Nanjing Leads Biolabs Co., Ltd. (Stock Code: 9887) reported that its bispecific antibody Opamtistomig (LBL-024), which targets both PD-L1 and 4-1BB, has successfully dosed the first patient in a Phase Ib/II clinical study for the treatment of recurrent or metastatic triple-negative breast cancer (TNBC). The trial, led by Professor Ying Yongmei of Jiangsu Province Hospital, will evaluate the efficacy and safety of Opamtistomig administered alone or in combination with albumin-bound paclitaxel.
According to the announcement, LBL-024 is the first treatment targeting the 4-1BB receptor to reach registrational stage globally for extrapulmonary neuroendocrine carcinoma (EP-NEC). Previous clinical studies have shown encouraging signals in several tumor types, including non-small cell lung cancer, small cell lung cancer, biliary tract cancer, ovarian cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, TNBC, and melanoma. The latest development marks another step in exploring Opamtistomig’s potential to address high unmet medical needs, particularly for aggressive tumors such as TNBC.
The report highlights that breast cancer remains one of the most prevalent cancers worldwide, with TNBC representing 15–20% of all cases. Characterized by the absence of estrogen receptor, progesterone receptor, and HER-2 expression, TNBC is known for its poor prognosis and limited treatment options. Domestic and international guidelines continue to recommend chemotherapy as the standard of care for PD-L1–negative patients, underlining the urgency of finding more effective therapies.
The company cautioned that development and commercialization of LBL-024 cannot be guaranteed. Shareholders and potential investors are advised to exercise caution when dealing in its shares.