Aprea Therapeutics Begins Phase 1 Trial for New Cancer Drug

Aprea Therapeutics

DOYLESTOWN, PAAprea Therapeutics, Inc. (Nasdaq: APRE) announced that the first patient has been dosed in its Phase 1 ACESOT-1051 study. The trial is evaluating APR-1051, a daily oral WEE1 inhibitor, as a monotherapy for patients with advanced solid tumors who have significant unmet medical needs.

APR-1051 is a highly selective small molecule designed to minimize off-target toxicity. It targets WEE1 kinase, an enzyme involved in the DNA damage response pathway. By inhibiting WEE1, APR-1051 aims to disrupt cancer cell repair mechanisms, potentially leading to better treatment outcomes. Preclinical studies suggest APR-1051 may overcome the limitations of existing WEE1 inhibitors, offering improved safety and tolerability.

The ACESOT-1051 trial focuses on advanced or metastatic solid tumors with specific genetic alterations. These include amplification or overexpression of CCNE1 or CCNE2, deleterious mutations in FBXW7 or PPP2R1A, colorectal cancer with KRAS-GLY12 and TP53 co-mutations, and uterine serous carcinoma.

“Dosing of the first patient in the ACESOT-1051 study is an important milestone,” said Oren Gilad, Ph.D., President and CEO of Aprea. “We are initially evaluating single-agent activity of APR-1051 to provide the basis for future combination treatments. We hope to confirm APR-1051’s safety profile in this Phase 1 study and generate data that will help us understand how it can be best utilized to treat patients.”

Unleashing WEE1 Inhibitors in Cancer Treatment

The initiation of this trial represents a significant step for Aprea’s clinical pipeline. WEE1 inhibitors are gaining attention in oncology due to their potential to disrupt cancer cells’ ability to repair DNA, thus enhancing the effectiveness of other treatments.

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Anthony Tolcher, M.D., Founder of NEXT Oncology, where the first patient was dosed, emphasized the urgency of finding new treatments for cancers that overexpress Cyclin E. “Patients with Cyclin E overexpression have poor prognosis and no effective therapies. WEE1 kinase is a validated oncology target, and we look forward to the results of this study,” Tolcher said.

APR-1051 Paving the Way for Personalized Medicine

The success of APR-1051 could have far-reaching implications. Effective WEE1 inhibitors can make existing cancer treatments more effective by targeting the DNA repair pathways that cancer cells rely on to survive. This has the potential to improve outcomes for patients with various types of advanced solid tumors.

Moreover, the trial’s focus on biomarker-driven patient selection aligns with the growing trend of personalized medicine. By targeting specific genetic alterations, treatments can become more effective and less toxic, leading to better patient outcomes.

Aprea plans to provide a clinical update by the end of 2024 and aims to generate preliminary efficacy data during 2025. The inclusion of prestigious centers like The University of Texas MD Anderson Cancer Center in the trial further underscores its potential impact.

In conclusion, Aprea Therapeutics’ Phase 1 trial of APR-1051 marks a promising development in cancer treatment. With its targeted approach and potential to overcome existing therapeutic limitations, APR-1051 could become a vital tool in the fight against cancer, offering new hope to patients with difficult-to-treat tumors.

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