Drugs / APR-1051
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2024-02-06 | “submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to initiate clinical trials of APR-1051.” aprea.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06260514 | Jun 2024 → Jun 2027 expected | neoplastic disease or syndrome | Aprea Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-01 | Aprea Therapeutics | Results Aprea Therapeutics Presents Updated Phase 1 Data on WEE1 Inhibitor APR-1051 at ASCO 2026, Demonstrating Early Monotherapy Activity and Manageable Tolerability in Advanced Solid Tumors aprea.com ↗ |
| 2026-03-30 | Aprea Therapeutics | Results Aprea Therapeutics Highlights Positive Emerging Clinical Activity for WEE1 Inhibitor, APR-1051, with a Confirmed Partial Response in the Ongoing Phase 1 ACESOT-1051 Trial aprea.com ↗
Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today announced the confirmation of a partial response (PR) in its ongoing ACESOT-1051 trial evaluating APR-1051, a potent and selective WEE1 kinase inhibitor. |
| 2026-02-18 | Aprea Therapeutics | Results Aprea Therapeutics Announces Additional Positive Clinical Activity for WEE1 Inhibitor, APR-1051, Including Second Partial Response in Ongoing ACESOT-1051 Trial aprea.com ↗
The Company reported a second unconfirmed partial response at first on-treatment scan in a patient with advanced endometrial cancer being treated at the 220 mg dose level (Cohort 8). |
| 2026-01-29 | Aprea Therapeutics | Results Aprea Therapeutics Announces Early Clinical Proof-Of-Concept in the Ongoing ACESOT-1051 Dose-Escalation Trial Evaluating WEE1 Inhibitor APR-1051, Including Partial Response Observed on First Scan aprea.com ↗
Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, today announced the first unconfirmed partial response (uPR) observed in a patient enrolled in its ongoing Phase 1 ACESOT-1051 dose-escalation study (A Multi-Center Evaluation of WEE1 Inhibitor APR-1051 in Patients with Advanced Solid Tumors). |
| 2025-10-24 | Aprea Therapeutics | Results Aprea Therapeutics Provides Clinical Update from ACESOT-1051 Trial Showing Early Signals of Activity for WEE1 Kinase Inhibitor APR-1051 aprea.com ↗
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. |
| 2025-08-12 | Aprea Therapeutics | Results Aprea Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Clinical Update aprea.com ↗ |
| 2025-06-25 | Aprea Therapeutics | Results 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 Collaboration with MD Anderson Cancer Center aprea.com ↗ |
| 2024-11-07 | Aprea Therapeutics | Results Aprea Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update aprea.com ↗
Preliminary results at subtherapeutic doses demonstrate the product to be well-tolerated with no unexpected toxicities. |
| 2024-10-23 | Aprea Therapeutics | Results Aprea Therapeutics Presents Preliminary Findings on Oral WEE1 Inhibitor APR-1051 at EORTC-NCI-AACR International Conference on Molecular Targets and Therapeutics aprea.com ↗
Preliminary results demonstrate that APR-1051 is safe and well-tolerated with no hematologic toxicity |
| 2024-04-10 | Aprea Therapeutics | Results Aprea Therapeutics Announces Presentations on its Next Generation WEE1 Inhibitor, APR-1051, and A Novel Macrocyclic ATR Inhibitor, ATRN-119, at AACR Annual Meeting 2024 aprea.com ↗
Pre-clinical findings underscore the potential of APR-1051, a next-generation WEE1 kinase inhibitor, to be a well-tolerated and effective treatment for Cyclin E-overexpressing cancers |
| 2024-03-11 | Aprea Therapeutics | Regulatory Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers aprea.com ↗
The FDA's clearance of our IND is a critical step in the APR-1051 development program. |
| 2024-02-06 | Aprea Therapeutics | Regulatory Aprea Therapeutics Announces Submission of IND Application for APR-1051, a Next Generation WEE1 Kinase Inhibitor aprea.com ↗ |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APR-1051 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06260514 ↗ |
| Route | Oral | “oral APR-1051” NCT06260514 ↗ |