Leads Biolabs’ Pivotal Phase IIb Study of Opamtistomig (LBL-024) in Advanced EP-NEC Selected as ESMO 2026 Late-Breaking Abstract; Three Studies Selected for Proffered Paper Presentations

NANJING, China, Sept. 21, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that its pivotal registrational Phase IIb study of opamtistomig (LBL-024), the Company’s proprietary PD-L1/4-1BB bispecific antibody, as monotherapy for patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC), has been selected as a Late-Breaking Abstract (LBA) and Proffered Paper presentation at the ESMO Congress 2026.

The selection highlights the clinical importance and scientific interest of the study and further demonstrates the growing international recognition of opamtistomig and Leads Biolabs’ clinical development capabilities. Notably, three Company-sponsored studies have been selected for Proffered Paper presentations at ESMO 2026, spanning EP-NEC and multiple myeloma.

Pivotal Phase IIb Study of Opamtistomig in Advanced EP-NEC Selected as Late-Breaking Abstract

The pivotal, registrational Phase IIb study is evaluating the efficacy and safety of opamtistomig monotherapy in patients with advanced EP-NEC who have received at least two prior lines of systemic therapy. The study generated key clinical data supporting the Company’s recent New Drug Application (NDA) submission to the National Medical Products Administration (NMPA).

Study Title:
Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after >2 prior lines of therapies: results from a pivotal, registrational Phase IIb study of a novel PD-L1×4-1BB bispecific antibody

Presentation Type: Late-Breaking Abstract (LBA) / Proffered Paper

Principal Investigator: Professor Lin Shen, Peking University Cancer Hospital

Presenter: Dr. Ming Lu, Peking University Cancer Hospital

Presentation Time: 10:15-10:25, local time, 26 October

The ESMO 2026 LBA presentation will provide the pivotal clinical results from this study, offering further insights into the efficacy and safety profile of opamtistomig in this high unmet-need patient population.

Three Proffered Paper Presentations at ESMO 2026

In addition to the EP-NEC pivotal study, two other Leads Biolabs studies have been selected for Proffered Paper presentations at ESMO 2026:

• A pivotal registrational Phase IIb study of opamtistomig monotherapy in advanced EP-NEC, also selected as a Late-Breaking Abstract;
• A Phase Ib/II study of opamtistomig in combination with chemotherapy as first-line treatment for advanced EP-NEC; and
• A Phase I study of LBL-034 in patients with relapsed/refractory multiple myeloma (RRMM).
  

The selection of three studies for Proffered Paper presentations underscores the breadth of Leads Biolabs’ clinical development portfolio and its continued focus on advancing innovative therapies across areas of significant unmet medical need.

Broad ESMO 2026 Representation Across the Pipeline

In addition, four other Company-sponsored studies have been selected for poster presentations at ESMO 2026, covering clinical research of opamtistomig in biliary tract cancer (BTC), a mechanistic study in microsatellite-stable colorectal cancer (MSS CRC), and several meta-analyses.

Together, these presentations span clinical development, translational research and evidence synthesis, reflecting the breadth of Leads Biolabs’ oncology research portfolio and its commitment to generating high-quality clinical and scientific evidence.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: “The selection of our pivotal study of opamtistomig in advanced EP-NEC as a Late-Breaking Abstract at ESMO 2026 represents important recognition of the scientific and clinical interest in this program and the significant unmet need faced by patients with advanced EP-NEC. The selection of three Company-sponsored studies for Proffered Paper presentations further reflects the strength and breadth of our clinical development portfolio.

Opamtistomig is a cornerstone of our IO 2.0 strategy, and we are advancing its development across multiple tumor types and treatment settings. We remain focused on translating our differentiated PD-L1/4-1BB bispecific antibody approach into meaningful clinical benefits for patients and on advancing innovative treatment options for patients with cancer worldwide.”

About EP-NEC

Neuroendocrine carcinoma (NEC) is a highly malignant, immunologically “cold” tumor, accounting for approximately 10% to 20% of neuroendocrine neoplasms. NEC may arise in various organs, including the lung, gastrointestinal tract and bladder. NEC can be classified into pulmonary NEC and extrapulmonary NEC. EP-NEC shares the highly aggressive and metastatic characteristics of small cell lung cancer (SCLC), progresses rapidly, and most patients with NEC present with advanced-stage disease or distant metastases at diagnosis. Systemic treatment options for NEC are limited, with suboptimal efficacy and poor prognosis.

There are currently no therapies specifically approved by regulatory authorities worldwide for EP-NEC. First-line treatment for advanced EP-NEC primarily consists of platinum-based chemotherapy, with an objective response rate (ORR) of approximately 30% to 50% and a median overall survival (mOS) of only around one year. There is no standard treatment following progression on first-line therapy. Second-line treatment options may include oxaliplatin-based FOLFOX, irinotecan-based FOLFIRI, CAPTEM with or without bevacizumab, or temozolomide monotherapy. However, the efficacy of these treatment options remains limited, with an ORR of approximately 10% to 25% and an mOS of approximately eight months. Accordingly, there remains a substantial unmet medical need for patients with advanced EP-NEC, underscoring the urgent need for new and 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. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-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. 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 potentially offering durable 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) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission, further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world's first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

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 15 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/