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Aprea Therapeutics, Inc. (Nasdaq: APRE) is a clinical-stage biopharmaceutical company developing oncology therapies that exploit specific vulnerabilities in cancer cell mutations while aiming to spare healthy tissue. News about Aprea focuses on the progress of its precision oncology pipeline, centered on DNA damage response–related targets.
The company’s updates frequently cover clinical data from its lead programs. APR-1051, an oral WEE1 kinase inhibitor, is being studied in the biomarker-focused Phase 1 ACESOT-1051 trial in advanced solid tumors. Press releases describe early signals of anti-tumor activity and disease stabilization in heavily pretreated gastrointestinal, gynecologic, and HPV-positive head and neck cancers, as well as details on dose escalation, safety, and biomarker-defined patient cohorts.
News flow also highlights ATRN-119, Aprea’s macrocyclic ATR inhibitor in the Phase 1/2a ABOYA-119 trial. The company reports identification of a recommended Phase 2 dose for once-daily dosing, early evidence of disease stabilization, and examples of tumor shrinkage in patients with DDR-related gene mutations. Recent announcements describe a strategic shift toward evaluating ATRN-119 in combination with radiation, immune checkpoint inhibitors, and antibody-drug conjugates, and the pausing of further monotherapy enrollment.
Investors following APRE news will also see regular financial results releases, updates on cash runway, private placement financings, and participation in scientific and investor conferences such as the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics and the H.C. Wainwright Global Investment Conference. Together, these items provide an ongoing view of Aprea’s clinical development milestones, research collaborations, and corporate activities.
Aprea Therapeutics, Inc. (Nasdaq: APRE) presented data from its Phase I/II trial at ESMO Congress 2021, evaluating the efficacy of eprenetapopt in combination with pembrolizumab for advanced solid tumors. As of July 31, 2021, 33 patients were enrolled, with no dose-limiting toxicities reported. The trial showed promising results, including complete remission in a bladder cancer patient and tumor reductions in lung cancer patients. Adverse events were primarily grade 1/2. Despite a previous trial failure for MDS, the company continues to progress with eprenetapopt in various cancers.
Aprea Therapeutics (Nasdaq: APRE) announced a presentation of data regarding eprenetapopt in combination with pembrolizumab for treating advanced solid tumors at the ESMO Congress 2021, scheduled from September 16-21, 2021. This presentation will cover the Phase I/II study and is set for September 20, 2021. The company is focused on developing therapies targeting the mutant tumor suppressor protein p53. Notably, a pivotal Phase 3 clinical trial of eprenetapopt in TP53 mutant myelodysplastic syndromes recently failed to meet its primary endpoint.
Aprea Therapeutics (Nasdaq: APRE) reported its financial results for Q2 2021, showing a net loss of $10.3 million or $0.48 per share, improved from a net loss of $16.4 million or $0.78 per share in Q2 2020. As of June 30, 2021, the company had $69.8 million in cash, projected to sustain operations into 2023. However, the FDA placed partial clinical holds on trials for eprenetapopt, affecting enrollment, despite positive results in some ongoing studies. The company emphasizes ongoing efforts to resolve these holds with the FDA and to present trial data at future conferences.
Aprea Therapeutics (Nasdaq: APRE) announced a clinical hold by the FDA on its trial evaluating eprenetapopt in combination with acalabrutinib or venetoclax and rituximab for lymphoid malignancies. This follows a previous clinical hold on its myeloid malignancies program, stemming from concerns regarding safety and efficacy data from a Phase 3 trial. Patients who are currently benefiting from the study can continue treatment, yet no new patients can be enrolled until the hold is lifted. Aprea is committed to working with the FDA to resolve these issues promptly.
Aprea Therapeutics (Nasdaq: APRE) announced a partial clinical hold on its eprenetapopt trials in myeloid malignancies after a review by the FDA. About 20 patients are currently in the program, which includes MDS and AML, and can continue treatment. No new enrollments are permitted until the hold is resolved. Aprea aims to address FDA concerns and resume trials quickly. Ongoing trials in lymphoid malignancies and solid tumors remain unaffected. A webcast to discuss the situation will be held on August 6, 2021.
Aprea Therapeutics, Inc. (Nasdaq: APRE) announced positive results from a Phase 2 trial of eprenetapopt combined with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML. The trial showed a 58% relapse-free survival and 79% overall survival at one year post-transplant. Previous trials reported much lower outcomes, indicating the potential impact of this therapy. The regimen was well tolerated, and discussions with the FDA are planned. Aprea has received multiple designations for its products aimed at treating hematologic malignancies.
Aprea Therapeutics (Nasdaq: APRE) announced promising results from its Phase 1/2 trial of eprenetapopt combined with venetoclax and azacitidine for treating TP53 mutant AML. The trial met its primary efficacy endpoint, achieving a 37% complete remission rate among 30 efficacy-evaluable patients, with a composite response rate of 53%. The findings will be discussed with the FDA in the latter half of 2021, and Aprea aims to present further data at upcoming conferences. The company continues to advance its myeloid malignancies program, leveraging the potential of eprenetapopt.
Aprea Therapeutics, Inc. (Nasdaq: APRE) announced on May 21, 2021, that Greg Korbel, Senior Vice President and Chief Business Officer, will present a corporate update at the 2021 Oppenheimer Rare & Orphan Disease Summit at 3:45 p.m. ET. A webcast can be accessed on the Aprea website. The company focuses on novel cancer therapeutics, primarily targeting the p53 tumor suppressor protein. Their lead candidate, eprenetapopt (APR-246), has received multiple FDA designations for conditions including myelodysplastic syndromes and acute myeloid leukemia. A next-generation candidate, APR-548, is also in development.
Aprea Therapeutics (Nasdaq: APRE) announced participation by CEO Christian S. Schade and CMO Eyal C. Attar in a fireside discussion at the 2021 RBC Capital Markets Global Healthcare Conference on May 18, 2021, at 2:30 p.m. ET. The conference will explore Aprea's focus on developing cancer therapeutics targeting mutant p53 protein. Their lead candidate, eprenetapopt (APR-246), has received multiple FDA designations for various cancers. A webcast of the event will be available on their website.
Aprea Therapeutics (Nasdaq: APRE) reports Q1 2021 financial results, revealing a net loss of $9.7 million or $0.46 per share. The company reported a decrease in R&D expenses to $6.8 million, down from $9.1 million a year earlier. Aprea continues development of eprenetapopt and APR-548 across several clinical trials. While a Phase 3 trial did not meet primary efficacy endpoints, interim analyses from other trials indicated promising rates of relapse-free survival and overall survival. The company expects its cash reserves will sustain operations into 2023.
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