This section highlights FDA-related milestones and regulatory updates for drugs developed by Aprea Therapeutics (APRE).
Over the past two years, Aprea Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
APR-1051, ATRN-119, ACESOT-1051, and ABOYA-119. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
APR-1051 FDA Regulatory Timeline and Events
APR-1051 is a drug developed by Aprea Therapeutics for the following indication: Next Generation WEE1 Kinase Inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- APR-1051
- Announced Date:
- October 24, 2025
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, Inc. today provided an update on the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) study. The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.1 criteria.
AI Summary
Aprea Therapeutics today shared new Phase 1 ACESOT-1051 results for APR-1051, a WEE1 kinase inhibitor, in patients with advanced solid tumors. At the 100 mg dose level, 3 of 4 heavily pretreated patients with gastrointestinal or gynecologic cancers achieved stable disease by RECIST v1.1 criteria. These tumors carried mutations linked to WEE1 inhibition, including FBXW7, CCNE1, KRAS G12V, and TP53.
Treatment at 100 mg was well tolerated, with no dose-limiting toxicities or unexpected safety issues. After successfully clearing this cohort, dose escalation has moved into the 150 mg group. Preliminary data through September 17, 2025 will be featured today in a poster at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
Investigators say these early signs of disease control support the scientific rationale for targeting WEE1 and lay a strong foundation for advancing to higher doses. Aprea plans to share further updates as the study progresses.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- October 14, 2025
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, Inc. y announced that two abstracts on its clinical programs, APR-1051 amd ATRN-119, have been accepted for poster presentation at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 - 26, 2025 at the Hynes Convention Center in Boston, Massachusetts.
AI Summary
Aprea Therapeutics announced that two abstracts on its clinical programs—APR-1051 and ATRN-119—have been accepted for poster presentation at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics. The meeting runs October 22–26, 2025, at Boston’s Hynes Convention Center.
The first poster, “Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations,” presents updated phase 1 ACESOT-1051 trial data. Dr. Anthony Tolcher is lead author and Dr. Philippe Pultar will present. The second poster, “Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage,” features Dr. Amit Mahipal’s data, presented by Dr. Oren Gilad. Both posters are in Poster Session B on Friday, October 24, from 12:30 to 16:00 ET in Exhibit Hall D.
Copies of both posters will be available the day of presentation on Aprea’s “Investor Resources” webpage. Aprea’s mission is to develop targeted cancer therapies that attack tumors while sparing healthy cells.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- June 25, 2025
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, announced new preclinical data and a clinical update on APR-1051, the Company's next-generation oral WEE1 inhibitor, in human papillomavirus–positive (HPV+) head and neck squamous cell carcinoma (HNSCC).
AI Summary
Aprea Therapeutics has shared promising updates on APR-1051, its next-generation oral WEE1 inhibitor being studied for HPV-positive head and neck squamous cell carcinoma (HNSCC). New preclinical data, developed in collaboration with MD Anderson Cancer Center, showed that APR-1051 works well both on its own and with anti–PD-1 immunotherapy. In laboratory models, the drug demonstrated strong anticancer activity by reducing tumor cell growth significantly, along with enhancing the effects of immune checkpoint inhibitors.
An early clinical update from the ongoing Phase 1 ACESOT‑1051 trial revealed that a 62-year-old male patient with advanced HPV+ oropharyngeal cancer achieved stable disease and a modest tumor reduction after treatment. These encouraging results support further testing of APR-1051, both as a single agent and in combination with immunotherapies, to address the needs of patients with HPV-associated HNSCC.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- October 9, 2024
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, Inc. announced that it has engaged Philippe Pultar, MD as its senior medical advisor to support Aprea with developing and advancing APR-1051, Aprea's potential best in class WEE1 inhibitor.
AI Summary
Aprea Therapeutics, Inc. has named Philippe Pultar, MD as its senior medical advisor to help drive the development of APR-1051, its promising, best in class WEE1 inhibitor. Dr. Pultar brings extensive oncology expertise, having led clinical development programs for WEE1 inhibitors at companies like Zentalis Pharmaceuticals, where he successfully managed the global clinical progression of a similar agent. His role will focus on advancing APR-1051 through strategic clinical development, optimizing trial design, and leveraging his proven track record in moving drugs from early to late-stage clinical studies. Aprea’s initiative is part of its broader commitment to precision oncology by using targeted, DDR-focused therapeutics to improve outcomes for patients with advanced, difficult-to-treat cancers. The company believes Dr. Pultar’s expertise will play a key role in enhancing their therapeutic portfolio and accelerating APR-1051’s clinical progress.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- June 21, 2024
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, Inc. announced that it will host a virtual KOL event to discuss APR-1051, a highly selective and potentially best-in-class oral WEE1 inhibitor, on Monday, June 24, 2024 at 9:00 AM ET.
