Aprea Therapeutics(APRE)
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Aprea Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Clinical Update
Globenewswire· 2025-08-12 12:00
Core Insights - Aprea Therapeutics is making progress in its clinical trials, particularly with its WEE1 inhibitor APR-1051, showing early signs of disease control in patients with stable disease [1][3][4] - The company reported financial results for Q2 2025, indicating a decrease in operating loss compared to the same period in 2024, with cash and cash equivalents of $16.5 million as of June 30, 2025 [2][8][11] Clinical Development - The ongoing Phase 1 ACESOT-1051 trial of APR-1051 has shown that three patients achieved stable disease, including one patient with HPV-positive head and neck squamous cell carcinoma [3][7] - Aprea's ATR inhibitor ATRN-119 is also in clinical trials, with seven patients demonstrating stable disease and three showing significant tumor shrinkage at the 550 mg dose [3][11] - The company is expanding enrollment criteria for ACESOT-1051 to include patients with HPV+ tumors, with additional data expected in the second half of 2025 [7][11] Financial Performance - For Q2 2025, Aprea reported an operating loss of $3.4 million, a decrease from $3.8 million in Q2 2024, with R&D expenses at $1.9 million [11][17] - The company’s net loss for the quarter was $3.2 million, or $0.53 per share, compared to a net loss of $3.5 million, or $0.58 per share, in the same quarter of 2024 [11][17] - As of June 30, 2025, Aprea's total assets were $17.3 million, down from $24.0 million at the end of 2024 [14][15] Strategic Collaborations - Aprea has entered into a translational research collaboration with MD Anderson Cancer Center, which has yielded promising preclinical results for APR-1051 [5][9] - The collaboration aims to explore the potential of APR-1051 in combination with anti-PD-1 therapies for HPV+ head and neck cancer [5][9] Future Outlook - Aprea plans to submit an abstract to a major oncology conference and anticipates additional safety and efficacy data from its trials in the near future [7][11] - The company is also considering future arms of its trials to evaluate APR-1051 and ATRN-119 in combination with other therapies to address unmet medical needs [11][12]
Aprea Therapeutics (APRE) Earnings Call Presentation
2025-07-07 08:25
Pipeline and Milestones - Aprea Therapeutics' WEE1 inhibitor (APR-1051) ACESOT-1051 Phase 1 study expects safety/efficacy data in H2 2025 and complete dose escalation in H1 2026 [7, 43] - Aprea Therapeutics' ATR inhibitor (ATRN-119) ABOYA-119 Phase 1/2a study expects safety/efficacy data in H2 2025 and Recommended Phase 2 Dose (RP2D) in H1 2026 [8, 68] - Six patients in the ATRN-119 dose escalation cohorts achieved stable disease, with three patients (50%) in the 550mg BID cohort demonstrating measurable tumor shrinkage of 7%, 14%, and 21% [53] APR-1051 (WEE1 Inhibitor) - APR-1051 is a potent WEE1 inhibitor with high selectivity, showing >150-fold, >50-fold, and >600-fold difference in IC50 compared to PLK1, PLK2, and PLK3 inhibition, respectively [31] - Clinical data cutoff on March 4, 2025, for APR-1051 (N=9) showed treatment-related adverse events, including alanine aminotransferase increased (2 patients), aspartate aminotransferase increased (2 patients), and lymphocyte count decreased (1 patient) [26] ATRN-119 (ATR Inhibitor) - ATRN-119 exhibits near-dose proportional exposure following oral administration, with AUC 0-24hr ranging from 180 ng*h/mL at 50mg to 6899 ng*h/mL at 550mg [55] - Clinical data cutoff on May 1, 2025, for ATRN-119 (N=32) showed treatment-related adverse events, including nausea (13 patients), diarrhea (12 patients), and fatigue (10 patients) [57] - ATRN-119 is the first and only macrocyclic ATR inhibitor, potentially offering increased selectivity and improved tolerability compared to first-generation acyclic structures [59, 66] Financials and Capitalization - As of March 31, 2025, Aprea Therapeutics had approximately $19.3 million in cash and equivalents [73] - Aprea Therapeutics has 5,531,373 common stock, 2,701,864 warrants, 782,243 options, and 30,607 restricted stock units outstanding as of May 14, 2025, resulting in 9,061,683 fully diluted equivalents [73]
