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
ABOYA-119, ACESOT-1051, and APR-1051. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ABOYA-119 - FDA Regulatory Timeline and 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:
- 2024-H2
- 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
ACESOT-1051 - FDA Regulatory Timeline and 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
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:
- 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
