January 4, 2024

OnKure’s lead cancer-drug candidate clears FDA hurdle

BOULDER — OnKure Inc., a precision oncology company, recently had its Investigational New Drug application for its leading cancer therapy OKI-219, a selective PI3K alpha H1047R inhibitor, approved by the U.S. Food and Drug Administration, clearing a path for the Boulder firm to begin clinical trials.

The company plans to initiate a first-in-human clinical trial during the first quarter of this year. OnKure, headquartered at 6707 Winchester Circle in the Gunbarrel neighborhood of northeast Boulder, raised a $54 million Series C round in 2023 to fund advancements in its drug pipeline.

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