Opamtistomig

NANJING, China, Aug. 14, 2025 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) today announced the successful completion of patient enrollment in the ongoing single-arm, pivotal registrational clinical trial (CTR20213023) for Opamtistomig (LBL-024), a novel PD-L1/4-1BB bispecific antibody. This marks the world's first registrational clinical trial evaluating an immunotherapy monotherapy for extrapulmonary neuroendocrine carcinoma (EP-NEC). The study, led by Professor Shen Lin from Peking University Cancer Hospital and conducted across multiple medical centers, aims to evaluate the efficacy and safety of Opamtistomig in patients with advanced EP-NEC who failed at least two lines of chemotherapy. EP-NEC is a highly aggressive, immunologically "cold" tumor. The current first-line standard treatment for advanced EP-NEC remains platinum-based chemotherapy, with an objective response rate (ORR) of 30%-50% and a median overall survival (mOS) of approximately 1 year. For patients with platinum-resistant, no established second-line standard of care exists, representing a pressing unmet need for new therapeutic options. Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:" As the first PD-L1/4-1BB-targeted bispecific antibody globally to have reached pivotal single-arm registrational stage, Opamtistomig has demonstrated compelling antitumor activity and favorable safety in early trials. Completing enrollment months ahead of schedule accelerates clinical development timelines and reflects both strong confidence of investigators in the trial design and the urgent patient need for effective, safer therapies. We remain committed to advancing rigorous clinical development across multiple indications, including EP-NEC." Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs, added, "This achievement was made possible by the exceptional execution of our clinical team, the dedication of investigators, and the trust of patients and their families. Every data point in this study represents hope for patients facing a devastating disease. Guided by our mission-care for life, focus on innovation, and win win cooperation-we will continue to invest in R&D to accelerate Opamtistomig's global development and deliver transformative therapies worldwide." About Opamtistomig Opamtistomig (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, Opamtistomig features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows Opamtistomig 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, Opamtistomig 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, Opamtistomig 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). Notably, 4-1BB agonism can reactivate exhausted T cells and drive robust proliferation, making it particularly promising for PD-1/PD-L1-resistant or immunologically "cold" tumors. Beyond EP-NEC, Opamtistomig has been approved for clinical trial across multiple cancer types with high unmet need, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in SCLC, BTC, OC, and other cancer types, supporting Opamtistomig's potential as a broad-spectrum oncology therapy. About EP-NEC Neuroendocrine carcinoma (NEC) is a class of poorly differentiated, high-grade neuroendocrine neoplasms (NENs), which originate in the diffuse neuroendocrine cell system and can occur in many different sites. NEC can be categorized into pulmonary NEC and EP-NEC. EP-NEC exhibits similar highly aggressive and metastatic characteristics to small cell lung cancer (SCLC). Most patients are diagnosed at a later stage or already have distant metastases, resulting in rapid disease progression and a poor prognosis. Currently, the primary first-line treatment for advanced EP-NEC involves platinum-based chemotherapy, achieving an overall response rate (ORR) of approximately 30% to 50%, with a median overall survival (mOS) of only approximately one year. Treatment options for patients with platinum-resistant are limited, and there are no established second-line standard of care for patients who progress after first-line therapy. These underscore the urgency to develop novel therapeutic approaches. 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 six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally. 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), 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 venture capitals. 