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Aprea Therapeutics, Inc. (APRE) is a clinical-stage biopharmaceutical leader developing precision oncology therapies through synthetic lethality approaches. This page provides investors and researchers with timely updates on the company’s progress in targeting DNA damage response pathways in solid tumors.
Access authoritative reporting on Aprea’s pipeline developments, including its ATRN-119 and APR-1051 programs. Our curated news collection covers clinical trial milestones, regulatory updates, and strategic collaborations, helping stakeholders track innovations in targeted cancer therapies.
Key content includes updates on phase 1/2 trial results, FDA communications, intellectual property expansions, and research partnerships. All content is verified through primary sources to ensure accuracy in this fast-evolving therapeutic area.
Bookmark this page for centralized access to Aprea’s latest scientific advancements and corporate announcements. Check regularly for developments in next-generation oncology treatments leveraging synthetic lethality mechanisms.
Adicet Bio (Nasdaq: ACET), a clinical stage biotechnology company focused on allogeneic gamma delta T cell therapies, has appointed Michael Grissinger to its Board of Directors. Grissinger brings over 40 years of pharmaceutical business development and strategic transaction experience, including more than two decades at Johnson & Johnson where he served as Vice President and Head of Worldwide Pharmaceutical Licensing and Corporate Development.
During his tenure at Johnson & Johnson, Grissinger led the Immunology Therapeutic Area Business Development and Licensing Group and was a member of the Immunology R&D/Commercial leadership team. Prior to J&J, he spent 12 years at Ciba-Geigy in finance, marketing, and business development roles. He currently serves on the board of Aprea Therapeutics and three private biotech companies.
Aprea Therapeutics (NASDAQ: APRE) has announced the dosing of the first HPV+ head and neck squamous cell carcinoma (HNSCC) patient in Cohort 5 of the ongoing ACESOT-1051 clinical trial, evaluating APR-1051 at 70mg once daily. The trial is expanding to target populations most likely to benefit from WEE1 inhibition.
The Phase 1 trial is studying APR-1051, a potent and selective small molecule, in patients with advanced solid tumors. Open label data is expected in H2 2025. The study consists of two parts: Part 1 for dose escalation (up to 39 patients) and Part 2 for dose optimization (up to 40 patients).
The trial's significance is highlighted by statistics showing that approximately 70% of the 20,000 annual US cases of oropharyngeal squamous cell carcinoma are HPV-related. The study is being conducted at MD Anderson Cancer Center, with whom Aprea has entered into a Material Transfer Agreement for additional preclinical research.
Aprea Therapeutics (APRE) reported its Q4 and full-year 2024 financial results, highlighting progress in its cancer treatment pipeline. The company ended 2024 with $22.8 million in cash, expected to fund operations into Q1 2026.
Key developments include the ACESOT-1051 trial now enrolling patients in Cohort 5, evaluating WEE1 kinase inhibitor APR-1051, with open-label safety and efficacy data expected H2 2025. The ABOYA-119 trial continues evaluating ATR inhibitor ATRN-119 with both once-daily and twice-daily dosing regimens.
Financial highlights for 2024:
- Full-year operating loss: $14.3 million vs $15.5 million in 2023
- R&D expenses: $9.4 million vs $7.6 million in 2023
- G&A expenses: $6.5 million vs $8.4 million in 2023
- Net loss: $13.0 million ($2.35 per share) vs $14.3 million ($3.95 per share) in 2023
Aprea Therapeutics (NASDAQ: APRE) has entered into a Material Transfer Agreement with MD Anderson Cancer Center to investigate APR-1051 for treating head and neck squamous cell carcinoma (HNSCC). The research will focus on both HPV+ and HPV- HNSCC expressing genomic markers of replication stress.
The collaboration will explore combining APR-1051, Aprea's proprietary WEE1 kinase inhibitor, with immune checkpoint inhibitors. The project is led by Professors Jeffrey N. Myers and Abdullah A. Osman from MD Anderson's Department of Head and Neck Surgery.
Key statistics highlight that approximately 70% of the 20,000 annual OPSCC cases in the US are HPV-related. APR-1051 is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial for advanced solid tumors with cancer-associated gene alterations.
