WILMINGTON, DE — Prelude Therapeutics Inc. (Nasdaq: PRLD) received U.S. Food and Drug Administration clearance to begin a Phase 1 trial of PRT13722, moving its experimental KAT6A-targeting breast cancer drug into human testing with enrollment expected to start in the fourth quarter of 2026.
The first-in-human, open-label, multicenter study will evaluate PRT13722 in adults with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.
The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity. PRT13722 will be studied as a monotherapy and in combination with endocrine and targeted therapies.
PRT13722 is an orally administered selective degrader of KAT6A, a target being investigated in estrogen receptor-positive breast cancer.
Prelude is pursuing selective degradation of KAT6A while sparing KAT6B, an approach the company believes could improve efficacy, tolerability and the ability to combine the drug with other treatments compared with dual KAT6A/B inhibitors.
Charles Morris, Prelude’s chief medical officer, said dual KAT6A/B inhibitors have demonstrated toxicities that overlap with existing backbone therapies and could limit their use in earlier treatment settings.
“Our approach of selectively degrading KAT6A has the potential to address this challenge by maximizing the therapeutic window with enhanced efficacy and improved hematological safety, as supported by our preclinical data,” Morris said.
Prelude is a precision oncology company developing therapies for cancer.
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