Health
Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Advances to Expansion Phase in First-Line Biliary Tract Cancer Following Positive Safety and Preliminary Efficacy Results
NANJING, China, April 09, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) announced that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has successfully completed the safety run-in stage of a Phase II clinical trial in the first-line treatment of advanced biliary tract cancer (BTC). Based on favorable safety and encouraging preliminary efficacy data, the study has progressed into the expansion phase, with
About this update from Nanjing Leads Biolabs Co., Ltd. Class H
[{"type":"text","content":"NANJING, China, April 09, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) announced that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has successfully completed the safety run-in stage of a Phase II clinical trial in the first-line treatment of advanced biliary tract cancer (BTC). Based on favorable safety and encouraging preliminary efficacy data, the study has progressed into the expansion phase, with the first patient already enrolled.","length":535,"tagName":"p"},{"type":"text","content":"The study is led by Dr. Jian Zhou from Zhongshan Hospital, Fudan University, and is being conducted across multiple clinical sites in China. A total of 20 patients were included in the safety run-in cohort and completed preliminary evaluation. Results demonstrated that Opamtistomig in combination with chemotherapy was generally well tolerated, with a favorable safety profile and no new safety signals observed. Preliminary efficacy assessments indicated encouraging tumor reduction trends. Based on these results, the study has advanced to the expansion phase with accelerated enrollment underway.","length":600,"tagName":"p"},{"type":"text","content":"Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).","length":751,"tagName":"p"},{"type":"text","content":"Executive CommentaryDr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented: ”Based on favorable safety and encouraging efficacy signals from the safety run-in cohort, Opamtistomig has advanced into the expansion phase of the Phase II BTC study, with strong support from investigators unanimously. This re...