Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced that it will be presenting data from preclinical studies of its Toll-like receptor (TLR) inhibitor, IMO-8400, in models of systemic lupus erythematosus (SLE) and psoriasis, which suggest that IMO-8400 may be useful for the treatment of both indications. The data from the SLE model will be presented in an oral presentation at the American Association of Immunologists (AAI) meeting in Boston, Massachusetts at 8:00a.m. ET on May 5, 2012. The oral presentation, entitled “IMO-8400, a novel TLR7, TLR8 and TLR9 antagonist, inhibits disease development in lupus-prone NZBW/F1 mice,” will be made during the session “Therapeutic Strategies for Rheumatologic Diseases.” Idera expects to submit to the FDA an Investigational New Drug application for IMO-8400 during the fourth quarter of 2012, and has selected lupus as the initial disease indication for clinical development. In addition to the oral presentation, a poster presentation entitled “IMO-8400, a novel TLR7, TLR8, and TLR9 antagonist, inhibits disease development in mouse models of psoriasis” is scheduled for May 6, 2012, in the session “Novel and Cellular Approaches to Autoimmunity” during AAI. About TLRs and Idera’s Pipeline Toll-like Receptors (TLRs) represent a class of proteins that play a key role in both inflammation and immunity. Of the 10 human TLRs identified to date, Idera is focusing on compounds targeted to TLRs 3, 7, 8, and 9, which are expressed in different cells and serve unique functions. For example, activation of TLR7 and TLR9 present in certain dendritic cells and lymphocytes may be useful for the treatment of various types of cancer by stimulating immunity. In contrast, inhibition of specific TLRs may be useful in treating autoimmune disorders, such as psoriasis and lupus, by blocking the production of multiple pro-inflammatory mediators. Using its chemistry-based approach, Idera is advancing novel drug candidates to modulate immune response through activation or inhibition of specific TLRs to treat a broad range of diseases, including autoimmune diseases and cancer, and to enhance the effectiveness of vaccines.
In autoimmune diseases, Idera is developing inhibitors of TLRs 7, 8, and 9 for the potential treatment of psoriasis, lupus, and other diseases. Idera’s lead clinical candidate is IMO-3100, an antagonist of TLR7 and TLR9, which is in Phase 2 development for psoriasis. IMO-8400 is an antagonist of TLRs 7, 8, and 9. Idera expects to file an IND application for IMO-8400 during the fourth quarter of 2012. Idera has selected lupus as the initial disease indication for clinical development of IMO-8400.In oncology, Idera's lead product candidate is IMO-2055, which is designed to activate TLR9. IMO-2055 is the subject of several clinical trials including a randomized, controlled Phase 2 trial in combination with Erbitux® as a second-line therapy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck that have not been previously treated with Erbitux. This multicenter, international trial is evaluating the effect of adding IMO-2055 to Erbitux alone in 2nd line treatment, with a primary endpoint of progression-free survival and secondary endpoints including RECIST objective response rate. In addition, crossover of the patients who progress on Erbitux alone is permitted to the combination arm of IMO-2055 and Erbitux. The crossover permits assessment of the efficacy (response rate and progression-free survival) of adding IMO-2055 to Erbitux as a third-line therapy in patients whose disease is refractory to Erbitux alone. A Phase 1b trial with IMO-2055 in combination with Tarceva® and Avastin® for the treatment of non-small cell lung cancer has been completed and top-line results were announced in the first quarter of 2012. A Phase 1b trial has been conducted with IMO-2055 in combination with FOLFIRI and Erbitux in patients with advanced colorectal cancer who have progressed following chemotherapy. About Systemic Lupus Erythematosus (SLE) Lupus is a chronic autoimmune disease where the body’s immune system becomes hyperactive and attacks normal healthy tissue. This results in symptoms such as inflammation, swelling, and damage to joints and almost every major organ in the body, including the heart, kidneys, skin, lungs and brain. According to The Lupus Foundation of America, an estimated 1.5 million Americans and at least five million people worldwide have a form of lupus.
About Idera Pharmaceuticals, Inc.Idera Pharmaceuticals applies its proprietary Toll-like receptor (TLR) drug discovery platform to create immunomodulatory drug candidates and has clinical development programs in autoimmune diseases and cancer. Additionally, Idera has a collaboration with Merck & Co. for the use of TLR-targeted candidates as vaccine adjuvants. The Company is also advancing its gene-silencing oligonucleotide (GSO) technology for the purpose of inhibiting the expression of disease-promoting genes. For more information, visit http://www.iderapharma.com. Erbitux® is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company. Tarceva® is a registered trademark of OSI Pharmaceuticals, LLC, an affiliate of Astellas Pharma US, Inc. Avastin® is a registered trademark of Genentech, Inc. Idera Forward Looking Statements This press release contains forward-looking statements concerning Idera Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated by such forward-looking statements, including whether results obtained in preclinical studies and clinical trials such as the trials referred to in this release will be indicative of results obtained in future clinical trials, whether for the same or different indications; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; whether the Company will be able to license IMO-2055 for further development for oncology on a timely basis or at all; whether the Company's collaboration with Merck & Co, Inc., will be successful; whether the patents and patent applications owned or licensed by the Company will protect the Company's technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund the Company's operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera's Annual Report on Form 10-K for the year ended December 31, 2011 which important factors are incorporated herein by reference. Idera disclaims any intention or obligation to update any forward-looking statements.