LEADS BIOLABS-B (09887.HK): First Patient Enrolled in Phase Ib/II Study of Vescuterlimab in mCRC

NewTimeSpace News: Nanjing Leads Biolabs Co., Ltd. (stock code: 09887) voluntarily announced on 16 October 2026 that the open-label, multicentre Phase Ib/II study of its internally developed Vescuterlimab (ivonescimab alias PD-L1/4-1BB bispecific antibody) in combination for the treatment of metastatic colorectal cancer has enrolled its first patient. The Company said this marks the extension of its strategy of targeting immune cold tumours with Vescuterlimab from epithelioid neuroendocrine cancer, biliary tract cancer, hepatocellular carcinoma and platinum-resistant ovarian cancer to colorectal cancer.

The Company noted that in metastatic colorectal cancer, around 95% of patients are microsatellite stable (MSS) or proficient mismatch repair (pMMR), and because of insufficient T cell infiltration in the tumour microenvironment, this group responds poorly to conventional immune checkpoint inhibitors, with standard treatment still based on chemotherapy combined with targeted therapy and new strategies needed. Vescuterlimab can conditionally activate 4-1BB, re-activating and amplifying T cells while relieving PD-1/PD-L1 immunosuppression, potentially filling the immunotherapy gap for this patient group.

The Phase Ib/II study is led by Academician Xu Ruihua of the Sun Yat-sen University Cancer Center and will be conducted across multiple hospitals to evaluate the efficacy and safety of Vescuterlimab in combination in patients with metastatic colorectal cancer. The Company added that the translational medicine study of Vescuterlimab in MSS colorectal cancer has been selected for poster presentation at the 2026 ESMO Congress, and that the product has shown a trend of survival benefit notably longer than historical data across several immune cold tumour indications including epithelioid neuroendocrine cancer, biliary tract cancer, hepatocellular carcinoma and platinum-resistant ovarian cancer.

The Company introduced Vescuterlimab as a bispecific antibody targeting both PD-L1 and 4-1BB, developed on its proprietary X-body™ platform to allow conditional activation of 4-1BB, with clinical studies ongoing in 14 indications, including one single-arm pivotal registrational study, one confirmatory Phase III study and nine proof-of-concept studies. Vescuterlimab received Breakthrough Therapy designation from the NMPA in October 2024 and Orphan Drug designation from the FDA in November 2024, Fast Track designation from the FDA and EU Orphan Drug designation in January 2026, priority review of its innovative biologics marketing application in July 2026 with acceptance in August, and Orphan Drug designation from Japan's MHLW in September 2026. The Company has made a warning statement under Rule 18A.05 of the Listing Rules, stating that it cannot guarantee the successful development or ultimate commercialisation of Vescuterlimab.