FDA Accepts IND Application for DK210 in EGFR Overexpressing Solid Tumors

Article

Investigators will evaluate DK210 in a first-in-human phase 1 clinical trial following the FDA’s review of an investigational new drug application for the compound for locally advanced or metastatic EGFR-positive solid tumors.

The FDA has completed its review of an investigational new drug (IND) application for DK210 for the treatment of patients with locally advanced or metastatic EGFR-overexpressing solid malignancies, according to a press release from Deka Biosciences.1

Primary end points of the first-in-human phase 1 trial investigating DK210 in locally advanced or metastatic EGFR-positive solid tumors include adverse effects and identifying a recommended dose for the compound.

Primary end points of the first-in-human phase 1 trial investigating DK210 in locally advanced or metastatic EGFR-positive solid tumors include adverse effects and identifying a recommended dose for the compound.

Following its review, the regulatory organization has given the greenlight to move ahead with a first-in-human, multicenter phase 1 trial (NCT05704985) assessing the safety of and biomarkers of response for DK210 in patients with EGFR-overexpressing tumors.

DK210 is an experimental therapeutic treatment consisting of 2 cytokines coupled onto a single chain variable fragment targeting system, enabling the cytokines to accumulate more specifically in certain tissues. The cytokine combination was designed to increase potency and reduce toxicity while the targeting system improves the compound’s efficacy, safety, and manufacturability.

Investigators of the phase 1 clinical trial will administer DK210 subcutaneously as monotherapy or in combination with chemotherapy, radiotherapy, or immunotherapy to patients with solid tumors harboring an EGFR overexpression.

The primary end points of the trial include adverse effects and identifying the recommended dose of DK210. Secondary end points include the overall response rate, progression-free survival, overall survival, and the pharmacokinetic profile of DK210.

Patients 18 years and older with a confirmed diagnosis of progressive metastatic or locally advanced unresectable solid cancer with EGFR overexpression or amplification and an ECOG performance status of 0 or 1 are eligible to enroll on the trial. Additional inclusion criteria include having measurable disease per RECIST v1.1 criteria; progressive disease at study entry; adequate cardiovascular, hematological, liver, and renal function; and not receiving anti-cancer medication for at least 4 weeks prior to beginning study treatment.

Patients with documented diffuse peritoneal disease or persistent abundant ascites are unable to enroll on the study. Patients are also unsuitable for enrollment if they have received anti-cancer treatment less than 4 weeks prior to beginning study treatment, had major surgery within 4 weeks before beginning treatment, or any uncontrolled intercurrent illness including COVID-19 and human immunodeficiency virus.

Investigators originally submitted the IND application for DK210 in December 2022.2 Filing of the application came approximately 18 months following the compound’s discovery.

“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,” Mumm said regarding the initial application submission.

References

  1. Deka Biosciences receives FDA clearance of DK210 (EGFR) investigational new drug application. News release. Deka Biosciences. January 30, 2023. Accessed January 31, 2023. prn.to/3wLefPc
  2. Deka Biosciences, Inc announces submission of investigational new drug (IND) application for lead oncology asset, DK210 (EGFR). News release. December 27, 2022. Accessed January 31, 2023. prn.to/3XSCd6P
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