Prelude Therapeutics said the FDA cleared its investigational new drug application for PRT13722, moving the company’s first-in-class oral KAT6A selective degrader into a Phase 1 study in HR+/HER2* breast cancer.
The company said patient enrollment is expected to begin in the fourth quarter of 2026.
PRT13722 is being developed as a first-in-human, open-label, multicenter study in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. The trial is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity, both as a monotherapy and in combination with endocrine and targeted therapies.
Prelude described KAT6 as a clinically validated target in ER+ breast cancer and said its approach is to selectively degrade KAT6A while sparing KAT6B. The company said that distinction is intended to improve efficacy, tolerability and combination potential versus dual KAT6A/B inhibitors, which it said have shown overlapping toxicities with backbone therapies.
In the company’s words, the program is aimed at maximizing the therapeutic window with enhanced efficacy and improved hematological safety, supported by preclinical data.
Prelude also said PRT13722 is part of a broader pipeline that includes highly selective KAT6A degraders and JAK2V617F mutant-selective inhibitors. Following these announcements, the company's shares moved 1.77%, and are now trading at a price of $5.18. For the full picture, make sure to review Prelude Therapeutics Inc's 8-K report.
