Announcement • Aug 03
Nanjing Leads Biolabs Co., Ltd. Receives IND Approval For LBL-024 (Opamtistomig, PD-L1/4-1BB Bispecific Antibody) For Treatment Of Metastatic Colorectal Cancer
Nanjing Leads Biolabs Co., Ltd. announced that the Center for Drug Evaluation of the National Medical Products Administration of the People’s Republic of China has approved the Investigational New Drug application of its self-developed drug candidate LBL-024 (Opamtistomig, a PD-L1/4-1BB bispecific antibody) for the treatment of metastatic colorectal cancer. The approved clinical trial is an open-label, multicenter Phase Ib/II study designed to evaluate the safety and efficacy of LBL-024 in combination therapy for the treatment of metastatic colorectal cancer. This milestone marks an important step in expanding the indications of LBL-024 into gastrointestinal cancers. It further extends the immuno-oncology portfolio from biliary tract cancer, gastric cancer and esophageal squamous cell carcinoma to colorectal cancer, a malignancy with significant unmet medical needs. Metastatic colorectal cancer remains difficult to treat and is associated with poor prognosis, with a five-year survival rate of less than 13%. Although immunotherapy has achieved significant advances in patients with microsatellite instability-high or mismatch repair-deficient tumors, these patients account for only approximately 5% of metastatic colorectal cancer cases. For the remaining approximately 95% of patients with microsatellite-stable or mismatch repair-proficient tumors, conventional immune checkpoint inhibitors provide limited clinical benefit, and chemotherapy in combination with targeted therapy remains the standard first- and second-line treatment, creating an urgent clinical need for more effective treatment options. LBL-024 is designed to simultaneously block the PD-1/PD-L1 immunosuppressive pathway and conditionally activate the 4-1BB co-stimulatory pathway. Through this dual mechanism of action, LBL-024 is intended to restore T-cell function while promoting T-cell proliferation and the formation of long-term immune memory. Clinical activity of LBL-024-based therapies has been observed in multiple tumor types, including extrapulmonary neuroendocrine carcinoma, non-small cell lung cancer, small cell lung cancer and biliary tract cancer. LBL-024 is a bispecific antibody simultaneously targeting PD-L1 and 4-1BB, and is a pan-tumor immuno-oncology 2.0 cornerstone therapy with potential survival benefit. Leveraging the self-developed X-body™ platform with full intellectual property rights, LBL-024 achieves conditional activation of 4-1BB, relieving PD-1/PD-L1 immunosuppression while enhancing 4-1BB regulated T-cell activation, achieving a synergistic effect in eliminating tumors. LBL-024 demonstrates a safety profile comparable to PD-1/PD-L1 inhibitors and greater potential for broad-spectrum cancer treatment, and has demonstrated first-in-class or best-in-class potential in non-small cell lung cancer, small cell lung cancer, extrapulmonary neuroendocrine carcinoma and biliary tract cancer. As the first molecule targeting the co-stimulatory receptor 4-1BB to have reached the pivotal single-arm registrational clinical stage globally, LBL-024 has the potential to become the first drug approved for treating extrapulmonary neuroendocrine carcinoma. LBL-024 has initiated clinical studies across 13 solid tumor indications in China, including one pivotal registrational clinical study and eight proof-of-concept studies, covering extrapulmonary neuroendocrine carcinoma, non-small cell lung cancer, small cell lung cancer, biliary tract cancer, ovarian cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, triple-negative breast cancer and melanoma, among other areas with high unmet medical needs. 4-1BB, as an agonist, can reactivate apoptotic T cells and induce substantial proliferation, making it suitable for treating “cold tumors” that are resistant or unresponsive to PD-1/PD-L1 therapies. LBL-024 received the Breakthrough Therapy Designation from Center for Drug Evaluation of the National Medical Products Administration in October 2024, as well as the Orphan Drug Designation in treating neuroendocrine carcinoma from the FDA in November 2024. In January 2026, LBL-024 received Fast Track Designation from the FDA for the treatment of extrapulmonary neuroendocrine carcinoma and Orphan Drug Designation from the European Union.
