eClinical Technology and Industy News

Codiak Provides Platform-Validating Clinical Update and Data from Phase 1 Trials of exoSTING™ and exoIL-12™

– Codiak’s engineered exosome candidates demonstrate potential for best-in-class profile, with tumor retention and delivery to the cells of interest allowing for increased therapeutic window –

– exoSTING and exoIL-12 demonstrated favorable safety and tolerability profile at repeat doses tested and antitumor activity was observed in both injected and uninjected/distal lesions –

– Codiak has identified recommended Phase 2 dose for each program and plans to initiate Phase 2 studies for both candidates in the first quarter of 2023 –

– Codiak to host conference call and webcast today at 8:00 am ET –

Excerpt from the Press Release:

CAMBRIDGE, Mass., June 30, 2022 (GLOBE NEWSWIRE) — Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today announced platform-validating clinical data from Phase 1 trials of exoSTINGTM and exoIL-12™ and plans to advance both candidates into Phase 2 trials. In an open-label Phase 1 trial, exoIL-12 demonstrated a differentiating favorable safety and tolerability profile, with no detectable systemic exposure of IL-12 and no treatment-related adverse events, which has not previously been reported by others with recombinant IL-12. The two patients with cutaneous T cell lymphoma (CTCL) who have been treated each received multiple (>20) injections of exoIL-12 and experienced tumor regressions in both injected and non-injected lesions, including a partial response in one patient. In the open-label Phase 1/2 clinical trial evaluating exoSTING as a single agent in patients with late-stage refractory solid tumors, data across all five dose cohorts showed repeat doses of exoSTING were well-tolerated, demonstrated tumor retention with no systemic exposure of the STING agonist, and in a subset of patients, tumor shrinkage was observed in injected and uninjected lesions.  

“We believe these positive datasets from our two lead programs provide further clinical validation of our engEx® Platform and the target profile for our engineered exosome therapeutic candidates. In the studies, we were able to deliver exoSTING and exoIL-12, with repeat dosing, to the tumor with a high level of specificity, no observed systemic exposure or associated toxicity, and an enhanced therapeutic index–while demonstrating tumor shrinkage in both injected and uninjected lesions,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “STING and IL-12 have been challenging targets that have historically been hampered by very toxic side effects, but we believe our approach may enable best-in-class therapies with favorable safety profiles. Based on these findings, we have identified a recommended Phase 2 dose for both programs. We plan to initiate a Phase 2 study of exoSTING in bladder cancer and a Phase 2 study of exoIL-12 in an expanded group of tumor types in the first quarter of 2023.”

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