Aprea Reports Anti-Proliferative Results and Promising Early-Stage Clinical Data for Next-Generation WEE1 Inhibitor, APR-1051, in HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) in Collaboration with MD Anderson Cancer Center
Globenewswire· 2025-06-25 13:00
Core Insights - Aprea Therapeutics announced promising preclinical data and an initial clinical update for APR-1051, a next-generation oral WEE1 inhibitor targeting HPV+ head and neck squamous cell carcinoma (HNSCC) [1][2] - The findings suggest that APR-1051 may provide significant differentiation in oncology, both as a single agent and in combination with checkpoint inhibitors [2] Preclinical Data - Preclinical studies conducted in collaboration with MD Anderson Cancer Center demonstrated robust antiproliferative effects of APR-1051 across various human and murine head and neck cancer cell lines, with IC₅₀ values ranging from 8.9 to 230 nM [6] - Significant anti-tumor synergy was observed when combining APR-1051 with anti–PD-1 therapies in HPV+ HNSCC models, indicating its potential for combination-based clinical trials [6] - Mechanistically, APR-1051 activates cGAS/STING-mediated immunogenic cell death and exploits the HPV E6-driven G2 checkpoint dependency in HPV+ tumors, highlighting a biomarker-driven strategy for patient selection [6] Clinical Update - In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV-positive oropharyngeal squamous cell carcinoma showed stable disease and a 5% tumor reduction after treatment with a subtherapeutic 70 mg oral dose of APR-1051 [7] - The patient tolerated the therapy well, with no dose-limiting toxicities reported [7] Future Development - Experts from MD Anderson Cancer Center expressed optimism regarding APR-1051 as a promising addition to the treatment portfolio for HPV-associated head and neck cancers, supported by robust preclinical data [8] - Aprea is committed to advancing APR-1051 as a precision oncology agent, leveraging biomarker insights to optimize patient outcomes [8][9] - Enrollment in the ACESOT-1051 trial is ongoing, with plans to evaluate APR-1051 in combination with checkpoint inhibitors for distinct patient populations [12]
Aprea Therapeutics(APRE) - 2025 Q1 - Quarterly Report
2025-05-14 12:10
Oncology Development - The company is focused on precision oncology through synthetic lethality, aiming to establish a pipeline of clinical and preclinical programs for cancer treatment [88]. - The lead product candidate, APR-1051, received FDA clearance for its IND application in March 2024, with the first patient enrolled in a Phase 1 study in Q2 2024 [90]. - The second product candidate, ATRN-119, is an oral small molecule inhibitor currently in a Phase 1/2a clinical trial, with safety and efficacy data expected in the second half of 2025 [91]. - The company is exploring combination therapies with other agents, such as PARP inhibitors, to enhance the therapeutic impact of its product candidates [92]. - The company has a preclinical research program in lead optimization for an undisclosed DDR target, focusing on synthetic lethality in oncology [93]. Financial Performance - Grant revenue for the three months ended March 31, 2025 was approximately $0.2 million, a decrease of 47.4% compared to $0.4 million for the same period in 2024 [125]. - Total operating expenses increased to $4.25 million for the three months ended March 31, 2025, up 20.4% from $3.53 million in the same period in 2024 [124]. - Research and development expenses rose to approximately $2.48 million for the three months ended March 31, 2025, an increase of 55.1% from $1.6 million in 2024 [126]. - Net loss for the three months ended March 31, 2025 was $3.93 million, compared to a net loss of $2.81 million for the same period in 2024, reflecting an increase of 40% [130]. - Cash and cash equivalents as of March 31, 2025 were $19.3 million, with substantial doubt about the ability to fund operations for the next twelve months [143]. - Net cash used in operating activities was $3.63 million for the three months ended March 31, 2025, a decrease of 7.7% from $3.94 million in 2024 [137]. - Foreign currency loss for the three months ended March 31, 2025 was $51,803, compared to a gain of $56,176 in 2024, indicating a change of $107,979 [128]. Future Outlook - The company anticipates completing dose escalation for APR-1051 in the first half of 2026 and determining the Recommended