MILAN, Italy, 16 MARCH 2026 – Nerviano Medical Sciences S.r.l. (NMS), a global oncology-focused biopharmaceutical company today announced that it is discontinuing its Phase 2 clinical study1 of the investigational Monopolar Spindle 1 (MPS1) inhibitor NMS-153 for the treatment of immune-experienced hepatocellular cancer patients in combination with atezolizumab (Tecentriq®).
The trial confirmed favorable safety profile, but no favorable overall benefit-risk profile. The novel anti-cancer mechanism targeting the mitotic checkpoint showed prior monotherapy activity, likely involving innate immunity, but in this more immune-experienced population the effects seem to be less strong,” noted Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. “The mitotic checkpoint kinase mechanism of NMS-153 is unique, and NMS remains committed to developing novel therapeutics that can address unmet medical needs in cancer,” stated Hugues Dolgos, PharmD, CEO of NMS.
With the closure of this Phase 2 trial, NMS has decided to discontinue further development of the NMS-153 program.
- Phase II Combination Study of NMS-01940153E and Atezolizumab with or without a prior priming with low dose decitabine for the Treatment of Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Immune Checkpoint Inhibitors” (EUCT Number: 2024-516737-12-00)
About NMS-153
NMS-153 is a potent, highly selective small-molecule inhibitor of MPS1 (TTK) with a dual anti-cancer mechanism, inducing mitotic catastrophe and apoptosis while potentially activating anti-tumor immunity via the cGAS/STING pathway. It shows prolonged target engagement and broad in vivo activity as a single agent and in combination therapies. In January 2024, the FDA granted Orphan Drug designation for the treatment of hepatocellular carcinoma (HCC).
About NMS
NMS is a global, integrated biopharmaceutical company focused on the discovery and development of innovative oncology therapies. With affiliates in Nerviano/Corsico (Italy), Boston (USA), and Shanghai (China). NMS leverages deep expertise in drug discovery and translational medicine to advance a pipeline of novel candidates from bench to bedside.
Forward-Looking Statements
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