On January 7, 2025 Nerviano Medical Sciences S.r.l. (NMS), a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that it has entered into a clinical trial supply agreement with Roche for provision of atezolizumab (Tecentriq)1 to be combined with the Monopolar Spindle 1 (MPS1) inhibitor NMS-153, and cGAS/STING pathway activator, for the treatment of hepatocellular cancer patients (Press release, Nerviano Medical Sciences, JAN 7, 2025, View Source [SID1234649469]).
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The new study, recently approved by health authorities, is a: "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).
The trial is a Phase IIa, open-label, non-randomized, 2-part multicenter study to explore the safety, tolerability, and antitumor activity of NMS-153 administered with atezolizumab to adult patients with unresectable HCC previously treated with an approved immune checkpoint inhibitor and that have experienced clinical benefit to this treatment.
NMS has recently completed the monotherapy "Phase I/II Study on Safety and Efficacy of NMS-01940153E in Adult Patients with Unresectable Hepatocellular Carcinoma (HCC) Previously Treated with Systemic Therapy" (NCT05630937), identifying early signs of clinical activity, with an adequate safety profile.
"MPS1 inhibition has been shown to be a potent upstream re-activator of the cGAS/STING pathway in multiple cancer types, including hepatocellular carcinoma. Coupling this with decitabine to reverse tumor cell epigenetic silencing of STING, along PD-L1 blockade, is an exciting novel strategy to attempt to restore immunogenicity in treatment-refractory disease", David A. Barbie, MD, Director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and NMS Scientific Advisory Board member commented.
"Our goal is to bring valid therapeutic options to liver cancer patients", said Hugues Dolgos, Pharm.D., Chief Executive Officer, NMS: "The combination of atezolizumab, a drug already approved for use in hepatocellular cancer, together with NMS-153, has strong potential since each has shown clinical activity in HCC2,3, bringing hope to improve outcomes for these patients. We sincerely thank Roche for their collaboration on the trial and for providing atezolizumab".
"Unmet medical need in hepatocellular cancer remains high and this novel combination with the MPS1 mechanism offers hope. NMS is committed to development of new therapies for cancer patients." according to Lisa Mahnke, MD, PhD, Chief Medical Officer, NMS.