Idera Pharmaceuticals Reports Third Quarter 2009 Financial Results and Provides Pipeline Update
“We have continued development of our pipeline of drug candidates
targeted to Toll-like receptors for potential applications in chronic
hepatitis C virus infection and autoimmune diseases, and to support our
partnered programs in oncology, respiratory disease, and vaccine
adjuvants,” said
“With
Third Quarter and Nine-Month 2009 Results
The Company reported net income of
Total revenues for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
As of
Clinical and Preclinical Programs
IMO-2055, a TLR9 agonist, in
- Phase 2 Clinical Trial of IMO-2055 in Renal Cell Carcinoma (RCC)
In
Based on the final data analysis:
- Progression-free survival (PFS) medians for treatment-naïve patients were 4.5 months at 0.16 mg/kg/week and 1.9 months at 0.64 mg/kg/week.
- PFS medians for second-line patients were 3.4 months at 0.16 mg/kg/week and 4.3 months at 0.64 mg/kg/week.
- Median overall survival was 23.5 months overall, although medians were not estimable in 2 of the 4 treatment groups.
- 7 patients received weekly IMO-2055 treatment for at least 1 year.
- 2 patients (1 second-line and 1 treatment-naïve), each receiving 0.64 mg/kg/week, had confirmed partial responses.
- 52 patients (58%) across all groups had stable disease.
- IMO-2055 treatment was generally well-tolerated: neither dosage was associated with any dose-limiting toxicity, although the relative dose intensity was higher with the 0.16 mg/kg dosage.
- The most common treatment-related adverse events (any grade across groups) were fatigue (51%), nausea (46%), chills (45%), headache (37%), and pyrexia (33%), consistent with IMO-2055-related immune stimulation.
- Phase 1b Clinical Trial of IMO-2055 in Combination with Tarceva® and Avastin® in Non-small Cell Lung Cancer (NSCLC)
In
- IMO-2055 was tolerated at dosages up to 0.48 mg/kg/week in combination with Tarceva plus Avastin.
- The most common possibly-related adverse events were injection site reactions, fatigue and fever.
- Six grade 3 adverse events were reported: injection site reactions (2), diarrhea (2), fatigue (1) and low potassium (1).
- 8 of 16 patients remained on treatment at least 18 weeks.
- Of the 13 evaluable patients, 3 had a partial response and 8 experienced stable disease.
Recruitment of additional patients is continuing at the anticipated recommended phase 2 dose level for IMO-2055 in this combination.
- Phase 1b Clinical Trial of IMO-2055 in Combination with Erbitux® and Camptosar® in Colorectal Cancer
Patient recruitment is ongoing with three escalating dose levels of IMO-2055 being investigated in combination with standard dose regimens of Erbitux and Camptosar to evaluate the safety of the combination.
In
IMO-2125, a TLR9 agonist, in Chronic Hepatitis C Virus (HCV) Infection
- Phase 1 Clinical Trial with IMO-2125 Monotherapy in Chronic HCV Infection in Patients Non-responsive to Standard of Care Therapy
The Company expects to complete patient enrollment in the fourth cohort of this trial by the end of 2009 and to announce interim data during the first quarter of 2010.
- Phase 1 Clinical Trial with IMO-2125 in Combination with Ribavirin in Treatment-naïve Patients with Chronic HCV Infection
In
QAX935 (IMO-2134), a TLR9 agonist, in Asthma and Allergy
(collaboration with
- Phase 1 Clinical Trial with QAX935
In
IMO-3100, a dual antagonist of TLR7 and TLR9, in Autoimmune and Inflammatory Diseases
- Investigational New Drug (IND)-Enabling Preclinical Development Studies of IMO-3100
The Company is currently conducting IND-enabling preclinical development
studies to support the clinical evaluation of IMO-3100 in autoimmune and
inflammatory diseases. The Company anticipates submitting an IND
application to the
In
TLR7, 8 and 9 agonists as vaccine adjuvants (collaboration with
-
The Company is collaborating with
Merck & Co. under an agreement to research, develop, and commercialize vaccine products containing the Company’s TLRs 7, 8, and 9 agonists in the fields of oncology, infectious diseases, and Alzheimer’s disease.