Phase 2 Dose for ATRN-119 in the same timeframe [90][91]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years due to ongoing development activities [130]. - The company plans to seek marketing approvals for product candidates that successfully complete clinical trials and establish a commercialization infrastructure [145]. - The company requires additional financing to support ongoing operations and may rely on public or private equity, debt financings, or collaborations [147]. - There is uncertainty regarding the timing and amount of increased expenses, and the company may not achieve or maintain profitability [148]. - Developing drug products is a lengthy and costly process, and the company may not generate necessary data for marketing approval [149]. - The company currently has no committed external source of funds and may face dilution of ownership interests if additional capital is raised through equity sales [150]. - Collaborations or licensing arrangements may require the company to relinquish valuable rights to technology or future revenue streams [151]. - The company anticipates costs related to patent applications, headcount growth, and operating as a public company [152]. Risk Factors - The company is exposed to interest rate risk, but historical fluctuations in interest income have not been significant [158]. - Foreign currency exchange rate changes may affect the revenues and expenses of the company's foreign subsidiaries [159]. - The company does not currently have significant direct foreign exchange risk and has not used derivative financial instruments for hedging [160]. - Inflation has not materially affected the company's business or financial condition in the recent quarter [161].
Aprea Therapeutics(APRE) - 2025 Q1 - Quarterly Results
2025-05-14 12:05
Financial Performance - Aprea reported cash and cash equivalents of $19.3 million, down from $22.8 million as of December 31, 2024, providing runway into early Q2 2026[15]. - The company incurred an operating loss of $4.1 million for Q1 2025, compared to an operating loss of $3.1 million in Q1 2024[15]. - Aprea reported a net loss of $3.9 million ($0.66 per basic share) for Q1 2025, compared to a net loss of $2.8 million ($0.67 per basic share) in Q1 2024[15]. - Total current assets decreased to $19.8 million as of March 31, 2025, from $23.6 million as of December 31, 2024[19]. - Total stockholders' equity decreased to $15.5 million as of March 31, 2025, from $19.3 million as of December 31, 2024[19]. - Grant revenue for Q1 2025 was $162,463, a decrease of 57.4% compared to $380,569 in Q1 2024[20]. - Total operating expenses increased to $4,248,045 in Q1 2025, up 20.3% from $3,530,239 in Q1 2024[20]. - Net loss for Q1 2025 was $3,932,659, representing an increase of 40% from a net loss of $2,810,091 in Q1 2024[20]. - Net loss per share attributable to common stockholders was $0.66 in Q1 2025, slightly improved from $0.67 in Q1 2024[20]. - Weighted-average common shares outstanding increased to 5,993,866 in Q1 2025, compared to 4,198,326 in Q1 2024[20]. - Total other income decreased to $152,923 in Q1 2025, down 55% from $339,579 in Q1 2024[20]. - Interest income, net, was $204,726 in Q1 2025, a decrease of 27.7% from $283,403 in Q1 2024[20]. - The comprehensive loss for Q1 2025 was $3,932,016, compared to a comprehensive loss of $2,825,174 in Q1 2024[20]. Research and Development - Research and Development (R&D) expenses increased to $2.5 million in Q1 2025 from $1.6 million in Q1 2024, primarily due to the initiation of clinical trials for APR-1051 and ATRN-119[15]. - Aprea's ATR inhibitor, ATRN-119, showed early evidence of anti-tumor activity with tumor shrinkage of 7%, 14%, and 21% in three patients at the 550 mg twice daily dose level[2]. - The ongoing ACESOT-1051 trial for the WEE1 inhibitor APR-1051 is advancing, with patients now being dosed at 100 mg once daily, and preliminary efficacy data is expected in the second half of 2025[3]. - The recommended Phase 2 dose (RP2D) for ATRN-119 is expected to be identified in the first half of 2026, with preliminary safety and efficacy data anticipated in the second half of 2025[6]. - Aprea entered into a Material Transfer Agreement with MD Anderson Cancer Center to support preclinical research on APR-1051 for treating head and neck squamous cell carcinoma[9].
