Prelude Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for PRT13722, Its First-in-Class Oral KAT6A Selective Degrader

Prelude Therapeutics (PRLD) received FDA clearance of its Investigational New Drug (IND) application for PRT13722, a first-in-class oral KAT6A selective degrader for HR-positive, HER2-negative breast cancer.

Rhea-AI Summary

Prelude Therapeutics (PRLD) received FDA clearance of its Investigational New Drug (IND) application for PRT13722, a first-in-class oral KAT6A selective degrader for HR-positive, HER2-negative breast cancer. The clearance allows Prelude to initiate a first-in-human Phase 1 clinical trial, with patient enrollment expected to begin in the fourth quarter of 2026.

The Phase 1, open-label, multicenter study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of PRT13722 in adults with locally advanced or metastatic HR+/HER2- breast cancer. The trial will assess PRT13722 as both monotherapy and in combination with endocrine and targeted therapies. Prelude discovered and is developing highly selective, orally bioavailable KAT6A degraders and believes sparing KAT6B may offer improved efficacy, tolerability and combinability compared with dual KAT6A/B inhibitors.

Positive

• FDA IND clearance for PRT13722 enables initiation of Phase 1 trial
• Phase 1 study start patient enrollment expected in Q4 2026
• First-in-class oral KAT6A selective degrader advancing into human testing

Negative

• None.

Market Context

On Feb 3, 2026, Prelude's FDA IND clearance for PRT12396 was followed by a 12.81% 24-hour gain; that...

Analysis

On Feb 3, 2026, Prelude's FDA IND clearance for PRT12396 was followed by a 12.81% 24-hour gain; that same regulatory milestone preceded today's clearance for PRT13722 and its Phase 1 plan.

Key Figures

Study phase: Phase 1 Enrollment timing: Q4 2026

Study phase

Phase 1

First-in-human study of PRT13722

Enrollment timing

Q4 2026

PRT13722 study in HR+/HER2- breast cancer

Previous Clinical trial,fda approval Reports

1 past event · Latest: Feb 03

Same Type 1 event

1. Feb 03

   FDA IND clearance

   24h Move

   +12.8%

   FDA cleared IND enabling Phase 1 study of PRT12396 in PV and MF

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug application, kat6a, pharmacokinetics, pharmacodynamics, +1 more

5 terms

investigational new drug application regulatory

"proceed with a Phase 1 study under its Investigational New Drug Application (IND)"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

kat6a medical

"an oral KAT6A selective degrader being developed for the treatment"

A gene that makes a protein acting like a volume knob for other genes, helping control whether they are turned on or off by changing how tightly DNA is packaged in cells. Mutations or abnormal activity can drive developmental disorders and certain cancers, so changes involving KAT6A can affect the prospects of drugs, diagnostics, and research programs; investors watch it because it can create opportunities or risks for companies developing targeted therapies.

pharmacokinetics medical

"evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

pharmacodynamics medical

"tolerability, pharmacokinetics, pharmacodynamics and antitumor activity"

Pharmacodynamics is how a drug actually affects the body — the strength, type and duration of its effects and the relationship between dose and response. Think of it like how turning a thermostat changes room temperature: it shows what the drug does and how much is needed to get the desired effect. Investors care because these properties drive clinical success, dosing convenience, safety profile and competitive advantage, all of which influence commercial potential and regulatory approval.

open-label medical

"a first-in-human, open-label, multicenter study"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Phase 1 study of PRT13722 in patients with HR+ breast cancer anticipated to begin enrolling patients in the fourth quarter of 2026.

WILMINGTON, Del., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT13722, an oral KAT6A selective degrader being developed for the treatment of patients with HR+/HER2- breast cancer. The Company expects to begin enrolling patients in the fourth quarter of 2026.

"Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/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. We look forward to advancing PRT13722 into the clinic with the ultimate goal of providing a new therapeutic option for patients with HR+/HER2- breast cancer.”

The Phase 1 study is 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.

Highly selective KAT6A oral degrader program
KAT6 is an emerging and clinically validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A degraders. Prelude believes that selectively degrading KAT6A and sparing KAT6B has the potential for improved efficacy, tolerability and combinability with other agents relative to dual inhibitors of KAT6A/B.  

About Prelude Therapeutics
Prelude Therapeutics is a leading precision oncology company developing innovative medicines in areas of high unmet need for cancer patients. Our pipeline features highly selective KAT6A degraders and JAK2V617F mutant selective inhibitors -- new approaches to clinically validated targets with transformative potential for patients. We are leveraging our expertise in targeted protein degradation to create and develop next generation degrader antibody conjugates (DACs) with novel payloads. We are on a mission to extend the promise of precision medicine to every cancer patient in need. For more information, visit preludetx.com.

Cautionary Note Regarding Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits and addressable market for Prelude’s product candidates, the expected timeline for clinical trial results for Prelude’s product candidates, and the sufficiency of Prelude’s cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Prelude’s Annual Report on Form 10-K for the year ended December 31, 2025, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.  

Investor Contact:
Robert A. Doody, Jr.
Senior Vice President, Investor Relations
Prelude Therapeutics Incorporated
484.639.7235
rdoody@preludetx.com

FAQ

What patient population will the Phase 1 study of PRT13722 enroll?

The Phase 1 study will enroll adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. This includes patients whose disease fits the HR+/HER2- classification targeted by PRT13722.

How is the Phase 1 clinical trial of PRT13722 designed?

The trial is a first-in-human, open-label, multicenter Phase 1 study. It will evaluate PRT13722 as monotherapy and in combination with endocrine and targeted therapies, assessing safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity.

Why is Prelude focusing on selective KAT6A degradation for PRT13722?

KAT6 is described as an emerging and clinically validated target in ER+ breast cancer. Prelude is developing highly potent, selective and orally bioavailable KAT6A degraders and believes that selectively degrading KAT6A while sparing KAT6B may offer improved efficacy, tolerability and combinability with other agents compared with dual KAT6A/B inhibitors.