TLR7 and TLR8 agonists
- The Company is studying its novel TLR7 and/or TLR8 agonists for potential applications in oncology and infectious diseases.
TLR Antisense
- The Company has identified antisense candidates targeted to human TLRs 2, 3, 4, 5, 6, 7, 8, and 9 and to the TLR-associated signaling protein MyD88. The Company is studying these candidates for potential applications in autoimmune and inflammatory diseases.
Scientific Highlights
The Company and its collaborators recently have presented and published on the following studies:
Data Presentations
-
Abstract P-9148 “Phase 1 study of the toll-like receptor 9 (TLR9)
agonist, IMO-2055, combined with erlotinib (E) and bevacizumab (B) in
patients (pts) with advanced or metastatic non-small cell lung cancer
(NSCLC)” at the joint 15th
Congress of theEuropean CanCer Organisation and 34thCongress of theEuropean Society for Medical Oncology held inSeptember 2009 . The presentation was made byDavid Smith , M.D., ofUS Oncology inVancouver, WA. -
Abstract O-1000 “A novel drug Toll-like receptor 9 (TLR9) agonist
synergizes with trastuzumab in different trastuzumab-resistant breast
tumours via multiple mechanisms of action” at the joint 15th
Congress of theEuropean CanCer Organisation and 34thCongress of theEuropean Society for Medical Oncology held inSeptember 2009 . The presentation was made byGiampaolo Tortora , M.D., of Universitàdi Napoli Federico II inNaples, Italy . -
Abstract 9.148 “A phase 2 multicenter, randomized, open-label study of
two dose levels of IMO-2055 in patients with metastatic or recurrent
renal cell carcinoma” at the Eighth International Kidney Cancer
Symposium held in
Chicago ,September 2009 . The presentation was made byTimothy Kuzel , M.D., of Northwestern University’sFeinberg School of Medicine inChicago, IL. -
Abstract 659 entitled “Studies of Combination of IMO-3100, An
Antagonist of TLR7 and TLR9, and Etanercept, a TNF-alpha Inhibitor, in
a Mouse Model of Collagen-Induced Arthritis (CIA)” at the 2009 Annual
Scientific Meeting of the
American College of Rheumatology and Association of Rheumatology Health Professionals in October, 2009. -
Abstract 1593: “IMO-2125, a TLR9 agonist, induces Th-1 type cytokines
and interferons with potent anti-HCV activity in human peripheral
blood mononuclear cells (PBMCs) and plasmacytoid dendritic cells
(pDCs)” at the 60th Annual Meeting of the
American Association for the Study of Liver Diseases inNovember 2009 . -
Abstract 1597: “Gene expression profiles induced by IMO-2125, an
agonist of Toll-like receptor 9, in human peripheral blood mononuclear
cells” at the 60th Annual Meeting of the
American Association for the Study of Liver Diseases inNovember 2009 .
Publications
-
A paper entitled “Modifications incorporated in CpG motifs of
oligodeoxynucleotides lead to antagonist activity of Toll-like
receptors 7 and 9” was published in
Journal of Medicinal Chemistry 2009, 52, 5108-14. -
A paper entitled “Coadministration of telomerase genetic vaccine and a
novel TLR9 agonist in nonhuman primates” was published in Molecular
Therapy 2009, 17, 1804-13. The paper was co-authored by scientists
from
Merck & Co. Inc. and Idera. -
A paper entitled “Synthetic oligoribonucleotides-containing secondary
structures act as agonists of Toll-like receptors 7 and 8” was
published in
Biochemical and Biophysical Research Communications 2009, 386, 443-8. - A paper entitled “Synthetic oligoribonucleotides containing arabinonucleotides act as agonists of TLR7 and 8” was published in Bioorganic & Medicinal Chemistry 2009, 19, 2044-7.
Intellectual Property
Idera’s intellectual property portfolio contains over 500 patents and patent applications worldwide.
