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Allarity Therapeutics Announces Research Collaboration with Indiana Biosciences Research Institute to Further Advance Understanding of Stenoparib’s Unique, Dual Therapeutic Mechanism of Action

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Allarity Therapeutics (NASDAQ: ALLR) has announced a research collaboration with Indiana Biosciences Research Institute (IBRI) to study stenoparib's dual mechanism of action. Stenoparib is a novel oral drug that uniquely combines PARP1/2 and tankyrase1/2 inhibition, targeting both DNA repair and WNT signaling pathway in cancer cells. The collaboration aims to understand how these dual mechanisms contribute to the drug's anticancer effects, particularly in cases resistant to standard treatments. This research will support Allarity's ongoing Phase 2 trial in advanced ovarian cancer and its combination trial with temozolomide in recurrent small cell lung cancer. The partnership is expected to enhance the company's DRP-based patient selection strategy and potentially expand therapeutic applications, including colorectal cancer treatment where WNT pathway activation is common.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato una collaborazione di ricerca con l'Indiana Biosciences Research Institute (IBRI) per studiare il duplice meccanismo d'azione di stenoparib. Stenoparib è un nuovo farmaco orale che combina in modo unico l'inibizione di PARP1/2 e tankyrase1/2, agendo sia sulla riparazione del DNA che sulla via di segnalazione WNT nelle cellule tumorali. La collaborazione mira a comprendere come questi due meccanismi contribuiscano agli effetti anticancro del farmaco, in particolare nei casi resistenti ai trattamenti standard. Questa ricerca supporterà la fase 2 in corso di Allarity nel carcinoma ovarico avanzato e lo studio in combinazione con temozolomide nel carcinoma polmonare a piccole cellule ricorrente. La partnership dovrebbe migliorare la strategia di selezione dei pazienti basata su DRP dell'azienda e potenzialmente ampliare le applicazioni terapeutiche, incluso il trattamento del cancro del colon-retto, dove l'attivazione della via WNT è comune.
Allarity Therapeutics (NASDAQ: ALLR) ha anunciado una colaboración de investigación con el Indiana Biosciences Research Institute (IBRI) para estudiar el mecanismo dual de acción de stenoparib. Stenoparib es un nuevo fármaco oral que combina de manera única la inhibición de PARP1/2 y tankyrase1/2, atacando tanto la reparación del ADN como la vía de señalización WNT en células cancerosas. La colaboración tiene como objetivo entender cómo estos mecanismos duales contribuyen a los efectos anticancerígenos del fármaco, especialmente en casos resistentes a tratamientos estándar. Esta investigación apoyará el ensayo de fase 2 en curso de Allarity en cáncer de ovario avanzado y el ensayo combinado con temozolomida en cáncer de pulmón de células pequeñas recurrente. Se espera que la asociación mejore la estrategia de selección de pacientes basada en DRP de la compañía y potencialmente amplíe las aplicaciones terapéuticas, incluyendo el tratamiento del cáncer colorrectal donde la activación de la vía WNT es común.
Allarity Therapeutics(NASDAQ: ALLR)는 인디애나 생명과학 연구소(IBRI)와 협력하여 스테노파립의 이중 작용 기전을 연구한다고 발표했습니다. 스테노파립은 PARP1/2와 탱크레이스1/2 억제를 독특하게 결합한 새로운 경구용 약물로, 암세포 내 DNA 수리와 WNT 신호 경로를 동시에 표적으로 합니다. 이번 협력은 이러한 이중 기전이 특히 기존 치료에 내성이 있는 경우에 약물의 항암 효과에 어떻게 기여하는지 이해하는 것을 목표로 합니다. 이 연구는 진행성 난소암에 대한 Allarity의 2상 임상시험과 재발성 소세포폐암에서 테모졸로마이드와의 병용 임상시험을 지원할 예정입니다. 이번 파트너십은 회사의 DRP 기반 환자 선별 전략을 강화하고, WNT 경로 활성화가 흔한 대장암 치료 등 치료 적용 범위를 확대할 가능성이 있습니다.
Allarity Therapeutics (NASDAQ : ALLR) a annoncé une collaboration de recherche avec l'Indiana Biosciences Research Institute (IBRI) pour étudier le mécanisme d'action dual de la stenoparib. La stenoparib est un nouveau médicament oral qui combine de manière unique l'inhibition de PARP1/2 et de tankyrase1/2, ciblant à la fois la réparation de l'ADN et la voie de signalisation WNT dans les cellules cancéreuses. Cette collaboration vise à comprendre comment ces mécanismes doubles contribuent aux effets anticancéreux du médicament, notamment dans les cas résistants aux traitements standards. Cette recherche soutiendra l'essai de phase 2 en cours d'Allarity dans le cancer de l'ovaire avancé ainsi que son essai en combinaison avec la témozolomide dans le cancer du poumon à petites cellules récidivant. Ce partenariat devrait renforcer la stratégie de sélection des patients basée sur le DRP de l'entreprise et potentiellement élargir les applications thérapeutiques, y compris le traitement du cancer colorectal où l'activation de la voie WNT est fréquente.
Allarity Therapeutics (NASDAQ: ALLR) hat eine Forschungskooperation mit dem Indiana Biosciences Research Institute (IBRI) angekündigt, um den dualen Wirkmechanismus von Stenoparib zu untersuchen. Stenoparib ist ein neuartiges orales Medikament, das einzigartig die Hemmung von PARP1/2 und Tankyrase1/2 kombiniert und sowohl die DNA-Reparatur als auch den WNT-Signalweg in Krebszellen anvisiert. Ziel der Zusammenarbeit ist es, zu verstehen, wie diese dualen Mechanismen zu den anticancerogenen Effekten des Medikaments beitragen, insbesondere bei Fällen, die resistent gegen Standardbehandlungen sind. Diese Forschung wird die laufende Phase-2-Studie von Allarity bei fortgeschrittenem Eierstockkrebs sowie die Kombinationsstudie mit Temozolomid bei rezidivierendem kleinzelligem Lungenkrebs unterstützen. Die Partnerschaft soll die DRP-basierte Patientenauswahlstrategie des Unternehmens verbessern und potenziell die therapeutischen Anwendungen erweitern, einschließlich der Behandlung von Darmkrebs, bei dem die WNT-Signalaktivierung häufig ist.
Positive
  • Stenoparib's unique dual mechanism of action (PARP and WNT pathway inhibition) differentiates it from other cancer treatments
  • Research collaboration could lead to expanded therapeutic applications and combinations
  • Potential application in multiple cancer types, including ovarian, small cell lung, and colorectal cancers
  • Study may strengthen the company's proprietary DRP patient selection technology
Negative
  • None.