AI Summary
Aprea Therapeutics, Inc. announced it will host a virtual KOL event on Monday, June 24, 2024 at 9:00 AM ET to discuss its oral WEE1 inhibitor, APR-1051. This highly selective inhibitor is designed to potentially be best-in-class by limiting off-target toxicity while targeting the WEE1 enzyme in the DNA damage response pathway.
The event will feature insights from leading experts. Dr. Joseph Vacca, a medicinal chemistry expert with extensive industry experience, will discuss the medicinal chemistry history, precise drug design, and preclinical findings associated with APR-1051. In addition, Dr. Eric J. Brown from the University of Pennsylvania will review preclinical data across the WEE1 inhibitor class. A live question and answer session will follow the formal presentations, allowing healthcare professionals to engage directly with the experts. Interested participants can register through the company’s website.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- June 17, 2024
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics, announced that the first patient has been dosed in the ACESOT-1051 Phase 1 study evaluating daily oral WEE1 inhibitor APR-1051 as monotherapy in advanced solid tumor patients with unmet medical need.
AI Summary
Aprea Therapeutics has reached an important milestone by dosing the first patient in its ACESOT-1051 Phase 1 study. The trial is evaluating APR-1051, a daily oral WEE1 inhibitor, as a monotherapy for advanced solid tumor patients with few treatment options. APR-1051 was developed to target the WEE1 kinase, a key enzyme in the DNA damage response, and is designed to minimize off-target effects and toxicity.
The study uses a dose escalation method to determine the optimal dose while monitoring safety, pharmacokinetics, and early signs of efficacy. By initiating this trial at NEXT Oncology in San Antonio, Texas, Aprea is bolstering its precision oncology efforts and expanding its clinical pipeline. This milestone paves the way for future combination treatments aimed at addressing unmet medical needs in cancer care.
Read Announcement- Drug:
- APR-1051
- Announced Date:
- April 10, 2024
- Indication:
- Next Generation WEE1 Kinase Inhibitor
Announcement
Aprea Therapeutics released details about four poster presentations at the ongoing American Association of Cancer Research (AACR) Annual Meeting, taking place April 5 to 10, 2024 in San Diego, CA.
AI Summary
Aprea Therapeutics, Inc. revealed details about four poster presentations at the American Association of Cancer Research (AACR) Annual Meeting in San Diego, CA, held from April 5 to 10, 2024. One of the highlight posters focused on APR-1051, their next-generation WEE1 kinase inhibitor. Preclinical data indicated that APR-1051 is both potent and selective in targeting cyclin E-overexpressing cancers, suggesting it may be a well-tolerated and effective treatment option. The poster showed promising results with low off-target activity, which could lower adverse effects. Additionally, the presentation detailed the upcoming Phase 1 clinical trial (ACESOT-1051) designed to evaluate the safety and efficacy of APR-1051 in patients with advanced solid tumors harboring cancer-linked genetic alterations.
Other posters at the meeting provided updates on the safety and early clinical benefits of Aprea’s ATR inhibitors, further underscoring their commitment to advancing precision oncology through novel treatment strategies.
Read Announcement
ATRN-119 FDA Regulatory Events
ATRN-119 is a drug developed by Aprea Therapeutics for the following indication: in patients with advanced solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATRN-119
- Announced Date:
- October 15, 2025
- Indication:
- in patients with advanced solid tumors.
Announcement
Aprea Therapeutics announced that it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors.
AI Summary
Aprea Therapeutics announced it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor, in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study in patients with advanced solid tumors.
Building on completed dose escalation and new preclinical data suggesting synergistic anti-tumor effects, Aprea is shifting its ATRN-119 program toward combination approaches. Potential partners include radiation therapy, antibody-drug conjugates, and immune checkpoint inhibitors.
To focus on these high-value combinations, the company has paused further enrollment in both once-daily and twice-daily monotherapy arms. Patients already dosing with ATRN-119 will continue to receive treatment without interruption.
Phase 1 monotherapy results showed a favorable safety profile with manageable side effects at the 1,100 mg RP2D, durable disease stabilization in heavily pretreated patients, dose-proportional pharmacokinetics, and early signs of clinical activity in biomarker-selected populations.
