Immuneering Submits IND Application To FDA For Phase 1/2a Trial Of IMM-1-104 On Solid Tumors

(RTTNews) - Immuneering Corp. (IMRX) said Friday that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration. 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.

IMM-1-104 is a third generation MEK inhibitor designed for broad pan-RAS activity as well as activity in other MAPK-activated tumors.

As per preclinical data, 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.

The FDA will review the company's IND application and determine whether the data package is acceptable to predict the safety of IMM-1-104, before clinical trial initiation.

The company noted that it continues to prepare for the planned Phase 1/2a trial evaluating IMM-1-104 for the treatment of advanced solid tumors with RAS mutations. The company is planning to sponsor the recruitment of patients at five internationally recognized clinical sites in the United States.

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