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) announced FDA acceptance of its IND application for APR-548, targeting TP53 mutant myelodysplastic syndromes (MDS). This milestone is crucial for the next-generation small molecule aimed at reactivating mutant p53. CEO Christian S. Schade expressed optimism about initiating a Phase 1 clinical trial for APR-548, reinforcing Aprea's commitment to advancing therapeutic options for p53 mutated cancers. The company is also progressing with its lead product, eprenetapopt, which has received multiple FDA designations for MDS and other malignancies.
Aprea Therapeutics (NASDAQ: APRE) announced the addition of Michael A. Kelly to its Board of Directors, where he will be part of the audit and governance committees. With over 20 years in life sciences, Kelly has held senior roles at Amgen and founded Sentry Hill Partners. His expertise is expected to enhance Aprea's mutant p53 reactivator oncology programs aimed at commercialization. The company focuses on developing innovative cancer therapies, including APR-246, which has received several FDA designations for hematologic malignancies.
Aprea Therapeutics (NASDAQ: APRE) announced the appointment of Michael A. Kelly to its Board of Directors, who brings over 20 years of life sciences leadership. Kelly's experience includes senior roles at Amgen and his own consulting firm, Sentry Hill Partners. He will serve on the audit and governance committees. His financial and operational expertise is expected to bolster Aprea's efforts in advancing its mutant p53 reactivator oncology programs, particularly APR-246, which is in clinical development for various cancers.
Aprea Therapeutics (NASDAQ: APRE) announced the promotion of Gregory S. Wessels to Chief Commercial Officer. This move is timely as the company approaches significant milestones in its frontline MDS program and continues developing eprenetapopt. Wessels brings extensive oncology experience from Bristol-Myers Squibb. Additionally, independent directors Scott Rocklage, Ph.D., and Jonathan Hepple, Ph.D., will step down from the Board after nearly a decade. The company has received multiple FDA designations for eprenetapopt, its lead candidate targeting mutant p53, crucial for cancer therapy.
Aprea Therapeutics (NASDAQ: APRE) announced the appointments of Fouad Namouni, M.D. and Richard Peters, M.D., Ph.D. to its Board of Directors, effective June 30, 2020. Dr. Namouni has over 20 years in oncology development, previously at Bristol-Myers Squibb, while Dr. Peters brings 25 years of experience from roles at Yumanity and Merrimack Pharmaceuticals. Their expertise is expected to bolster Aprea's mutant p53 reactivator oncology programs. Guido Magni, M.D., Ph.D. is stepping down from the Board. Aprea focuses on developing cancer therapeutics, particularly APR-246 for hematologic malignancies.
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.