Codiak BioSciences, Inc. announced a reprioritization of its clinical and research initiatives, an acceleration of discussions related to potential strategic corporate and program-based partnerships, and a restructuring of operations to support a streamlined set of priorities. Program Updates: exoASO™-STAT6 is Codiak's first systemically administered exosome-based drug candidate, and its third candidate to enter clinical trials. exoASO-STAT6 is engineered to selectively deliver antisense oligonucleotides to disrupt STAT6 signaling in tumor associated macrophages (TAMs) and induce an anti-tumor immune response.

Preclinical studies of exoASO-STAT6 showed single agent anti-tumor activity in models of aggressive hepatocellular carcinoma (HCC). Enrollment continues in the Phase 1 clinical trial of exoASO™-STAT6 in patients with advanced HCC, liver metastases from primary gastric cancer and colorectal cancer where high STAT6 transcript levels correlate with poor prognosis for patients. Data is expected during the first half of 2023.

Codiak announced last month a new partnership with CEPI (Coalition for Epidemic Preparedness Innovations) to advance its exoVACC™ pan betacoronavirus program. As part of the partnership, CEPI is providing seed funding of up to $2.5 million, which Codiak anticipates will fund the completion of preclinical development and identification of a clinical candidate by early next year. Preclinical data presented at ASGCT earlier this year on the Company's engEx-AAV™ discovery program, demonstrated efficient incorporation of AAV capsids inside exosomes where they were not subject to neutralization by antibodies against AAV.

These engineered constructs efficiently transduce target cells and support the idea of engEx-AAV for repeat dosing of gene delivery constructs. Codiak's team will continue to advance this program toward generation of in vivo proof-of-concept data later this year. Codiak is pausing plans to initiate Phase 2 trials of exoSTING™ and exoIL-12™.

Platform-validating data from Phase 1 trials for both programs were reported in June, demonstrating potential for best-in-class profiles, and Codiak identified a recommended Phase 2 dose for each candidate. Codiak is prioritizing discussions related to establishing potential new strategic and collaborative initiatives for the Company, including program-based partnerships. Codiak's existing research and business partnerships with Lonza and Jazz Pharmaceuticals are continuing, with resources committed to attain key goals.