On September 9, 2024 Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, reported the publication of an abstract regarding PRT3789 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place in Barcelona, Spain September 13-17, 2024 (Press release, Prelude Therapeutics, SEP 9, 2024, View Source [SID1234646438]). The abstract can be found on the ESMO (Free ESMO Whitepaper) 2024 website Registration | ESMO (Free ESMO Whitepaper) Congress 2024

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"We are excited for the opportunity to share the first ever clinical data of a novel, highly-selective SMARCA2 degrader," stated Jane Huang, M.D., President and Chief Medical Officer of Prelude. "Patients whose cancer has a SMARCA4 mutation have limited treatment options and generally very aggressive disease. Although PRT3789 as a first-in-class molecule targeting a novel mechanism is early in its development, we are highly encouraged by the safety profile, target engagement and clinical activity we have seen to date."

PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader, in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation by year end 2024 and identify a recommended Phase 2 dose. In addition, enrollment of patients into back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations is ongoing. Objectives for this first Phase 1 clinical study are to establish the safety and tolerability profile of PRT3789 as both monotherapy and in combination with docetaxel, evaluate activity, pharmacokinetics and pharmacodynamics and determine a dose and potential indications for advancement into a registrational clinical trial.

Oral presentation title: First Clinical Results from a Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation.

Observations in the abstract include:

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As of the March 7, 2024 data cutoff date, 40 pts had been enrolled (NSCLC [18], pancreatic [5], breast [3], esophageal [2], other [12]; 55% have loss-of-function mutations;

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Dose escalation had proceeded through 6 levels, from 24-212 mg, with 2 backfill cohorts opened;
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No DLTs or study drug-related SAEs have been reported;
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The most common AEs reported, of any grade or relatedness, are nausea (25%), constipation and dyspnea (each 17.5%), decreased appetite and fatigue (each 15%), and anemia (12.5%);
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Dose-related increases in AUC were observed;
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Dose-dependent decreases in SMARCA2 levels were seen at all doses with a trend for increasing depth and duration with increasing doses;
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Minimal effects on SMARCA4 levels were seen;
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Clinical activity of PRT3789 therapy noted to date includes RECIST partial responses, tumor shrinkage and prolonged stable disease (longer than response to most recent therapy) in patients with advanced, heavily pretreated esophageal cancer and NSCLC.

Updated data will be presented at ESMO (Free ESMO Whitepaper).

Investor Conference Call and Webcast Information

Prelude Therapeutics will host a conference call, live webcast with slides and a Q&A on Friday, September 13, 2024 at 12:00 PM EST. A live webcast of the presentation will be available at Events & Presentations – Prelude Therapeutics (preludetx.com). A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 60 days following the call. The Company will be posting its updated corporate presentation shortly after 10:00 AM EST on its website at Events & Presentations – Prelude Therapeutics (preludetx.com).