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idera pharmaceuticals inc (IDRA) Key Developments

Idera Pharmaceuticals, Inc. Announces Key Additions to Management Team

Idera Pharmaceuticals, Inc. announced that it has appointed J. Peter Wolf as Senior Vice President, General Counsel and Elizabeth Eberhardt as Vice President, Oncology Team. Mr. Wolf most recently served as Vice President, General Counsel and Secretary of ViroPharma Incorporated from January 2008 until January 2014 and Associate General Counsel upon joining ViroPharma in 2004. Ms. Eberhardt most recently served as Senior Director of Project Management at ViroPharma Incorporated. .

Idera Pharmaceuticals, Inc. Presents Data Supporting Imo-8400 as Novel Therapy for Genetically Defined Forms of B-Cell Lymphoma at Annual Ash Meeting

Idera Pharmaceuticals, Inc. announced that data for its product candidate IMO-8400 were presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco. The data included a presentation on clinical safety results from Phase 1 and Phase 2 clinical trials of IMO-8400. In addition, a second presentation reported preclinical data demonstrating the activity of IMO-8400 in combination with rituximab in B-cell lymphoma models. Overall, these data support continued development of IMO-8400 as a novel therapy for genetically defined forms of B-cell lymphoma. In multiple independent studies, Toll-like receptor (TLR) signaling has been shown to be over-activated in B-cell lymphomas characterized by the MYD88 L265P oncogenic mutation, thereby enabling tumor cell survival and proliferation. IMO-8400 is a synthetic, oligonucleotide-based antagonist of TLRs 7, 8 and 9. Previously reported preclinical data showed that IMO-8400 inhibited TLR-mediated signaling and tumor cell survival in B-cell lymphoma models. Idera is currently conducting a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström's macroglobulinemia (WM). In addition, the Company has commenced patient screening in a Phase 1/2 trial of IMO-8400 in patients with diffuse large B-cell lymphoma (DLBCL) harboring the MYD88 L265P oncogenic mutation. Results from clinical trials in healthy volunteers and patients with psoriasis showed that IMO-8400 was well tolerated when administered weekly via subcutaneous injection at doses up to 0.6 mg/kg for up to 12 weeks. In these trials, there were no treatment-related serious adverse events, no drug-related discontinuations, and no pattern of systemic adverse events or laboratory changes. The only treatment-related adverse events in more than one patient were injection site reactions, comprised of generally mild erythema with occasional induration, pruritus, tenderness or pain. Idera is currently conducting a Phase 1/2 dose escalation trial to evaluate the safety, clinical activity and optimized dosing of IMO-8400 in patients with relapsed or refractory WM over 24 weeks. In the first of three escalating dose cohorts, IMO-8400 was well tolerated in patients treated weekly with 0.6 mg/kg for four weeks. An independent Data Review Committee (DRC) evaluated safety data from the first cohort and recommended that patients continue treatment and that the trial escalate to the second dose cohort of 1.2 mg/kg. Based on current enrollment, Idera anticipates DRC review of four-week safety data from the second dose cohort in the fourth quarter. Pending this review, the Company expects to initiate enrollment in the third dose cohort of 2.4 mg/kg by year end. Final 24-week safety and clinical activity data are anticipated in the second half of 2015. In multiple in vivo studies in B-cell lymphoma models, combination therapy with IMO-8400 and rituximab significantly improved measures of disease activity. In a preclinical DLBCL model, combination therapy with IMO-8400 and rituximab significantly reduced tumor volume and significantly decreased production of IL-10, a cytokine that enhances B-cell survival and proliferation, compared to monotherapy with either agent. In a WM model, the combination therapy also significantly reduced tumor volume and significantly decreased production of Immunoglobulin M, a protein overexpressed in WM patients, compared to monotherapy with either agent. In both models, tumor histology demonstrated marked improvements favoring the combination regimen. Rituximab is a monoclonal antibody against the protein CD20 and is approved by the U.S. Food and Drug Administration. It is commonly used as first-line therapy in combination with chemotherapy in patients with DLBCL and WM. Rituximab was developed and is marketed by Biogen Idec and Genentech.

Idera Pharmaceuticals Announces Cancer Immunotherapy Regimen with Intratumoral IMO-2055 Demonstrated Potent and Systemic Anti-Tumor Activity in Preclinical Models

Idera Pharmaceuticals, Inc. announced new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2055 and ipilimumab demonstrated potent and systemic anti-tumor activity in multiple preclinical cancer models. IMO-2055 is a synthetic oligonucleotide-based agonist of Toll-like receptor (TLR) 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The data were presented at the American Association for Cancer Research (AACR) Tumor Immunology and Immunotherapy Meeting in Orlando, Fla. In the presentation at the AACR meeting, Idera scientists summarized the results of several studies of IMO-2055 alone and in combination with ipilimumab in well-established preclinical models of bladder, colon and lung cancer. Results showed that intratumoral injections of IMO-2055 inhibited the growth of treated and distant tumors, as evaluated by tumor volume and histology. Compared to monotherapy with either agent, the combination regimen involving intratumoral injections of both agents demonstrated increased and sustained inhibition of treated and distant tumor growth. In addition, there were statistically significant increases in cytotoxic T cells against two antigens (AH1 and -gal) expressed in treated and distant tumors, respectively, for the combination therapy versus monotherapy with either agent.

Idera Pharmaceuticals, Inc. Appoints Robert A. Doody Jr. as Vice President of Investor Relations and Corporate Communications

Idera Pharmaceuticals, Inc. announced that it has appointed Robert A. Doody Jr. as Vice President, Investor Relations and Corporate Communications. Mr. Doody, most recently served for the past eight years as Head of Investor Relations of ViroPharma, which was acquired by Shire Pharmaceuticals in January 2014. During his tenure at ViroPharma the company transformed to a leading developer of innovative therapies for rare diseases, highlighted by its lead product, Cinryze, for the treatment of hereditary angioedema in the United States and Europe. Prior to joining ViroPharma, Mr. Doody spent several years at the healthcare communications firm, Dorland Sweeney Jones in Philadelphia.

Idera Pharmaceuticals, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 03:30 PM

Idera Pharmaceuticals, Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-03-2014 03:30 PM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States.


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