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About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to advancing precision oncology through the innovative approach of synthetic lethality. With a focus on disrupting DNA damage response (DDR) pathways, Aprea is developing novel, small-molecule inhibitors to target specific genetic vulnerabilities in solid tumors. The company leverages its deep scientific and technical expertise to explore therapies that aim to selectively target cancer cells harboring DDR-related mutations while minimizing toxicity to healthy tissue.
Core Focus and Technological Approach
The core mission at Aprea is to develop next-generation oncology treatments by exploiting the concept of synthetic lethality. This approach involves targeting complementary pathways in cancer cells that, when inhibited, result in tumor cell death. Aprea’s key therapeutic candidates include:
- ATRN-119: A macrocyclic ATR inhibitor designed for use as monotherapy in patients with advanced solid tumors. Through precise targeting of the ATR pathway, ATRN-119 demonstrates a focused action against tumors with DDR-related gene mutations.
- APR-1051: An oral WEE1 inhibitor developed with a strong emphasis on selectivity. The molecule is designed to limit off-target effects common with other inhibitors in the class, potentially offering a favorable safety and tolerability profile.
Clinical Development and Research
Aprea’s pipeline is built upon extensive preclinical research and a robust portfolio of IND-enabling studies. The company employs a strategic approach to clinical development by initiating early-phase trials that explore the safety, pharmacokinetics, and initial efficacy of its drug candidates. The design of these studies is biomarker-driven, ensuring that treatments can be tailored for patients with specific cancer-associated gene alterations.
In its clinical programs, Aprea is committed to using data-driven insights to optimize dosing regimens and maximize therapeutic potential. This commitment is reflected in the refined design of clinical studies that focus on key endpoints such as safety, tolerability, and pharmacodynamic response as markers of treatment success. The rigorous approach underscores Aprea’s expertise and its dedication to advancing treatments in the competitive field of oncology therapeutics.
Intellectual Property and Innovation
Aprea’s innovation is further reinforced by a strong intellectual property portfolio that covers its therapeutic candidates and methods of use. The company’s expansive patent estate not only protects its proprietary compounds and pharmaceutical compositions but also solidifies its competitive positioning in the market. This focus on protecting scientific breakthroughs ensures that Aprea remains at the forefront of advancing novel therapeutic strategies, maintaining both authoritativeness and trust in its innovative approach.
Market Position and Competitive Landscape
Operating in a highly specialized niche within the broader biopharmaceutical industry, Aprea Therapeutics distinguishes itself through its targeted approach to cancer treatment. The emphasis on precision medicine positions the company uniquely as it capitalizes on the growing understanding of genetic drivers in cancer. By focusing on well-defined molecular targets such as ATR and WEE1 kinases, the firm is developing therapies that offer potential advantages in selectivity and safety compared to less targeted approaches.
The company navigates a competitive landscape populated by other biopharmaceutical firms advancing DDR inhibitors and targeted oncology treatments. However, Aprea’s integrative strategy, based on synthetic lethality and backed by extensive research and clinical data, provides it with a distinct position. Its commitment to scientific excellence, coupled with an emphasis on developing therapies for patients with limited treatment options, contributes to its reputation as a firm with deep expertise in oncology drug development.
Scientific and Clinical Expertise
Aprea’s leadership team, composed of experienced scientists and clinical experts, is integral to the company’s progress. The involvement of seasoned professionals in guiding clinical trials, research design, and regulatory strategy drives the company’s commitment to high standards in all aspects of drug development. This experienced team collaborates with premier academic institutions and clinical centers, ensuring that the latest scientific insights are incorporated into its therapeutic programs.
Operational Excellence and Future Directions
Designed to address the unmet medical need in solid tumors with DDR gene mutations, Aprea’s operations emphasize rigorous clinical assessment and scalable research strategies. While the company prioritizes advancing its current pipeline candidates through well-structured clinical trials, it continuously refines its protocols to adapt to new scientific findings. This operational discipline, combined with a commitment to intellectual rigor and technical precision, supports the company in delivering detailed insights into its therapeutic mechanisms.
Conclusion
In summary, Aprea Therapeutics, Inc. embodies a focused and expert-driven approach to the development of precision oncology therapies. Its strategic emphasis on synthetic lethality, coupled with a robust research framework and a strong intellectual property portfolio, positions the company as an authoritative entity in the realm of targeted cancer treatments. With promising lead candidates addressing critical needs in oncology, Aprea remains dedicated to advancing the field through scientific excellence and innovative treatment paradigms.
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.
Aprea Therapeutics (Nasdaq: APRE) has engaged Philippe Pultar, MD as senior medical advisor to support the development of APR-1051, their potential best-in-class WEE1 inhibitor. Dr. Pultar brings extensive oncology experience, including the development of azenosertib, another WEE1 inhibitor. This aligns with Aprea's commitment to providing top resources for their WEE1 inhibitor program.
The Phase 1 ACESOT-1051 study is ongoing, evaluating APR-1051 in advanced solid tumors with specific gene alterations. Aprea plans to update on this study by year-end 2024. The WEE1 program is part of Aprea's DDR-targeted therapeutics portfolio, aiming to deliver precision medicine solutions.
Dr. Pultar expressed excitement about APR-1051's potential, citing its differentiated profile and compelling pre-clinical data. Aprea's CEO, Oren Gilad, Ph.D., highlighted Dr. Pultar's expertise as valuable for advancing their WEE1 program. Concurrently, Dr. Nadeem Mirza will step down as Chief Medical Officer, effective October 9, 2024.
Halda Therapeutics, a biotech company developing RIPTAC™ (Regulated Induced Proximity TArgeting Chimeras) therapeutics for cancer, has appointed Christian Schade as President, CEO, and Board member. Schade brings over 20 years of pharma and biotech industry experience, including leadership in clinical pipeline development and value-creating deals. Tim Shannon continues as Board Chairman.
Schade's appointment comes as Halda prepares to enter clinical trials, with the first RIPTAC therapeutic expected to begin trials in the first half of 2025. The company is focusing on developing therapies for prostate and breast cancer. Schade's previous roles include CEO of Aprea Therapeutics, Growth Partner at Flagship Pioneering, and executive positions at Novira, Omthera Pharmaceuticals, and Medarex.
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