Idera Pharmaceuticals Reports Fourth Quarter and Full Year 2011 Financial Results and Provides Pipeline Update
"Idera’s proprietary drug candidates targeting Toll-like Receptors, or
TLRs, have advanced to Phase 2 clinical trials in both of our key
therapeutic areas of focus: oncology and autoimmune diseases,” said
Dr. Agrawal continued, “We have expanded our pipeline in autoimmune diseases with the addition of IMO-8400, a first-in-class antagonist of TLRs 7, 8 and 9. We have selected lupus as the first disease indication for IMO-8400. However, based on the roles of TLR7, 8 and 9 in multiple autoimmune diseases, IMO-8400 has potential applications in additional disease indications.”
Financial Results
As of
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended
Full Year Results
Net loss applicable to common stockholders for the year ended
2011 Research and Development Highlights
Autoimmune and Inflammatory Disease Program
IMO-3100, a dual antagonist of TLR7 and TLR9, is the lead candidate in this program. We are developing it as a novel approach to treat autoimmune and inflammatory diseases. IMO-3100 has shown activity in preclinical models of psoriasis, lupus, rheumatoid arthritis and hyperlipidemia. We have selected psoriasis as the initial disease indication for clinical development of IMO-3100.
Idera has completed Phase 1 clinical trials of IMO-3100 monotherapy in healthy subjects. In these studies, IMO-3100 was well-tolerated at the doses studied and showed target engagement of TLR7 and TLR9. Data from these studies have been presented at scientific meetings.
Phase 2 Trial of IMO-3100 in Patients with Psoriasis
- The Company anticipates the initiation of a Phase 2 study during the second quarter of 2012. In this study, IMO-3100 will be evaluated in adult patients with moderate to severe plaque psoriasis, randomized into three arms. Two dose levels of IMO-3100 will be evaluated with a concurrent placebo arm.
IMO-8400 is an antagonist of TLRs 7, 8 and 9 that the Company has selected as its second drug candidate for the treatment of autoimmune diseases. The Company created IMO-8400 using Idera’s chemistry-based approach to target TLRs.
- IMO-8400 has shown activity in mouse models of lupus as evidenced by increased survival, suppression of anti-DNA and anti-RNA antibodies and inflammatory cytokines, decreased tissue pathology and improved renal function.
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The Company expects to submit to the
FDA an Investigational New Drug application for IMO-8400 during the fourth quarter of 2012, and has selected lupus as the initial disease indication for clinical development.
Oncology Program
IMO-2055, a TLR9 agonist, is the lead candidate in the Company’s
oncology program. The Company is developing IMO-2055 as a novel immune
modifier for the treatment for cancer. The Company’s clinical
development strategy involves the use of IMO-2055 in combination with
targeted anti-cancer agents, including biologics and small molecules.
The Company reacquired the rights to IMO-2055 in oncology from
The Company is evaluating IMO-2055 in clinical trials in multiple cancer indications in combination with targeted agents, including Tarceva®, Avastin® and Erbitux®.
Phase 1b Trial of IMO-2055 in Combination with Tarceva and Avastin for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
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The goal of the study was to establish a recommended Phase 2 dose of
IMO-2055 for use in either doublet or triplet combinations.
Top-line efficacy results based on thirty-three evaluable patients show a disease control rate of 79%, a median progression-free survival of 5.6 months and a median overall survival of 16 months. The recommended dose of IMO-2055 for Phase 2 was identified at 0.32 mg/kg. Top-line results were announced inJanuary 2012 . Detailed data will be presented at a medical meeting.
In this study, IMO-2055 was evaluated at four dose levels in combination with standard doses of Tarceva and Avastin in 36 patients with advanced NSCLC. The recruited patient population was second- to fifth-line. Patients received oral Tarceva at 150 mg once per day and Avastin at 15 mg/kg once every three weeks by intravenous infusion in addition to subcutaneous doses of IMO-2055 once per week until disease progression or other discontinuation criteria was met. The trial was conducted at 10 centers inthe United States .
Nineteen patients were recruited to the dose-escalation portion of the trial, in which 0.32 mg/kg was identified as the recommended Phase 2 dosage of IMO-2055. An additional 17 patients were recruited and treated at 0.32 mg/kg/week to further document safety and efficacy. No new or unexpected toxicities were observed in the study, and rates of well-known side effects of the three agents were consistent with results from previously presented clinical trials of IMO-2055 and of the combination of Tarceva and Avastin. In this trial, the combination of IMO-2055 with Tarceva and Avastin was well tolerated, and the most common adverse events were diarrhea, nausea, fatigue and rash.
Phase 2, 1:1 Randomized, Controlled Trial of IMO-2055 in Combination with Erbitux in Second-Line Erbitux-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
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The study is fully enrolled. Patient treatment and follow-up are
ongoing. The Company anticipates top-line data during the second
quarter of 2012.
In this study, 104 patients with SCCHN who had progressed on a cytotoxic therapy were randomized into two arms. In one arm, patients were treated with IMO-2055 at a dose of 0.32 mg/kg given once weekly subcutaneously in combination with weekly Erbitux. In the other arm of the study, patients were treated with Erbitux alone. The trial is being conducted at multiple centers inEurope andthe United States .
