Allarity Therapeutics Announces Two Patients Now Exceeding One Year of Treatment with Stenoparib in Advanced Ovarian Cancer Trial
Allarity Therapeutics (NASDAQ: ALLR) has announced a significant milestone in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer. Two patients, pre-screened using Allarity's Drug Response Predictor (DRP®) companion diagnostic, have exceeded one year of treatment. This achievement highlights stenoparib's potential to provide durable clinical benefit in heavily pre-treated patients with options.
The trial continues to show promising results, including a confirmed complete response and long-term disease stability in multiple patients. Stenoparib's unique mechanism as a dual PARP/Tankyrase inhibitor sets it apart from other treatments. The company is now planning to accelerate the program's path toward regulatory approval.
Allarity Therapeutics (NASDAQ: ALLR) ha annunciato un traguardo significativo nel suo studio clinico di Fase 2 su stenoparib per il cancro ovarico avanzato e ricorrente. Due pazienti, pre-selezionati utilizzando il Drug Response Predictor (DRP®) diagnostico companion di Allarity, hanno superato un anno di trattamento. Questo risultato evidenzia il potenziale di stenoparib di fornire un beneficio clinico durevole in pazienti pesantemente pre-trattati con opzioni limitate.
Lo studio continua a mostrare risultati promettenti, inclusi una risposta completa confermata e stabilità della malattia a lungo termine in diversi pazienti. Il particolare meccanismo di stenoparib come inibitore duale di PARP/Tankyrase lo distingue da altri trattamenti. L'azienda sta ora pianificando di accelerare il percorso del programma verso l'approvazione regolatoria.
Allarity Therapeutics (NASDAQ: ALLR) ha anunciado un hito significativo en su ensayo clínico de Fase 2 de stenoparib para el cáncer de ovario avanzado y recurrente. Dos pacientes, preseleccionados utilizando el Drug Response Predictor (DRP®) como diagnóstico companion de Allarity, han superado un año de tratamiento. Este logro resalta el potencial de stenoparib para proporcionar un beneficio clínico duradero en pacientes con múltiples tratamientos previos.
El ensayo sigue mostrando resultados prometedores, incluyendo una respuesta completa confirmada y estabilidad de la enfermedad a largo plazo en varios pacientes. El mecanismo único de stenoparib como inhibidor dual de PARP/Tankyrase lo distingue de otros tratamientos. La empresa ahora planea acelerar el camino del programa hacia la aprobación regulatoria.
Allarity Therapeutics (NASDAQ: ALLR)가 스테노파립에 대한 2상 임상 시험에서 중요한 이정표를 발표했습니다. 두 명의 환자가 Allarity의 약물 반응 예측기 (DRP®) 동반 진단을 통해 사전 선별되어 1년 이상의 치료를 견뎌냈습니다. 이러한 성과는 스테노파립이 내성이 강한 환자들에게 지속 가능한 임상적 혜택을 제공할 수 있는 가능성을 강조합니다.
시험은 여러 환자에서 확인된 완전 반응과 장기적인 질병 안정성을 포함하여 유망한 결과를 지속적으로 보여주고 있습니다. 이중 PARP/Tankyrase 억제제로서의 스테노파립의 독특한 메커니즘은 다른 치료제와 차별화됩니다. 회사는 이제 이 프로그램의 규제 승인을 빨리 진행할 계획입니다.
Allarity Therapeutics (NASDAQ: ALLR) a annoncé une étape importante dans son essai clinique de Phase 2 sur stenoparib pour le cancer de l'ovaire avancé et récurrent. Deux patientes, présélectionnées à l'aide de l'outil de diagnostic compagnon Drug Response Predictor (DRP®) d'Allarity, ont dépasse un an de traitement. Ce résultat met en évidence le potentiel de stenoparib à fournir un bénéfice clinique durable chez les patientes lourdement prétraitées avec peu d'options.
L'essai continue de montrer des résultats prometteurs, y compris une réponse complète confirmée et une stabilité de la maladie à long terme chez plusieurs patientes. Le mécanisme unique de stenoparib en tant qu'inhibiteur double de PARP/Tankyrase le distingue des autres traitements. La société prévoit désormais d'accélérer le chemin de son programme vers l'approbation réglementaire.
Allarity Therapeutics (NASDAQ: ALLR) hat einen bedeutenden Meilenstein in seiner Phase-2-Studie zu Stenoparib bei fortgeschrittenem, wiederkehrendem Eierstockkrebs bekannt gegeben. Zwei Patienten, die mit dem Drug Response Predictor (DRP®) Begleitdiagnosetool von Allarity vorselektiert wurden, haben ein Jahr Behandlung überschritten. Diese Leistung unterstreicht das Potenzial von Stenoparib, dauerhafte klinische Vorteile bei stark vorbehandelten Patienten zu bieten.
Die Studie zeigt weiterhin vielversprechende Ergebnisse, darunter eine bestätigte vollständige Ansprechrate und Langzeitstabilität der Krankheit bei mehreren Patienten. Der einzigartige Mechanismus von Stenoparib als dual PARP/Tankyrase-Inhibitor hebt es von anderen Behandlungen ab. Das Unternehmen plant nun, den Weg des Programms zur behördlichen Genehmigung zu beschleunigen.
- Two patients have exceeded one year of treatment with stenoparib in advanced ovarian cancer trial
- Trial shows a confirmed complete response and long-term disease stability for multiple patients
- Stenoparib demonstrates potential for durable clinical benefit in heavily pre-treated patients
- Company is planning to accelerate stenoparib's path toward regulatory approval
- None.
