Allarity Therapeutics to Begin Enrollment for New Phase 2 Protocol to Advance Stenoparib Toward FDA Approval in Advanced Ovarian Cancer Patients
Allarity Therapeutics (NASDAQ: ALLR) announced the initiation of a new Phase 2 protocol for stenoparib in ovarian cancer, with patient enrollment ready to begin at U.S. clinical sites. The protocol was developed following review of ongoing Phase 2 data and consultation with ovarian cancer experts and FDA input.
The current Phase 2 study has shown promising results, including a complete confirmed response and two patients maintaining treatment without progression for over 17 months. The new protocol aims to provide critical data by summer 2026 for a pivotal registration trial.
The trial will evaluate stenoparib's impact on the Wnt pathway in the $9B+ PARP inhibitor market. The study will assess both the current twice-daily dosing and an additional dose level to optimize clinical benefit. Allarity plans to pursue expedited regulatory pathways for approval in the first half of 2025, advancing both stenoparib and its companion diagnostic stenoparib-DRP simultaneously.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato l'avvio di un nuovo protocollo di Fase 2 per stenoparib nel cancro ovarico, con l'arruolamento dei pazienti pronto a cominciare presso i siti clinici negli Stati Uniti. Il protocollo è stato sviluppato a seguito della revisione dei dati attuali della Fase 2 e della consultazione con esperti in cancro ovarico e input della FDA.
Lo studio di Fase 2 attuale ha mostrato risultati promettenti, compresa una risposta completa confermata e due pazienti che mantengono il trattamento senza progressione per oltre 17 mesi. Il nuovo protocollo mira a fornire dati critici entro l'estate del 2026 per un trial di registrazione fondamentale.
Il trial valuterà l'impatto di stenoparib sulla via Wnt nel mercato degli inibitori PARP da oltre 9 miliardi di dollari. Lo studio valuterà sia il dosaggio attuale due volte al giorno che un ulteriore livello di dosaggio per ottimizzare il beneficio clinico. Allarity prevede di perseguire percorsi normativi accelerati per l'approvazione nella prima metà del 2025, avanzando sia stenoparib che il suo diagnostico companion stenoparib-DRP simultaneamente.
Allarity Therapeutics (NASDAQ: ALLR) anunció el inicio de un nuevo protocolo de Fase 2 para el stenoparib en cáncer de ovario, con la inscripción de pacientes lista para comenzar en sitios clínicos de EE. UU. El protocolo se desarrolló tras la revisión de los datos en curso de la Fase 2 y la consulta con expertos en cáncer de ovario y la opinión de la FDA.
El estudio actual de Fase 2 ha mostrado resultados prometedores, incluyendo una respuesta completa confirmada y dos pacientes que han mantenido el tratamiento sin progresión durante más de 17 meses. El nuevo protocolo tiene como objetivo proporcionar datos críticos para el verano de 2026 para un ensayo de registro pivotal.
El ensayo evaluará el impacto del stenoparib en la vía Wnt en el mercado de inhibidores PARP de más de 9 mil millones de dólares. El estudio evaluará tanto la dosificación actual dos veces al día como un nivel adicional de dosis para optimizar el beneficio clínico. Allarity planea seguir caminos regulatorios acelerados para la aprobación en la primera mitad de 2025, avanzando simultáneamente tanto el stenoparib como su diagnóstico companion stenoparib-DRP.
Allarity Therapeutics (NASDAQ: ALLR)는 난소암에 대한 stenoparib의 새로운 2상 프로토콜을 시작한다고 발표했으며, 미국 임상 사이트에서 환자 등록이 곧 시작될 예정입니다. 이 프로토콜은 진행 중인 2상 데이터 검토 및 난소암 전문가와 FDA의 의견을 바탕으로 개발되었습니다.
현재 2상 연구는 완전한 확인된 반응과 17개월 이상 진행 없이 치료를 유지하는 두 환자를 포함하여 유망한 결과를 보여주었습니다. 새로운 프로토콜은 2026년 여름까지 중요한 데이터를 제공하는 것을 목표로 하고 있습니다.
