James Breitmeyer, M.D., Ph.D., Oncternal's President and CEO, commented: "We are very pleased that the FDA has awarded Fast Track Designation for TK216 in Ewing sarcoma patients who have failed standard of care therapy. This rare bone cancer strikes children and young adults and there are few treatment alternatives, so it is imperative that we rapidly advance new therapeutics that have the potential to extend the lives of these patients. We look forward to beginning enrollment and dosing of Ewing sarcoma patients shortly in our Phase 1 trial of TK216."
The FDA describes Fast Track as a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier by enabling more frequent communications with the agency to address potential questions and requirements, and to streamline regulatory submissions.
TK216 is a first-in-class small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types, stopping cancer cell growth and tumor formation. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease. TK216 is based upon the discoveries of Jeffrey A. Toretsky, M.D. at Georgetown University, who conducted extensive research on the ets-family of oncogenes that cause or drive tumor growth in a number of solid and hematologic malignancies. Oncternal and Georgetown are also planning clinical studies in glioblastoma, prostate cancer and lymphoma in the next year.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage oncology company developing first-in-class therapies for both rare and common malignancies. The company is leveraging its scientific and development expertise, as well as academic collaborations, to rapidly advance its two pipeline products focused on targets that are uniquely expressed by cancer cells. Cirmtuzumab is an-anti ROR1 monoclonal antibody, and TK216 is a small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins. For more information, visit http://www.oncternal.com.
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SOURCE Oncternal Therapeutics, Inc.