Mirna Therapeutics

Mirna Therapeutics, Inc. was a clinical-stage biopharmaceutical company that operated in the oncology therapeutics market, focusing on a field known as microRNA (miRNA) replacement therapy. The company was founded by Matthew M. Winkler in 2007 and was incorporated in Delaware as a wholly-owned subsidiary of Asuragen, Inc., before being spun out to Asuragen's stockholders in December 2009. The foundational research and drug discovery program that led to Mirna's creation began as early as 2002 at Ambion, Inc. and was later continued at Asuragen. This extensive scientific groundwork, led by the company's scientists, established that certain naturally occurring miRNAs function as tumor suppressors and that their levels are often diminished in cancerous tissues.

The company's core business strategy was centered on developing miRNA mimics to restore the function of these lost tumor suppressor miRNAs in cancer cells. This approach, termed miRNA replacement therapy, aimed to re-regulate multiple oncogenic pathways simultaneously, a departure from many cancer therapies that target single genes or pathways. Mirna's business model involved advancing its proprietary pipeline of miRNA drug candidates through clinical trials, with the goal of commercializing these novel oncology therapeutics. The company also sought partnerships with other pharmaceutical and biotechnology firms to leverage its intellectual property. Its operations were financed through a combination of private funding rounds, federal and state grants, and eventually, public equity. Dr. Paul Lammers, who was not a founder but joined as President and CEO in 2009, was instrumental in steering the company through its major financing and clinical phases. His background includes extensive executive, clinical, and regulatory experience at companies like EMD Serono and Organon, which was vital for navigating the complex drug development process.

Mirna's lead product candidate was MRX34, a mimic of the naturally occurring miR-34, encapsulated in a liposomal nanoparticle formulation for delivery. It was the first miRNA mimic to enter human clinical trials for cancer and was being evaluated for treating various solid tumors, including liver cancer, and hematological malignancies. A significant milestone was achieved in October 2015 when Mirna Therapeutics went public, listing on the NASDAQ under the ticker "MIRN" and raising approximately $43.8 million in its initial public offering. However, the company's trajectory dramatically changed in September 2016 when it voluntarily halted the Phase 1 clinical trial of MRX34. This decision was prompted by the observation of multiple severe immune-related adverse events in patients. Following this setback, the company suspended further research and development activities and began exploring strategic alternatives to enhance stockholder value. This process culminated in a reverse merger with Synlogic, Inc., which was announced in May 2017 and completed in August 2017. The merger effectively ended Mirna's independent operations, with the combined entity continuing under the Synlogic name and focusing on Synlogic's synthetic biology platform.

Keywords: Mirna Therapeutics, microRNA replacement therapy, miRNA mimics, oncology therapeutics, MRX34, Matthew Winkler, Paul Lammers, Asuragen spin-off, cancer drug development, clinical-stage biopharmaceutical, tumor suppressor miRNA, liposomal nanoparticle formulation, NASDAQ:MIRN, Synlogic merger, gene regulation, cancer therapy, biopharmaceutical, advanced solid tumors, hematological malignancies, liver cancer treatment