Immuneering Granted FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has granted fast track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1-based immune checkpoint inhibitors. IMM-1-104 is currently being evaluated in a Phase IIa clinical trial in patients with advanced solid tumors, including melanoma.

“Immune checkpoint inhibitors play a vital role in the treatment of melanoma, yet patients who progress on or are intolerant to them have limited options,” said Ben Zeskind, PhD, co-founder and CEO of Immuneering. “Targeted therapies, including MEK and RAF inhibitors, have shown promise in melanoma but historically are severely limited by toxicity. As we presented at the European Society for Medical Oncology 2024 congress, IMM-1-104 is a new kind of MEK inhibitor that was observed to be uniquely well-tolerated in our Phase I trial, relative to MEK inhibitors currently used to treat melanoma. We believe this creates opportunities for IMM-1-104 to benefit melanoma patients both alone and in combination with RAF inhibitors and/or immune checkpoint inhibitors. Against this backdrop, we are pleased with the FDA’s decision to grant fast track designation for IMM-1-104 in advanced melanoma, an area of significant unmet need. Melanoma patients are actively enrolling in one of the five arms of our Phase IIa clinical trial, and this designation follows our announcements earlier this year that IMM-1-104 has also been granted fast track designations for the treatment of both first and second-line pancreatic cancer.”