Important Regulatory Milestone Provides Runway to Move DK210 (EGFR) into the Clinical Phase
GERMANTOWN, Md., Dec. 27, 2022 /PRNewswire/ -- Today, Deka Biosciences, Inc. (Deka), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 23, 2022. The IND application supports Deka's DK210 (EGFR), a promising new cancer treatment that combines normal interleukin-2 with a high affinity interleukin-10, that is designed to accumulate in tumors by binding to the epidermal growth factor receptor (EGFR).
"With no dual cytokine therapy currently approved for the treatment of cancer, this IND application brings us one step closer to fulfilling our mission – to bring cures to patients with cancer and inflammatory diseases," said John Mumm, CEO & Co-Founder of Deka. "We are thrilled to advance DK210 (EGFR) to the clinical phase and anticipate beginning our Phase 1 trial as soon as possible after the FDA's acceptance of our IND."
The IND filing comes nearly 18 months after the discovery of DK210 (EGFR), and the company is projecting to dose its first patient in early 2023.
DK210 (EGFR) is the first of many experimental therapeutics developed as part of Deka's platform of molecules. Each Diakine™ in Deka's platform consists of two complementary cytokines coupled together via attachment to a single chain variable fragment that enables the cytokines to accumulate more specifically in targeted 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 also identified genetic markers that are related to the differentiated responses to each Diakine™. 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 Diakine™ treatment in later stage trials.
Deka Biosciences is a biotech company led by entrepreneur Dr. John Mumm, who is backed by a team of experienced academic, biopharma and CDMO innovators with expertise in drug discovery, product development, characterization, and testing. Deka has developed disease specific Diakines™ designed to maximize patient benefits through improved pharmacokinetics / pharmacodynamics (PK/PD) function by the targeted accumulation of dual and complimentary cytokines into affected tissues. Through developing a better understanding of each patient's immune response to different Diakines™, Deka hopes to maximize the impact of its Diakines™ by building these targeted therapies for everyone.
SOURCE Deka Biosciences
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