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NANJING, China, July 24, 2025 /PRNewswire/ -- On 25 July, 2025 (China Time), Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company") listed on the Main Board of The Stock Exchange of Hong Kong Limited (HKEX) under the stock code "09887". The clinical-stage biotech company priced its IPO at HKD 35 per share, offering 36.86 million shares (excluding green shoe option). The deal included a Hong Kong public tranche of 16.03 million shares (43% of the total) and an international placement of 20.84 million shares (57%). Morgan Stanley and CITIC Securities acted as joint sponsors of the transaction. Gross proceeds totaled approximately USD 189 million (including green shoe option). According to Leads Biolabs, the proceeds will be allocated as follows: ~65% for ongoing and planned clinical trials and regulatory affairs; ~15% for advancing preclinical assets, expanding existing pipelines, and optimizing technology platforms ~10% for upgrading manufacturing capacity and commercialization preparedness post-approval; ~10% for working capital and general corporate purposes. Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, commented: "Our HKEX debut represents a major leap from laboratory innovation to global capital markets, accelerating our innovation-driven international expansion. For more than a decade, we've pursued one goal: becoming a global leader in immuno-oncology therapeutics. At this inflection point, we reaffirm our founding commitment to eradicating disease while maintaining the entrepreneurial vigor that defines us. Through strengthened global execution and accelerated translation of breakthrough therapies from bench to bedside, we will deliver paradigm-shifting treatments to patients across the globe." Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address unmet medical needs in oncology, autoimmune, and other severe diseases both in China and globally. The Company has built a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally. Leads Biolabs operates an integrated business model encompassing in-house discovery, development and commercialization of innovative tumor immunotherapies. The Company has strategically developed assets in three areas: Immuno-oncology 2.0 (IO 2.0), T-cell engagers (TCEs), and antibody-drug conjugates (ADCs). Its oncology pipeline includes 12 investigational products, including 3 monoclonal antibodies, 5 bispecific antibodies, 3 ADCs and 1 bispecific fusion protein. The Company is also progressing two promising candidates for autoimmune diseases—a bispecific fusion protein and a trispecific antibody. Leads Biolabs' R&D is powered by multiple proprietary technology platforms that feature integrated, AI-powered and diversified antibody engineering capabilities, including LeadsBody™ (a CD3 T-cell engager platform), X-body™ (a 4-1BB engager platform) and its linker-payload platform for ADC development. These platforms have demonstrated clinical proof-of-concept, particularly with bispecific antibody combinations. The LeadsBody™ platform delivers strong technological capabilities for developing CD3-targeted bispecific antibodies. Its innovative molecular design enables precise affinity modulation between TCEs and both CD3 and tumor-associated antigens (TAAs). With spatially optimized steric hindrance architecture, the platform enables conditional T-cell activation exclusively within the tumor microenvironment (TME), significantly lowering the risk of cytokine release syndrome (CRS) and systemic toxicity. This molecular engineering approach is designed to optimize the therapeutic index through customized spatial configurations that reduce treatment interruptions due to toxicity. By minimizing adverse systemic effects, the platform enables extended treatment durations and, ultimately, aims to improve patient quality of life (QoL). Building on this platform, Leads Biolabs has established a position of leadership in the promising field of solid tumor immunotherapies. The company has developed six differentiated TCE therapeutic candidates, forming a portfolio spanning three major therapeutic areas: hematologic malignancies, solid tumors, and autoimmune diseases. Hematologic Malignancies: LBL-034: A GPRC5D/CD3 bispecific antibody for the treatment of multiple myeloma (MM) LBL-043: A LILRB4/CD3 bispecific antibody targeting acute myeloid leukemia (AML) and multiple myeloma (MM) Solid Tumors: LBL-033: A MUC16/CD3 bispecific antibody targeting solid tumors overexpressing MUC16, with a focus on gynecologic cancers including ovarian cancer, cervical cancer, and endometrial carcinoma LBL-054: A CDH17/CD3 T-cell engager under development for colorectal cancer (CRC), gastric cancer, pancreatic ductal adenocarcinoma (PDAC), and neuroendocrine neoplasms (NENs) LBL-058: A first-in-class TCE-ADC (antibody-drug conjugate) targeting DLL3, demonstrating encouraging efficacy in DLL3-positive small cell lung