The U.S. Food and Drug Administration has granted Fast Track designation to Idera Pharmaceuticals’ lead development candidate, IMO-2125. The treatment is to be used in combination with Ipilimumab for the treatment of anti-PD-1 refractory metastatic melanoma in combination with ipilimumab therapy.

IMO-2125 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.

“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.”