Aprea Therapeutics Announces First Patient Dosed in ACESOT-1051 Phase 1 Trial Evaluating Oral WEE1 Inhibitor APR-1051

Core Viewpoint - Aprea Therapeutics has initiated the ACESOT-1051 Phase 1 clinical trial for APR-1051, a selective oral WEE1 inhibitor, targeting advanced solid tumors with significant unmet medical needs [1][3]. Company Overview - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Doylestown, Pennsylvania, focusing on precision oncology through synthetic lethality [7]. Product Details - APR-1051 is a potent and selective small molecule designed to minimize off-target toxicity, potentially offering good safety and tolerability [2]. - The drug targets WEE1 kinase, an enzyme involved in the DNA damage response pathway, and aims to address limitations seen in other WEE1 inhibitors [2]. Clinical Trial Information - The ACESOT-1051 study is a biomarker-driven trial focusing on advanced/metastatic solid tumors with specific gene alterations, including CCNE1/CCNE2 amplification and mutations in FBXW7 or PPP2R1A [3]. - The trial consists of two parts: Part 1 involves dose escalation with up to 39 patients, while Part 2 focuses on dose optimization with an additional 40 patients [5][6]. - The primary objectives include measuring safety, dose-limiting toxicities, and determining the maximum tolerated dose, while secondary objectives assess pharmacokinetics and preliminary efficacy [6]. Milestones and Future Plans - The dosing of the first patient marks a significant milestone in the APR-1051 development program, with plans to provide a clinical update by the end of 2024 and preliminary efficacy data in 2025 [3][4].