Aprea Therapeutics Presents Preliminary Findings On Oral WEE1 Inhibitor APR-1051 At EORTC-NCI-AACR International Conference On Molecular Targets And Therapeutics; Date Demonstrates APR-1051 Is Safe And Well-Tolerated With No Hematologic Toxicity

Author: Benzinga Newsdesk | October 23, 2024 08:35am

Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need; active enrollment is ongoing at three sites in the U.S.

Preliminary results to date demonstrate APR-1051 is safe and well-tolerated with no hematologic toxicity

DOYLESTOWN, Pa., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that preliminary safety results on its WEE1 inhibitor APR-1051 are highlighted in a poster being presented today at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place in Barcelona, Spain.

The results are from ACESOT-1051, a first-in-human Phase 1 study assessing the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations.

The dose escalation part of the study (Part 1) is currently ongoing and is expected to include up to 39 patients with advanced solid tumors. Oral APR-1051 is being administered once daily for 28-day cycles. A total of 8 cohorts are planned, evaluating doses of 10 mg to 150 mg once daily. So far, patients have been enrolled in single patient Cohorts 1, 2 and 3, evaluating subtherapeutic doses of 10 mg, 20 mg and 30 mg, respectively.

Preliminary results

Data are available on two of three patients, with a cutoff date of October 7, 2024

• Preliminary results demonstrate that APR-1051 is safe and well-tolerated with no hematologic toxicity
• Hemoglobin, hematocrit, and platelet counts were stable or increased slightly during the first treatment cycle
• There were no signs of neutropenia, with white blood cells and neutrophils trending up for both patients during the first treatment cycle
• All adverse events (AEs) recorded were Grade 1 and 2, with one Grade 1 AE (abdominal distention) possibly related to APR-1051
• No QT prolongation has been observed
• Three patients have been dosed to date with data available on two of these. One had disease progression at 49 days, a second withdrew following 36 days of treatment and dosing is ongoing in the third patient.

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