Immuneering Corp

We are a late-stage clinical oncology company focused on developing and commercializing a new category of anti-cancer medicines called Deep Cyclic Inhibitors. Deep Cyclic Inhibition® ("DCI") is a novel mechanism designed to deprive tumor cells of the sustained proliferative signaling needed for rapid growth, while sparing healthy cells by maintaining a cadenced, normalized level of signaling. Our Deep Cyclic Inhibitors inhibit clinically-validated core signaling pathways, such as the mitogen-activated protein kinase ("MAPK") pathway. This approach aims to improve durability and tolerability, differentiating it from chronically targeted precision therapies often limited by toxicity, resistance, or application to specific mutations. Our lead product candidate is atebimetinib (IMM-1-104), an oral, once-daily Deep Cyclic Inhibitor of mitogen-activated protein kinase kinase ("MEK"). Atebimetinib is designed to improve durability and tolerability across various cancer indications, including MAPK pathway-driven tumors like pancreatic cancer. We are initiating a Phase 3 clinical trial for atebimetinib, named the MAPKeeper 301 trial. This trial will evaluate atebimetinib in combination with modified gemcitabine/nab-paclitaxel ("mGnP") in first-line pancreatic cancer patients. The MAPKeeper 301 is a global Phase 3 registrational trial comparing atebimetinib (320 mg QD) plus mGnP to standard of care gemcitabine/nab-paclitaxel ("GnP") alone in first-line metastatic pancreatic ductal adenocarcinoma ("PDAC"). The primary endpoint is overall survival, with secondary endpoints including progression-free survival, overall response rate, disease control rate, and quality of life measurements. We plan to enroll approximately 510 patients in MAPKeeper 301, divided equally across the two arms.