Aprea Therapeutics Announces Dosing of Patient with HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) in Ongoing ACESOT-1051 Trial
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 (NASDAQ: APRE) ha annunciato la somministrazione del primo paziente con carcinoma squamoso della testa e del collo (HNSCC) positivo per HPV nel Coorte 5 del trial clinico ACESOT-1051 in corso, che valuta APR-1051 a 70mg una volta al giorno. Il trial si sta espandendo per mirare a popolazioni che hanno maggiori probabilità di beneficiare dell'inibizione di WEE1.
Il trial di Fase 1 sta studiando APR-1051, una piccola molecola potente e selettiva, in pazienti con tumori solidi avanzati. I dati dell'etichetta aperta sono attesi nel secondo semestre del 2025. Lo studio consiste di due parti: Parte 1 per l'escalation della dose (fino a 39 pazienti) e Parte 2 per l'ottimizzazione della dose (fino a 40 pazienti).
Il significato del trial è evidenziato da statistiche che mostrano che circa il 70% dei 20.000 casi annuali di carcinoma squamoso orofaringeo negli Stati Uniti sono correlati all'HPV. Lo studio è condotto presso il MD Anderson Cancer Center, con il quale Aprea ha stipulato un Accordo di Trasferimento di Materiale per ulteriori ricerche precliniche.
Aprea Therapeutics (NASDAQ: APRE) ha anunciado la dosificación del primer paciente con carcinoma de células escamosas de cabeza y cuello (HNSCC) positivo para HPV en la Cohorte 5 del ensayo clínico ACESOT-1051 en curso, que evalúa APR-1051 a 70mg una vez al día. El ensayo se está expandiendo para dirigirse a poblaciones que probablemente se beneficien de la inhibición de WEE1.
El ensayo de Fase 1 está estudiando APR-1051, una pequeña molécula potente y selectiva, en pacientes con tumores sólidos avanzados. Se esperan datos de etiqueta abierta en la segunda mitad de 2025. El estudio consta de dos partes: Parte 1 para la escalación de dosis (hasta 39 pacientes) y Parte 2 para la optimización de dosis (hasta 40 pacientes).
La importancia del ensayo se destaca con estadísticas que muestran que aproximadamente el 70% de los 20,000 casos anuales de carcinoma de células escamosas orofaríngeas en EE. UU. están relacionados con el HPV. El estudio se lleva a cabo en el MD Anderson Cancer Center, con el cual Aprea ha firmado un Acuerdo de Transferencia de Material para investigación preclínica adicional.
Aprea Therapeutics (NASDAQ: APRE)는 ongoing ACESOT-1051 임상 시험의 Cohort 5에서 첫 번째 HPV+ 두경부 편평세포암(HNSCC) 환자의 투여를 발표했습니다. 이 시험은 하루에 70mg의 APR-1051을 평가하고 있으며, WEE1 억제를 통해 혜택을 볼 가능성이 높은 인구를 대상으로 확대되고 있습니다.
1상 시험은 진행성 고형 종양 환자에서 강력하고 선택적인 소분자 APR-1051을 연구하고 있습니다. 공개 라벨 데이터는 2025년 하반기에 예상됩니다. 연구는 두 부분으로 구성되어 있습니다: 1부는 용량 증가(최대 39명 환자) 및 2부는 용량 최적화(최대 40명 환자)입니다.
이 시험의 중요성은 미국에서 매년 발생하는 20,000건의 인두 편평세포암 중 약 70%가 HPV와 관련이 있다는 통계로 강조됩니다. 이 연구는 MD Anderson Cancer Center에서 수행되고 있으며, Aprea는 추가 전임상 연구를 위한 물질 이전 계약을 체결했습니다.
Aprea Therapeutics (NASDAQ: APRE) a annoncé la dose du premier patient atteint de carcinome à cellules squameuses de la tête et du cou (HNSCC) positif pour le HPV dans la Cohorte 5 de l'essai clinique ACESOT-1051 en cours, évaluant APR-1051 à 70mg une fois par jour. L'essai s'élargit pour cibler les populations les plus susceptibles de bénéficier de l'inhibition de WEE1.
L'essai de Phase 1 étudie APR-1051, une petite molécule puissante et sélective, chez des patients atteints de tumeurs solides avancées. Les données en ouvert sont attendues au second semestre 2025. L'étude se compose de deux parties : Partie 1 pour l'escalade de dose (jusqu'à 39 patients) et Partie 2 pour l'optimisation de dose (jusqu'à 40 patients).
L'importance de l'essai est soulignée par des statistiques montrant qu'environ 70 % des 20 000 cas annuels de carcinome à cellules squameuses oropharyngés aux États-Unis sont liés au HPV. L'étude est menée au MD Anderson Cancer Center, avec lequel Aprea a signé un Accord de Transfert de Matériel pour des recherches précliniques supplémentaires.
Aprea Therapeutics (NASDAQ: APRE) hat die Dosis des ersten HPV+ Kopf-Hals-Plattenepithelkarzinom (HNSCC) Patienten in Kohorte 5 der laufenden ACESOT-1051-Studie bekannt gegeben, die APR-1051 bei 70mg einmal täglich bewertet. Die Studie wird ausgeweitet, um Bevölkerungsgruppen anzusprechen, die am wahrscheinlichsten von der WEE1-Hemmung profitieren.
Die Phase-1-Studie untersucht APR-1051, ein potentes und selektives kleines Molekül, bei Patienten mit fortgeschrittenen soliden Tumoren. Offene Studiendaten werden im 2. Halbjahr 2025 erwartet. Die Studie besteht aus zwei Teilen: Teil 1 zur Dosissteigerung (bis zu 39 Patienten) und Teil 2 zur Dosisoptimierung (bis zu 40 Patienten).
Die Bedeutung der Studie wird durch Statistiken unterstrichen, die zeigen, dass etwa 70% der jährlich 20.000 Fälle von oropharyngealem Plattenepithelkarzinom in den USA HPV-assoziiert sind. Die Studie wird am MD Anderson Cancer Center durchgeführt, mit dem Aprea eine Materialübertragungsvereinbarung für zusätzliche präklinische Forschung unterzeichnet hat.
- First HPV+ HNSCC patient dosed in Phase 1 trial, expanding potential market opportunity
- Strategic collaboration with MD Anderson Cancer Center through Material Transfer Agreement
- Trial progressing with encouraging safety profile to date
- Early-stage Phase 1 trial with no efficacy data yet
- Results not expected until second half of 2025
Insights
The dosing of an HPV+ head and neck cancer patient in Cohort 5 (70mg once daily) of the ACESOT-1051 trial represents incremental progress in Aprea's clinical development plan. This Phase 1 trial has now advanced through multiple dose escalation cohorts (10mg, 20mg, 30mg, 50mg, and now 70mg), suggesting acceptable safety at previous dose levels, though specific safety data wasn't disclosed.
The trial's design is methodologically sound, transitioning from accelerated titration in early cohorts to a Bayesian Optimal Interval approach for higher doses - a standard approach for managing unknown toxicity risks. With up to 39 patients planned for Part 1 (dose escalation) and 40 patients for Part 2 (dose optimization), this represents a robust Phase 1 program.
What's particularly notable is the strategic expansion to include HPV+ HNSCC patients, targeting a biologically rational population with DNA damage response defects that theoretically make them susceptible to WEE1 inhibition. This indicates Aprea is refining its development strategy toward precision oncology, focusing on mechanistically-aligned patient populations rather than pursuing a broad approach.
The parallel Material Transfer Agreement with MD Anderson for preclinical research further supports this targeted strategy, potentially generating supporting translational data. However, investors should note that meaningful clinical efficacy data remains pending until H2 2025, making this a milestone of progress rather than a definitive value inflection point.
The expansion of ACESOT-1051 to include HPV+ head and neck squamous cell carcinoma is scientifically well-reasoned. HPV-driven cancers exhibit heightened replication stress and DNA damage response (DDR) deficiencies, creating a compelling biological rationale for WEE1 inhibition in this population.
