LEADS BIOLABS-B (09887) shares climbed more than 5% during Tuesday morning trading, last up 4.42% at HK$72.10 with turnover reaching HK$33.55 million.
The company announced that its self-developed investigational drug, Vilizin (Opasotumimab, a PDL1/4-1BB bispecific antibody, LBL-024), has completed the safety run-in phase of its Phase II clinical study for first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). Based on the observed positive efficacy signals, along with a favorable safety and tolerability profile, the study has now entered the expansion stage.
The trial is led by Professor Shen Lin of Beijing Cancer Hospital. During the safety run-in phase, Vilizin combined with chemotherapy demonstrated promising efficacy signals in ESCC patients, with an overall acceptable safety and tolerability profile. Following a comprehensive assessment by both the sponsor and investigators, the study has progressed to the combination-dose expansion phase.
The expansion phase employs a randomized, controlled design that head-to-head compares the efficacy and safety of Vilizin plus chemotherapy against tislelizumab plus chemotherapy as first-line treatment for ESCC, with the goal of further enhancing the clinical benefits of the current standard of care.