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Prelude Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for PRT13722, Its First-in-Class Oral KAT6A Selective Degrader

PRLD
  • Prelude Therapeutics received FDA clearance to proceed with a Phase 1 study for PRT13722, an oral KAT6A selective degrader.
  • The study targets patients with HR+/HER2- breast cancer & is expected to begin patient enrollment in the fourth quarter of 2026.
  • PRT13722 is a first-in-class, highly selective, & orally bioavailable KAT6A degrader designed to spare KAT6B to improve the therapeutic window.
  • The Phase 1 trial is a first-in-human, open-label, multicenter study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, & antitumor activity.
  • PRT13722 will be tested as monotherapy & in combination with endocrine & targeted therapies for locally advanced or metastatic HR-positive, HER2-negative breast cancer.
  • Clinical validation supports KAT6 as a targetable mechanism, while selective degradation aims to address toxicity limitations seen with dual KAT6A/B inhibitors.