Sosei Group is paying £35 million (approximately $45.2 million) to acquire a 25.6% stake in RNA activation therapeutics firm MiNA Therapeutics, and an exclusive option to buy the U.K. firm outright for an additional £140 million ($181 million). 

The deal gives Sosei a hand in MiNA’s small activating RNA (saRNA) drug MTL-CEBPA and includes phased options based on the achievement of clinical milestones associated with the Phase I/IIa OUTREACH study evaluating MTL-CEBPA in patients with advanced hepatocellular carcinoma (HCC). The firms expect that the milestones could be reached within the next 12 to 18 months. MTL-CEBPA is in development initially for the advanced HCC indication, but could potentially also be developed more broadly for restoring liver function in progressive liver diseases, the firms suggest. MiNA will also continue to develop its RNA activation platform and pipeline of saRNA therapeutics for multiple indications.

Peter Bains, Sosei CEO, said, “We believe MTL-CEBPA could allow us to advance our pipeline strategy with a novel clinical asset that could be developed and ultimately commercialized by Soseii. We also believe that MiNA’s RNA activation platform can be applied to other gene targets, providing the opportunity to create a pipeline of innovative products.”

If Sosei fully exercises its option, MiNA shareholders could receive up to another £240 million ($310 million) in development and regulatory milestones, and royalties on commercialized products developed from the RNA activation platform.

Robert Habib, MiNA Therapeutics CEO added, “With MTL-CEBPA, MiNA has achieved rapid entry into the clinic with a groundbreaking new approach for the treatment of liver cancer. It also represents a novel modality to address many previously undruggable targets. We look forward to a close and productive working relationship to support the future development of MTL-CEBPA and our RNA activation platform.” 

saRNAs are designed to selectively upregulate intracellular or secreted proteins by increasing mRNA expression. MTL-CEBPA is a double-stranded RNA designed to activate the CEBPA gene and increase levels of the transcription factor C/EBP-α (CCAAT/enhancer-binding protein alpha), which acts as a master gene regulator in multiple tissue types. MiNA says preclinical studies have shown that MTL-CEBPA can slow or reverse liver disease and improve liver function in a range of liver disease models, including liver cancer, liver cirrhosis, nonalcoholic fatty liver disease (NAFLD), and nonalcoholic steatohepatitis (NASH).

MTL-CEBPA is formulated in a SMARTICLES® liposomal nanoparticle. MiNA and Marina Biotech inked a potentially $50 million deal to combine the saRNA technology with the latter’s SMARTICLES drug delivery platform in 2014.

MiNA’s platform is founded on saRNA technology licensed from the Norwegian University of Science and Technology. The firm also has exclusive licenses to IP from UT Southwestern Medical Center and UC San Francisco, which broadly cover RNA activation therapeutics.
 

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