Idera Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Corporate Update

CAMBRIDGE, Mass. and EXTON, Pa., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, today reported its financial and operational results for the second quarter ended June 30, 2017.Since April 1, 2017, the Company:Presentations/Publications:Submitted and gained acceptance of an abstract (#1187P) for presentation of updated clinical trial data from the ongoing IMO-2125 Phase 2 clinical trial at the European Society of Medical Oncology (ESMO) 2017 Congress.  The data will be presented by lead trial investigator, Adi Diab, MD of MD Anderson Cancer Center at 1:15 PM CEST (7:15 AM ET) on Sunday, September 10, 2017.  The conference is being held in Madrid, Spain September 8th through the 12th; andSubmitted and gained acceptance of an abstract (#B240) for presentation of IMO-2125 pre-clinical data in a poster presentation entitled, "Intratumoral IMO-2125 treatment in combination with anti-CTLA4 mAb induces durable anti-tumor responses associated with tumor-specific memory in pre-clinical studies" at the Third Annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference.  The presentation will be given by Idera Principal Scientist, Daquing Wang, Ph.D. at 6:15 PM on Friday, September 8, 2017.  The conference is being held in Frankfurt, Germany from September 6th through 9th.Clinical Trial Activities:Commenced enrollment of the Phase 2 portion of the clinical trial of 8 mg intratumoral IMO-2125 in combination with ipilimumab in anti-PD-1 refractory melanoma;21 patients planned for evaluation; andOverall Response Rate (ORR) data expected to be available in first quarter of 2018;Continued enrollment into the dose escalation cohorts of the pembrolizumab combination arm of the Phase 1/2 clinical trial of intratumoral IMO-2125 in anti-PD-1 refractory metastatic melanoma;Initiated and commenced enrollment into the Phase 1 clinical trial of intratumoral IMO-2125 monotherapy in multiple tumor types;Continued accruing patients into the IMO-8400 Phase 2 clinical trial in dermatomyositis which is being conducted at approximately 20 sites both in the U.S. and abroad and is expected to complete enrollment in 2017 with data planned for the first half of 2018; andContinued all pre-clinical and IND-enabling activities for IDRA 008, Idera's first clinical candidate from the Third Generation Antisense (3GA) technology platform, with expected IND filing and initiation of human proof-of-concept clinical trial in the first half of 2018.Regulatory Activity:Announced the granting of Orphan Drug Designation from the U.S Food and Drug Administration (FDA) for IMO-2125 for the treatment of melanoma Stages IIb to IV."As we continue to advance through 2017, our organization is incredibly energized and focused on rapidly advancing IMO-2125 through the clinical development pathway and ultimately towards our intended goal of delivering this therapeutic option for patients, particularly those who have not derived benefit from prior checkpoint inhibition therapies and in many cases have run out of options," stated Vincent Milano, Idera's Chief Executive Officer.  "This effort is consistent with our corporate mission to transform Idera into a company delivering commercially available options for patients suffering with life-threating conditions.  Our efforts across all of our development pipeline programs continues to drive forward, and we look forward to the opportunities to provide updates in the months and quarters ahead as these programs continue to mature. We have several opportunities to present further updates from the IMO-2125 program between now and year end and also intend to provide additional specificity on our plans to expeditiously advance our first indication in PD-1 refractory melanoma."Research and Development Program UpdatesIMO-2125 and IMO-8400 are the Company's lead clinical development drug candidates.  IMO-2125 is an oligonucleotide-based agonist of Toll-like receptor (TLR) 9.  IMO-8400 is an oligonucleotide-based antagonist of TLRs 7, 8, and 9.  The Company also announced, in early 2017, the selection of the first development target from its proprietary 3GA technology platform.  The company plans to disclose the specific target, disease and clinical pathway in the second half of 2017.  The Company plans to take the first 3GA candidate (IDRA 008) into human proof of concept studies in 2018.Toll-like Receptor (TLR) Agonism Immuno-Oncology ProgramIdera's development program in immuno-oncology is based on the rationale that intra-tumoral injections of IMO-2125, a TLR9 agonist, will activate dendritic cells and modulate the tumor microenvironment to potentiate the anti-tumor activity of checkpoint inhibitors and other immunotherapies.  This rationale is supported by both pre-clinical data in multiple tumor types as well as emerging clinical results and translational research from ongoing trials. Idera is currently conducting a Phase 2 clinical trial of intratumoral IMO-2125 in combination with ipilimumab, a CTLA4 antibody, and in a separate arm exploring the combination of intratumoral IMO-2125 with pembrolizumab, an anti-PD1 antibody.  The Phase 1 dose exploration portion of the trial was conducted at the University of Texas MD Anderson Cancer Center and the Phase 2 portion of the trial is being conducted at multiple centers.  This trial is being conducted in patients with relapsed or refractory metastatic melanoma who have failed prior anti-PD-1 therapy. In the second half of 2016, the Company announced positive preliminary clinical data from the initial dosing cohorts in the ipilimumab arm of the dose escalation portion of the trial.  The company has completed the dose escalation of the intratumoral IMO-2125 plus ipilimumab arm of the trial and the combination appears generally well tolerated across all doses explored, without any dose-limiting toxicity and without reaching a maximally tolerated dose.  The company selected the 8mg dose for Phase 2 and enrollment is underway. The company is currently enrolling patients in the dose-finding Phase 1 IMO-2125 plus pembrolizumab combination arm of the trial.Additionally, during the first half of 2017, the company initiated a multi-center clinical trial of intratumoral IMO-2125 monotherapy in multiple tumor types, including melanoma.  The purpose of this trial is to demonstrate the activity of single-agent IMO-2125 for regulatory filing purposes as well as to direct further clinical development in tumor types beyond refractory melanoma.Lastly, the company has begun and will continue to engage in discussions with regulatory authorities regarding the path to registration for IMO-2125 in combination with ipilimumab in anti-PD-1 refractory metastatic melanoma patients.  IMO-2125 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma Stages IIb to IV.Toll-like Receptor (TLR) Antagonism Dermatomyositis Clinical Development ProgramIn late 2015, Idera announced the initiation of a Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis, a rare, auto-immune condition, which negatively affects skin and in many cases also results in ...Full story available on Benzinga.com
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