The primary endpoint of the study is progression-free survival. Secondary outcome measures include overall response rate (by RECIST), disease control rate, overall survival, safety and tolerability in subjects treated with IMO-2055 + Erbitux compared to Erbitux alone.
In this study, crossover of the patients who progress on Erbitux alone is permitted to the combination arm of IMO-2055 and Erbitux. Evaluation of response rate and progression-free survival in the crossover patients presents a second setting to evaluate the efficacy of adding IMO-2055 to Erbitux in patients whose disease is refractory to that agent.
Phase 1b Trial of IMO-2055 in Combination with FOLFIRI and Erbitux in Patients with Colorectal Cancer who have Progressed Following Chemotherapy for Advanced or Metastatic Disease
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The goal of the study was to establish a recommended Phase 2 dose.
16 patients have been enrolled at three dose levels. We anticipate the data from this study to be available during the second quarter of 2012.
Gene-silencing Oligonucleotide Technology
Idera has developed a gene-silencing oligonucleotide (GSO) drug discovery platform with the potential to overcome specific limitations associated with traditional gene silencing technologies. GSOs are proprietary single-stranded RNA or DNA constructs that are complementary to targeted messenger RNA and microRNA sequences of therapeutic interest that do not require conventional delivery techniques.
- GSOs targeted to the mRNA of apolipoprotein B (ApoB) or proprotein convertase subtilisin/kexin type 9 (PCSK9), two validated targets associated with cardiovascular diseases, have been studied following systemic administration in mice. In these studies, GSOs showed a dose-dependent reduction in the level of the targeted mRNA and associated protein and resulted in a decrease in serum total cholesterol and LDL-cholesterol concentration. The reduction of cholesterol was sustained for an extended duration following the termination of the dosing. These studies have been conducted to validate the potential of GSO technology. Further studies are ongoing for undisclosed gene targets.
Partnered Programs
TLR7, 8 and 9 Agonists as Vaccine Adjuvants
Idera and
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In
January 2012 , Merck selected several novel agonists targeted to TLR7, TLR8 or TLR9 for evaluation and exclusive use as vaccine adjuvant candidates under the companies' collaboration and license agreement.
Additional Proprietary Programs
The Company is seeking to advance its other TLR-targeted programs in infectious diseases, respiratory diseases, hematologic oncology and adjuvant applications of TLR3 agonists through licensing and partnering.
Intellectual Property
In 2011, the Company was issued 19 new U.S. and foreign patents related to its TLR-targeted compounds. Presently, the Company's intellectual property portfolio contains over 500 patents and patent applications worldwide, including over 300 patents and patent applications covering the Company's TLR-targeted compounds. In addition, the Company's intellectual property portfolio includes more than 200 patents and patent applications for antisense technology and 5 patent applications for GSO technology.
Financing
In
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
ERBITUX® is a registered trademark of
Idera Pharmaceuticals, Inc. | ||||||||||||||||
Condensed Statements of Operations | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||
Three Months Ended | Years Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(Unaudited) | ||||||||||||||||
Revenues | $ | 8 | $ | 1,058 | $ | 53 | $ | 16,110 | ||||||||
Operating Expenses | ||||||||||||||||
Research & Development | 5,700 | 4,893 | 17,969 | 24,226 | ||||||||||||
General & Administrative | 1,539 | 2,158 | 7,939 | 9,867 | ||||||||||||
Total Operating Expenses | 7,239 | 7,051 | 25,908 | 34,093 | ||||||||||||
Loss from Operations | (7,231 | ) | (5,993 | ) | (25,855 | ) | (17,983 | ) | ||||||||
Decrease in Fair Value of Warrant Liability | 1,974 | - | 1,974 | - | ||||||||||||
Other, net | 97 | (20 | ) | 105 | 20 | |||||||||||
Net Loss | (5,160 | ) | (6,013 | ) | (23,776 | ) | (17,963 | ) | ||||||||
Preferred Stock Accretion and Dividends | 4,548 | - | 4,548 | - | ||||||||||||
Net Loss Applicable to Common Stockholders | $ | (9,708 | ) | $ | (6,013 | ) | $ | (28,324 | ) | $ | (17,963 | ) | ||||
Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders | $ | (0.35 | ) | $ | (0.22 | ) | $ | (1.03 | ) | $ | (0.71 | ) | ||||
Shares Used in Computing Basic and Diluted Net Loss Per Common Share Applicable to Common Stockholders | 27,635 | 27,587 | 27,623 | 25,139 |
Idera Pharmaceuticals, Inc. | |||||||
Condensed Balance Sheet Data | |||||||
(In thousands) | |||||||
At December 31, | |||||||
2011 | 2010 | ||||||
Cash, Cash Equivalents | |||||||
& Investments | $ | 24,571 | $ | 34,643 | |||
Other Assets | 1,024 | 2,238 | |||||
Total Assets | $ | 25,595 | $ | 36,881 | |||
Total Liabilities | $ | 7,650 | $ | 3,780 | |||
Redeemable Preferred Stock | 5,921 | - | |||||
Stockholders' Equity | 12,024 | 33,101 | |||||
Total Liabilities, Redeemable Preferred | |||||||
Stock & Stockholders' Equity | $ | 25,595 | $ | 36,881 |
Source:
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com