Codiak BioSciences Announces FDA Clearance of IND for exoASO™-STAT6

Codiak BioSciences, a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for exoASO-STAT6. exoASO-STAT6 is Codiak’s third engineered exosome therapeutic candidate to be cleared for clinical evaluation, and the first intended for systemic (intravenous) administration. It is designed to silence the transcription factor STAT6 selectively in tumor associated macrophages (TAMs). Preclinical studies of exoASO-STAT6 showed single agent anti-tumor activity in models of aggressive hepatocellular carcinoma.

“This is an important milestone for Codiak and we are excited to be advancing exoASO-STAT6 into clinical development. This program is our first systemically administered exosome therapeutic candidate, our first antisense oligonucleotide payload, our first candidate showing cell specific targeting of a transcription factor, and the first macrophage targeting candidate to show single agent anti-tumor activity of this magnitude in preclinical models,” said Douglas E. Williams, Ph.D., CEO of Codiak. “We are eager to confirm this biological profile in the clinic and expect to begin enrolling patients in this Phase 1 study in the first half of 2022.”

In data recently presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021), exoASO-STAT6 was observed to induce significant and prolonged reduction of STAT6 mRNA in hepatocellular carcinoma models, attenuate tumor growth, and induce complete remission of tumor lesions in 50% of mice. This response rate was further enhanced (75% complete remissions) when exoASO-STAT6 was administered in combination with anti-PD1 antibodies. This monotherapy activity seen in preclinical models was accompanied by considerable remodeling of the tumor model microenvironment, including significant expansion of M1-like, immune stimulatory macrophages, ultimately resulting in tumor elimination.

Source – Globe Newswire

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