IMO-2055, a TLR9 agonist, is in clinical development for the treatment of cancer.

IMO-2055 was created by Idera through its chemistry-based approach to making TLR-targeted compounds and became the Company’s first Immune Modulatory Oligonucleotide (IMO) drug candidate to enter clinical development. IMO-2055 has demonstrated activity as an immune modulator in preclinical models, both in vitro and in vivo. Idera has shown IMO-2055 to have anticancer activity in preclinical mouse models when administered as a single agent and when administered in combination with other cancer therapies. After the submission of an Investigational New Drug filing, Idera conducted three Phase 1 clinical trials of IMO-2055, one in healthy subjects and two in refractory cancer patients, as well as a Phase 2 Stage A clinical trial in patients with renal cell carcinoma.

In May 2007, Idera defined its strategic plan for further clinical development of IMO-2055 in oncology with a focus on combination therapies with biologically targeted agents.

In December 2007, Idera entered into an exclusive, worldwide licensing and collaboration agreement with Merck KGaA, of Darmstadt, Germany, for the research, development, and commercialization of Idera's TLR9 agonists, including IMO-2055, for the treatment of cancer, excluding vaccines. About the collaboration.

Ongoing Clinical Trials of IMO-2055

IMO-2055 Phase 1b Clinical Trial in Non-Small Cell Lung Cancer
In December 2007, a Phase 1b clinical trial of IMO-2055 in combination with Tarceva® and Avastin® was initiated in patients with non-small cell lung cancer (NSCLC) whose cancer has progressed on previous therapy. Idera reported preliminary data from the dose-escalation portion of the trial at the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany, in September 2009. Patient recruitment is ongoing at a selected dose level of IMO-2055 combined with fixed standard dose regimens of Avastin and Tarceva to evaluate safety and pharmacokinetics. [Press Release]

IMO-2055 Phase 1b Clinical Trial in Colorectal Cancer
In February 2009, a Phase 1b clinical trial to investigate IMO-2055 in combination with Erbitux® and Camptosar® was initiated in patients with colorectal cancer whose cancer has progressed on previous therapy. Patient recruitment is ongoing with dose-escalation at three dose levels of IMO-2055 and standard dosages and schedules of Erbitux and Camptosar. [Press Release]

Prior Clinical Trials of IMO-2055

• IMO-2055 Phase 2 Stage A Clinical Trial in Renal Cell Carcinoma [Press Release]
• IMO-2055 Phase 1 Clinical Trial in Combination with Gemzar® and Camptosar® in Refractory Solid Tumor Cancer Patients [Press Release]
• IMO-2055 Phase 1 Clinical Trial in Refractory Solid Tumor Cancer Patients [Press Release]
• IMO-2055 Phase 1 Clinical Trial in Healthy Subjects [Press Release]