NEWS: Pancreatic cancer is one of the most aggressive and deadliest cancers and has the highest mortality rate amongst all cancers. This FDA Fast Track Designation first -in-line Tx is SIGNIFICANT.
Immuneering Granted FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer
Immuneering (Nasdaq: IMRX) has received FDA Fast Track designation for IMM-1-104 as a first-line treatment for pancreatic ductal adenocarcinoma (PDAC).
This follows the February 2024 Fast Track designation for second-line PDAC treatment. IMM-1-104 is designed to provide universal-RAS activitythrough Deep Cyclic Inhibition of the MAPK pathway with once-daily oral dosing.
The ongoing Phase 2a trial includes multiple arms evaluating IMM-1-104 in combination with chemotherapy for first-line PDAC patients, as monotherapy for first and second-line PDAC, and for RAS-mutant melanoma and lung cancer.
Immuneering expects to share initial data from multiple arms in the second half of 2024.
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