이 시험은 90억 달러 이상의 PARP 억제제 시장에서 stenoparib의 Wnt 경로에 대한 영향을 평가할 것입니다. 연구는 현재의 하루 두 번 복용량과 임상적 이점을 최적화하기 위한 추가 복용량 수준을 평가할 것입니다. Allarity는 2025년 상반기 내 승인을 위한 신속한 규제 경로를 추구할 계획이며, stenoparib와 그 동반 진단인 stenoparib-DRP를 동시에 발전시킬 것입니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé le lancement d'un nouveau protocole de Phase 2 pour le stenoparib dans le cancer de l'ovaire, avec l'inscription des patients prête à commencer sur des sites cliniques aux États-Unis. Le protocole a été développé après un examen des données en cours de Phase 2 et une consultation avec des experts en cancer de l'ovaire ainsi que des retours de la FDA.
La présente étude de Phase 2 a montré des résultats prometteurs, y compris une réponse complète confirmée et deux patientes maintenant le traitement sans progression pendant plus de 17 mois. Le nouveau protocole vise à fournir des données critiques d'ici l'été 2026 pour un essai d'enregistrement décisif.
L'essai évaluera l'impact du stenoparib sur la voie Wnt dans le marché des inhibiteurs PARP de plus de 9 milliards de dollars. L'étude évaluera à la fois la posologie actuelle deux fois par jour et un niveau de dose supplémentaire pour optimiser le bénéfice clinique. Allarity prévoit de poursuivre des voies réglementaires accélérées pour l'approbation dans la première moitié de 2025, faisant avancer simultanément le stenoparib et son diagnostic compagnon, le stenoparib-DRP.
Allarity Therapeutics (NASDAQ: ALLR) hat den Beginn eines neuen Phase-2-Protokolls für Stenoparib bei Eierstockkrebs angekündigt, wobei die Patientenrekrutierung an klinischen Standorten in den USA bereit zur Aufnahme ist. Das Protokoll wurde nach Überprüfung der laufenden Phase-2-Daten und Konsultationen mit Experten für Eierstockkrebs sowie Rückmeldungen von der FDA entwickelt.
Die aktuelle Phase-2-Studie hat vielversprechende Ergebnisse gezeigt, darunter eine vollständig bestätigte Reaktion und zwei Patienten, die ihre Behandlung ohne Fortschreiten über 17 Monate aufrechterhalten haben. Das neue Protokoll zielt darauf ab, bis zum Sommer 2026 entscheidende Daten für eine wegweisende Zulassungsstudie bereitzustellen.
Die Studie wird die Auswirkungen von Stenoparib auf den Wnt-Weg im 9 Milliarden Dollar+ PARP-Inhibitorenmarkt bewerten. Die Studie wird sowohl die aktuelle zweimal tägliche Dosierung als auch eine zusätzliche Dosisstufe zur Optimierung des klinischen Nutzens bewerten. Allarity plant, im ersten Halbjahr 2025 beschleunigte regulatorische Wege zur Genehmigung zu verfolgen und gleichzeitig sowohl Stenoparib als auch seinen Begleitdiagnosetest Stenoparib-DRP voranzutreiben.
- Two patients in ongoing Phase 2 trial showing sustained response for over 17 months
- Complete confirmed response observed in platinum-resistant advanced ovarian cancer patients
- New drug manufacturing completed and product ready for immediate trial initiation
- Protocol received FDA input and IRB approval for first trial sites
- Final approval timeline extends to 2025, requiring additional clinical validation
- Multiple dose levels still being evaluated, indicating optimal dosing not yet determined
Insights
The new Phase 2 protocol for stenoparib represents a significant milestone in Allarity's clinical development strategy, with several key advantages that strengthen its market position:
The dual PARP/Wnt pathway inhibition mechanism is particularly noteworthy, as it differentiates stenoparib from existing PARP inhibitors in the market. This unique mechanism could potentially address resistance mechanisms that limit current PARP inhibitor efficacy, especially given the Wnt pathway's established role in ovarian cancer progression and chemoresistance.
The durability data is particularly compelling - two patients maintaining treatment beyond 17 months in platinum-resistant advanced ovarian cancer is noteworthy, as this population typically shows progression within 3-6 months on standard therapies. The inclusion of a complete confirmed response further validates the drug's potential efficacy.
The parallel development of the stenoparib-DRP companion diagnostic represents a strategic approach to personalized medicine. This diagnostic tool could potentially improve patient selection, enhancing response rates and providing a competitive advantage in the crowded PARP inhibitor space.
