Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer

Ensem Therapeutics

1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific allosteric PI3Kα inhibitor and degrader, ETX-636, for the treatment of adult patients with PIK3CA mutant, hormone receptor positive, human epidermal growth factor negative advanced breast cancer.

ETX-636 was designed using ENSEM’s unique Kinetic Ensemble platform to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα and can selectively inhibit multiple activating mutant forms of PI3Kα, while sparing wild type PI3Kα.

Read Ensem Therapeutics press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track