– Healthy volunteer clinical data for exoIL-12 accepted as a late-breaking abstract –
– Preclinical data demonstrating single-agent complete responses following exosome delivery of antisense oligonucleotide selectively targeting the STAT6 transcription factor –
CAMBRIDGE, Mass., March 10, 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 that the company will present data from two of its programs evaluating engineered exosome therapeutic candidates for the treatment of cancer at the upcoming virtual American Association for Cancer Research (AACR) Annual Meeting 2021.
“Following the initial data we reported last month, we look forward to presenting as a late-breaking poster the complete pharmacokinetic and pharmacodynamic results from the healthy volunteer portion of our Phase 1 trial of exoIL-12, which demonstrated localized pharmacologic activity without systemic IL-12 exposure,” said Benny Sorensen, M.D., Ph.D., SVP and Head of Clinical Development, Codiak. “These results represent the first human data of an engineered exosome therapeutic candidate to be presented in a peer reviewed setting. In addition, we will share encouraging preclinical data supporting the use of engineered exosomes to deliver an antisense oligonucleotide targeting STAT6. We expect exoASO-STAT6 will be our third clinical program with a planned Investigational New Drug (IND) filing later this year.”
Both posters will be available beginning the first day of the virtual meeting on Saturday, April 10, 2021 at 8:30 a.m. ET and remain available through June 21, 2021.
Late-Breaking Poster Presentation:
Randomized placebo-controlled Phase 1 trial in healthy volunteers investigating safety, PK and PD of exoIL-12 – a novel engineered exosome therapeutic candidate
Abstract number: CT114
Session: Phase I Clinical Trials
Poster Presentation:
Engineered exosome mediated STAT6 knockdown in Tumor Associated Macrophages (TAMs) results in potent single agent activity in a Hepatocellular Carcinoma (HCC) model
Abstract number: 1792
Session: Modifiers of the Tumor Microenvironment
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, 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.
Last month, Codiak reported positive Phase 1 results for Part A in healthy volunteers, confirming local pharmacology and dose selection for Part B of the study, a safety and efficacy trial in early-stage Cutaneous T Cell Lymphoma (CTCL) patients. Codiak intends to focus development of exoIL-12 on tumors that have, in previous clinical testing, shown clinical responses to recombinant IL-12 used as a monotherapy. This list includes CTCL, melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme, triple negative breast cancer, among others.
About exoASO™-STAT6
exoASO-STAT6 is an exosome engineered to overexpress PTGFRN to selectively target uptake in M2 polarized tumor-associated macrophages. The drug modality carried by exoASO-STAT6 is an antisense oligonucleotide (ASO) targeting the STAT6 transcription factor and is engineered onto the exosome surface. Targeting STAT6 acts as a potent switch of the polarization of tumor-associated macrophages from an M2 tumor permissive/anti-inflammatory phenotype to an M1 T cell attractive, anti-tumor/inflammatory phenotype. Codiak plans to initially develop exoASO-STAT6 for primary and metastatic cancers of the liver, such as hepatocellular carcinoma, pancreatic ductal adenocarcinoma, colorectal carcinoma, lung adenocarcinoma, uveal melanoma, glioma, thyroid cancer and ovarian cancer.
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 disease areas, spanning oncology, neuro-oncology, neurology, neuromuscular disease and infectious disease.
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 exoIL-12 and exoASO-STAT6, including future development plans and regulatory filings and timing with respect thereto. 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.