Codiak Initiates Patient Dosing in Phase 1/2 Clinical Trial of exoSTING™ for the Treatment of Solid Tumors

Codiak BioSciences, Inc., a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the initiation of patient dosing in its Phase 1/2 clinical trial of exoSTING. exoSTING is a novel exosome therapeutic candidate engineered with the company’s engEx Platform and designed to deliver Codiak’s proprietary STING (stimulator of interferon genes) agonist specifically to tumor-resident antigen presenting cells (APCs) to locally activate the innate immune response. The trial, which will study exoSTING in solid tumors, is Codiak’s second human clinical trial and the second clinical development program the Company has initiated in the past month.

“We are enormously proud to now have both of our lead candidates in the clinic, the result of years of engineering and manufacturing innovation and a significant step forward towards fulfilling our goal of pioneering the development of engineered exosomes as a new class of medicines for diseases with high unmet medical needs,” said Douglas E. Williams, Ph.D., CEO, Codiak. “With exoSTING, the data from our in vitro and in vivo preclinical studies support our desired product profile, demonstrating that we can achieve targeted engagement of the STING pathway to potentially overcome the lack of cell specificity, tolerability, and limited single-agent antitumor activity associated with previous STING agonists.”

exoSTING is an exosome therapeutic candidate engineered with Codiak’s engEx Platform to incorporate its proprietary STING agonist inside the lumen of the exosome while expressing high levels of the exosomal protein, PTGFRN, on the surface. The high-level display of PTGFRN is designed to promote targeted delivery of Codiak’s proprietary STING agonist into APCs in the tumor microenvironment.

Engagement of the STING pathway has been validated to elicit an anti-tumoral response, yet therapeutic development has been generally limited by non-selective cell delivery, off-target toxicity to important immune cells in the tumor and dose-related toxicity due to leakage of the STING agonist into the circulation. In preclinical models of exoSTING, the targeted delivery of a STING agonist to tumor resident APCs promoted localized innate immune activation, T cell attraction and expansion in the tumor, and the development of systemic immunity not observed with a STING agonist delivered without exosomes (e.g., “free”).

The Phase 1/2 dose escalation clinical trial of exoSTING is designed to investigate 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 is expected in mid-2021. As part of the Phase 2 portion of the trial, Codiak intends to enroll further expansion cohorts of patients at the optimal exoSTING dose to be identified in the Phase 1 portion of the clinical program.

Source – BusinessWire