Immuneering Announces Positive Initial Phase 2a Data Including Complete and Partial Responses with IMM-1-104 in Combination with Chemotherapy in First-Line Pancreatic Cancer Patients

Core Insights - Immuneering Corporation announced positive initial response data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer, showing an overall response rate (ORR) of 40% and a disease control rate (DCR) of 80% from the first five patients treated [1][5][6] Clinical Trial Results - In the Phase 2a trial, two out of five patients exhibited complete or partial responses, leading to an initial ORR of 40% and a DCR of 80%, with all patients continuing treatment [1][5] - The initial data from the trial is consistent with preclinical findings that indicated IMM-1-104 combined with chemotherapy could induce deeper responses than either agent alone [1][6] - The trial has progressed to dosing additional patients at 320 mg QD, following the approval from the Data and Safety Monitoring Board (DSMB) based on the emerging safety profile [5][6] Future Development - The company expects a clear path forward for the clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, especially given the FDA's Fast Track designation for this treatment [1][5] - Further data from the ongoing Phase 2a arms is anticipated by the end of the year, with a focus on evaluating the efficacy of IMM-1-104 across various tumor types [2][8] Company Overview - Immuneering Corporation is a clinical-stage oncology company focused on developing universal-RAS/RAF medicines, with IMM-1-104 as its lead product candidate currently in a Phase 1/2a trial for advanced solid tumors harboring RAS mutations [10][11] - The company aims to achieve universal-RAS activity through Deep Cyclic Inhibition of the MAPK pathway, selectively impacting cancer cells while sparing healthy cells [10][11]