Insights
This clinical update on stenoparib is highly promising for ovarian cancer treatment. The one-year durability in heavily pre-treated patients is exceptional, as these individuals typically progress rapidly through available therapies. Stenoparib's dual PARP/Tankyrase inhibition mechanism offers a unique advantage over existing PARP inhibitors.
The revised dosing regimen (200mg morning, 400mg evening) likely contributes to improved efficacy and tolerability. The DRP® companion diagnostic appears important in identifying responsive patients, potentially increasing the success rate of personalized treatment. This approach could revolutionize ovarian cancer therapy selection, especially for those who've exhausted standard options.
The longevity of response in this trial is remarkable, especially considering the patients' treatment history. The complete response and long-term disease stability in multiple patients suggest stenoparib's potential to significantly improve outcomes in a difficult-to-treat population.
The DRP® companion diagnostic is a key differentiator, potentially enhancing treatment efficacy by selecting patients most likely to benefit. This personalized approach could reduce healthcare costs and improve quality of life by avoiding ineffective treatments. The ongoing trial will be important in validating these promising results and determining stenoparib's place in ovarian cancer treatment algorithms.
This clinical update is highly positive for Allarity Therapeutics. The extended treatment duration and durable responses in heavily pre-treated patients could position stenoparib as a potential breakthrough in ovarian cancer treatment. If these results are replicated in larger studies, it could lead to accelerated regulatory approval and significant market potential.
The company's DRP® companion diagnostic adds value by potentially improving treatment efficacy and reducing healthcare costs. This dual approach of drug and diagnostic could be attractive to payers and oncologists. Investors should monitor upcoming updates on the program's progress and future trials, as positive results could significantly impact Allarity's market valuation and partnership opportunities.
- Durable Clinical Benefit Observed Beyond a Year on Treatment in Heavily Pre-Treated Patients
Boston (September 16, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded one year on therapy.
The patients had been pre-screened using Allarity’s Drug Response Predictor (DRP®) companion diagnostic, which identified them as having a high likelihood of benefiting from stenoparib, the Company’s novel dual PARP/Tankyrase inhibitor.
This remarkably lengthy treatment period highlights the potential of stenoparib to provide durable clinical benefit, even in heavily pre-treated ovarian cancer patients who have limited treatment options. The trial continues to evaluate stenoparib’s safety and efficacy, showing a confirmed, complete response as well as long term disease stability for multiple patients.
Thomas Jensen, CEO of Allarity Therapeutics, commented on this clinical achievement:
“We are incredibly encouraged by the sustained clinical benefit seen in these patients, who have now been on stenoparib for over a year. For heavily pre-treated ovarian cancer patients, extending life by 52 weeks is particularly noteworthy. Stenoparib’s unique mechanism of action, as both a PARP and Tankyrase inhibitor, sets it apart from other treatments. These results reinforce our belief in stenoparib’s potential as an important new therapy for ovarian cancer patients who have exhausted other treatment options.”
Dr. Fernanda B. Musa, Director of Clinical Research in Gynecology Oncology and site Principal Investigator at the Swedish Cancer Institute for the trial added:
“We have been surprised and excited to see a long duration of response to a single-agent oral therapy in patients with ovarian cancer who had failed multiple other types of treatment. I credit the success to personalized medicine: the pairing of the therapy to the patient’s specific tumor profile. I look forward to seeing further development of this program!”
Allarity is actively planning the further advancement of its stenoparib program, with a focus on accelerating its path toward regulatory approval. The Company remains dedicated to exploring stenoparib’s long-term clinical benefit in DRP®-selected patients and is preparing for the next phase of development. Additional updates on the program’s progress and future trials will be shared in the coming months.
Background Information about the Trial
The above-mentioned trial is a Phase 2, prospective open-label, single-arm study with multiple sites in both the US and the UK. Investigators prescreened women with advanced, recurrent ovarian cancer using Allarity’s DRP® companion diagnostic (CDx), which comprises a complex transcriptomic signature of 414 mRNA biomarkers indicative of drug response or resistance. Each participant was assigned a DRP score, and those with scores above 50 -suggesting a higher likelihood of benefiting from treatment – were selected to receive stenoparib. The selected patients were administered stenoparib under a revised protocol implemented in Q1 2023, which involved a twice-daily dosing regimen (200 mg in the morning and 400 mg in the evening) instead of the previous once-daily 600 mg dose. This change was made to optimize daily drug exposure and target inhibition.
The patients enrolled have advanced through multiple lines of therapy, including platinum, taxanes, anti-angiogenesis inhibitors, and even the recently approved Antibody Drug Conjugate, Elahere. Importantly, most of the enrolled patients to date have been previously treated with a PARP inhibitor. These patients have few, if any, effective treatment options and typically advance through available therapies after only a few months.
About stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 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. Allarity has 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 proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used 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® companion diagnostic for patient selection in the ongoing phase 2 clinical trial, NCT03878849. 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 clinical progress of stenoparib, including the long-term benefit observed in patients, and the Company's plans to advance stenoparib toward regulatory approval]. 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, Allarity’s ability to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for stenoparib or any of our other therapeutic candidates and companion diagnostics or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates]. 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 registration statement filed on October 30, 2023, as amended and our Form 10-K annual report on file with the Securities and Exchange Commission (the “SEC”), 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 is the latest update on Allarity Therapeutics' stenoparib trial for ovarian cancer?
How does Allarity Therapeutics select patients for the stenoparib trial?
What makes stenoparib unique compared to other ovarian cancer treatments?
What is the current dosing regimen for stenoparib in the Allarity Therapeutics trial?
