Regulus Therapeutics Inc., a biopharmaceutical company, focuses on discovering and developing first-in-class drugs that target microRNAs to treat a range of diseases. microRNAs are naturally occurring ribonucleic acid (RNA) molecules that play a critical role in regulating key biological pathways. Regulus microMarkers In 2014, the company established Regulus microMarkers, a division focused on identifying microRNAs as biomarkers of human disease, which is designed to support its therapeutic pipeline, collaborators and strategic partners. Through its microRNA target identification and validation efforts, the company has developed proprietary technologies for microRNA profiling and analysis of human clinical samples such as tissue. Regulus microMarkers utilizes a clinically-validated, highly reproducible, proprietary technology platform to identify microRNAs as potential biomarkers for disease and the company controls key intellectual property and know-how related to the division. Development Candidates The company is in the process of developing single-stranded oligonucleotides, which are chemically synthesized chains of nucleotides that are mirror images of specific target microRNAs. The company incorporates proprietary chemical modifications to enhance drug properties, such as potency, stability and tissue distribution. The company refers to these chemically modified oligonucleotides as anti-miRs. Strategic Alliances/Collaborations In 2010, the company formed a strategic alliance with Sanofi to discover and develop microRNA therapeutics for fibrotic diseases. In 2012, the company expanded the alliance to include potential microRNA therapeutics in oncology. In 2012, the company formed a strategic alliance with AstraZeneca AB to discover and develop microRNA therapeutics for cardiovascular diseases, metabolic diseases and oncology. Pursuant to this alliance, the company continues to work towards the identification of development candidates on its programs partnered with AstraZeneca, such as its program targeting microRNA 103/107, or miR-103/107 for the treatment of metabolic diseases and microRNA-19, or miR-19 in oncology, a target selected by AstraZeneca in 2012. In addition, AstraZeneca has a contractual right to select a third microRNA target. In August 2014, the company and Biogen Idec entered into a new collaboration and license agreement to collaborate on microRNA biomarkers for multiple sclerosis. Strategy The main elements of the company’s strategy are to build a meaningful clinical portfolio by advancing its clinical programs and rapidly advancing its preclinical programs into clinical development; focus its resources on developing drugs for oncology indications or orphan diseases where the development and commercialization activities are appropriate for its size and financial resources; selectively form strategic alliances to augment its expertise and accelerate development and commercialization; develop microRNA biomarkers to support its therapeutic product candidates; and maintain its scientific and intellectual leadership in the microRNA field. Research and Development In 2014, the company’s research and development expenses included $41.0 million. Intellectual Property The company has intellectual property position and substantial know-how relating to the development and commercialization of microRNA therapeutics, composed of: approximately 200 patents and patent applications that the company owns or has in-licensed from academic institutions and third parties including its founding companies, related to microRNA and microRNA drug products; and approximately 850 patents or patent applications exclusively licensed from its founding companies, related to RNA technologies, including patent and patent applications relating to chemical modification of oligonucleotides that are useful for microRNA therapeutics. The company’s portfolio of exclusively and jointly owned patent and patent applications is composed of approximately 130 U.S. and foreign patents and patent applications with claims to compositions-of-matter or methods related to its microRNA drug products and microRNA product platform. The company jointly owns approximately 10 of the patents and pending applications including patents claiming methods for treating liver cancer, including hepatocellular carcinoma, or HCC, using anti-miRs targeting miR-21 and a patent claiming methods for treating liver cancer, including hepatocellular carcinoma, using miR-34a mimic. History Regulus Therapeutics Inc. was founded in the state of Delaware in 2007.
regulus therapeutics inc
3545 John Hopkins Court
San Diego, CA 92121
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