Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian Cancer
Allarity Therapeutics (NASDAQ: ALLR) announced plans to expand its Phase 2 clinical trial for stenoparib in advanced ovarian cancer. The expanded protocol aims to optimize dosing and refine patient selection criteria using their proprietary Drug Response Predictor (DRP®) technology.
The new trial will focus specifically on patients with advanced, recurrent, platinum-resistant disease, a group that has shown durable clinical benefit from stenoparib in current trials, with some patients continuing therapy for over 14 months. The study will also investigate stenoparib's impact on the Wnt pathway, which is involved in advanced ovarian and colon cancers.
Patient enrollment is expected to begin in the first half of 2025 at U.S. trial sites, with potential expansion to U.K. locations. The trial will assess DRP scores for all enrolled patients to generate data supporting the companion diagnostic approval alongside stenoparib.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato piani per espandere il suo studio clinico di Fase 2 per stenoparib nel trattamento del carcinoma ovarico avanzato. Il protocollo ampliato mira a ottimizzare il dosaggio e affinare i criteri di selezione dei pazienti utilizzando la loro tecnologia proprietaria Drug Response Predictor (DRP®).
Il nuovo studio si concentrerà specificamente sui pazienti con malattia avanzata, ricorrente e resistente al platino, un gruppo che ha mostrato un beneficio clinico duraturo da stenoparib negli attuali trial, con alcuni pazienti che continuano la terapia per oltre 14 mesi. Lo studio indagherà inoltre l'impatto di stenoparib sulla via Wnt, coinvolta nei tumori ovarici e colon rettali avanzati.
Il reclutamento dei pazienti è previsto per iniziare nella prima metà del 2025 nei siti di sperimentazione statunitensi, con una potenziale espansione verso località nel Regno Unito. Il trial valuterà i punteggi DRP per tutti i pazienti arruolati per generare dati a supporto dell'approvazione diagnostica companion insieme a stenoparib.
Allarity Therapeutics (NASDAQ: ALLR) anunció planes para expandir su ensayo clínico de Fase 2 para stenoparib en cáncer de ovario avanzado. El protocolo ampliado tiene como objetivo optimizar la dosificación y refinar los criterios de selección de pacientes utilizando su tecnología propietaria Drug Response Predictor (DRP®).
El nuevo ensayo se centrará específicamente en pacientes con enfermedad avanzada, recurrente y resistente al platino, un grupo que ha mostrado un beneficio clínico duradero de stenoparib en los ensayos actuales, con algunos pacientes que continúan la terapia por más de 14 meses. El estudio también investigará el impacto de stenoparib en la vía Wnt, que está involucrada en los cánceres de ovario y colon avanzados.
Se espera que la inscripción de pacientes comience en la primera mitad de 2025 en sitios de ensayo en EE. UU., con una posible expansión a localidades en el Reino Unido. El ensayo evaluará las puntuaciones DRP para todos los pacientes inscritos para generar datos que apoyen la aprobación del diagnóstico compañero junto con stenoparib.
Allarity Therapeutics (NASDAQ: ALLR)는 진행성 난소암에 대한 stenoparib의 2상 임상시험을 확장할 계획을 발표했습니다. 확장된 프로토콜은 독점 소프트웨어 Drug Response Predictor (DRP®) 기술을 사용하여 용량을 최적화하고 환자 선택 기준을 개선하는 것을 목표로 합니다.
새로운 시험은 진행성, 재발성, 백금 내성 질환을 가진 환자에 특히 집중할 것이며, 이 그룹은 현재의 시험에서 stenoparib로부터 지속적인 임상적 혜택을 보였으며, 일부 환자는 14개월 이상 치료를 지속하고 있습니다. 이 연구는 또한 stenoparib가 진행성 난소암과 대장암에 관련된 Wnt 경로에 미치는 영향을 조사할 것입니다.
