Cancer

IMO-2055, a TLR9 agonist, is the lead candidate in the Company’s oncology program.

IMO-2055 has been evaluated in clinical trials alone and in combination with other anti-cancer agents in several cancer indications.

Clinical Development

Idera previously has conducted Phase 1 studies in healthy subjects. In these studies, IMO-2055 was well tolerated at the doses studied and showed the desired induction of immune responses.

The following clinical trials with IMO-2055 in combination with targeted agents in various cancer indications have been conducted.

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)

Phase 1b Trial of IMO-2055 in Combination with Tarceva and Avastin for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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)

Scientific Rationale

IMO-2055 is designed to activate immune responses through TLR9, resulting in the induction of cytokines and activation of immune cells. In preclinical studies, IMO-2055 has been shown to induce both innate and adaptive immune responses, and to exert potent anti-tumor activity in various cancer models. Idera’s approach to using IMO-2055 for cancer immunotherapy is in combination with targeted agents, both biologics and small molecules. In preclinical models of cancer, IMO-2055 has been shown to potentiate the activity of several targeted agents, including Erbitux^®, Tarceva^®, Avastin^®, Herceptin^®, Sutent^®, Nexavar^®, and Alimta^®.