Prelude wins FDA clearance to begin testing a new breast-cancer candidate

Prelude Therapeutics ($PRLD) received FDA clearance of its investigational-new-drug application for PRT13722, an oral KAT6A-selective degrader being developed for hormone-receptor-positive, HER2-negative breast cancer. The company expects to begin enrolling patients in a first-in-human Phase 1 trial in the fourth quarter of 2026. The study will assess the candidate alone and in combination with other treatments.

The planned open-label, multicenter trial will examine safety, drug exposure, pharmacodynamic effects and preliminary antitumor activity. Prelude’s rationale is based on selectively targeting KAT6A, but any proposed tolerability or efficacy advantages still need to be tested in people. FDA clearance allows the clinical program to start; it is not approval to market the drug and does not validate the candidate’s eventual benefit-risk profile.

Sources:

• Prelude Therapeutics — FDA IND clearance