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Aprea Therapeutics, Inc. reports developments as a clinical-stage precision medicine oncology company developing targeted therapies for patients with biomarker-defined cancers. Its updates center on small-molecule programs designed to exploit cancer-specific genetic vulnerabilities, including APR-1051, an oral WEE1 kinase inhibitor, and ATRN-119, a small-molecule ATR inhibitor, for solid tumor indications.
Recurring news themes include clinical activity from the ACESOT-1051 study of APR-1051, oncology conference presentations, pipeline and corporate updates, financial results, and financing activity supporting research and development. Company communications also describe biomarker-guided development, safety and tolerability observations, and capital actions tied to its clinical-stage oncology strategy.
Aprea Therapeutics (Nasdaq: APRE) presented updated data from its Phase 1b/2 clinical trial of APR-246 combined with azacitidine for TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) at the EHA Annual Meeting. The trial showed a 75% overall response rate (ORR) and a 57% complete remission (CR) rate in evaluable MDS patients. The median overall survival (OS) was 12.1 months across all patients and improved to 13.7 months for those receiving 3 or more cycles. The results indicate significant therapeutic potential for high-risk MDS and AML patients.
Aprea Therapeutics, Inc. (Nasdaq: APRE) has completed patient enrollment in its Phase 3 trial for eprenetapopt, a treatment targeting front-line TP53 mutant myelodysplastic syndromes (MDS). Topline results are anticipated by year-end 2020. The trial, involving 154 patients, compares eprenetapopt with azacitidine against azacitidine alone, focusing on the complete response rate. Aprea plans to submit applications for regulatory approvals in the U.S. and EU in 2021, bringing hope for a much-needed therapy for patients suffering from TP53 mutated MDS.
Aprea Therapeutics (APRE) reported its Q1 2020 financial results on May 15, 2020, showcasing a net loss of $9.4 million, or $0.45 per share, compared to a loss of $3.5 million, or $2.97 per share in Q1 2019. The company's cash and cash equivalents totaled $122.5 million, sufficient to support operations through 2023. Despite challenges from COVID-19, patient enrollment in clinical trials for its lead compound, eprenetapopt, is improving. Aprea has received FDA Breakthrough Therapy Designation for eprenetapopt in combination with azacitidine for MDS treatment.