Data from Codiak’s exoSTING™ Preclinical Development Program for the Treatment of Solid Tumors Published in the Nature Research Publication, Communications Biology

– exoSTING has demonstrated enhanced potency, preferential activation of antigen presenting cells, and systemic anti-tumor immunity in vivo –

– Novel engineered exosome therapeutic candidate currently in Phase 1/2 clinical trial with initial proof-of-concept data expected mid-year –

CAMBRIDGE, Mass., April 22, 2021 (GLOBE NEWSWIRE) — Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the online publication of a new manuscript, exoSTING, an extracellular vesicle loaded with STING agonists, promotes tumor immune surveillance, in Communications Biology, a Nature Research publication. exoSTING is a novel engineered exosome therapeutic candidate currently being investigated in a Phase 1/2 clinical trial as a single agent for the treatment of multiple solid tumors. This publication details the findings from the preclinical development program and highlights the potential of exoSTING to stimulate a broad immune response without the detrimental effects on intratumoral T cells observed with other STING agonists. 

“We believe exoSTING represents a novel strategy to harness and improve upon the natural properties of exosomes in the tumor microenvironment and may overcome the limitations of off-target delivery, poor tumor retention and systemic inflammation which have hindered prior drug development of free STING agonist molecules targeting this well-validated pathway,” said Sriram Sathyanarayanan, PhD, SVP, Preclinical Research, Codiak. “This publication describes the therapeutic potential of this candidate based on the preclinical evidence and demonstrates the capability of our exosome engineering platform to leverage the natural biology of exosomes to expand the therapeutic index of attractive yet historically challenging cancer immunotherapy agents.”

exoSTING is one of two Codiak programs currently in clinical development. Engineered using the company’s proprietary engEx™ Platform to provide targeted delivery of Codiak’s STING agonist to antigen presenting cells (APCs) in the tumor microenvironment, exoSTING demonstrates greater than 100-fold increased potency in in vivo tumor models and increased tumor retention and lower levels of systemic inflammatory cytokine production as compared to free STING agonist (delivered without exosomes). Additionally, exoSTING demonstrates CD8 T-cell preservation, expansion, Th1 polarization and establishment of systemic antigen-specific T-cell mediated immune responses across a wide dose range without evidence of immune ablation as seen with free STING agonists.

A Phase 1/2 dose escalation clinical trial of exoSTING is currently underway investigating safety, tolerability, pharmacological activity, and objective tumor response in patients with advanced/metastatic, recurrent, injectable solid tumors, with a focus on tumors likely to be enriched in APCs. Examples of such tumors include metastatic head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC), and cutaneous squamous cell carcinoma (cSCC). Safety, biomarker and preliminary efficacy data from the dose-escalation phase of the trial are expected in mid-2021.

About exoSTING™
exoSTING is Codiak’s exosome therapeutic candidate engineered to incorporate a proprietary STING (stimulator of interferon genes) agonist inside the lumen of the exosome while expressing the exosomal protein, PTGFRN, on the exosome surface to facilitate specific uptake in tumor-resident antigen presenting cells (APCs). Codiak believes that exoSTING has the potential to overcome certain limitations of free STING agonists, and enhance the therapeutic index and selectivity of delivery to desired cells in the tumor microenvironment.

Codiak is developing exoSTING for the treatment of multiple solid tumors enriched in the target APCs. exoSTING has demonstrated encouraging activity in preclinical models and is now being evaluated in a Phase 1/2 clinical trial in patients with advanced/metastatic, recurrent, and injectable solid tumors. Future development of exoSTING may be expanded to neuro-oncology indications such as glioblastoma and leptomeningeal cancer disease.

About the engEx™ Platform
Codiak’s proprietary engEx Platform is designed to enable the development of engineered exosome therapeutics for a wide spectrum of diseases and to manufacture them reproducibly and at scale to pharmaceutical standards. By leveraging the inherent biology, function and tolerability profile of exosomes, Codiak is developing engEx exosomes designed to carry and protect potent drug molecules, provide selective delivery and elicit the desired pharmacology at the desired tissue and cellular sites. Through its engEx Platform, Codiak seeks to direct tropism and distribution by engineering exosomes to carry on their surface specific targeting drug moieties, such as proteins, antibodies/fragments, and peptides, individually or in combination. Codiak scientists have identified two exosomal proteins that serve as surface and luminal scaffolds. By engineering the exosome surface or lumen and optimizing the route of administration, Codiak aims to deliver engEx exosomes to the desired cell and tissue to more selectively engage the drug target, potentially enhancing the therapeutic index by improving potency and reducing toxicity.

About Codiak BioSciences
Codiak is a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of diseases, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease. For more information, visit http://www.codiakbio.com and follow @CodiakBio.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING and exoIL-12, including timing of release of data, and statements regarding the capabilities and potential of Codiak’s engEx Platform and engineered exosomes generally. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Codiak’s Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak’s subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law. 

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