Idera Pharmaceuticals, Inc. announced top-line results of a randomized, controlled Phase 2 clinical trial of IMO-2055, the Company's investigational oncology product candidate targeting Toll-like Receptor 9 in combination with Erbitux(R) (cetuximab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in patients who previously progressed on chemotherapy. The study did not meet its primary endpoint of improved progression-free survival following treatment with IMO-2055 in combination with cetuximab compared to treatment with cetuximab alone. The median progression-free survival based on investigator assessments was 2.9 months in both arms; based on independent radiology review, it was 1.9 months in the cetuximab arm and 1.5 months in the combination arm.
The Phase 2 trial was designed and conducted by Merck KGaA of Darmstadt, Germany, under Idera's oncology collaboration with Merck KGaA that was terminated in November 2011. As part of the termination, Idera regained from Merck KGaA all rights for developing TLR9 agonists for the treatment of cancer, including all rights to IMO-2055, and Merck KGaA agreed to conduct the Phase 2 trial through completion.
"We are disappointed with the results of this trial, considering the favorable results reported earlier this year from a single-arm Phase 1b study of IMO-2055 in combination with Tarceva(R) and Avastin(R) in patients with non-small cell lung cancer as well as the safety profile of IMO-2055 in combination with targeted anti-cancer agents that has been observed in multiple clinical trials," said Sudhir Agrawal, D.Phil., Chairman and Chief Executive Officer. "We believe that IMO-2055 may have clinical and commercial potential for certain cancer indications and plan to seek to advance IMO-2055 through collaborations with third parties."
"Idera is focusing its development efforts on the drug candidates in our autoimmune disease program where we recently initiated a Phase 2 clinical trial of IMO-3100 in patients with psoriasis. Further, we are planning to submit an IND for IMO-8400 for the treatment of lupus in 2012. Additionally, we continue to validate our proprietary gene-silencing oligo technology and support our collaborative activities in the area of vaccine adjuvants for cancer, infectious diseases and Alzheimer's disease," Dr. Agrawal concluded.