Aprea Therapeutics Commences Patient Dosing in Phase 1 Trial

Aprea Therapeutics, Inc., a biopharmaceutical firm that specializes in precision oncology through synthetic lethality, declared that the first patient has been dosed in the ACESOT-1051 phase 1 study. The study evaluates which is evaluating the daily oral WEE1 inhibitor APR-1051 as monotherapy in advanced solid tumor patients with unmet medical requirements.

Aprea's chemists and scientists discovered and preclinically studied APR-1051. APR-1051 is a powerful and highly selective small molecule designed to prevent off-target toxicity. It may provide good safety and tolerability and has demonstrated potential for favorable drug exposure in preclinical studies.

The targeted biomarker-driven trial ACESOT-1051 focuses on solid tumors that are progressed or metastatic and have the following cancer-associated gene alterations:

Regardless of the kind of tumor, amplification or overexpression of CCNE1 or CCNE2, harmful mutations in FBXW7 or PPP2R1A, colorectal cancer with a co-mutation of TP53 and KRAS-GLY12, or uterine serous carcinoma regardless of the presence of biomarkers.

“Dosing of the first patient in the ACESOT-1051 study is an important milestone in our APR-1051 development program and represents a key advancement of our clinical pipeline,” said Oren Gilad, Ph.D., president and chief executive officer of Aprea. “Adding a second clinical programme enriches our asset portfolio. We are initially evaluating single agent activity of APR-1051 to provide the basis for future rational combination treatments. We hope to confirm APR-1051’s safety profile in this phase 1 study and generate the necessary data that will help us understand how it can be best utilized to treat patients. We plan to provide a clinical update by year-end 2024 and generate preliminary efficacy data during 2025.”