Immuneering Corporation announced that the first patient has been dosed in the Phase 2a portion of its Phase 1/2a clinical trial of IMM-1-104, its lead program. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of MEK in the MAPK pathway with once-daily oral dosing. The Phase 2a portion of the Phase 1/2a clinical trial of IMM-1-104 is expected to include approximately 150 patients in five arms at our recommended Phase 2 dose of 320 mg once daily.

The five arms are as follows: IMM-1-104 monotherapy in patients with pancreatic ductal adenocarcinoma (PDAC) in the first- or second-line setting (n=30). IMM-1-104 monotherapy in patients with RAS-mutant melanoma in the second- or third-line setting post-immunotherapy, or in the first-line setting for patients who are not candidates for existing therapies (n=30). IMM-1-104 monotherapy in patients with RAS-mutant non-small cell lung cancer (NSCLC) in the second- or third-line setting (n=30).

IMM-1-104 in combination with mFOLFIRINOX in patients with PDAC in the first-line setting (n=30). IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel in patients with PDAC in the first-line setting (n=30).