By Robb M. Stewart

 

Codiak BioSciences Inc.'s investigational new drug application for exosome therapeutic candidate exoASO-STAT6 has been cleared by the U.S. Food and Drug Administration.

The company said Tuesday it expect to begin enrolling patients in a Phase 1 study in the first half of 2022. The trial will evaluate safety, tolerability, biomarkers and preliminary anti-tumor activity of exoASO-STAT6 in hepatocellular carcinomas.

In premarket trading, Codiak's shares were 21% higher after ending the previous session at $12.53, down roughly 60% since the end of last year.

ExoASO-STAT6 is designed to silence the transcription factor STAT6 selectively in tumor associated macrophages and preclinical studies showed single agent anti-tumor activity in models of aggressive hepatocellular carcinoma, Codiak said.

 

Write to Robb M. Stewart at robb.stewart@wsj.com

 

(END) Dow Jones Newswires

November 30, 2021 09:09 ET (14:09 GMT)

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