Immune Modulatory Oligonucleotides (IMO®)
This portfolio holds over 280 patents and patent applications worldwide covering Idera’s IMO technologies and includes claims covering novel agonists of Toll-like Receptors (TLRs) 7, 8 and 9 and antagonists of TLRs 7 and 9. These patents and patent applications include claims covering IMO-2055, IMO-2125, IMO-3100, and QAX935. The following patents were recently issued:
- US 7,595,305, entitled “Modulation Of Immunostimulatory Properties Of Oligonucleotide-Based Compounds By Utilizing Modified Immunostimulatory Dinucleotides”
- US 7,569,554, entitled “Synergistic Treatment of Cancer Using Immunomers in Conjunction with Chemotherapeutic Agents”
- US 7,566,702, entitled “Immunostimulatory Oligonucletide Multimers”
In addition to the issued U.S. patents, patents corresponding to the US
7,569,554 patent were granted to the Company in
Antisense Technology
This portfolio holds over 220 patents and patent applications worldwide covering novel antisense compounds and methods of their use. These patents and patent applications include claims covering second-generation antisense chemistry, oral delivery of second-generation antisense compounds, and certain genes, antisense sequences, and therapeutic targets (including various TLRs and signaling molecules).
About
Idera Forward Looking Statements
This press release contains forward-looking statements concerning
Tarceva is a registered trademark of
Idera Pharmaceuticals, Inc. Condensed Statements of Operations (Unaudited) |
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(in thousands, except per share data) |
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||
2009 |
2008 |
2009 |
2008 |
|||||||||||
Revenue | $ | 6,538 | $ | 7,517 | $ | 24,338 | $ | 20,196 | ||||||
Operating Expenses: | ||||||||||||||
Research & Development | 4,288 | 3,580 | 14,177 | 11,866 | ||||||||||
General & Administrative | 2,210 | 2,323 | 6,492 | 8,013 | ||||||||||
Total Operating Expenses | 6,498 | 5,903 | 20,669 | 19,879 | ||||||||||
Income from Operations | 40 | 1,614 | 3,669 | 317 | ||||||||||
Other, net | 14 | 366 | 116 | 828 | ||||||||||
Income before Income Taxes | 54 | 1,980 | 3,785 | 1,145 | ||||||||||
Income Tax Provision | (30 | ) | - | (170 | ) | - | ||||||||
Net Income | $ | 24 | $ | 1,980 | $ | 3,615 | $ | 1,145 | ||||||
Basic Net Income per Share |
$ | 0.00 | $ | 0.09 | $ | 0.15 | $ | 0.05 | ||||||
Diluted Net Income per Share | $ | 0.00 | $ | 0.08 | $ | 0.15 | $ | 0.04 | ||||||
Shares Used in Computing Basic Net
Income per Share |
23,441 | 23,022 | 23,409 | 22,428 | ||||||||||
Shares Used in Computing Diluted
Net Income per Share |
24,341 | 25,779 | 24,188 | 25,538 |
Idera Pharmaceuticals, Inc. Condensed Balance Sheet Data (Unaudited) |
||||||
(in thousands) | September 30, | December 31, | ||||
2009 |
2008 |
|||||
Cash, Cash Equivalents | ||||||
and Investments | $ | 46,071 | $ | 55,606 | ||
Other Assets | 3,890 | 3,794 | ||||
Total Assets | $ | 49,961 | $ | 59,400 | ||
Accounts Payable and Accrued Liabilities | $ | 3,796 | $ | 2,773 | ||
Deferred Revenue | 17,711 | 34,460 | ||||
Stockholders' Equity | 28,454 | 22,167 | ||||
Total Liabilities & | ||||||
Stockholders' Equity | $ | 49,961 | $ | 59,400 |
Source:
Idera Pharmaceuticals, Inc.
Kelly Luethje, 617-679-5519
kluethje@iderapharma.com
or
MacDougall
Biomedical Communications
Chris Erdman, 781-235-3060
cerdman@macbiocom.com