FDA Clears IND for Prelude Therapeutics' First-in-Class Oral KAT6A Degrader PRT13722 in HR+/HER2- Breast Cancer
核心洞察
Prelude Therapeutics received FDA clearance of its IND application for PRT13722 (搜索), a first-in-class oral KAT6A (搜索) selective degrader for HR+/HER2- breast cancer (搜索).
The company expects to begin enrolling patients in a first-in-human Phase 1 trial in the fourth quarter of 2026.
Selective KAT6A (搜索) degradation aims to improve efficacy and hematological safety versus dual KAT6A/B inhibitors, which show overlapping toxicities with backbone therapies.
Prelude Therapeutics Incorporated (Nasdaq: PRLD) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for PRT13722 (搜索), a first-in-class oral KAT6A (搜索) selective degrader being developed for patients with HR-positive, HER2-negative breast cancer. The Wilmington, Delaware-based precision oncology company said it expects to begin enrolling patients in a Phase 1 study in the fourth quarter of 2026.
Targeting a Clinically Validated Mechanism
KAT6 is described by the company as an emerging and clinically validated target in the treatment of ER-positive breast cancer. According to Prelude, recent clinical data have validated KAT6 as a targetable mechanism in HR+/HER2- breast cancer (搜索), including in patients with actionable mutations.
"Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer (搜索), including those with actionable mutations," said Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. "Dual KAT6A (搜索)/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies may limit the utility in earlier lines of treatment. 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."
Prelude discovered and is developing highly potent, highly selective and orally bioavailable KAT6A (搜索) degraders. The company believes that selectively degrading KAT6A while sparing KAT6B (搜索) has the potential for improved efficacy, tolerability and combinability with other agents relative to dual inhibitors of KAT6A/B.
Phase 1 Design and Endpoints
The planned Phase 1 study is a first-in-human, open-label, multicenter trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of PRT13722 (搜索). The agent will be tested both as monotherapy and in combination with endocrine and targeted therapies in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
Morris added that advancing PRT13722 (搜索) into the clinic represents a significant step toward providing a new therapeutic option for patients with HR+/HER2- breast cancer (搜索), with selective KAT6A (搜索) degradation offering the potential to expand treatment options through improved efficacy and tolerability compared with dual inhibitors.
Broader Pipeline
Prelude's pipeline features highly selective KAT6A (搜索) degraders and JAK2V617F (搜索) mutant selective inhibitors, which the company describes as new approaches to clinically validated targets. The company is also leveraging its expertise in targeted protein degradation to create and develop next generation degrader antibody conjugates (DACs) with novel payloads.
The FDA clearance marks the company's advancement of its first-in-class oral KAT6A (搜索) degrader into clinical development. Prelude noted that its forward-looking statements regarding development timelines and the potential safety, efficacy and benefits of its product candidates are subject to risks and uncertainties, including those related to clinical trial enrollment, manufacturing and regulatory timing.