CAMBRIDGE, Mass., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company using translational bioinformatics to advance a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, today announced it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1/2a clinical trial of IMM-1-104, an oral once daily small molecule in development for the treatment of advanced RAS mutant solid tumors. In contrast to the narrow approach of targeting specific mutations such as KRAS-G12C, IMM-1-104 is a third generation MEK inhibitor designed for broad pan-RAS activity as well as activity in other MAPK-activated tumors. Based on preclinical data to date, IMM-1-104 has demonstrated robust single-agent anti-tumor activity across a broad range of in vitro and in vivo tumor models driven by MAPK pathway activation events. This includes animal models of KRAS mutant pancreatic cancer, NRAS mutant melanoma, KRAS mutant colorectal cancer, and KRAS mutant lung cancer, regardless of the specific mutation upstream of MEK that drives activation of the MAPK pathway, and all while maintaining a well-tolerated safety profile in such models.

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Immuneering Announces Submission of IND Application to the FDA for Phase 1/2a Trial of IMM-1-104 to Treat Advanced Solid Tumors with RAS Mutations