Press release
Dec 20, 2018

Sosei Heptares notes that MiNA Therapeutics has started enrolment of patients with advanced liver cancer in Phase 1b trial of MTL-CEBPA in combination with sorafenib

Tokyo, Japan and London, UK, 20 December 2018 – Sosei Group Corporation (“the Company”; TSE: 4565), announces that MiNA Therapeutics (“MiNA”), a UK company in which Sosei Heptares has a strategic minority holding, yesterday announced enrolment of the first patients treated with MTL-CEBPA in combination with sorafenib in OUTREACH, the multi-center Phase 1b clinical trial in patients with advanced liver cancer.

Below is an excerpt of yesterday’s press release from MiNA. For full details, please see the media section of MiNA’s website here (English only).

The study is designed to assess the safety, tolerability and clinical activity of MTL-CEBPA in combination with sorafenib. OUTREACH is currently being conducted at multiple clinical trials sites in the United Kingdom, Singapore and Taiwan.

Evaluation of MTL-CEBPA in combination with sorafenib follows the evaluation of MTL-CEBPA as a single agent in 38 patients with advanced liver cancer. Preliminary clinical results of MTL-CEBPA as a single agent presented in June 2018 at the American Society of Clinical Oncology (ASCO) Annual Meeting showed encouraging safety, pharmacology and clinical activity. Furthermore, in September 2018 at the International Liver Cancer Association (ILCA) Conference, investigators reported complete tumor responses in patients off-study when subsequently administered Sorafenib. Sorafenib is the standard of care for first line treatment of advanced liver cancer.

MTL-CEBPA consists of a double stranded RNA formulated in a liposomal nanoparticle and is designed to activate the CEBPA gene. The CEBPA gene encodes CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of cell lineage determination and differentiation in several tissues including myeloid cells, liver cells and adipose tissue. In cancer, C/EBP-α plays important roles in regulating both tumour growth and the tumor immune microenvironment.

The Company holds a 25.6% equity share in MiNA (Holdings) Limited, the holding company of MiNA.