Immuneering Corporation announced on December 12, 2024, that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104. This designation is for the treatment of 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 2a clinical trial, with melanoma patients actively enrolling in one of the five arms of the study. The company highlighted that IMM-1-104 was observed to be uniquely well tolerated in its Phase 1 trial, a key differentiator compared to existing MEK inhibitors used in melanoma treatment.
Fast Track designation facilitates more frequent interactions with the FDA to discuss the development plan and may qualify the investigational medicine for accelerated approval and priority review if relevant criteria are met. This marks another significant regulatory recognition for IMM-1-104, following previous Fast Track designations for first and second-line pancreatic cancer.
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