Prelude Therapeutics Inc., headquartered in Wilmington, Delaware, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for PRT13722, an oral selective degrader of the KAT6A protein.
The agency’s clearance permits a first‑in‑human, open‑label, multicenter Phase 1 trial that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of the agent both as a monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR‑positive, HER2‑negative breast cancer. Patient enrollment is targeted for the fourth quarter of 2026.
PRT13722 is engineered to degrade KAT6A while sparing the related KAT6B isoform, a strategy intended to broaden the therapeutic window and reduce hematologic toxicity, according to Chief Medical Officer Charles Morris.
