Opamtistomig

NANJING, China, July 13, 2026 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced that six of its latest research studies have been accepted for presentation at the 2026 European Society for Medical Oncology (ESMO) Annual Congress. Among these, two have been selected as Proffered Papers—the congress's highest-profile oral presentation format, while four will be presented as posters, covering multiple tumor types such as extrapulmonary neuroendocrine carcinoma (EP‑NEC), biliary tract cancer (BTC), and relapsed/refractory multiple myeloma (RRMM). In addition, the Company has been granted a Late‑Breaking Abstract (LBA) status and plans to submit the full LBA abstract in September. The ESMO Annual Congress is one of the most influential scientific conferences in oncology. The 2026 congress will take place in Madrid, Spain, from October 23 to 27, 2026. Proffered Papers are reserved for studies considered to have the greatest clinical significance and scientific innovation, while LBA features the latest clinical findings with breakthrough potential and the ability to change clinical practice. The selection of multiple Leads Biolabs' studies underscores the international academic community's strong recognition of the Company's clinical data and the value of its pipeline, further demonstrating its sustained innovation capabilities and expanding leadership in cancer immunotherapy. The full data from the selected studies will be released through the ESMO online abstract publication and during the congress. Separately, the Company previously announced that Opamtistomig for first‑line non‑small cell lung cancer (1L NSCLC) has been selected for an oral presentation at the 2026 World Conference on Lung Cancer (WCLC), to be held in September 2026. The full abstract is scheduled to be published on the WCLC website on August 19. Executive Commentary Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The acceptance of multiple studies at ESMO represents strong international recognition of Leads Biolabs' innovative capabilities and clinical development achievements, and marks another important step in our journey toward becoming a leading global innovator in drug development. Opamtistomig continues to demonstrate encouraging depth of responses, favorable survival trends, and a well-tolerated safety profile across multiple tumor types, further reinforcing its strategic positioning as an IO 2.0 pan‑tumor backbone therapy. Meanwhile, LBL‑034 further validates the global competitiveness of our proprietary LeadsBody platform in the TCE field. Looking ahead, we remain committed to advancing global registrational clinical development and commercialization of our core assets, with the goal of bringing breakthrough therapies to more patients worldwide as quickly as possible." 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 LBL-034 LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company's proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner. LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies. It is currently being evaluated in a Phase I/II clinical trial for RRMM and other malignant plasma cell neoplasms in China. Notably, breakthrough clinical data from LBL-034 monotherapy in RRMM were presented as the first oral presentation on the opening day of the ASH 2025 Annual Meeting, highlighting its emerging clinical profile. In October 2024, LBL-034 received Orphan Drug Designation from the U.S. FDA for the treatment of multiple myeloma. In January 2026, LBL-034 received Fast Track Designation from the U.S. FDA for the treatment of RRMM. 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 four 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 SOURCE Leads Biolabs 21% more press release views with Request a Demo