2015 was a rough year for shareholders of Idera Pharmaceuticals Inc (NASDAQ:IDRA). While the company made considerable progress, shares were on a downtrend for all of 2015. Investors were more focused on the fact that IDRA still remains in the early stages for most of its trials and will require more funding to continue its R&D efforts. However, for patient investors, things might be better going forward.Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera’s proprietary technology involves using a TLR-targeting technology, to design synthetic oligonucleotide-based drug candidates to act by modulating the activity of specific TLRs. In addition to its TLR programs, Idera is developing a third generation antisense technology platform that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA.While 2015 was a bad one for its share price, there were several significant corporate developments. IDRA received orphan drug designation for IMO-8400, which is being researched as a treatment for diffuse large B-cell lymphoma. IDRA entered into an alliance with MD Anderson Cancer Center to advance research on IMO-2125, Idera's TLR9 agonist. Idera signed an agreement with pharma giant GlaxoSmithKline (NYSE:GSK) to identify third-generation antisense molecules to be used to treat renal disease. GlaxoSmithKline provided Idera with an initial payment of $2.5 million and set up potential $100 million in milestones. If the product's annual net sales exceed $500 million, GlaxoSmithKline will pay up to 5% in royalties.
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In December, IDRA announced that it had commenced enrollment in a Phase 1/2 clinical trial evaluating intra-tumoral IMO-2125, a TLR9 agonist in combination with ipilimumab (an anti-CTLA4 antibody) in patients with previously treated metastatic melanoma. In this clinical trial, escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg will be administered intra-tumorally into one of two selected tumor lesions, with a standard dosing regimen of ipilimumab. The primary objectives of the phase 1 portion of the trial will be to determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLTs) of IMO-2125 when administered intra-tumorally in combination with ipilimumab. The primary objective of the phase 2 portion will be to determine the efficacy of the combination utilizing the immune-related response criteria (irRC) in additional to traditional RECIST criteria. Serial biopsies will be taken of selected injected and non-injected tumor lesions to assess immune changes and response assessments. The trial will enroll approximately 45 patients and initial data from the ongoing trial will be available this year.At the 57th Annual Meeting of the American Society of Hematology (ASH) in Orlando, IDRA presented initial clinical data from its ongoing Phase 1/2 clinical trial for IMO-8400, a Toll-like receptor 7, 8 and 9 antagonist, being evaluated for the treatment of patients with relapsed or refractory Waldenström’s Macroglobulinemia (WM). The results that were reported came from 15 evaluable patients with Waldenström’s Macroglobulinemia who had a history of relapse or failure to one or more prior therapies and who completed at least one cycle of therapy with IMO-8400. Patients enrolled in the multi-center, open-label, dose ranging clinical trial which evaluated 3 dose levels of IMO-8400 (06. mg/kg weekly, 1.2 mg/kg weekly, 1.2mg/kg twice a week) administration for a period of up to 24 weeks. The primary objectives of the study were to assess safety and tolerability. Secondary objectives were to assess clinical activity, PK and define the optimal dose for further clinical evaluation. In addition to clinical treatment parameters, cytokine levels were analyzed as an exploratory endpoint in the trial.
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Currently trading with a market cap of $223 million, IDRA has $95 in cash, but will burn through approximately $50 million this year on R&D. The company will most likely do another financing that will dilute shareholders. We think this is the prime reason for the weakness in 2015. However, we expect some big news this year. Results from another study focusing on IMO-8400 as a potential treatment for diffuse large B-cell lymphoma are expected in June. IMO-8400 could be a huge winner down the road, with peak annual sales potential of over $1 billion. This is what we think investors will focus on this year and why shares of IDRA are due for a comeback. We will be updating Insider Financial with the latest developments from IDRA. Sign up today and stay on top of the latest from IDRA!
Disclosure: We have no position in IDRA either long or short. We have not been compensated for this article.
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