Tokalas’ first lead product candidate, TK-216, is a novel, first-in-class ets-family transcription factor inhibitor that targets the EWS-FLI1 fusion protein (Company Web Page, Tokalas, MAY 10, 2016, View Source [SID:1234512166]). Oncogenic fusion proteins involving ets-family gene translocations are known to cause Ewing sarcoma, the company’s first targeted therapy for high unmet need cancers.

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TK-216 is based on technology developed under the direction of Jeffrey Toretsky, M.D. at Georgetown University and licensed to Tokalas through an academic-private development partnership. IND enabling non-clinical studies of TK-216 have been completed, and Tokalas will initiate Phase 1 clinical testing in patients with advanced Ewing sarcoma in early 2016 at MD Anderson, Memorial Sloan Kettering, and UCLA. Tokalas is exploring expedited registration strategies with both US and European regulatory agencies.
Tokalas is also evaluating the unmet medical need in other cancers that sometimes carry overexpressed or translocated ets-family oncogenes, including prostate cancer, AML, and glioblastoma.