Immuneering Corporation announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have failed one line of treatment. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing. Fast Track Designation is a program designed to facilitate the development and expedite the review of medicines with the potential to treat serious conditions and fulfill an unmet medical need.

An investigational medicine that receives Fast Track Designation may be eligible for more frequent interactions with the FDA to discuss the candidate?s development plan and, if relevant criteria are met, may be eligible for accelerated approval and priority review.