The U.S. Food and Drug Administration (FDA) granted fast track status to Idera Pharmaceuticals‘ IMO-2125, in combination with Yervoy (ipilimumab), for the treatment of metastatic melanoma patients whose disease progressed after anti-PD-1 therapy.
The new designation is meant to expedite the clinical development of the combination therapy. It follows the orphan drug designation granted to IMO-2125 in June for the treatment of stage 2b-4 melanoma.
“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,” Joanna Horobin, chief medical officer at Idera, said in a press release.
Idera’s IMO-2125 was made to activate the toll-like receptor 9 (TLR9), a molecule that is found in dendritic and B-cells. Its activation triggers immune-signaling cascades that boost the anti-cancer activity of T cells.
Based on its unique activity, IMO-2125 represents a new strategy to boost immune responses and treat solid cancers that do not respond to immune checkpoint inhibitors such as anti-PD-1 drugs.
Results presented in September at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference revealed that IMO-2125 plus Yervoy significantly reduced tumor size and induced sustained anti-tumor immune responses in mice.
The effects were seen both in tumors that received a IMO-2125 injection and in distant tumors. Also, when mice were challenged with cancer cells for a second time they were able to completely clear any traces of cancer without the need of additional therapies.
Results from the first 18 patients treated with IMO-2125 plus Yervoy have shown that intratumoral IMO-2125 plus Yervoy is well-tolerated and promotes anti-tumor immune responses.
“We’re thrilled with the dramatic response rate that has been observed 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,” Horobin said.