Several de-risking elements are evident:
- IRB approval and site readiness indicate strong institutional support
- Completed manufacturing campaign ensures no supply chain delays
- Protocol design incorporating FDA's Project Optimus guidelines (which emphasize optimal dosing rather than maximum tolerated dose) aligns with current regulatory preferences
- Multiple accepted abstracts suggest robust data package
The summer 2026 timeline for pivotal data readout provides a clear catalyst pathway. The protocol's design to explore an additional dose level while building on existing twice-daily dosing data demonstrates a thoughtful approach to dose optimization, potentially strengthening the eventual regulatory submission.
- Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already delivered
- Trial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approval
- Two patients in the ongoing phase 2 trial have now exceeded 17 months on stenoparib treatment
Boston (February 24, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific patient selection technology—the Drug Response Predictor (DRP®)—today announced that the new protocol for its Phase 2 clinical trial of stenoparib in ovarian cancer is set to begin and will be expected to provide critical data by end of summer 2026 for a pivotal registration trial.
The new protocol design was constructed following in-depth review of the Company’s ongoing Phase 2 clinical data in collaboration with key ovarian cancer thought leaders and treating physicians, including the gynecologic oncologists who have been treating patients with stenoparib in the ongoing phase 2 study. This comprehensive review revealed compelling evidence for stenoparib’s durable clinical benefit in platinum-resistant, advanced ovarian cancer patients, including a complete, confirmed response as well as two patients remaining on therapy without progression for more than 17 months. The protocol reflects the feedback of these gynecologic oncology experts as well as input from the FDA. The protocol has now also been approved by the Institutional Review Board of the first trial sites, paving the way for the trial to begin patient enrollment immediately. Anticipating IRB approval, to advance stenoparib, Allarity recently completed a new drug manufacturing campaign and has readied finished drug product for delivery to sites to expedite patient enrollment.
”The intensive review and finalization of this new protocol, with feedback from the FDA, the IRB and our treating physicians marks a critical milestone in our effort to accelerate stenoparib as a potentially safer, more effective alternative to additional lines of chemotherapy,” said Thomas Jensen, CEO of Allarity Therapeutics. “Importantly, this new protocol simultaneously allows us to accelerate the development of stenoparib alongside the stenoparib-DRP as a companion diagnostic. Pushing both in parallel will generate the critical data needed to support timely, connected regulatory approval for both. We are very excited about the thoughtful, unique design of this new protocol as it allows us to quickly and effectively get stenoparib into the hands of the world’s best gynecologic oncologists, benefiting patients who need safer and more effective treatment options than the toxic chemotherapy options they would otherwise have to rely upon. We are particularly excited about the prospects of this trial advancing stenoparib’s journey toward commercialization.”
This new protocol was designed expressly to enrich the understanding of clinical benefit in a well-defined ovarian cancer patient population with significant unmet medical need. In addition to further deepening the clinical experience for stenoparib, this trial will allow for the evaluation of the impact of stenoparib on the Wnt pathway, a critical cellular signaling pathway implicated in advanced ovarian cancer and multiple other malignancies, including colon cancer. A deeper understanding of stenoparib’s role in modulating the Wnt pathway would further differentiate stenoparib in the
Allarity expects to pursue multiple advantaged regulatory pathways to expedite approval in the first half of 2025. Allarity will also be presenting key data, with abstracts now accepted, at multiple upcoming scientific and clinical conferences. Details will be announced as embargo policies for these conferences allow.
About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the continued development and regulatory progress of stenoparib, as well as plans to implement a new clinical protocol, including collaboration with leading U.S.
clinical trial sites. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the successful execution of clinical trials for stenoparib, securing regulatory approval, and other operational and financial risks that could impact the Company’s ability to achieve its goals. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form S-1/A registration statement filed on April 17, 2024, our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”) and our Form 10-Q quarterly report filed with the SEC on November 14, 2024, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
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Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
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FAQ
What are the key results from Allarity's (ALLR) ongoing Phase 2 stenoparib trial?
When will Allarity Therapeutics (ALLR) complete the new Phase 2 stenoparib trial?
What is the market potential for Allarity's (ALLR) stenoparib drug?
When does Allarity (ALLR) expect FDA approval for stenoparib?
What makes stenoparib different from other ovarian cancer treatments?