Insights

Allarity's research collaboration with IBRI explores stenoparib's unique dual-inhibition mechanism, potentially differentiating it in cancer treatment landscape.

This research collaboration with Indiana Biosciences Research Institute represents a strategic scientific investment for Allarity, focused on elucidating the dual mechanism of action of their lead candidate stenoparib. Unlike standard PARP inhibitors already on market (olaparib, niraparib, rucaparib), stenoparib targets both PARP1/2 and tankyrase1/2, giving it potential advantages through simultaneous DNA repair impairment and WNT pathway inhibition.

The WNT pathway angle is particularly intriguing as this signaling cascade is implicated in chemoresistance and advanced disease progression across multiple cancer types. WNT pathway activation is especially prevalent in colorectal cancer, which Allarity specifically mentions as a potential new indication they might explore.

This mechanistic research could enhance Allarity's clinical development in two critical ongoing programs: their Phase 2 trial in advanced ovarian cancer and their combination study with temozolomide in recurrent small cell lung cancer. The findings may also refine their proprietary DRP® patient selection technology, potentially improving response rates by better identifying patients likely to benefit from stenoparib.

From an industry perspective, this collaboration demonstrates scientific rigor but represents an incremental research step rather than a near-term clinical catalyst. For a Phase 2 company, establishing differentiated mechanism of action can support future partnering discussions and regulatory interactions, though commercial potential remains dependent on forthcoming efficacy data.

    

TARPON SPRINGS, Fla., June 4, 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—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP®) patient selection technology—today announced a research collaboration with the Indiana Biosciences Research Institute (IBRI). The collaboration is aimed primarily at further deepening the Company’s mechanistic understanding of the dual mechanism of action of stenoparib.