Aprea Therapeutics Reports First Quarter 2025 Financial Results and Provides a Clinical Update
Globenewswire· 2025-05-14 12:00
Core Insights - Aprea Therapeutics is making significant clinical progress with its lead candidates, ATRN-119 and APR-1051, showing early evidence of anti-tumor activity and advancing towards recommended Phase 2 doses [2][4] Clinical Trials - ATRN-119 has shown tumor shrinkage in three patients (7%, 14%, and 21%) in the ongoing ABOYA-119 clinical trial, indicating its potential effectiveness against DDR-deficient cancers [2][9] - The ACESOT-1051 trial for APR-1051 is progressing, with patients currently dosed at 100 mg once daily, and preliminary efficacy data expected in the second half of 2025 [3][5] Financial Position - As of March 31, 2025, Aprea reported cash and cash equivalents of $19.3 million, down from $22.8 million at the end of 2024, which is projected to cover operating expenses into early Q2 2026 [10][15] - The company reported an operating loss of $4.1 million for Q1 2025, compared to a loss of $3.1 million in Q1 2024, with R&D expenses increasing to $2.5 million due to the initiation of new clinical trials [10][17] Business Strategy - Aprea is focused on developing therapies that exploit cancer cell vulnerabilities while minimizing damage to healthy cells, targeting cancers with specific mutations [11][9] - The company has entered into a Material Transfer Agreement with MD Anderson Cancer Center to support preclinical research on APR-1051 for treating head and neck cancers [10]
Aprea Therapeutics Announces Dosing of Patient with HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) in Ongoing ACESOT-1051 Trial
Newsfilter· 2025-03-31 12:30
Core Insights - Aprea Therapeutics has initiated dosing of the first patient with HPV+ head and neck squamous cell carcinoma in the ACESOT-1051 clinical trial evaluating APR-1051, marking a significant milestone in the study [1][4] - The ACESOT-1051 trial aims to assess the safety and efficacy of APR-1051, a WEE1 inhibitor, in patients with advanced solid tumors, particularly those with specific gene alterations [3][5] Company Overview - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells [1][7] - The company's lead product, APR-1051, is a small molecule designed to address tolerability issues associated with the WEE1 class of inhibitors [3][7] Clinical Trial Details - The ACESOT-1051 trial is a Phase 1 study that will evaluate APR-1051's safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy in advanced solid tumors [5][6] - The trial consists of two parts: Part 1 focuses on dose escalation with an expected enrollment of up to 39 patients, while Part 2 aims for dose optimization with up to 40 patients [5][6] HPV+ Cancer Context - HPV+ head and neck squamous cell carcinoma is characterized by defects in the DNA damage response pathway, making it a potential target for WEE1 inhibition [2] - Approximately 70% of the 20,000 annual cases of oropharyngeal squamous cell carcinoma in the U.S. are linked to HPV [2]
Aprea Therapeutics(APRE) - 2024 Q4 - Annual Report
2025-03-25 12:45
Financial Condition - The company incurred a net loss of $14.3 million for the year ended December 31, 2023, and an accumulated deficit of $321.0 million as of the same date [271]. - The company has not generated any commercial revenue to date and expects to continue incurring significant operating losses for the foreseeable future [271]. - The company has approximately $22.8 million in cash and cash equivalents as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern [276]. - The company has identified conditions that raise substantial doubt regarding its ability to continue as a going concern within one year after the filing of its Annual Report [276]. - The company has incurred significant losses since inception and may never achieve or maintain profitability [271]. - The company expects expenses to increase due to planned operations and will finance cash needs through equity offerings, debt financings, collaborations, and strategic alliances [286]. - Future capital requirements will depend on various factors, including the costs and outcomes of clinical trials and regulatory reviews [285]. - The company may need to seek additional funds