Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced data from preclinical studies of IMO-8400, demonstrating a novel mechanism of action that may be applicable to the treatment of systemic lupus erythematosus (SLE) and psoriasis. IMO-8400 is an inhibitor of specific Toll-like receptors (TLRs). The data were presented at the American Association of Immunologists (AAI) meeting being held in Boston, Massachusetts May 4-8, 2012. “We are encouraged by the preclinical results with IMO-8400 as a novel approach for the treatment of lupus and other autoimmune disorders,” said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. “The dose-dependent protection we see in the lupus-prone mouse model suggests that pharmacologic inhibition of TLR7, 8, and 9 with IMO-8400 may provide a therapeutic strategy to suppress many lupus disease-associated parameters, including autoimmune antibodies, multiple pro-inflammatory serum cytokines, and indicators of kidney damage.” A characteristic of SLE is the production of antinuclear autoantibodies complexed with self-RNA or -DNA. These abnormal antibodies inappropriately activate TLR7, 8, and 9 and initiate immune responses that damage the body’s own tissues and organs, thereby releasing more self-RNA and DNA. The data presented at AAI demonstrate that inhibition of TLR7, 8 and 9 with IMO-8400 suppressed the cycle between autoimmune antibody production and tissue damage, leading to improved renal function in lupus-prone mice. No treatment-related side effects were observed in the mice from IMO-8400 treatment at the doses employed in the study. Idera expects to submit an Investigational New Drug application for IMO-8400 to the FDA during the fourth quarter of 2012, and has selected lupus as the initial disease indication for clinical development. The oral presentation entitled “IMO-8400, a novel TLR7, TLR8 and TLR9 antagonist, inhibits disease development in lupus-prone NZBW/F1 mice” was made on May 5 th. In addition a poster presentation entitled “IMO-8400, a novel TLR7, TLR8, and TLR9 antagonist, inhibits disease development in mouse models of psoriasis” was presented at AAI on May 6 th. In the poster presentation, data demonstrated that IMO-8400 suppressed lesion development and related immunological makers in mouse models of psoriasis. In addition to the above presentations, a poster presentation entitled “Modification of immune activation in HIV-1 infected humanized mouse model using TLR7/9 antagonists” was given in the Vaccine and Immunotherapy session on Sunday, May 6 th at 2:30 pm by investigators from the Ragon Institute of MIT, Massachusetts General Hospital, and Harvard Medical School in collaboration with Idera Pharmaceuticals. These presentations are accessible on the Idera Pharmaceuticals website.
About TLRs and Idera’s PipelineToll-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 submit 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 has been 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; a Phase 1b trial in combination with Tarceva® and Avastin® for the treatment of non-small cell lung cancer; and a Phase 1b trial in combination with FOLFIRI and Erbitux in patients with advanced colorectal cancer who 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. 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. 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. 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 such as the studies referred to in this release will be indicative of results obtained in future clinical trials; 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.