On November 30, 2021 Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for exoASO-STAT6 (Press release, Codiak Biosciences, NOV 30, 2021, View Source [SID1234596249]). 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 antitumor activity in models of aggressive hepatocellular carcinoma.
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"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) (Free SITC Whitepaper) (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.
About exoASO-STAT6
exoASO-STAT6 is an exosome engineered to deliver antisense oligonucleotides and selectively target uptake in M2 polarized tumor-associated macrophages via overexpression of the exosomal protein, PTGFRN. Targeting STAT6 acts as an effective switch of the polarization of TAMs from an M2 tumor permissive/anti-inflammatory phenotype to an M1 T cell attractive, anti-tumor/inflammatory phenotype. Codiak plans to initially develop exoASO-STAT6 for primary cancers of the liver.