Read Announcement
ACESOT-1051 FDA Regulatory Events
ACESOT-1051 is a drug developed by Aprea Therapeutics for the following indication: For Cyclin E Overexpressing Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ACESOT-1051
- Announced Date:
- March 31, 2025
- Indication:
- For Cyclin E Overexpressing Cancers
Announcement
Aprea Therapeutics, announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in the ongoing ACESOT-1051 clinical trial evaluating APR-1051.
AI Summary
Aprea Therapeutics recently announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in its ongoing ACESOT-1051 clinical trial evaluating APR-1051. This patient, representing the first in Cohort 5 of the study, received a 70 mg daily dose. The trial is part of Aprea’s efforts to explore the potential of APR-1051, a potent and selective WEE1 inhibitor, especially in patients with tumors exhibiting high replication stress and DNA damage. Since HPV+ cancers, like HNSCC, often have defects in the DNA damage response pathway, they may be particularly susceptible to this approach. The study aims to assess safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy, and open-label data are expected in the second half of 2025.
Read Announcement
ABOYA-119 FDA Regulatory Events
ABOYA-119 is a drug developed by Aprea Therapeutics for the following indication: With mutations in DDR-related genes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ABOYA-119
- Announced Date:
- December 11, 2024
- Indication:
- With mutations in DDR-related genes
Announcement
Aprea Therapeutics, announced today that the first patient has been dosed at Dose Level 7, evaluating ATRN-119 550 mg twice daily, in the ongoing ABOYA-119 Phase 1/2a clinical trial.
AI Summary
Aprea Therapeutics announced that the first patient in its ongoing ABOYA-119 Phase 1/2a clinical trial has been dosed at Dose Level 7 with ATRN-119 using a twice-daily regimen. In this trial, patients with advanced solid tumors and mutations in DNA damage response genes receive 550 mg of ATRN-119 twice daily, amounting to a total of 1,100 mg per day. This dosing strategy is designed to maintain optimal drug levels over a 24-hour period, which is expected to maximize the drug’s therapeutic potential and improve patient outcomes.
The study primarily focuses on evaluating the tolerability and pharmacokinetics of ATRN-119, a first-in-class macrocyclic ATR inhibitor. By adjusting the dosing schedule, Aprea aims to accelerate the clinical development process and enhance the overall efficacy of this innovative cancer therapy.
Read Announcement- Drug:
- ABOYA-119
- Announced Date:
- May 28, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- With mutations in DDR-related genes
Announcement
Aprea Therapeutics, announced that On track to complete dose escalation in ABOYA-119 clinical trial and potentially generate initial human efficacy data in 2H 2024
AI Summary
Aprea Therapeutics announced positive progress in its ABOYA-119 clinical trial for ATRN-119, the first and only macrocyclic ATR inhibitor in clinical testing. The study is progressing as planned, and the safety review committee has allowed an increase to an 800 mg once-daily dose. Researchers have observed that ATRN-119 is safe and well tolerated up to the current dose levels, with no significant toxicities noted in the early cohorts.
The company is on track to complete the dose escalation phase of the trial by the fourth quarter of 2024. They also expect to possibly share initial human efficacy data in the second half of 2024. This phase will help determine the recommended dose for further clinical testing, potentially paving the way for a new treatment option for patients with advanced solid tumors.
Read Announcement- Drug:
- ABOYA-119
- Announced Date:
- May 28, 2024
- Indication:
- With mutations in DDR-related genes
Announcement
Aprea Therapeutics, announced that the Safety Review Committee (SRC) overseeing the ongoing ABOYA-119 clinical trial has determined that dosing of patients with ATRN-119 at 800 mg once daily (Cohort 6) can commence and that Cohort 6 is open for enrollment. This decision follows review of the safety and pharmacokinetic data from patients treated at 550 mg once daily (Cohort 5).
AI Summary
Aprea Therapeutics announced that the trial’s Safety Review Committee has approved starting Cohort 6 by dosing patients with ATRN-119 at 800 mg once daily. This decision comes after a careful review of the safety and pharmacokinetic data from Cohort 5, where patients received 550 mg once daily, and showed promising tolerability.
ATRN-119 is the first and only macrocyclic ATR inhibitor in clinical testing. Early studies in the ABOYA-119 trial indicate that rising dose levels lead to increased systemic exposure with no dose limiting toxicities observed. The trial focuses on individuals with advanced solid tumors harboring specific mutations in DNA damage response pathways, aiming to evaluate both safety and potential therapeutic benefits as dosing escalates.
Read Announcement
