DOYLESTOWN, PA — Aprea Therapeutics, Inc. (Nasdaq: APRE) has revealed new preclinical findings and a clinical update on APR-1051, an innovative oral WEE1 inhibitor being studied for the treatment of human papillomavirus-positive (HPV+) head and neck squamous cell carcinoma (HNSCC). These developments underline the compound’s potential as both a standalone therapy and in combination with immunotherapies.
The latest data emerges from an ongoing research collaboration with MD Anderson Cancer Center, a leading institution in oncology. The preclinical studies demonstrated strong anti-cancer activity of APR-1051 against HPV+ tumor models. It also highlighted significant potential for synergy when combined with anti–PD-1 checkpoint inhibitors, supporting its development for combination-based treatment strategies.
“We are excited by the preclinical data generated by independent researchers, and the early clinical signal of APR-1051 in an HPV-positive cancer patient,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea Therapeutics. “We believe that APR-1051 could offer significant differentiation in the competitive oncology landscape, as a single agent, as well as in combination with checkpoint inhibitors.”
Preclinical Study Highlights
Key findings from the collaborative research include:
- Strong Single-Agent Potency: APR-1051 demonstrated significant antiproliferative activity across a broad panel of human and murine HPV+ cancer cell lines.
- Combination Synergy: The compound, when combined with anti–PD-1 therapies, showed enhanced anti-tumor effects, positioning it for combination treatment strategies in future clinical trials.
- Mechanistic Insight: APR-1051 leverages the vulnerabilities of HPV+ tumors, specifically their dependency on WEE1 for survival, while activating immune pathways such as the cGAS/STING-mediated cell death mechanism.
Clinical Progress Update
The Phase 1 ACESOT-1051 trial enrolled a 62-year-old male patient with advanced HPV+ oropharyngeal cancer who had previously undergone three lines of platinum-based therapies. Daily administration of a 70 mg oral dose of APR-1051 resulted in stable disease and a 5% reduction in tumor size during the first radiographic assessment. Notably, the patient tolerated the treatment without any dose-limiting toxicities reported.
The ongoing trial is advancing with dose escalations and further inclusion of HPV+ patients. Additional data will guide exploration of combination therapies with checkpoint inhibitors in future trial arms to address broader clinical needs.
Drs. Abdullah Osman and Jeffrey Myers of MD Anderson Cancer Center expressed enthusiasm for the findings, noting, “We are very encouraged by these early findings and see APR-1051 as a potentially promising addition to the therapeutic portfolio for treating HPV-associated head and neck cancers. The mechanistic rationale and robust preclinical data strongly support the potential for enhanced patient outcomes when APR-1051 is administrated as a single agent or in combination with existing immunotherapies.”
Addressing a Significant Need
HPV-positive head and neck cancer remains a complex area with limited treatment options. By advancing APR-1051’s development, Aprea Therapeutics aims to meet a critical unmet need, offering hope for improved outcomes in this challenging patient population.
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