Nanjing Leads Biolabs Co. Ltd. said the first patient has been enrolled in an open-label, multi-center Phase II clinical study of Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for first-line esophageal squamous cell carcinoma in China. The company said the trial, led by Professor Shen Lin of Beijing Cancer Hospital, will evaluate the efficacy and safety of Opamtistomig in first-line ESCC patients. The company also provided development updates for LBL-024 in extrapulmonary neuroendocrine carcinoma, including National Medical Products Administration approval in April 2024 for a single-arm registrational trial, Breakthrough Therapy Designation from the NMPA in October 2024 for late-line advanced EP-NEC, FDA Orphan Drug Designation for neuroendocrine carcinoma in November 2024, FDA Fast Track Designation for EP-NEC in January 2026, and European Commission Orphan Drug Designation for EP-NEC in January 2026.
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