FDA Grants Fast Track Designation to IMM-1-104 for Advanced Melanoma
Source: Pharmacy Times, December 2024
The FDA granted a fast track designation to IMM-1-104 (Immuneering Corp.) to treat patients with unresectable or metastatic NRAS-mutant melanoma whose disease progressed or is intolerant to PD-1-/PD-L1-based immune checkpoint inhibitors. Currently, the treatment is undergoing evaluation in a phase 2a clinical trial (NCT05585320)2, which enrolled patients with advanced solid tumors, including melanoma.
IMM-1-104 is a novel oral dual MEK1/2 inhibitor that aims to achieve a universal-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells. It is administered once daily and achieves deep cyclic inhibition of the MAPK pathway.
“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. Targeted therapies including MEK and RAF inhibitors have shown promise in melanoma but historically are severely limited by toxicity,” said Ben Zeskind, PhD, co-founder and CEO of Immuneering, in a news release.