Idera Pharmaceuticals Expands Pipeline By Initiating Clinical Development Of Proprietary TLR Antagonist Candidate IMO-9200

Idera Pharmaceuticals, Inc. IDRA, a clinical-stage biopharmaceutical company developing nucleic acid therapeutics for patients with cancer and rare diseases, today announced it has advanced IMO-9200 into Phase 1 clinical development following acceptance of an Investigational New Drug application by the U.S. Food and Drug Administration. In addition, the company announced today the presentation of new data that showed IMO-9200 inhibited Toll-like receptor- (TLR-) mediated immune responses in multiple preclinical models at the 10th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) in San Diego, California. These data support the development of IMO-9200, a synthetic oligonucleotide-based antagonist of TLRs 7, 8 and 9, as a potential treatment for autoimmune diseases in which TLRs are over-activated. Idera's pipeline of clinical-stage TLR antagonists also includes IMO-8400, the company's lead product candidate currently in development for genetically defined forms of B-cell lymphoma and rare autoimmune diseases. In two presentations at the OTS meeting, Idera scientists summarized the results of several preclinical studies of IMO-9200. Collectively, the data showed that IMO-9200 dose-dependently inhibited the induction of multiple inflammatory cytokines, including IL-12, IP-10, IFN-α, IL-6, IL-1β and MCP-1, in cell-based assays, mice and non-human primates. In addition, data from a well-characterized preclinical model of lupus showed that IMO-9200 improved disease-associated parameters in MRL/lpr mice, with decreases in blood urea nitrogen levels, proteinuria, autoantibodies and kidney interstitial inflammation. Idera has evaluated IMO-9200 in additional autoimmune disease models, and plans to present data from these studies in the future. "The findings announced today provide further support for our proprietary TLR antagonism technology by demonstrating the specific and potent inhibitory activity of IMO-9200 against TLRs that have been implicated in multiple autoimmune diseases," said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. "While we continue to advance our lead TLR antagonist candidate IMO-8400 in ongoing and planned clinical trials in genetically defined forms of B-cell lymphoma and rare autoimmune diseases, we believe that the expansion of our clinical-stage pipeline with IMO-9200 may allow us to address an even broader range of autoimmune and inflammatory disorders in which TLRs have been shown to be over-activated." Idera plans to begin dosing of IMO-9200 in a Phase 1 clinical trial in healthy volunteers in the fourth quarter. In addition, the company plans to finalize a strategic assessment of potential indications for further clinical development of IMO-9200 by year end. The two presentations, entitled "IMO-9200, a Novel Clinical-stage TLR Antagonist for the Treatment of Autoimmune Diseases, Inhibits TLR-mediated Immune Responses and Shows Activity in Animal Models" and "IMO-9200, a Novel Clinical-stage TLR Antagonist for the Treatment of Autoimmune Diseases, Suppresses TLR-mediated Immune Responses in Non-human Primates following Systemic Administration," are available on Idera's website at: http://www.iderapharma.com/our-science/key-presentations-and-publications.