Aprea Therapeutics (NASDAQ: APRE) has announced the dosing of the first patient with HPV-positive head and neck squamous cell carcinoma (HNSCC) in Cohort 5 of its ongoing ACESOT-1051 clinical trial. The study is evaluating APR-1051, the company's proprietary WEE1 kinase inhibitor, with open label data expected in the second half of 2025.
"Enrollment of the first patient with HPV+ head and neck cancer in the Phase 1 ACESOT-1051 trial is an important step and is in line with our goal of identifying patient populations most likely to benefit from WEE1 inhibition," said Philippe Pultar, MD, Senior Medical Advisor and Lead WEE1 Clinical Development at Aprea. "We are pleased with the progress of the trial and encouraged by the safety profile of APR-1051 to date."
Dr. Pultar added that the company is working toward identifying the optimal dose for future studies and continues to believe that APR-1051 has best-in-class potential in the competitive WEE1 inhibitor landscape.
Strategic Research Collaboration with MD Anderson
This clinical advancement follows Aprea's recent Material Transfer Agreement with MD Anderson Cancer Center, announced earlier. Under this agreement, Aprea will supply APR-1051 to support preclinical research exploring its potential in treating both HPV-positive and HPV-negative head and neck squamous cell carcinoma that express genomic markers of replication stress.
The collaboration enables MD Anderson researchers to conduct a series of preclinical experiments designed to generate preliminary efficacy and mechanistic data that could support future clinical trials and treatment regimens. The research will include studies combining APR-1051 with immune checkpoint inhibitors.
Expert Leadership in HNSCC Research
The MD Anderson research project is being overseen by Professors Jeffrey N. Myers, MD, PhD, FACS, and Abdullah A. Osman, PhD, from the Department of Head and Neck Surgery. Professor Myers is recognized as a leading expert on head and neck cancers.
Under the terms of the agreement, Aprea will retain all rights, title, and interest in APR-1051 while gaining valuable insights into its potential applications.
Head and Neck Cancer Treatment Landscape
Head and neck cancers represent a significant unmet medical need, with HPV-positive cases showing distinct biological characteristics compared to HPV-negative tumors. The exploration of WEE1 inhibition in this context could potentially address treatment gaps in the current therapeutic landscape.
WEE1 kinase inhibitors work by preventing cancer cells from repairing DNA damage, potentially making them more vulnerable to other treatments or triggering cell death. This mechanism is particularly relevant in cancers with high replication stress, a characteristic often seen in HPV-associated malignancies.
The company's dual approach—advancing clinical trials while simultaneously supporting preclinical research—demonstrates a comprehensive strategy to develop APR-1051 for specific patient populations who may derive the greatest benefit from this targeted therapy.