환자 등록은 2025년 상반기에 미국의 시험 사이트에서 시작될 것으로 예상되며, 영국의 위치로 확장될 가능성이 있습니다. 시험은 모든 등록된 환자의 DRP 점수를 평가하여 stenoparib와 함께 동반 진단 승인을 지원하는 데이터를 생성할 것입니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé des projets d'expansion de son essai clinique de Phase 2 pour le stenoparib dans le cancer de l'ovaire avancé. Le protocole élargi vise à optimiser le dosage et à affiner les critères de sélection des patients en utilisant leur technologie propriétaire Drug Response Predictor (DRP®).
Le nouvel essai se concentrera spécifiquement sur les patients présentant une maladie avancée, récurrente et résistante au platine, un groupe qui a montré un bénéfice clinique durable grâce au stenoparib dans les essais actuels, certains patients poursuivant le traitement pendant plus de 14 mois. L'étude investiguera également l'impact du stenoparib sur la voie Wnt, qui est impliquée dans les cancers avancés de l'ovaire et du colon.
L'inscription des patients devrait commencer dans la première moitié de 2025 sur des sites d'essai aux États-Unis, avec une expansion potentielle vers des lieux au Royaume-Uni. L'essai évaluera les scores DRP pour tous les patients inscrits afin de générer des données soutenant l'approbation du diagnostic compagnon avec le stenoparib.
Allarity Therapeutics (NASDAQ: ALLR) gab Pläne bekannt, die Phase-2-Studie für Stenoparib bei fortgeschrittenem Eierstockkrebs zu erweitern. Das erweiterte Protokoll zielt darauf ab, die Dosierung zu optimieren und die Auswahlkriterien für Patienten mithilfe ihrer proprietären Drug Response Predictor (DRP®)-Technologie zu verfeinern.
Die neue Studie wird sich speziell auf Patienten mit fortgeschrittenen, rezidivierenden und platinsensiblen Erkrankungen konzentrieren, einer Gruppe, die in aktuellen Studien einen nachhaltigen klinischen Nutzen von Stenoparib gezeigt hat, wobei einige Patienten die Therapie über 14 Monate fortsetzen. Die Studie wird auch die Auswirkungen von Stenoparib auf den Wnt-Weg untersuchen, der an fortgeschrittenen Eierstock- und Dickdarmkrebsarten beteiligt ist.
Die Patientenrekrutierung wird voraussichtlich in der ersten Hälfte des Jahres 2025 an US-Studienstandorten beginnen, mit möglicher Erweiterung auf Standorte im Vereinigten Königreich. Die Studie wird die DRP-Werte für alle registrierten Patienten bewerten, um Daten zu generieren, die die Genehmigung des begleitenden diagnostischen Verfahrens zusammen mit Stenoparib unterstützen.
- Current trial shows durable clinical benefit with patients continuing therapy for over 14 months
- Trial expansion targets commercially significant patient population with treatment options
- Potential for dual mechanism of action through PARP and Wnt pathway inhibition
- Development of companion diagnostic (CDx) could improve patient selection and treatment outcomes
- Trial expansion indicates need for additional data before seeking regulatory approval
- Patient enrollment hasn't started yet and is subject to regulatory review
- Current data based on diverse patient population with varied treatment histories
Insights
This clinical trial expansion represents a significant strategic refinement in Allarity's development of stenoparib, with several key implications for investors:
The focus on platinum-resistant ovarian cancer is particularly noteworthy. This patient population represents a substantial market opportunity with treatment options. Current standards of care typically show modest efficacy, making the 14+ month duration of clinical benefit observed in some patients particularly compelling.
The dual PARP/Wnt pathway inhibition mechanism differentiates stenoparib from existing PARP inhibitors like olaparib and niraparib. The Wnt pathway's involvement in both ovarian and colon cancers suggests potential pipeline expansion opportunities, effectively increasing the drug's market potential.