sooner than planned due to changing circumstances and potential faster capital consumption [285]. - The company faces risks from global economic uncertainty, including geopolitical conflicts and regulatory changes, which could adversely affect its financial condition [288]. Product Development and Clinical Trials - The company is substantially dependent on the success of its product candidates ATRN-119 and APR-1051, which are currently in clinical development [264]. - The company has never obtained marketing approval for any product candidate and may face challenges in doing so in the future [268]. - The company is in the early stages of testing product candidates ATRN-119 and APR-1051 in Phase 1 clinical trials, with no later phase trials conducted yet [308]. - The company has filed and obtained INDs for ATRN-119 and APR-1051, but may face delays in filing INDs for other candidates due to manufacturing or study delays [309]. - The success of ATRN-119 and APR-1051 will depend on timely patient enrollment and completion of clinical trials, as well as obtaining marketing approvals [306]. - Patient enrollment in clinical trials is critical, and difficulties in enrollment could delay necessary marketing approvals [315]. - Adverse events during clinical trials could lead to interruptions or halts in trials, affecting the approval process by the FDA [321]. - The company has limited experience in conducting clinical trials, which may hinder the ability to complete pivotal trials [312]. - The company may need to conduct additional clinical trials or testing, which could lead to unplanned costs and delays in obtaining marketing approval [335]. - There is a high failure rate for product candidates in clinical trials, and setbacks could materially harm the company's business and financial condition [308]. - Clinical trials are lengthy and costly, with no assurance that they will demonstrate safety and efficacy to the satisfaction of regulatory authorities, potentially leading to additional funding needs [331]. Competition and Market Risks - The company may face substantial competition from larger pharmaceutical and biotechnology companies with greater resources and expertise [347]. - The commercial opportunity could be diminished if competitors develop safer or more effective drugs that gain market approval faster [348]. - Market acceptance of approved products is uncertain and may depend on factors such as efficacy, safety, and the willingness of healthcare providers to prescribe them [344]. - The company may need to develop companion diagnostic tests for its product candidates, which could present additional challenges and delays [339]. - The company is developing ATRN-119, an orally bioavailable small molecule targeting Ataxia ATR protein, which may face significant competition from other late-stage clinical drugs [352]. - APR-1051, another product candidate, is an orally bioavailable small molecule inhibitor of WEE1, with potential competition from various other companies' products in clinical development [353]. Regulatory and Compliance Challenges - The company must comply with stringent regulatory requirements for clinical trials and manufacturing, and failure to do so could result in significant sanctions [390]. - The FDA placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine, and a clinical hold on trials evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab [374]. - Regulatory agencies may require extensive additional clinical trials post-approval, which could be expensive and time-consuming, potentially limiting or withdrawing product sales [363]. - The company may be subject to unfavorable pricing regulations and reimbursement policies that could negatively impact revenue generation from approved products [366]. - Coverage and reimbursement from government authorities and private insurers are uncertain, which may affect the demand and pricing of commercialized products [367]. Intellectual Property Risks - The company faces risks related to intellectual property, including potential challenges to the validity and enforceability of its patents, which could adversely affect its business and financial condition [399]. - The patent portfolio for eprenetapopt consists of method-of-use and