Idera Pharma (IDRA) Issues Update on Drug Candidate Pipeline Target to Toll-Like Receptors

June 16, 2009 10:17 AM EDT

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today provided an update on its drug candidate pipeline targeted to Toll-like Receptors during its 2009 Annual Meeting of Stockholders.

"We have three drug candidates in clinical evaluation for multiple indications, two of which are being advanced by our partners. We expect to file an IND application for a fourth drug candidate by the end of 2009," said Sudhir Agrawal, D. Phil., President, Chief Executive Officer and Chief Scientific Officer. "Over the next 18 months we expect to obtain data from ongoing clinical trials of each of these candidates to enable decisions on further development directions."

IMO-2055 in Cancer Treatment (collaboration with Merck KGaA)

IMO-2055 is a TLR9 agonist

-- Phase 2 Clinical Trial of IMO-2055 in Renal Cell Carcinoma (RCC)

The Company expects to report detailed data from the first part of a Phase 2 clinical trial of IMO-2055 monotherapy in patients with metastatic or recurrent clear cell RCC at a scientific meeting in the third quarter of 2009. Based on the final data analysis, the median progression-free survival for each of the four arms in the trial was 4.5 months, 4.3 months, 3.4 months, and 1.9 months. Preliminary data from the trial were announced October 1, 2008.

-- Phase 1b Clinical Trial of IMO-2055 in Combination with Avastin(R) and
Tarceva(R) in Non-small Cell Lung Cancer (NSCLC)

The Company expects to report preliminary data from the dose-escalation portion of the Phase 1b trial at a scientific meeting in the third quarter of 2009. In the trial, IMO-2055 is being administered with fixed standard dose regimens of Avastin and Tarceva. Patient recruitment is ongoing at a selected dose level of IMO-2055 to evaluate the safety and pharmacokinetics of the combination.

-- Phase 1b Clinical Trial of IMO-2055 in Combination with Erbitux(R) and
Camptosar(R) in Colorectal Cancer

Patient recruitment is ongoing with dose-escalation through three dose levels of IMO-2055 administered with standard dose regimens of Erbitux and Camptosar to evaluate the safety of the combination.

IMO-2125 in Chronic Hepatitis C Virus (HCV) Infection

IMO-2125 is a TLR9 Agonist

-- Phase 1 Clinical Trial with IMO-2125 Monotherapy in Chronic HCV
Infection in Patients Non-responsive to Standard of Care Therapy

Patient enrollment in the third cohort has been completed. The Company expects to complete dosing in the fourth planned cohort and to announce interim data by the end of 2009.

-- Phase 1 Clinical Trial with IMO-2125 in Combination with Ribavirin in
Chronic HCV Infection in Treatment-naive Patients

The Company is preparing to conduct a Phase 1 clinical trial to assess the safety of IMO-2125 in combination with ribavirin in treatment-naive patients with chronic HCV infection. The Company expects to commence this trial in the second half of 2009. The design of this trial is subject to review by regulatory authorities.

QAX935 (IMO-2134) in Asthma and Allergy (collaboration with Novartis)

QAX935 is a TLR9 Agonist

-- Phase 1 Clinical Trial with QAX935

In September 2008, Novartis initiated a Phase 1 clinical trial of QAX935. QAX935 is intended for the treatment of asthma and allergies.

IMO-3100 in Autoimmune Diseases

IMO-3100 is a dual antagonist of TLR7 and TLR9

-- Submission of Investigational New Drug (IND) Application for IMO-3100

The Company is conducting IND-enabling preclinical development studies to support the evaluation of IMO-3100 in autoimmune diseases. The Company expects to submit an IND application to the U.S. Food and Drug Administration by the end of 2009.

Research Programs

TLR7 and TLR8 Agonists

-- The Company is studying its novel TLR7 and/or TLR8 agonists for
potential applications in oncology and infectious diseases.

TLR7, 8 and 9 Agonists as Adjuvants in Vaccines (collaboration with Merck & Co., Inc.)

-- Idera and Merck & Co. are collaborating under an agreement to research,
develop and commercialize vaccine products containing Idera's agonist
compounds targeting TLRs 7, 8, and 9 in the fields of oncology,
infectious diseases and Alzheimer's disease.

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 the potential application of TLR
antisense in autoimmune and inflammatory diseases.

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