cancer (SCLC) and NENs Autoimmune Diseases: LBL-051: A first-in- class CD19/BCMA/CD3 trispecific antibody designed to block autoantibody production by B cells and plasma cells while regulating B-cell hyperactivation, differentiation, and plasmacytic transformation. The candidate's unique mechanism of action enables broad-based B-cell modulation, potentially delivering superior clinical outcomes. The program is being advanced through a strategic collaboration with NewCo, a portfolio company of leading biotech investor Aditum Bio. The company's X-body™ platform utilizes advanced antibody engineering to develop 2:2 bispecific antibody structures. Its lead candidate, LBL-024 (PD-L1/4-1BB), represents a key advance in 4-1BB agonist therapies, becoming the first agent in this class to enter global registrational trials. The platform's 2:2 configuration is designed to restrict 4-1BB activation to the tumor microenvironment (TME), addressing systemic toxicity issues, particularly hepatotoxicity, that have undermined earlier efforts in this category. This platform-driven approach enables precise control of immune activation within the TME, minimizing off-target adverse effects while reactivating exhausted T cells and driving clonal expansion. The mechanism has shown particular promise in tumors resistant to PD-1/PD-L1 inhibitors, as well as in so-called immunologically "cold" tumors. The successful execution of this strategy with LBL-024 underscores its potential as a best-in-class immunotherapy candidate. At the 2025 ASCO Annual Meeting, Leads Biolabs presented data from a multicenter Phase Ib/II trial evaluating LBL-024 in combination with etoposide and platinum-based chemotherapy in first-line advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC). The study reported a 75.0% objective response rate (ORR) and a 92.3% disease control rate (DCR) among the efficacy-evaluable population (n=52). In the 15 mg/kg cohort, ORR reached 83.3%, with a DCR of 100%. Overall, 57.7% of patients (30/52) achieved tumor reduction exceeding 50%. These results substantially outperformed historical benchmarks for chemotherapy alone, which typically show ORR in the 30–55% range. While progression-free survival (PFS) data were not yet mature at the April 15, 2025 cutoff (median follow-up: 8.2 months), all dose cohorts showed favorable trends compared with historical controls. EP-NEC is a rare and aggressive cancer with poor advanced-stage outcomes and no approved second-line or later therapies. Recognizing this unmet medical need, China's National Medical Products Administration (NMPA) granted approval on April 30, 2024 for a pivotal single-arm registrational trial of LBL-024 in EP-NEC, potentially establishing it as the first approved therapy for this indication. As the world's first 4-1BB-targeted molecule to have reached registrational stage, LBL-024 could establish 4-1BB as the fourth approved immuno-oncology target following PD-1/L1, CTLA-4 and LAG-3. The candidate has earned Breakthrough Therapy Designation from China's NMPA for relapsed/refractory EP-NEC and Orphan Drug Designation from U.S. FDA for neuroendocrine neoplasms (NENs). LBL-024 has also secured regulatory approvals to investigate indications including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and gastric cancer (GC). Early clinical data have shown promising antitumor activity in SCLC, BTC and OC, supporting its potential as a broad-spectrum oncology therapeutic. Leads Biolabs has enhanced end-to-end capabilities across the entire drug development lifecycle—from early-stage target screening and discovery to preclinical research, clinical development, CMC (Chemistry, Manufacturing, and Controls), and pilot manufacturing. Demonstrating exceptional efficiency, the Company has achieved IND submission within just three years of target selection, significantly outpacing the industry average of 5 to 6 years (based on Frost & Sullivan data). In addition to its proprietary R&D initiatives, Leads Biolabs is exploring strategic collaborations to accelerate clinical development and commercialization of promising drug candidates. The Company is well-positioned to capitalize on market opportunities through out-licensing agreements, co-marketing partnerships, and other strategic alliances. As its clinical-stage assets progress toward commercialization, Leads Biolabs may expand its infrastructure to include commercial-scale manufacturing facilities while bolstering commercialization capabilities—both through collaborative ventures and the development of an in-house sales force. SOURCE Leads Biolabs WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED