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About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. (NASDAQ: APRE) is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, specializing in precision oncology through the innovative approach of synthetic lethality. The company is dedicated to developing targeted therapies that exploit specific vulnerabilities in cancer cells while minimizing harm to healthy cells. This cutting-edge strategy addresses a significant unmet medical need in oncology, particularly for patients with cancers harboring mutations in DNA Damage Response (DDR) pathways.
Core Programs and Pipeline
Aprea's lead programs include ATRN-119, a macrocyclic ATR inhibitor, and APR-1051, a next-generation WEE1 kinase inhibitor. These small-molecule therapeutics are designed for patients with solid tumors exhibiting DDR-related gene mutations, such as ovarian, colorectal, breast, and prostate cancers. ATRN-119 is currently undergoing clinical evaluation in the ABOYA-119 Phase 1/2a trial, with a focus on optimizing dosing regimens to maximize therapeutic efficacy. Similarly, APR-1051 is being tested in the ACESOT-1051 Phase 1 trial, which employs a biomarker-driven approach to assess safety, pharmacokinetics, and preliminary efficacy.
Innovative Approach: Synthetic Lethality
Synthetic lethality leverages the interplay between genetic mutations in cancer cells and DDR pathways, creating opportunities to selectively kill tumor cells while sparing normal tissue. Aprea's approach is particularly promising for cancers with poor prognoses and limited treatment options. By targeting ATR and WEE1 kinases, the company aims to disrupt critical processes in cancer cell replication and repair, thereby halting tumor progression.
Intellectual Property and Market Differentiation
Aprea's robust intellectual property portfolio underscores its leadership in DDR-targeted therapeutics. The company holds multiple patents covering its ATR and WEE1 inhibitor programs, with exclusivity extending into the 2030s and 2040s. This strategic focus on intellectual property strengthens its competitive positioning in the oncology market. Furthermore, Aprea's differentiated approach, including macrocyclic design for ATRN-119 and enhanced selectivity for APR-1051, addresses common limitations of existing DDR-targeted therapies, such as toxicity and off-target effects.
Commitment to Precision Medicine
Aprea is at the forefront of precision medicine, employing biomarker-driven clinical trials to ensure that the right patients receive the most effective treatments. This approach not only enhances therapeutic outcomes but also aligns with the broader industry trend toward personalized healthcare solutions. By focusing on cancers with specific genetic alterations, Aprea aims to deliver safer, more effective therapies that improve patient quality of life.
Strategic Outlook
As a pioneer in synthetic lethality, Aprea Therapeutics is well-positioned to capitalize on the growing demand for targeted cancer therapies. Its commitment to scientific innovation, clinical excellence, and intellectual property protection underscores its potential to transform the oncology landscape. Through its advanced pipeline and strategic focus, Aprea continues to make strides toward addressing some of the most challenging cancers, offering hope to patients and value to stakeholders.
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.
Aprea Therapeutics, Inc. (Nasdaq: APRE) announced a virtual R&D Day on April 22, 2021, at 1:00 p.m. ET. This event will feature presentations by CEO Christian S. Schade and CMO Eyal C. Attar, focusing on the results of a completed Phase 3 trial for MDS and ongoing research. Register for the event on Aprea's website, where a replay will be available afterward. Aprea specializes in cancer therapies that reactivate the p53 protein, with its lead candidate, eprenetapopt (APR-246), showing promise in treating various cancers.
Aprea Therapeutics (Nasdaq: APRE) announced the FDA's Orphan Drug designation for eprenetapopt, aimed at treating acute myeloid leukemia (AML). This follows the prior Fast Track designation granted in November 2020. Orphan Drug designation offers several benefits, including a seven-year market exclusivity post-approval and FDA support in clinical trial design. Eprenetapopt is being developed to reactivate the mutant p53 protein in cancer cells, with additional designations for other conditions, including myelodysplastic syndromes and ovarian cancer.
Aprea Therapeutics (Nasdaq: APRE) reported financial results for 2020, highlighting a net loss of $15.4 million, or $0.73 per share. Their pivotal Phase 3 trial for eprenetapopt missed its primary endpoint for complete remission but showed a 53% improvement versus control. The Company has multiple ongoing trials for eprenetapopt and APR-548, their next-generation p53 reactivator, and expects to present additional findings in Q2 2021. As of December 31, 2020, cash and cash equivalents were $89 million, with anticipated cash burn of $30-35 million for 2021.
Aprea Therapeutics (Nasdaq: APRE), a biopharmaceutical company, is set to present a corporate update at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 2:50 p.m. ET. The presentation will provide insights into the company's innovative cancer therapeutics aimed at reactivating the p53 tumor suppressor protein. A live webcast will be available on the company's website. Aprea's lead product candidate, eprenetapopt (APR-246), is in clinical development and has received various FDA designations for myelodysplastic syndromes and acute myeloid leukemia.
Aprea Therapeutics (Nasdaq: APRE) announced the results of its Phase 3 clinical trial evaluating eprenetapopt with azacitidine (AZA) for TP53 mutant myelodysplastic syndromes (MDS). The trial did not achieve its primary endpoint of complete remission (CR) rate, with 33.3% CR in the eprenetapopt plus AZA arm compared to 22.4% in the AZA alone arm (P = 0.13). Despite this, secondary endpoints showed some favor toward the experimental arm. The combination was well-tolerated, and further analyses will be conducted as patient data matures.
Aprea Therapeutics (Nasdaq: APRE) announced that the FDA granted Fast Track designation for eprenetapopt, aimed at treating patients with TP53 mutant acute myeloid leukemia (AML). This designation helps expedite the development and review process for drugs addressing serious conditions. Aprea previously obtained Breakthrough Therapy and Orphan Drug designations for eprenetapopt for myelodysplastic syndromes (MDS). The company is actively enrolling patients in clinical trials for eprenetapopt combined with azacitidine and venetoclax, with promising initial data expected in 2021.
Aprea Therapeutics (Nasdaq: APRE), a biopharmaceutical company focused on cancer therapeutics, will have its CEO Christian S. Schade and CMO Eyal Attar participate in a fireside chat at the virtual Piper Sandler Healthcare Conference from December 1-3, 2020. The pre-recorded chat will be available for limited viewing starting November 23, 2020, on the company's investors website. Aprea is known for developing drugs that reactivate the mutant tumor suppressor protein, p53, with its lead product candidate, eprenetapopt (APR-246), targeting hematologic malignancies.
Aprea Therapeutics (Nasdaq: APRE) reported its Q3 2020 financial results and business updates, focusing on its lead product candidate, eprenetapopt. The company has completed enrollment in pivotal Phase 3 trials for TP53 mutant MDS with azacitidine and is enhancing its clinical pipeline in AML and solid tumors. As of September 30, 2020, Aprea had $101.1 million in cash, down from $130.1 million at 2019 year-end, and anticipates a cash burn of $35-40 million for 2020. The net loss for Q3 2020 was $12.3 million, or $0.58 per share, compared to $6.2 million in Q3 2019.
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