On August 30, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported a reprioritization of its clinical and research initiatives, an acceleration of discussions related to potential strategic corporate and program-based partnerships, and a restructuring of operations to support a streamlined set of priorities (Press release, Codiak Biosciences, AUG 30, 2022, View Source [SID1234618756]).
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"We are focused on positioning Codiak for success in the current capital markets environment, prioritizing engEx platform programs which we believe are well-positioned to generate compelling new clinical and preclinical data in the near term. We are also accelerating strategic and collaborative discussions at both the corporate level and for specific clinical candidates and engEx 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."
Program Updates
exoASO-STAT6 is Codiak’s first systemically administered exosome-based drug candidate, and its third candidate to enter clinical trials. exoASO-STAT6 is engineered 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 showed 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 high STAT6 transcript levels correlate with poor prognosis for patients. Data is expected during 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. As part of the partnership, CEPI is providing seed funding of up to $2.5 million, which Codiak anticipates will fund the completion of preclinical development and identification of a clinical candidate by early next year.
Preclinical data presented at ASGCT (Free ASGCT Whitepaper) earlier this year on the Company’s engEx-AAV discovery program, demonstrated efficient incorporation of AAV capsids inside exosomes where they were not subject to neutralization by antibodies against AAV. These engineered constructs efficiently transduce target cells and support the idea of engEx-AAV for repeat dosing of gene delivery constructs. Codiak’s team will continue to advance this program toward generation of in vivo proof-of-concept data later this year.
Codiak is pausing plans to initiate Phase 2 trials of exoSTING and exoIL-12. Platform-validating data from Phase 1 trials for both programs were reported in June, demonstrating potential for best-in-class profiles, and Codiak identified a recommended Phase 2 dose for each candidate.
Codiak is prioritizing 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 are continuing, with resources committed to attain key goals.
Organizational Updates
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’re incredibly proud of the work of our team having created, manufactured and brought into the clinic the first engineered exosomes. I would like to personally thank every Codiak employee for their trailblazing work, particularly those who are impacted by today’s announcement. Together we have made great strides toward making this new modality a reality for patients, and we remain strongly committed to realizing this important goal."
Financial Overview
As of June 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $41.8 million. An essential component of the Company’s strategic corporate and partnering discussions and other initiatives is exploring prospective opportunities to provide funding to enable extension of Codiak’s cash runway and the potential to resource additional programs.