China‑based Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced today that the first patient has been successfully dosed in the Phase II clinical trial of LBL‑024 (opamtistomig), a bispecific antibody targeting PD‑L1 and 4‑1BB for the first‑line treatment of biliary tract cancer (BTC).
About LBL‑024
- Bispecific Design – LBL‑024 is the world’s first 4‑1BB‑targeting therapy to reach the registrational clinical stage for extra‑pulmonary neuroendocrine tumors (EP‑NETs).
- Dual‑Arm Functionality – By simultaneously engaging PD‑L1 and 4‑1BB, LBL‑024 disinhibits T‑cell activity while providing a potent co‑stimulatory signal, producing a synergistic tumor‑killing effect.
- X‑Body Platform – Leveraging the company’s proprietary X‑body platform, LBL‑024 is engineered in an optimal 2:2 architecture that maximizes effector function and minimizes off‑target activity.
Clinical Significance
- First‑Patient Dose – The first patient dose in the Phase II BTC study marks a critical milestone, indicating the safety profile and pharmacodynamics needed for accelerated development.
- Potential First‑In‑Class Approval – LBL‑024 is poised to become the first approved drug for advanced EP‑NETs, expanding therapeutic options beyond conventional PD‑1/PD‑L1 inhibitors.
- Broad‑Spectrum Promise – The bispecific mechanism offers a mechanistic advantage that may translate into efficacy across a range of solid tumors, positioning LBL‑024 as a platform candidate.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech
