By a News Reporter-Staff News Editor at Gene Therapy Weekly -- Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing novel nucleic acid therapeutics for orphan diseases, reported its financial and operational results for the quarter ended March 31, 2014. The Company's clinical focus has now evolved to center on patients with genetically defined forms of B-cell lymphoma and on patients with rare autoimmune diseases (see also Idera Pharmaceuticals, Inc.).
"We believe we have made tremendous progress in 2014 based on the foundation we built in 2013. During this year, we initiated clinical development of IMO-8400 in Waldenstrom's macroglobulinemia and in diffuse large B-cell lymphoma (DLBCL) patients harboring the MYD88 L265P mutation. We look forward to progressing IMO-8400 in clinical trials for these indications," said Sudhir Agrawal, D. Phil., Chief Executive Officer of Idera Pharmaceuticals. "In addition, our strategic assessment of orphan autoimmune diseases has led us to identify graft-versus-host disease (GvHD), polymyositis, and dermatomyositis as the initial prioritized disease indications for clinical development of our TLR antagonist candidates."
Dr. Agrawal continued, "To support the clinical development of our pipeline of candidates and technology platforms, we strengthened the management team in key areas with the addition of Lou Brenner, M.D., as Senior Vice President and Chief Medical Officer; Kate Haviland as Vice President Rare Diseases; Joe Lobacki as General Manager of Oncology; Walter Strapps, Ph.D., as Executive Director of RNA Therapeutics; and Nancy Wyant as Vice President of Clinical Operations. Our new team members bring extensive biopharmaceutical industry expertise and the skills which would enable us to advance our pipeline to commercialization. We are very pleased to have them on board." Recent Corporate Updates Program for Genetically Defined Forms of B-cell Lymphoma Idera's program in genetically defined forms of B-cell lymphoma is directed to patients harboring the MYD88 L265P oncogenic mutation. Clinical development has been initiated.
A Phase 1/2 clinical trial of IMO-8400 in patients with Waldenstrom's macroglobulinemia, who have relapsed or were refractory to prior therapy, is ongoing. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial.
Idera is preparing to conduct a Phase 1/2 clinical trial of IM0-8400 in patients with DLBCL who harbor the MYD88 L265P mutation and have relapsed or were refractory to prior therapy. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial and expects to initiate patient treatment in the second half of 2014.
In April 2014, Idera presented preclinical data at the American Association of Cancer Research (AACR) Annual Meeting demonstrating the ability of IMO-8400 to inhibit tumor growth and survival signaling in human B-cell lymphoma cells harboring the MYD88 L265P oncogenic mutation.
In May 2014, Idera entered into an agreement with Abbott, Inc., a leader in companion diagnostics, for the development of an in vitro companion diagnostic test in support of Idera's clinical development program to treat certain genetically defined forms of B-cell lymphoma with IMO-8400. Program in Orphan Autoimmune Diseases In March 2014, Idera announced its plans to initiate clinical development of IMO-8400 to treat patients with polymyositis and dermatomyositis. In addition to myositis, GvHD has also been prioritized for development, in continuation of a previously announced strategy of orphan autoimmune diseases. The Company anticipates initiating treatment in clinical trials for each of these patient populations during the second half of 2014.
In March 2014, the Company announced positive top-line data from a randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. The trial met the primary objective of demonstrating safety and tolerability, as well as a secondary objective of clinical activity of IMO-8400. The Company intends to submit the full data set, including data from an additional higher dose cohort, for presentation at a medical meeting in 2014.
Idera has selected IMO-9200, a second novel antagonist of TLR7, TLR8, and TLR9, as an additional drug candidate for development. The Company expects to initiate a Phase 1 clinical trial of IMO-9200 in the second half of 2014. Gene Silencing Oligonucleotide (GSO) Platform Idera's gene silencing oligonucleotide (GSO) platform represents an optimized third generation antisense technology. In preclinical studies to date, the Company's GSOs have shown favorable characteristics and a potentially improved therapeutic index relative to other antisense technologies. Idera plans to initiate clinical proof-of-concept studies for two disease indications as early as the second half of 2015. Leadership Team Additions Idera has appointed Nancy Wyant as Vice President of Clinical Operations. Nancy joins Idera with over 18 years of extensive experience in clinical trial development and management. She most recently worked at Sarepta Therapeutics, where she served as Senior Director and Head of Clinical Operations. Prior to that, she held roles of increasing responsibility in clinical operations at Shire Human Genetic Therapies.
Keywords for this news article include: Antisense Technology, Biotechnology, Idera Pharmaceuticals Inc., Drugs, Genetics, Immunology, Gene Therapy, Therapeutics, Bioengineering, Biopharmaceuticals, Pre-Trial Research, Autoimmune Diseases, Autoimmune Disorders, Investment and Finance, Clinical Trials and Studies.
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