U.S. FDA grants Fast Track designation for Idera Pharmaceuticals’ IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma.
The Food and Drug Administration (FDA) has placed Idera Pharmaceutical’s lead development candidate IMO-2125 on the fast track for the treatment of anti-PD-1 refractory metastatic melanoma in combination with ipilimumab.
IMO-2125 received orphan drug designation from the FDA this year for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting T-cells to target solid tumors in refractory melanoma patients. The combination of ipilimumab and IMO-2125 appears to activate an immune response in patients who have exhausted all options, according to Idera.
“Patients with recurrent or refractory metastatic melanoma may be divided into 2 groups: patients who have failed initial systemic therapy (chemotherapy and/or biologic therapy) and experience progression or recurrence after an initial response to treatment or patients who have local recurrences (skin and/or regional lymph nodes) after initial surgery or surgery and adjuvant therapy.” — The University of New Mexico Comprehensive Cancer Center
The FDA’s’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.
“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.
Horobin added that the company intends to continue enrolling more patients through both the Phase 2 expansion of its ongoing trial and initiating a Phase 3 trial early in 2018.
(Source: Idera Pharmaceuticals, Inc.)
Filed Under: Drug Discovery