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May 16, 2017

Synlogic, Mirna Agree to Stock-Based Merger to Focus on Synthetic Biotic Pipeline

  • Synlogic and Mirna Therapeutics inked a definitive stock-based merger agreement to form a combined entity that will develop Synlogic’s engineered microbiome-based Synthetic Biotic platform and pipeline. The combined entity will retain the Synlogic name and will be owned 83% by the current Synlogic shareholders and 17% by existing Mirna stockholders. Clinical studies with an initial Synlogic candidate are expected to start this year. Both companies’ boards have approved the merger transaction, which has still to be cleared by their respective shareholders, and is subject to customary closing conditions.

    Mirna brings the merged company cash, cash equivalents, and marketable securities that were worth $57.5 million at the end of March. Synlogic separately recently closed a $42 million Series C preferred stock financing. “This merger and our recently completed Series C financing are projected to provide the capital to progress our two lead metabolic disease programs through patient proof-of-concept studies as well as advance the development of our earlier product candidates,” commented Jose Carlos Gutiérrez-Ramos, Ph.D., the current CEO of Synlogic. Dr. Gutiérrez-Ramos will be appointed CEO of the merged company, which will also appoint two of Mirna’s directors to its board of seven.

    Synlogic’s Synthetic Biotics platform uses synthetic biology to engineer probiotic microbes. The powered microbiome pipeline is headed by candidates for the treatment of inborn errors of metabolism (IEM). The Synthetic Biotics platform is also being leveraged to generate treatments for liver disease, inflammatory and immune disorders, and cancer.

    Synlogic projects starting a Phase I study by mid 2017 with lead candidate SYNB1020, which is in development as a potential treatment for urea cycle disorders (UCDs) and hepatic encephalopathy (HE). Both diseases are characterized by elevated ammonia levels. SYNB1020 is based on a live Escherichia coli Nissle bacterium, which has been modified to assimilate ammonia. The candidate was granted FDA orphan drug designation in August last year. If the initial study with SYNB1020 is successful, then separate trials in symptomatic UCD and HE patients will be undertaken, Synlogic says. A second candidate, SYNB1618, will be evaluated as a potential treatment for phenylketonuria (PKU). 

    The firm is working with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease (IBD), through a global R&D collaboration established in 2016.

    In September last year, microRNA (miRNA) drugs firm Mirna Therapeutics voluntarily halted a Phase I study evaluating its lead anticancer miRNA candidate MRX34 in patients with solid and hematologic cancers, due to multiple immune-related severe adverse events (SAEs). The trial was subsequently put on full clinical hold by FDA, and the firm ceased all R&D activities in late 2016.

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