On November 29, 2017 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with rare cancers and rare diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s lead development candidate IMO-2125 in combination with Ipilimumab for the treatment of anti-PD-1 refractory metastatic melanoma in combination with ipilimumab therapy (Press release, Idera Pharmaceuticals, NOV 29, 2017, View Source [SID1234522339]). FDA’s Fast Track program is designed to expedite the development and review of drugs and biologics to treat serious or life-threatening conditions with non-clinical or clinical data demonstrating the potential to address unmet medical needs. Such drugs may qualify for Fast Track designation.1
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"This Fast Track designation represents another positive step for the development of IMO-2125 and is a clear recognition of the serious unmet need that exists for patients who do not benefit from anti-PD-1 therapy," stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer. "We’re thrilled with the dramatic response rate that has been observed to date so far with IMO-2125 in combination with ipilimumab and are eager to continue enrolling more patients through both the Phase 2 expansion of our ongoing trial and initiating the Phase 3 trial early next year."
About Fast Track Designation1
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions. A drug that is intended to treat a serious or life-threatening condition with nonclinical or clinical data that demonstrate the potential to address an unmet medical need may qualify for Fast Track designation. When Fast Track designation is requested later in development, available clinical data should demonstrate the potential to address an unmet medical need. There are opportunities for frequent interactions with the review team for a fast track product. In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.
About IMO-2125
IMO-2125 is a toll-like receptor (TLR) 9 agonist that received orphan drug designation from the FDA in 2017 for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors in refractory melanoma patients. Currently approved immuno-oncology treatments for patients with metastatic melanoma, specifically checkpoint inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy making them so-called "refractory." The combination of ipilimumab and IMO-2125 appears to activate an immune response in these patients who have exhausted all options. Intratumoral injections with IMO-2125 are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers. Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths. The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016. Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.