DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) announced encouraging early clinical data from its ongoing Phase 1 ACESOT-1051 trial evaluating APR-1051, a first-in-class WEE1 kinase inhibitor, in patients with advanced solid tumors. The preliminary findings show early signals of anti-tumor activity and a favorable safety profile among heavily pretreated patients.
At the 100 mg dose level, three out of four patients achieved stable disease based on RECIST v1.1 criteria. The study, known as ACESOT-1051, includes patients with gastrointestinal and gynecologic cancers harboring mutations associated with WEE1 pathway sensitivity, including FBXW7, CCNE1, KRAS G12V, and TP53. No dose-limiting toxicities have been reported to date, and enrollment has advanced to the 150 mg cohort.
“We continue to be encouraged by these early clinical findings, which demonstrate signals of anti-tumor activity with APR-1051 in a heavily pretreated patient population,” said Dr. Philippe Pultar, Senior Medical Advisor at Aprea Therapeutics. “We believe these promising data provide an important foundation as we continue with dose escalation in the ongoing study.”
The trial’s primary objective is to determine safety, dose-limiting toxicity, and the recommended Phase 2 dose. Secondary goals include characterizing pharmacokinetics and assessing preliminary efficacy.
Individual patient data highlighted stable disease in multiple tumor types: rectal, endometrial, and colon cancers. One rectal cancer patient with an FBXW7 mutation saw a 13% reduction in tumor size after five prior lines of therapy and remains on treatment after more than 140 days.
APR-1051 is part of Aprea’s precision oncology pipeline, which targets vulnerabilities in cancer cell biology while minimizing harm to healthy tissue. The company is also advancing ATRN-119, a macrocyclic small-molecule ATR inhibitor, for solid tumor indications.
Aprea’s Phase 1 results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics and are available on the company’s investor relations website.
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