Immuneering Submits IND Application for IMM-1-104 Tumor Treatment

By Chris Wack

Immuneering Corp. said Friday it submitted an investigational new drug application to the Food and Drug Administration in support of a Phase 1/2a clinical trial of IMM-1-104, an oral small molecule in development for the treatment of advanced RAS mutant solid tumors.

The biopharmaceutical company said that based on preclinical data to date, IMM-1-104 has demonstrated robust anti-tumor activity across a broad range of in vitro and in vivo 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 will continue to prepare for the planned Phase 1/2a trial evaluating IMM-1-104 for the treatment of advanced solid tumors with RAS mutations, Immuneering said.

The company said it is planning to sponsor the recruitment of patients at five clinical sites in the U.S.

Immuneering shares were up 9% to $7.57 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

September 02, 2022 08:41 ET (12:41 GMT)

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