strong recognition from the international academic community of Opamtistomig’s innovative mechanism and clinical value, and further validates its breakthrough therapeutic potential in first-line NSCLC. As we accumulate data from larger patient cohorts and longer follow-up, we continue to observe significant trends toward deeper and more durable responses across broader patient populations. We look forward to sharing these important findings with global experts at WCLC and continuing to advance Opamtistomig toward becoming a new backbone of cancer immunotherapy worldwide.”
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 four indications: 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. 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.
We are a front-runner in next-generation immuno-oncology treatments with a differentiated pipeline of 14 innovative drug candidates, including four clinical-stage drug candidates and one registration-stage asset.
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) and ImBiTDC (TDC 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/
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