formulation patent claims, but does not include composition-of-matter patents, which may limit competitive protection [406]. - The company may need to cease development or commercialization of product candidates if it cannot obtain necessary licenses from third parties involved in patent disputes [413]. - The company may face significant harm if it fails to obtain patent term extensions or data exclusivity for its product candidates, which could allow competitors to launch similar products after patent expiration [416]. - The company may incur substantial costs and time in defending its patents against infringement claims, which could distract from its core business operations [424]. Sales and Marketing Challenges - The company lacks a sales and marketing infrastructure and has no experience in selling or marketing pharmaceutical drugs, which may hinder commercialization efforts [357]. - Establishing a sales and marketing organization or outsourcing these functions could incur significant costs and delays in product launches [358]. - The company may face adverse effects on sales if the FDA approves generic versions of its product candidates, as generic drugs typically capture a significant percentage of sales from branded products [361]. - The lengthy approval process and unpredictability of clinical trial results may hinder the marketing approval of ATRN-119, significantly harming the company's business and prospects [451]. Miscellaneous Risks - The company may encounter unforeseen expenses and difficulties as it transitions from a research-focused entity to one capable of supporting commercial activities [282]. - The company may have to relinquish valuable rights to technology or revenue streams if it raises additional funds through collaborations or licensing arrangements [287]. - The company is dependent on a single third-party manufacturer for the active pharmaceutical ingredient, increasing the risk of supply issues [385]. - The company currently holds clinical trial liability insurance coverage for up to $5.0 million, which may not be adequate to cover all potential liabilities [370]. - The consequences of the U.K.'s withdrawal from the EU remain largely unknown, creating uncertainty regarding macro-economic and financial implications [455].
Aprea Therapeutics(APRE) - 2024 Q4 - Annual Results
2025-03-25 12:40
Drug Development and Clinical Trials - Aprea Therapeutics is advancing its WEE1 inhibitor, APR-1051, which has shown a 29.4% overall response rate (ORR) in a Phase 2 study for recurrent uterine serous carcinoma[16]. - The company is currently enrolling the fourth cohort in a Phase 1 study for APR-1051, with safety and efficacy data expected in H1 2025[6]. - Aprea's ATR inhibitor, ATRN-119, is in a Phase 1/2a study, with data readout anticipated in H2 2025[6]. - The clinical study for ACESOT-1051 is enrolling up to 79 patients, focusing on advanced solid tumors with specific gene alterations[40]. - The ongoing study for ATRN-119 aims to establish a maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) with a total enrollment of up to 132 patients[62]. - The study design for ATRN-119 includes a dose escalation phase with up to 72 patients, followed by a dose expansion phase[62]. - Aprea Therapeutics is conducting ongoing Phase 1/2a clinical studies for ATRN-119, with preliminary signs of clinical benefit observed at low doses[74]. Drug Safety and Efficacy - Aprea's WEE1 inhibitor has demonstrated minimal off-target effects, preserving hematologic safety profiles in clinical trials[6]. - APR-1051 has shown negligible inhibition of hERG channels, suggesting a low risk of QT prolongation at effective doses[29]. - APR-1051 has been reported to be safe and well-tolerated, with no hematologic toxicity observed in preclinical studies[48]. - No serious adverse events (SAE) or Grade 4 adverse events related to ATRN-119 were reported, with the most common adverse events being Grade 1 and Grade 2[71]. - ATRN-119 is potentially differentiated from other ATR inhibitors in selectivity and toxicity profile, providing continuous tumor suppression[74]. Financial Position and Funding - Aprea Therapeutics reported cash and equivalents of approximately $22.8 million as of December 31, 2024[77]. - The company