Stenoparib is a novel, orally available small-molecule inhibitor of PARP1/2 and tankyrase1/2. As such, stenoparib not only impairs DNA repair to selectively kill cancer cells but also inhibits the WNT signaling pathway—a cellular pathway commonly associated with chemoresistance and advanced-stage disease in multiple cancer types. This unique dual activity distinguishes stenoparib as a highly differentiated therapeutic candidate with the potential to address cancers that are resistant to standard-of-care therapies. Under the agreement, IBRI will conduct advanced molecular and cellular studies to clarify the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s observed anticancer effects.

“Understanding how stenoparib exerts its dual biological effects is central to our long-term clinical development strategy. It will enhance our ability to raise awareness of this molecule among leading oncologists and help us engage more effectively with sophisticated biotech investors,” said Thomas Jensen, CEO of Allarity Therapeutics. “In addition to deepening our understanding of the foundational biology behind stenoparib’s differentiated profile, this research may further strengthen our DRP®-based patient selection strategy and potentially open new opportunities for additional therapeutic combinations and indications, such as colorectal cancer, where WNT pathway activation is very common.”

The collaboration is also expected to support Allarity in potential future efforts to pursue marketing approval for stenoparib, and to further clarify its mechanism of action in both the Company’s ongoing Phase 2 trial in advanced ovarian cancer and its recently announced combination trial evaluating stenoparib with temozolomide in recurrent small cell lung cancer (SCLC).

Furthermore, this collaboration underscores Allarity’s commitment to scientific excellence, translational research, and data-driven development, which form the foundation of its personalized oncology strategy.

About The Indiana Biosciences Research Institute
The Indiana Biosciences Research Institute (IBRI) is a leading translational research institute that accelerates innovation by bridging academic and industry science through collaboration. Its team of scientists is focused on solving high-impact biomedical challenges in areas such as cancer, diabetes, Alzheimer’s disease, and pediatric rare diseases, while also providing molecular innovation platforms and enabling technologies to drive the development of novel therapies. For more information, visit indianabiosciences.org.

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.

Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/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 related to the research collaboration with the Indiana Biosciences Research Institute (IBRI); the potential to further elucidate the dual mechanism of action of stenoparib; the role of PARP inhibition and WNT pathway modulation in clinical benefit; the ability to enhance or refine the Company’s DRP® companion diagnostic; the potential identification of new therapeutic indications or combinations; and the impact of the collaboration on future clinical strategy, development timelines, or regulatory engagement. 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 the risk that the collaboration may not yield actionable insights; the risk that mechanistic findings may not translate into clinical outcomes; the possibility that the DRP® may not be enhanced, validated, or accepted by regulators; and the broader risks related to drug development, including clinical, regulatory, manufacturing, and commercial risks. 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.

###

Company Contact:         
        investorrelations@allarity.com

        
Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390
        tsp@carrotize.com

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FAQ

What is the purpose of Allarity Therapeutics' collaboration with IBRI?

The collaboration aims to better understand stenoparib's dual mechanism of action as both a PARP1/2 and tankyrase1/2 inhibitor, supporting ongoing clinical trials and potential marketing approval.

What makes Allarity Therapeutics' stenoparib (ALLR) unique in cancer treatment?

Stenoparib is differentiated by its dual mechanism, inhibiting both PARP1/2 for DNA repair and the WNT signaling pathway, potentially addressing cancers resistant to standard therapies.

Which cancer types is Allarity Therapeutics (ALLR) targeting with stenoparib?

Stenoparib is being evaluated in Phase 2 trials for advanced ovarian cancer, recurrent small cell lung cancer (in combination with temozolomide), and shows potential for colorectal cancer treatment.

How does Allarity's DRP technology relate to stenoparib development?

The Drug Response Predictor (DRP) technology is used for patient selection, helping identify which patients are most likely to respond to stenoparib treatment.

What stage of development is stenoparib currently in?

Stenoparib is currently in Phase 2 clinical trials, being tested in advanced ovarian cancer and in combination with temozolomide for recurrent small cell lung cancer.
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