The refinement of the DRP® companion diagnostic is strategically crucial. A well-validated companion diagnostic could:
- Increase the probability of regulatory success by demonstrating enhanced efficacy in a selected patient population
- Support premium pricing through demonstrated superior outcomes in biomarker-positive patients
- Improve reimbursement prospects by identifying patients most likely to benefit
The company's pursuit of an "advantaged regulatory path" suggests potential for accelerated approval or breakthrough therapy designation, which could significantly expedite market entry. The timing of patient enrollment in H1 2025 indicates potential interim data readouts by year-end, providing near-term catalysts for investor consideration.
However, investors should note that success in Phase 2 trials doesn't guarantee Phase 3 success or regulatory approval. The company's market capitalization suggests significant upside potential if successful, but also reflects the inherent risks in clinical-stage oncology development.
Boston (February 6, 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 plans for the next step in advancing the clinical development of stenoparib toward FDA approval in advanced ovarian cancer. With this new phase 2 protocol, Allarity will capitalize and expand on the ongoing phase 2 clinical trial data to optimize the dose of stenoparib and to refine the DRP® patient selection criteria in order to maximize the clinical benefit from stenoparib.
An in-depth review of Allarity’s maturing clinical data, in collaboration with leading clinical investigators, prompted Allarity to design this new Phase 2 protocol to enable a more aggressive push of stenoparib toward regulatory approval. The protocol will enable new enrollment expressly focusing on patients with advanced, recurrent, platinum-resistant disease, a group that has shown durable clinical benefit from stenoparib in the current phase 2 trial and who have only limited treatment options following standard chemotherapy. In addition to expanding and deepening the clinical data set necessary for regulatory approval, this trial is also designed to enhance the understanding of stenoparib’s unique therapeutic mechanism of action. Of particular interest will be the impact of stenoparib treatment on the Wnt pathway, a key cellular pathway repeatedly shown to be involved in advanced ovarian cancers as well as many other advanced cancer types, most notably colon cancers. A richer understanding of stenoparib’s potential for controlling the Wnt pathway—a key aspect of the newly designed trial—could further distinguish stenoparib as a unique investigational cancer treatment.
The protocol will also further refine Allarity’s understanding of the stenoparib-DRP® for identifying patients most likely to benefit from stenoparib treatment. As part of the trial, a DRP score will be assessed for all enrolled patients to generate the deeper, more robust data set necessary to refine the DRP cut-off that would ring-fence patients most likely to benefit from stenoparib. These data will be fundamental for supporting any regulatory approval for the stenoparib-DRP as a companion diagnostic (CDx) specific to stenoparib.
The Company has previously announced long-lasting clinical benefit for advanced, recurrent ovarian cancer patients, with some of these patients continuing on therapy for more than 14 months. Based upon these encouraging clinical benefit data, Allarity intends to pursue an advantaged regulatory path toward approval to further enable stenoparib’s clinical development.
Patient enrollment is expected to begin in the first half of 2025, subject to final protocol review by regulatory authorities. Recruitment will commence at leading U.S. trial sites, with the potential inclusion of additional sites in the U.K. as warranted.
“Until now, patients receiving stenoparib have had diverse and often extensive treatment histories, with many being very heavily pretreated. Based on data we have gathered to date from our clinical trials, and through in-depth analysis and consultation with leading gynecologic oncologists, we have developed a new clinical trial protocol focused on a well-defined, commercially significant patient population in desperate need of newer, safer treatment options beyond more chemotherapy, which comes with well-documented side effects,” said Thomas Jensen, CEO of Allarity Therapeutics. “We are therefore pleased to have submitted this trial design and are eager to begin patient enrollment as soon as we receive the final green light from the regulatory authorities, including the FDA.”
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 selelct 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.
Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
X: https://twitter.com/allaritytx
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. 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.
###
Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
Attachment
FAQ
What is the purpose of Allarity's expanded Phase 2 trial for stenoparib (ALLR)?
When will Allarity Therapeutics (ALLR) begin patient enrollment for the expanded stenoparib trial?
How long have patients shown clinical benefit in Allarity's current stenoparib trial?
What is unique about stenoparib's mechanism of action in ALLR's clinical trials?
Where will Allarity Therapeutics (ALLR) conduct the expanded stenoparib trial?
