On January 30, 2023 Deka Biosciences ("Deka"), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States (Press release, Deka Biosciences, JAN 30, 2023, View Source [SID1234626653]). The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985).
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"Obtaining FDA clearance for our company’s first program to start clinical trials is a significant achievement," said Dr. John Mumm, CEO and co-founder of Deka. "We are excited to move forward with the clinical development of DK210 (EGFR) and the potential it holds for positively impacting the lives of many cancer patients."
DK210 (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules. Each DiakineTM in Deka’s platform consists of two cytokines coupled together onto a single chain variable fragment targeting system that enables the cytokines to accumulate more specifically into specific tissues. The combination of the two cytokines increases potency and reduces toxicity while the targeting system also improves the drug’s efficacy, safety, and manufacturability. Deka has identified genetic markers that are related to responses to each DiakineTM. These markers will be evaluated in early clinical trials with the hope of using them as potential diagnostic tools to match patients with the most effective DiakineTM treatment in later stage trials.