Benzinga | Feb 4, 2021 07:33AM EST

Codiak Reports Additional Positive Phase 1 Results For exoIL-12; Says 'Pharmacodynamic results confirm localized exoIL-12 pharmacologic activity'

-- Pharmacodynamic results confirm localized exoIL-12 pharmacologic activity



without systemic IL-12 exposure --

-- Plan to initiate multi-dose study in CTCL patients, with data anticipated by year-end 2021--

CAMBRIDGE, Mass., Feb. 04, 2021 (GLOBE NEWSWIRE) -- 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, today announced pharmacodynamic (PD) activity results from the healthy volunteer portion of its randomized, placebo-controlled, double-blind Phase 1 trial of the company's clinical candidate, exoIL-12. Analyses of skin punch biopsies bordering the subcutaneous injection site of exoIL-12 revealed local retention of immunologically detectable IL-12 at the injection site, and localized pharmacological activity as measured by levels of the T cell attractant chemokine, IP-10, in the skin. IL-12 was not detected in plasma at any dose of exoIL-12 tested and plasma IP-10 was only detectable at the highest, 12 ?g dose. Results confirmed the desired localization and retention of IL-12 at the injection site for at least 24 hours, as well as prolonged IP-10 production for 8-15 days depending upon dose.

exoIL-12 is the first engineered exosome therapeutic candidate to be evaluated in humans and one of two Codiak programs currently in clinical development. exoIL-12 was engineered using the company's proprietary engEx(tm) Platform and designed to display functional IL-12 -- a potent anti-tumor cytokine -- on the exosome surface using the exosomal protein, PTGFRN, as a scaffold.

"We now have clinical evidence in healthy volunteers of local, IL-12-driven pharmacology without detectable systemic exposure to IL-12 or drug-related adverse events for exoIL-12," said Benny Sorensen, M.D., Ph.D., Senior Vice President and Head of Clinical Development, Codiak. "These results further support the target profile that we are hoping to achieve with this candidate and have enabled us to identify the optimal dose for the next phase of our clinical program in patients with active, early-stage CTCL. Moreover, this data further validates the capacity of our engEx Platform to engineer precise properties into our exosome-based therapeutic candidates that potentially expand their therapeutic index."

These results are consistent with Codiak's preclinical testing and confirm exoIL-12's target product profile of local drug retention at the injection site, prolonged local pharmacodynamic activity, and lack of systemic IL-12 exposure. Codiak plans to initiate the next portion of the Phase 1 clinical trial, evaluating the safety and efficacy of exoIL-12, in CTCL patients at the dose of 6 ?g, which Codiak believes to be the optimal pharmacologically active dose based upon this healthy volunteer data and prior preclinical data with exoIL-12.

"We are pleased with the data we have obtained with exoIL-12 in healthy human volunteers and look forward to the initiation of trials in CTCL patients," said Douglas E. Williams, Ph.D., President and Chief Executive Officer, Codiak. "It is heartening to see one of the founding principles of Codiak validated in the current trial, namely that engineered exosomes can offer the opportunity to tailor therapeutic payloads to provide an active biological response while at the same time limiting unwanted side effects."