Sosei to invest in UK biopharmaceutical firm MiNA Therapeutics

Sosei will make an upfront strategic investment of GBP 35 million into MiNA Therapeutics in return for a 25.6% equity share and an exclusive option to potentially acquire MiNA Therapeutics

Phased options will be based on achievement of clinical milestones of MiNA’s Phase1/2a OUTREACH study with MTL-CEBPA in advanced liver cancer

MiNA will continue to develop further and enhance its RNA activation platform and build its pipeline of novel saRNA therapeutics targeting multiple indications

Peter Bains, Chief Executive Officer 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 Therapeutics, 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 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.”

The agreement is consistent with Sosei’s stated inorganic growth strategy, which is focused on identifying innovative clinical-stage assets that have the potential to be developed rapidly and in addition could be commercialised by Sosei in select markets.

This inorganic strategy is complementary to Sosei’s organic strategy, which is focused on advancing a growing pipeline of novel pre-clinical and clinical drug candidates originating from its Heptares Therapeutics subsidiary.

Sosei has entered this structured agreement following an extensive assessment and evaluation of the potential of MiNA’s lead clinical-stage saRNA asset MTL-CEBPA for treating patients with advanced liver cancer (hepatocellular carcinoma, HCC), and more broadly for restoring liver function in other major progressive liver diseases.

MTL-CEBPA is currently under evaluation in OUTREACH, a first-in-human Phase 1/2a study in patients with HCC, a disease with clear unmet medical needs based on the low response rates, high recurrence rates and sub-optimal safety profiles of existing treatments. Important clinical read-outs from OUTREACH are expected during 2018.

Under the terms of the agreement, Sosei will pay GBP 35 million for a 25.6% equity stake and an exclusive option to acquire further defined stakes and potentially 100% of MiNA for a further GBP 140 million.

In addition, and should Sosei fully exercise its option, MiNA shareholders could receive up to a further GBP 240 million. This amount is contingent on the successful achievement of development and regulatory milestones and includes significant potential royalties from the successful commercialisation of products emanating from MiNA’s RNA activation platform.

The exercise of future options in relation to the MiNA agreement is dependent on the achievement and evaluation of certain clinical milestones in the OUTREACH study, which are expected to occur within the next 12-18 months. The milestones are intended to provide a more extensive and robust clinical data set on MTL-CEBPA in HCC and greater clarity on the clinical potential of the candidate in this indication.

In this agreement, MiNA Therapeutics was advised by Ferghana Partners and Taylor Wessing LLP. Sosei Group Corporation has been advised by Clifford Chance LLP.