Aprea Therapeutics (NASDAQ: APRE) provided an update on its patent portfolio for DNA Damage Response (DDR) cancer therapeutics. The company's ATR inhibitor program is protected by four granted U.S. patents, one pending U.S. application, and one provisional application, along with 19 granted non-U.S. patents and 16 pending non-U.S. applications. These patents expire between 2035-2037, with pending applications potentially extending exclusivity to 2044.
The company's lead ATR inhibitor, ATRN-119, is being evaluated in the ABOYA-119 clinical trial for advanced solid tumors. Additionally, Aprea's WEE1 kinase inhibitor program includes one pending U.S. patent application and 12 pending non-U.S. applications, set to expire in 2043 if granted. The lead WEE1 inhibitor, APR-1051, is currently in Phase 1 clinical trials (ACESOT-1051) for advanced/metastatic solid tumors.
Aprea Therapeutics (NASDAQ: APRE) has initiated twice daily (BID) dosing at 550mg in its ABOYA-119 Phase 1/2a clinical trial of ATRN-119, the first macrocyclic ATR inhibitor in clinical trials. The study, which previously tested once-daily doses from 50 to 800mg, now includes a protocol amendment for BID dosing starting at 550mg twice daily (1,100mg total daily dose).
The strategic shift to BID dosing aims to maintain optimal therapeutic levels over 24 hours, potentially enhancing efficacy and accelerating the path to regulatory approval. The trial continues to evaluate ATRN-119 as monotherapy in patients with advanced solid tumors having DNA damage response gene mutations. The Phase 1 readout is anticipated in the second half of 2025.
Aprea Therapeutics (NASDAQ: APRE) reported Q3 2024 financial results and provided updates on its clinical pipeline. The company reported preliminary results from Phase 1 ACESOT-1051 trial of WEE1 inhibitor APR-1051, showing good tolerability. Cash position stands at $26.2 million as of September 30, 2024, providing runway for at least 12 months. Q3 operating loss was $4.1 million with net loss of $3.8 million ($0.64 per share). Active enrollment continues in both ACESOT-1051 and ABOYA-119 trials, with preliminary efficacy data from ACESOT-1051 expected in H1 2025.
Aprea Therapeutics (APRE) presented preliminary safety results for its WEE1 inhibitor APR-1051 at the EORTC-NCI-AACR Symposium. The Phase 1 ACESOT-1051 trial is evaluating APR-1051 as monotherapy in advanced solid tumors. Data from two of three enrolled patients show the drug is safe and well-tolerated with no hematologic toxicity. All adverse events were Grade 1 and 2, with no QT prolongation observed. The trial is actively enrolling at three U.S. sites, with planned doses ranging from 10mg to 150mg daily. The study consists of two parts: dose escalation (up to 39 patients) and dose optimization (up to 40 patients).
Aprea Therapeutics (Nasdaq: APRE), a clinical-stage biopharmaceutical company specializing in precision oncology through synthetic lethality, has announced its participation in the Maxim 2024 Healthcare Virtual Summit. Dr. Oren Gilad, President and CEO of Aprea, will be presenting at two sessions during the event, which is scheduled from October 15 to 17, 2024.
The first presentation will be part of the Precision and Immune Oncology Panel on Wednesday, October 16, from 2:00 - 3:00 PM ET. This will be followed by a Fireside Chat on Thursday, October 17, from 3:30 - 4:00 PM ET. The conference will be hosted live on M-Vest, and interested parties can access the presentations by signing up for M-Vest membership.
Aprea Therapeutics (Nasdaq: APRE) announced that four abstracts have been accepted for poster presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25, 2024. The posters showcase progress in Aprea's oncology pipeline of DNA damage response (DDR) inhibitors, featuring updates on two clinical-stage candidates: APR-1051 and ATRN-119.
The presentations include two clinical posters on the safety and efficacy of APR-1051 (a WEE1 inhibitor) and ATRN-119 (a novel macrocyclic ATR inhibitor) in patients with advanced cancers. Additionally, two preclinical posters will be presented, focusing on APR-1051's favorable characteristics for treating CCNE1-overexpressing cancers and the development of macrocyclic ATR inhibitors for cancer treatment.
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