Aprea Therapeutics Reports Initial Efficacy of APR-1051 in Uterine Cancer Patient
Aprea Therapeutics announced the first unconfirmed partial response observed in a patient enrolled in its ongoing Phase 1 ACESOT-1051 dose-escalation study. This early clinical activity was observed in a patient with PPP2R1A-mutated uterine serous carcinoma, a form of endometrial cancer, treated at the 150 mg dose level of APR-1051, with dose escalation continuing into higher dose cohorts to establish the recommended Phase 2 dose. At the protocol-defined 8-week imaging assessment, the patient achieved a 50% reduction in target lesion size per RECIST v1.1 criteria, along with a marked reduction in cancer antigen 125 levels, from 732 to 70 U/mL, a well-recognized tumor marker in endometrial cancer. In earlier cohorts of ACESOT-1051 study, multiple patients achieved stable disease with reductions in tumor burden, including a 5% reduction at the 70 mg dose in a patient with HPV-positive head and neck squamous cell carcinoma and a 15% reduction in a patient with FBXW7-mutated colon cancer treated at the 100 mg dose. This patient has remained on therapy for over 210 days and is approaching their eighth treatment cycle. In addition, a second patient treated at the 150 mg dose level achieved stable disease at the first follow-up imaging assessment. Collectively, these findings suggest that APR-1051 may have therapeutic potential across a range of solid tumors. Enrollment in the 220 mg dose level cohort of the study is currently underway, and the company intends to increase enrollment of HPV-positive patients in the ongoing trial.
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- Securities Purchase Agreement: Aprea Therapeutics has signed a securities purchase agreement with new and existing healthcare-focused institutional investors to sell an aggregate of 6.29 million shares of common stock, expected to close on January 30, 2026, indicating proactive financing efforts.
- Offering Details: Each share and accompanying warrant is priced at $0.89, with warrants exercisable immediately at $0.765 and expiring two years after the registration statement becomes effective, aimed at providing liquidity support for the company.
- Use of Proceeds: The net proceeds from the offering will be utilized for general corporate purposes and research and development expenses, reflecting the company's strategic direction towards continuous innovation and business development.
- Market Reaction: Despite a 7.83% drop in stock price following the announcement of the offering, this move may lay the groundwork for future growth, reflecting market caution regarding the company's financing strategy.

Clinical Trial Results: In the ongoing Phase 1 ACESOT-1051 trial, 3 out of 4 patients treated with a 100 mg dose of APR-1051 achieved stable disease in heavily pretreated gastrointestinal and gynecologic malignancies, with disease stabilization linked to specific genetic mutations.
Dose Escalation: Following the positive results at the 100 mg level, the trial has progressed to a 150 mg cohort, with no dose-limiting toxicities or unexpected safety issues reported so far.
Presentation at Conference: Preliminary findings from the trial will be presented in a poster at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting the early safety and efficacy of APR-1051.
Company Mission: Aprea Therapeutics aims to develop innovative cancer therapies that target cancer cells while minimizing harm to healthy cells, focusing on exploiting vulnerabilities in cancer cell mutations.

Preclinical and Clinical Findings: Aprea Therapeutics has reported promising preclinical data for APR-1051, a WEE1 inhibitor, showing strong anti-tumor effects in HPV+ head and neck squamous cell carcinoma (HNSCC) models, particularly when combined with anti–PD-1 therapies. Initial clinical results from a Phase 1 trial indicate early disease control in an HPV+ patient.
Future Development Plans: The company is progressing with the ACESOT-1051 trial, which includes dose escalation and further evaluation of APR-1051 in combination with checkpoint inhibitors to enhance treatment outcomes for patients with HPV-associated cancers.
Quarterly Performance: Sutro Biopharma reported a quarterly loss of $0.89 per share, slightly worse than the expected loss of $0.86, with revenues of $14 million exceeding estimates by 34.11%. The company has seen mixed earnings estimate revisions and currently holds a Zacks Rank #3 (Hold).
Market Outlook: Despite underperforming the market with a 27.2% decline this year, the stock's future performance will depend on management's commentary and changes in earnings expectations, as well as the overall industry outlook, which is currently favorable within the top 26% of Zacks industries.
Quarterly Performance: Merus N.V. reported a quarterly loss of $0.41 per share, outperforming the Zacks Consensus Estimate of a loss of $0.95, while revenues of $9.14 million fell short of expectations by 22.35%.
Future Outlook: The company's earnings outlook is currently unfavorable, reflected in a Zacks Rank #4 (Sell), indicating expected underperformance in the near future, with consensus estimates predicting further losses for upcoming quarters.

Aprea Therapeutics Update: Aprea Therapeutics has announced a robust patent portfolio for its cancer treatment programs, including ATR and WEE1 inhibitors, which are currently in clinical trials targeting advanced solid tumors.
Commitment to Innovation: The company emphasizes its dedication to developing innovative therapies that specifically target cancer cell vulnerabilities while minimizing harm to healthy cells, aiming to secure global intellectual property rights to protect its advancements in oncology.







