Prelude Therapeutics gets FDA clearance for KAT6A degrader IND

Prelude Therapeutics announced on September 10, 2026 that the FDA had granted clearance of its Investigational New Drug application for PRT13722, described as an oral KAT6A selective degrader being developed for the treatment of patients with HR+/HER2- breast cancer.¹ The company said it expects to begin enrolling patients in the fourth quarter of 2026.¹

Prelude's chief medical officer, Charles Morris, said recent clinical data validated KAT6 as a targetable mechanism in HR+/HER2- breast cancer, including cases with actionable mutations.¹ He added that dual KAT6A/B inhibitors have shown overlapping toxicities with current backbone therapies that may limit their use in earlier treatment lines.¹ Morris said the company's approach of selectively degrading KAT6A aims to widen the therapeutic window, citing improved efficacy and hematological safety in preclinical work.¹

The planned trial is titled a "first-in-human, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of PRT13722 as monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer."¹

Prelude describes KAT6 as an emerging and clinically validated target in the treatment of ER+ breast cancer.¹ The company said it discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A degraders,¹ and that its strategy of targeting KAT6A while leaving KAT6B intact could offer improved efficacy, tolerability and combinability with other agents relative to dual KAT6A/B inhibitors, according to the company.¹