Immuneering receives FDA Fast Track designation for IMM-1-104

Immuneering 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. “We welcome FDA’s decision to grant Fast Track designation for IMM-1-104. Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway. We look forward to a data-rich 2024 as we plan to provide multiple readouts from our study this year,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.