Immuneering Advances Towards Dosing First Patient in Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients, Securing Alignment with FDA and EMA

Core Insights - Immuneering Corporation is on track to initiate a global Phase 3 registrational trial for atebimetinib in first-line pancreatic cancer patients by mid-2026, evaluating its efficacy in combination with modified gemcitabine and nab-paclitaxel [1][4] Regulatory Interactions - The company has completed End-of-Phase 2 interactions with the FDA and received scientific advice from the EMA, achieving alignment on key elements of the proposed Phase 3 trial [2][5] - Feedback from both regulatory agencies supports the trial design and the primary endpoint of overall survival [3][5] Trial Design and Objectives - The MAPKeeper 301 trial will enroll approximately 510 patients and will compare atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP) against standard care gemcitabine and nab-paclitaxel (GnP) [3][4] - Secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements [3] Financial Outlook - The company expects to have sufficient cash and cash equivalents to fund operations into 2029 based on current operating plans [4] Industry Context - There is an urgent need for new therapies for pancreatic cancer, and the Phase 2a data for atebimetinib combined with chemotherapy shows promising signals [5]