Codiak BioSciences Gets FDA Approval for ExoASO-STAT6 IND Application
November 30 2021 - 09:24AM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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