Sosei pays £35M stake, with future buyout option, for British biotech MiNA

The Japanese pharma could pay £140 million for a full buyout, gaining access to its early-stage liver cancer and NASH pipeline

Tokyo-based Sosei is looking to bolster its U.K. biotech reach after making an equity investment in MiNA, with an option tagged on to buy the private RNA company if its early-stage work goes well.

Sosei, which in 2015 bought out British biotech Heptares Therapeutics and its pipeline of G protein-coupled receptor-targeted drugs, has injected £35 million ($45.2 million) into MiNA, owning 25% in all, but has also inked an exclusive option to potentially acquire MiNA down the line. To bring its stake to 100%, Sosei says it will pay £140 million.

The buyout clause is linked to the progress of its lead candidate, MTL-CEBPA, a small activating RNA candidate in phase 1/2a for advanced liver cancer.

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For now, MiNA says it “will continue to develop further and enhance its RNA activation platform and build its pipeline of novel saRNA therapeutics targeting multiple indications.”

Peter Bains, CEO of Sosei, said: “We are very pleased to enter into this agreement with MiNA, which strongly supports Sosei’s vision to become a global biotechnology company and is consistent with our inorganic strategy to both accelerate Sosei’s pipeline development and to identify complementary technologies to our world-leading Heptares GPCR platform.

“We believe MTL-CEBPA could allow us to advance our pipeline strategy with a novel clinical asset that could be developed and ultimately commercialised by Sosei. We recognise that this asset is early stage and that more robust data will be available in the near term; these considerations have influenced the prudent and phased deal structure. 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.”

Robert Habib, CEO of MiNA, added: “We are excited to develop further our platform and view Sosei as a valuable strategic partner with a real commitment to cutting-edge products and technologies, including RNA activation. We look forward to a close and productive working relationship to support the future development of MTL-CEBPA and our RNA activation platform.”

MTL-CEBPA is undergoing testing in the OUTREACH study, a first-in-human test in patients with a form of liver cancer that has low response rates and high recurrence rates. It works as an saRNA, restoring the expression of CCAAT/enhancer binding protein alpha (C/EBP-α).

C/EBP-α plays an important role in normal liver function and the benefits of increasing its expression have been shown in preclinical models of disease, according to the biotech. The company also hopes it could prove efficacious in fatty liver disease.

MTL-CEBPA consists of a double stranded RNA formulated into a “Smarticles” liposomal nanoparticle and is designed to activate the CEBPA gene. The Smarticles tech have also used by Bothell, WA-based biotech Marina Biotech, which has also out-licensed some of this tech to ProNAi Therapeutics.

Smarticles uses amphoteric liposomes composed of unique combinations of lipids having anionic and cationic groups that work together to enable cell uptake, provide serum stability, and provide pH-triggered endosomal escape. It is designed to deliver both single-stranded and double-stranded nucleic acid payloads.

The first set of clinical read-outs from OUTREACH are expected during 2018. Should Sosei like what it sees and hits the buyout button, MiNA shareholders could get up to £240 million in biobucks coming out of any and all products emanating from MiNA’s RNA platform.

MiNA came to life from the 2006 work by Long-Cheng Li (who worked for UCSF at the time) and David Corey (UT Southwestern) who found that double strand RNA can not only silence gene expression (RNAi), but also activate it (RNAa).

The company was founded by John Rossi (City of Hope), Pål Sætrom (Norwegian University of Science and Technology) and Nagy Habib (Imperial College London) to apply these research ideas in specific gene activation by double strand RNA to drug discovery and development.

The biotech in-licensed the original Li and Corey patents, which had previously been licensed to Alnylam Pharmaceuticals.