Allarity Therapeutics Announces Dosing of Second Patient in New Phase 2 Trial of Stenoparib in Advanced Ovarian Cancer
Allarity Therapeutics (NASDAQ: ALLR) has announced the dosing of the second patient in its new Phase 2 clinical trial of stenoparib, a dual PARP and WNT pathway inhibitor, for treating advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer.
The trial builds upon previous Phase 2 data that showed durable clinical benefit and favorable tolerability with twice-daily dosing. The study aims to evaluate stenoparib as a potential novel, targeted treatment option for patients with limited alternatives. Additionally, the trial will advance Allarity's proprietary Drug Response Predictor (DRP®) companion diagnostic and further study stenoparib's unique WNT-modulating mechanism of action.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato la somministrazione della seconda dose al secondo paziente nel suo nuovo studio clinico di Fase 2 su stenoparib, un inibitore duale delle vie PARP e WNT, per il trattamento del cancro ovarico avanzato, ricorrente, resistente al platino o non idoneo al trattamento con platino.
Lo studio si basa sui dati precedenti di Fase 2 che hanno evidenziato un beneficio clinico duraturo e una buona tollerabilità con somministrazione due volte al giorno. L’obiettivo è valutare stenoparib come possibile nuova opzione terapeutica mirata per pazienti con poche alternative. Inoltre, la sperimentazione permetterà di sviluppare ulteriormente il Drug Response Predictor (DRP®), il test diagnostico companion proprietario di Allarity, e approfondire il meccanismo d’azione unico di stenoparib che modula la via WNT.
Allarity Therapeutics (NASDAQ: ALLR) ha anunciado la dosificación del segundo paciente en su nuevo ensayo clínico de Fase 2 con stenoparib, un inhibidor dual de las vías PARP y WNT, para el tratamiento del cáncer de ovario avanzado, recurrente, resistente al platino o no apto para tratamiento con platino.
El ensayo se basa en datos previos de Fase 2 que mostraron un beneficio clínico duradero y buena tolerabilidad con dos dosis diarias. El estudio busca evaluar stenoparib como una posible nueva opción terapéutica dirigida para pacientes con alternativas limitadas. Además, el ensayo impulsará el diagnóstico complementario propietario Drug Response Predictor (DRP®) de Allarity y estudiará más a fondo el mecanismo único de acción modulador de la vía WNT de stenoparib.
Allarity Therapeutics (NASDAQ: ALLR)는 진행성, 재발성, 백금 내성 또는 백금 치료가 부적합한 난소암 치료를 위한 이중 PARP 및 WNT 경로 억제제인 stenoparib의 새로운 2상 임상시험에서 두 번째 환자에게 투약을 시작했다고 발표했습니다.
이 임상시험은 2상 이전 데이터에서 하루 두 번 투여 시 지속적인 임상적 이점과 우수한 내약성을 보여준 결과를 기반으로 합니다. 본 연구는 제한된 치료 옵션을 가진 환자들을 위해 stenoparib를 잠재적인 새로운 표적 치료제로 평가하는 것을 목표로 합니다. 또한, 이번 시험은 Allarity의 독자적인 Drug Response Predictor (DRP®) 동반진단을 발전시키고 stenoparib의 독특한 WNT 조절 작용기전을 추가 연구할 예정입니다.
Allarity Therapeutics (NASDAQ : ALLR) a annoncé la dose administrée au deuxième patient dans son nouvel essai clinique de phase 2 portant sur stenoparib, un inhibiteur double des voies PARP et WNT, destiné au traitement du cancer de l’ovaire avancé, récurrent, résistant au platine ou inéligible au traitement au platine.
L’essai s’appuie sur des données de phase 2 antérieures ayant montré un bénéfice clinique durable et une bonne tolérance avec une administration deux fois par jour. L’étude vise à évaluer le stenoparib comme une nouvelle option thérapeutique ciblée pour des patients disposant de peu d’alternatives. Par ailleurs, l’essai permettra de faire progresser le diagnostic compagnon propriétaire Drug Response Predictor (DRP®) d’Allarity et d’étudier plus en détail le mécanisme d’action unique modulant la voie WNT du stenoparib.
Allarity Therapeutics (NASDAQ: ALLR) hat die Dosierung des zweiten Patienten in seiner neuen Phase-2-Studie mit Stenoparib angekündigt, einem dualen PARP- und WNT-Signalweg-Inhibitor zur Behandlung von fortgeschrittenem, rezidivierendem, platinhresistentem oder platinnicht geeignetem Eierstockkrebs.
Die Studie baut auf früheren Phase-2-Daten auf, die einen dauerhaften klinischen Nutzen und eine gute Verträglichkeit bei zweimal täglicher Dosierung zeigten. Ziel der Studie ist es, Stenoparib als potenzielle neuartige, zielgerichtete Behandlungsoption für Patienten mit begrenzten Alternativen zu evaluieren. Darüber hinaus wird die Studie Allaritys firmeneigenen Drug Response Predictor (DRP®) Begleitdiagnostik voranbringen und den einzigartigen WNT-modulierenden Wirkmechanismus von Stenoparib weiter untersuchen.
- Rapid enrollment pace indicates strong investigator engagement
- Previous Phase 2 data showed durable clinical benefit and favorable tolerability
- Potential to address unmet medical need in platinum-resistant ovarian cancer patients
- Still in early Phase 2 stage with only second patient dosed
- Final trial results and potential FDA approval still far in the future
TARPON SPRINGS, Fla., June 27, 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 and WNT pathway inhibitor today announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer.
Commenting on the development, Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated:
“We are pleased to see the second patient enrolled so soon after the trial’s launch. This pace of enrollment suggests a strong level of engagement from our investigators, who appear highly attuned to the opportunity to explore stenoparib’s potential for patients with few or no remaining treatment options.”
This new trial builds on earlier Phase 2 data demonstrating durable clinical benefit and favorable tolerability with twice-daily dosing of stenoparib. It focuses on the platinum resistant patient population for whom current treatment options are extremely limited. Stenoparib may represent a novel, targeted and better-tolerated treatment option for these patients who are typically offered only marginally effective, toxic chemotherapies.
In parallel, this trial will serve to advance Allarity’s proprietary Drug Response Predictor (DRP®) companion diagnostic and further evaluate the WNT-modulating mechanism of action unique to stenoparib.
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, may 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 enhanced. 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 across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of 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 progress and expected pace of enrollment in the Company’s Phase 2 trial of stenoparib; the potential therapeutic benefit of stenoparib for patients with advanced ovarian cancer; and the Company’s efforts to develop and validate the DRP companion diagnostic. 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 clinical trial execution and enrollment rates; the potential for delays or negative outcomes in the trial; regulatory uncertainties; and the Company’s ability to generate and interpret clinical data to support future development milestones. 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 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, 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
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