Aprea Therapeutics presents preclinical data on APR-1051 for HNSCC treatment.

Aprea Therapeutics has announced new preclinical data and a clinical update on APR-1051, an oral WEE1 inhibitor for head and neck squamous cell carcinoma (HNSCC). Initial Phase 1 data show early disease control in the first HPV+ patient treated with APR-1051, and preclinical data demonstrate potent single-agent and combination effects in HNSCC models, including synergy with anti–PD-1 therapy.

Aprea Therapeutics, Inc. (Nasdaq: APRE) has announced new preclinical data and a clinical update on APR-1051, its next-generation oral WEE1 inhibitor, in treating human papillomavirus-positive (HPV+) head and neck squamous cell carcinoma (HNSCC). The drug demonstrated potent antiproliferative effects with IC₅₀ values between 8.9 to 230 nM in preclinical studies [1]. In collaboration with MD Anderson Cancer Center, research showed significant anti-tumor synergy when combining APR-1051 with anti-PD-1 therapies.

In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV+ cancer showed stable disease with a 5% tumor reduction at the first radiographic assessment, with no dose-limiting toxicities reported. This early clinical signal indicates APR-1051's potential as a single agent and in combination with checkpoint inhibitors.

The preclinical data and the early clinical results are promising for APR-1051, positioning it as a candidate for combination-based clinical trials. The drug's ability to exploit specific vulnerabilities in HPV+ tumors and its potential to enhance immunotherapy responses make it a significant development in the targeted therapy landscape for HPV-positive head and neck squamous cell carcinoma (HNSCC).

References:
[1] https://www.globenewswire.com/news-release/2025/06/25/3105158/0/en/Aprea-Reports-Anti-Proliferative-Results-and-Promising-Early-Stage-Clinical-Data-for-Next-Generation-WEE1-Inhibitor-APR-1051-in-HPV-Head-and-Neck-Squamous-Cell-Carcinoma-HNSCC-in-C.html