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Oncology

The human immune system is capable of recognizing cancer cells as abnormal, leading to an immune response. However, the human body’s immune response to cancer cells is generallly weak or, in some cases, absent. Idera believes that its TLR agonists may enhance the body’s immune response to cancer cells, providing a potential means to control cancer cell growth.  Idera has selected IMO-2055, a TLR9 agonist, as a lead candidate for oncology.

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 for the treatment of cancer. Under the agreement, Idera agreed to exclusively license the applications of its lead TLR9 agonists, IMO-2055 and IMO-2125, for treating cancer, excluding the use of these compounds with cancer vaccines. In addition, Merck KGaA and Idera have agreed to engage in a research collaboration to identify a specified number of novel, follow-on TLR9 agonists, which will be derived using Idera’s chemistry-based approach and for which Merck KGaA will have the exclusive right to use for treating cancer, excluding the use of these compounds with cancer vaccines.

IMO-2055
IMO-2055 is designed to act as an agonist of TLR9 and has demonstrated activity as an immune modulator in preclinical models, both in vitro and in vivo.   IMO-2055 anticancer activity has been observed in preclinical mouse models when administered as a single agent.  IMO-2055 also has shown potentiation of anticancer activity when administered in combinations with certain chemotherapeutic agents, antibodies, and newer biologically targeted agents approved for use in cancer therapy.

IMO-2055 has been evaluated for its safety and immunological activity in Phase 1 studies involving healthy subjects and refractory cancer patients. 

Phase 1b Trial in Non-Small Cell Lung Cancer
In December 2007, Idera initiated a Phase 1b trial of IMO-2055 in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer (NSCLC) who have progressed on first line chemotherapy.

Phase 2 Trial in Renal Cell Carcinoma
IMO-2055 is being evaluated at two dose levels in a Phase 2 trial for metastatic renal cell carcinoma.  Treatment naïve patients and patients who have received one prior therapy are included in Stage A of the trial, which has been closed to further enrollment as of June 29, 2007.  When final Stage A data are available, we plan to report the results at an appropriate scientific meeting and decide on the next steps for evaluation of IMO-2055 in RCC.

Phase 1/2 Trial in Combination with Chemotherapy
IMO-2055 also is being evaluated in combination with Gemzar® and carboplatin.  The Phase 1 portion is a dose escalation study in patients with refractory solid tumors.