Prelude Therapeutics said the FDA cleared its investigational new drug application for PRT13722, an oral KAT6A selective degrader, setting up a phase 1 study in HR+/HER2* breast cancer.
The company said enrollment in the first-in-human, open-label, multicenter trial is expected to begin in the fourth quarter of 2026.
PRT13722 is being tested as both a monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity.
Prelude described the program as its first-in-class, highly selective KAT6A degrader, designed to spare KAT6B. The company said that approach is intended to improve efficacy, tolerability and compatibility with other agents compared with dual KAT6A/B inhibitors.
The announcement follows recent clinical data cited by the company as validating KAT6 as a target in HR+/HER2* breast cancer, including tumors with actionable mutations. Prelude said dual KAT6A/B inhibitors have shown overlapping toxicities with current backbone therapies, while selective KAT6A degradation may widen the therapeutic window.
Prelude’s pipeline also includes JAK2V617F mutant-selective inhibitors and degrader antibody conjugates. Following these announcements, the company's shares moved 1.77%, and are now trading at a price of $5.18. If you want to know more, read the company's complete 8-K report here.
