The National University Cancer Institute, Singapore (NCIS) and MiNA Therapeutics have dosed the first patients in an investigator-sponsored Phase I study of MiNA’s small activating RNA oligonucleotide, MTL-CEBPA, in combination with first-line standard of care, atezolizumab and bevacizumab, in patients with previously untreated, advanced hepatocellular carcinoma (HCC). Atezolizumab and bevacizumab are being provided by F. Hoffmann-La Roche (Roche), who is also supporting the study.
More on the study
The study has been designed by Principal Investigator Dr. Cheng Ean Chee, Senior Consultant at the Department of Haematology-Oncology, NCIS and supported by the Singapore Ministry of Health’s National Medical Research Council under its Centre Grant programme (CG; NMRC/CG/M005/2017_NCIS). The study will be conducted at NCIS’s clinical trial facility with the Haematology-Oncology Research Group (HORG) at the National University Hospital, Singapore.
This is a single-centre, Phase I, open label dose-escalation and dose expansion study of MTL-CEBPA, co-administered with atezolizumab and bevacizumab, in approximately 30 patients with unresectable or advanced HCC who have not previously received systemic therapy.
The primary endpoint for the dose escalation phase will be determination of any dose-limiting toxicity, and the primary endpoint of the dose expansion phase will be objective response rate (ORR). The study is expected to read out top-line data in 2023.
Dr Cheng Ean Chee, Senior Consultant in the Department of Haematology-Oncology at NCIS, said: “Despite the recent progress of immunotherapies, advanced liver cancer remains a significant unmet medical need. With only 30% of patients benefiting from objective responses to first-line standard of care, new treatment combinations are needed in order to improve patient outcomes. We are excited to evaluate investigational agent MTL-CEBPA in combination with the current standard of care and we are glad to collaborate with MiNA Therapeutics and Roche.”
Nagy Habib, Head of R&D at MiNA Therapeutics, commented: “We are delighted to collaborate with the National University Cancer Institute, Singapore, and Roche to evaluate this new immunotherapy combination. In preclinical and clinical studies, MTL-CEBPA has been reported to improve the anti-tumour activity of leading oncology drugs by counteracting a new cancer immune evasion pathway which causes resistance to those drugs. Based on this data, we believe that MTL-CEBPA combinations have the potential to improve the standard of care significantly in patients with advanced HCC.”
Dr Sivabalan Sivanesan, Medical Director at Roche Singapore, commented: “Roche is both proud and excited to join this investigation of a new treatment combination in advanced HCC. Having established a role in metastatic HCC and other cancers, atezolizumab is currently being investigated in many different cancers including early HCC. With more than 70% of the global liver cancers being diagnosed in Asia, this is an amazing opportunity to study the role of a new combination with atezolizumab in HCC.”
Image credit: Anna Tarazevich