New Publication in Molecular Cancer Therapeutics Highlights Data from Preclinical Development of exoIL-12™ for the Treatment of Cancer

– exoIL-12 has demonstrated tissue-retained pharmacology, enhanced anti-tumor activity, potent M1 myeloid recruitment, and superior T cell responses in vivo –

– Novel engineered exosome therapeutic candidate currently in Phase 1 clinical trial with data from healthy volunteers expected at year end –

CAMBRIDGE, Mass., Dec. 21, 2020 (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, Exosome surface display of IL-12 results in tumor-retained pharmacology with superior potency and limited systemic exposure compared to recombinant IL-12, in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research. exoIL-12 is a novel engineered exosome therapeutic candidate currently being investigated in a Phase 1 clinical trial as a single agent for the treatment of early-stage cutaneous T cell lymphoma (CTCL) and potentially other cancers. This publication details the findings from the preclinical development program and highlights the potential of exoIL-12 to inhibit tumor growth by facilitating potent local pharmacology, precisely quantified doses, undetectable systemic exposure, and the robust generation of systemic anti-tumor immunity superior to recombinant IL-12 (rIL-12).  

“We believe exoIL-12 represents a potentially first-in-class approach for a number of cancers that have previously shown clinical responses to IL-12, a potent anti-tumor cytokine for which prior development has been limited due to unwanted systemic exposure and related toxicity,” said Sriram Sathyanarayanan, PhD, Senior Vice President, Preclinical Research, Codiak. “This publication profiles the strength of the preclinical results that supported the advancement of exoIL-12 into the clinic and provides preclinical evidence that we can leverage the inherent biology of exosomes as delivery vehicles and potentially widen the therapeutic window of this potent cytokine.”

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™ Platform and designed to display IL-12 on the exosome surface using the exosomal protein, PTGFRN, as a scaffold, the capability of which was identified by Codiak scientists.

Data from the Phase 1 single-ascending dose trial of exoIL-12 in healthy volunteers are expected by the end of 2020, including safety, tolerability, and systemic IL-12 exposure. The trial, which consists of two parts, is designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of exoIL-12 first in healthy volunteers, followed by repeat dose exoIL-12 in patients with stage IA-IIB CTCL. Patients with CTCL will be monitored for safety, pharmacokinetics, pharmacodynamic effects in blood and tumor biopsies, and local and systemic anti-tumor efficacy using validated CTCL assessment criteria. Safety, biomarker and preliminary efficacy results from CTCL patients are anticipated in mid-2021.

About exoIL-12™
exoIL-12 is Codiak’s exosome therapeutic candidate engineered to display fully active IL-12 on the surface of the exosome, using the exosomal protein, PTGFRN, as a scaffold protein, and designed to facilitate potent local pharmacology at the injection site with precisely quantified doses. By limiting systemic exposure of IL-12 and associated toxicity, Codiak hopes to enhance the therapeutic index with exoIL-12, delivering a more robust tumor response, dose control and an improved safety profile.

Codiak intends to focus development of exoIL-12 on tumors that have, in previous clinical testing, shown clinical responses to IL-12 used as a monotherapy. This includes cutaneous T cell lymphoma (CTCL), melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme and triple negative breast cancer.

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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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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