FDA grants fast track designation to TK216 in Ewing sarcoma

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FDA granted Fast Track Designation to ets-family inhibitor TK216 in Ewing sarcoma patients that have relapsed or are refractory to standard of care therapy.

Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma.

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, according to the company. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease.

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