The market opportunity is substantial - with
APR-1051's development focus on addressing the tolerability challenges seen with other WEE1 inhibitors is noteworthy. Earlier WEE1 inhibitors like adavosertib have shown promising activity but dose-limiting toxicities have hindered development. If APR-1051 can maintain efficacy while improving tolerability, it could potentially differentiate in this emerging drug class.
The partnership with MD Anderson to explore genomic markers of replication stress in both HPV+ and HPV- HNSCC demonstrates a sophisticated biomarker strategy that could eventually lead to patient selection beyond just HPV status. However, as a Phase 1 trial primarily focused on safety and dosing, evidence of clinical benefit remains to be established, and the open-label data expected in H2 2025 will be the true test of this program's potential.
ACESOT-1051 Trial Expanded to Include HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) Patients, Targeting Populations Most Likely to Benefit for WEEI Inhibition
DOYLESTOWN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today announced that a patient with HPV+ head and neck squamous cell carcinoma (HNSCC) has been dosed in the ongoing ACESOT-1051 clinical trial evaluating APR-1051. This is the first patient to be dosed in Cohort 5 (70 mg once daily) of the study. Open label data from the study are expected in the second half of 2025.
WEE1 inhibition has emerged as a promising strategy for targeting tumor cells with high replication stress and DNA damage accumulation. HPV driven cancers, including HPV+ HNSCC, are characterized by defects in the DDR pathway, making them potentially susceptible to WEE1 inhibition. HPV+ cancers are those where the underlying cause is persistent infection with human papillomavirus, a group of viruses that infect the skin and mucous membranes. A high proportion of HNSCC cases are attributable to HPV. An estimated
APR-1051 is a potent and selective small molecule that has been designed to potentially solve tolerability challenges of the WEE1 class. The ongoing ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) clinical trial is a Phase 1 trial evaluating single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated specific gene alterations.
“Enrollment of the first patient with HPV+ head and neck cancer in the Phase 1 ACESOT-1051 trial is an important step and is in line with our goal of identifying patient populations most likely to benefit from WEE1 inhibition,” said Philippe Pultar MD., Senior Medical Advisor and Lead WEE1 Clinical Development of Aprea. “We are pleased with the progress of the trial and encouraged by the safety profile of APR-1051 to date. We look forward to continuing the study as we work toward identifying the optimal dose for future studies. We continue to believe that APR-1051 has best in class potential.”
The latest patient in ACESOT-1051 was enrolled at MD Anderson Cancer Center. Aprea recently entered into a Material Transfer Agreement (MTA) with MD Anderson to support preclinical research aimed at exploring the potential of APR-1051 in treating HPV+ and HPV- head and neck squamous cell carcinoma (HNSCC) expressing genomic markers of replication stress.
ACESOT-1051 Study Design
ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) is designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in advanced solid tumors harboring cancer-associated gene alterations. Oral APR-1051 will be administered once daily for 28-day cycles. The study consists of two parts. Part 1 is dose escalation and is expected to enroll up to 39 patients with advanced solid tumors. The first three dose levels (10mg, 20mg and 30mg) used accelerated titration. Bayesian Optimal Interval (BOIN) design is now being employed for the remaining dose levels (50mg and above). Part 2 (up to 40 patients) is designed for dose optimization, with the goal of selecting the Recommended Phase 2 Dose (RP2D).
The primary objectives of the study are to measure safety, dose-limiting toxicities (DLTs), maximum tolerated dose or maximum administered dose (MTD/MAD), and RP2D; secondary objectives are to evaluate pharmacokinetics, preliminary efficacy according to RECIST or PCWG3 criteria; pharmacodynamics is an exploratory objective. The University of Texas MD Anderson Cancer Center is the lead site, and the study will be performed at between 3 and 10 sites in the U.S. For more information refer to clinicaltrials.gov NCT06260514.
About Aprea
Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs, our ability to continue as a going concern, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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