– Recruitment Continues in Phase 1 Clinical Trial of exoASO™-STAT6 Administered Intravenously in Patients With Advanced Hepatocellular Carcinoma –
– Prioritize CEPI-funded vaccination program and advancement of engEx-AAV™ for gene delivery –
– Plans to launch phase 2 studies on exoSTING™ and exoIL-12™ suspended –
– Codiak expanding strategic discussions; align workforce with current priorities –
CAMBRIDGE, Mass., Aug. 30, 2022 (GLOBE NEWSWIRE) — Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapies as a new class of drugs, today announced a new prioritization of its clinical and research initiatives, an acceleration of discussions related to potential corporate and program-based strategic partnerships, and a restructuring of operations to support a streamlined set of priorities.
“We are focused on positioning Codiak to succeed in the current capital markets environment, prioritizing engEx® platform programs that we believe are well positioned to generate compelling new clinical and preclinical data in the short term. We also accelerate strategic and collaborative discussions at the enterprise level and for specific clinical candidates and engineers.® platform programs,” said Douglas E. Williams, Ph.D., President and CEO of Codiak. “The preclinical and human clinical data generated to date validate our initial vision for this broad platform and support the tolerability and predictable pharmacology of exosome therapeutic candidates with early signs of clinical activity.
- exoASO™-STAT6 is Codiak’s first systemically administered exosome drug candidate, and its third candidate to enter clinical trials. exoASO-STAT6 is designed to selectively deliver antisense oligonucleotides to disrupt STAT6 signaling in tumor-associated macrophages (TAMs) and induce an anti-tumor immune response. Preclinical studies of exoASO-STAT6 have shown single-agent anti-tumor activity in models of aggressive hepatocellular carcinoma (HCC). Enrollment continues in the Phase 1 clinical trial of exoASO™-STAT6 in patients with advanced HCC, liver metastases from primary gastric cancer, and colorectal cancer, where elevated levels of STAT6 transcript are correlated with a poor prognosis for patients. Data is expected in the first half of 2023.
- Codiak announced last month a new partnership with CEPI (Coalition for Epidemic Preparedness Innovations) to advance its exoVACC™ pan betacoronavirus program. Under the partnership, CEPI is providing seed funding of up to $2.5 million, which Codiak says will fund the completion of preclinical development and the identification of a clinical candidate by early next year.
- Preclinical data presented at ASGCT earlier this year on engEx-AAV™ discovery program, demonstrated efficient incorporation of AAV capsids into exosomes where they were not subject to neutralization by antibodies against AAV. These modified constructs efficiently transduce target cells and support the idea of engEx-AAV for repeat dosing of gene delivery constructs. The Codiak team will continue to advance this program towards the generation of live proof-of-concept data later this year.
- Codiak is suspending plans to initiate Phase 2 trials of exoSTING™ and exoIL-12™. Platform validation data from Phase 1 trials for both programs was reported in June, demonstrating the potential for the best profiles, and Codiak has identified a recommended Phase 2 dose for each candidate.
- Codiak prioritizes discussions related to establishing potential new strategic and collaborative initiatives for the Company, including program-based partnerships. Codiak’s existing research and business partnerships with Lonza and Jazz Pharmaceuticals continue, with resources committed to achieve key objectives.
Codiak BioSciences has aligned the organization to reflect its smaller, refocused pipeline. The Company’s workforce will be reduced by 37%, to 53 full-time employees, to support the priority programs mentioned above.
Dr. Williams added: “We are incredibly proud of the work of our team who created, manufactured and brought the first engineered exosomes into the clinic. I want to personally thank all Codiak employees for their pioneering work, especially those affected by today’s announcement. Together, we have made great strides in making this new modality a reality for patients, and we remain firmly committed to achieving this important goal.
As of June 30, 2022, Codiak had cash, cash equivalents and marketable securities of approximately $41.8 million. A critical part of the company’s strategic corporate and partnership discussions and other initiatives is to explore potential funding opportunities to enable the expansion of Codiak’s cash trail and the potential for additional program funding.
About Codiak BioSciences
Codiak is a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of drugs with the potential to transform the treatment of a wide range of diseases with high unmet medical need. By exploiting the biology of exosomes as natural mechanisms of intercellular transfer, Codiak has developed its proprietary engEx® Platform to develop the innate properties of exosomes in order to design, engineer and manufacture new exosome therapeutic candidates. Codiak used his engEx® Platform to generate a large pipeline of engineered exosomes aimed at addressing a wide range of disease areas, spanning oncology, infectious diseases and rare diseases.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and therapeutic potential of the Company’s portfolio, the clinical development of exoASO-STAT6, statements regarding the capabilities and potential of Codiak’s engEx platform and engineered exosomes generally, and statements regarding reprioritization of the program, plans to expand discussions related to potential strategic partnerships with companies and programs, and the restructuring of operations. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. In particular, statements regarding the initiation and timing of clinical trials are dependent on the availability of sufficient cash resources, and statements regarding the restructuring are dependent on Codiak’s ability to successfully implement the restructuring and the impact of restructuring on the activities of Codiak, as for the Company can not give any guarantee. For a discussion of these risks and uncertainties, and other important factors, each of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Codiak’s Annual Report. on Form 10-K for the fiscal year ended December 31, 2021, and in subsequent filings with the Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties and other important factors in Codiak’s subsequent filings with the SEC. All information in this press release is current as of the date of this report, and Codiak undertakes no obligation to update such information except as required by law.
Vice President, Investor Relations and Corporate Communications
Such. : 617-949-4220
E: [email protected]
E: [email protected]