closed a private placement of common stock in March 2024, raising approximately $16.0 million, with potential additional funds of up to $18.0 million from warrant exercises[77]. - Aprea Therapeutics is financed into Q4 2025, with near-term catalysts expected from ongoing clinical trials[81]. Strategic Goals and Market Positioning - The company aims to identify lead candidates for its discovery platform by 2024, focusing on optimizing drug development[6]. - Aprea's clinical pipeline includes multiple anticipated milestones from 2024 to 2026, indicating a robust development strategy[7]. - The company emphasizes the need for highly efficient WEE1 inhibitors with improved safety profiles, addressing significant unmet medical needs in oncology[16]. - The company is focused on expanding its market presence through innovative therapies that address critical gaps in cancer treatment[5]. - Aprea Therapeutics has a strong intellectual property portfolio, including four issued US patents protecting lead molecules and analogs[76]. - The company aims to achieve short-term inflection points and evaluate optimal strategic partnerships in the oncology space[81]. - The company has opportunities in various cancers, including ovarian, colorectal, prostate, and breast cancers, with both single-agent and combination therapies being explored[81]. Drug Characteristics and Performance - APR-1051 demonstrated a Cmax of 1,460 ng/ml at a dose of 10 mg/kg/day, indicating potentially favorable drug exposure compared to competitors[28]. - In preclinical studies, APR-1051 showed a tumor volume reduction in OVCAR-3 xenograft models, with significant suppression of tumor growth[32]. - ATRN-119 exhibits near-dose proportional exposure following oral administration, with a Tmax of approximately 2 hours and a half-life estimated between 4-6 hours[68][74]. - APR-1051 is being developed as a best-in-class WEE1 inhibitor, targeting specific cancer-associated gene alterations[47]. - ATRN-119 is positioned as a potentially best-in-class oral ATR inhibitor, with continuous daily dosing being evaluated[55].
Aprea Therapeutics Announces Agreement with MD Anderson Cancer Center to Explore APR-1051 as a Potential Treatment for Head and Neck Squamous Cell Carcinoma (HNSCC)
Globenewswire· 2025-03-11 12:30
Core Viewpoint - Aprea Therapeutics has entered into a Material Transfer Agreement with MD Anderson Cancer Center to supply its WEE1 kinase inhibitor, APR-1051, for preclinical research on head and neck squamous cell carcinoma (HNSCC) [1][2][3] Group 1: Agreement and Research Goals - The agreement allows MD Anderson to conduct preclinical experiments to generate efficacy and mechanistic data for future clinical trials [2] - The research aims to characterize the therapeutic potential of APR-1051 in treating both HPV+ and HPV- HNSCC tumors [2][3] - The project is overseen by leading experts in head and neck cancers, Professors Jeffrey N. Myers and Abdullah A. Osman [2] Group 2: Clinical Significance and Background - HNSCC, particularly HPV-associated cases, poses significant clinical challenges, with approximately 70% of oropharyngeal squamous cell carcinoma (OPSCC) cases in the US linked to HPV [4] - Previous studies at MD Anderson indicated that HPV+ HNSCC tumor lines are sensitive to WEE1 kinase inhibition, suggesting a promising therapeutic target [4] - The inhibition of WEE1 kinase may enhance the sensitivity of cancer cells to existing treatments, representing a novel therapeutic strategy [3] Group 3: Product Information - APR-1051 is a potent and selective small molecule designed to address tolerability challenges and potentially achieve greater clinical activity than other WEE1 inhibitors [6] - The candidate is currently being evaluated in the ongoing ACESOT-1051 clinical trial for advanced solid tumors with cancer-associated gene alterations [6] - Aprea retains all rights to APR-1051 under the terms of the agreement with MD Anderson [5] Group 4: Company Overview - Aprea Therapeutics focuses on innovative cancer treatments that exploit vulnerabilities in cancer cell mutations while minimizing damage to healthy cells [7] - The company's lead programs include APR-1051 and ATRN-119, both in clinical development for solid tumor indications [7]