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Allarity Therapeutics to be Granted European Patent for DRP® Companion Diagnostic for Stenoparib

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Allarity Therapeutics (NASDAQ: ALLR) has announced that the European Patent Office (EPO) intends to grant a patent for its Drug Response Predictor (DRP®) companion diagnostic specific to stenoparib, the company's dual-targeted PARP/Tankyrase inhibitor. This patent is a significant step in securing Allarity's market position for stenoparib and its companion diagnostic, which identifies patients most likely to benefit from stenoparib treatment.

The company is also pursuing patent applications for the Stenoparib DRP in other key markets, including the United States, Japan, China, Australia, and India. Allarity has previously been granted 17 patents for drug-specific DRPs, including eight in the United States. CEO Thomas Jensen emphasized the importance of securing patents in key markets to pave the way for potential future commercialization, particularly as they advance their clinical program for stenoparib.

Allarity Therapeutics (NASDAQ: ALLR) ha annunciato che l'Ufficio europeo dei brevetti (EPO) intende concedere un brevetto per il suo Drug Response Predictor (DRP®), un test diagnostico complementare specifico per il stenoparib, l'inibitore dual-target PARP/Tankyrase dell'azienda. Questo brevetto rappresenta un passo significativo per garantire la posizione di mercato di Allarity per il stenoparib e il suo test diagnostico, che identifica i pazienti più propensi a beneficiare del trattamento con stenoparib.

La società sta inoltre perseguendo domande di brevetto per il DRP di stenoparib in altri mercati chiave, tra cui gli Stati Uniti, il Giappone, la Cina, l'Australia e l'India. Allarity ha precedentemente ottenuto 17 brevetti per DRP specifici per farmaci, inclusi otto negli Stati Uniti. Il CEO Thomas Jensen ha sottolineato l'importanza di ottenere brevetti nei mercati chiave per aprire la strada a una potenziale commercializzazione futura, soprattutto mentre avanzano il loro programma clinico per il stenoparib.

Allarity Therapeutics (NASDAQ: ALLR) ha anunciado que la Oficina Europea de Patentes (EPO) tiene la intención de conceder una patente para su Drug Response Predictor (DRP®), un diagnóstico complementario específico para el stenoparib, el inhibidor dual dirigido PARP/Tankyrase de la compañía. Esta patente es un paso significativo para asegurar la posición de mercado de Allarity para el stenoparib y su diagnóstico complementario, que identifica a los pacientes más propensos a beneficiarse del tratamiento con stenoparib.

La compañía también está buscando solicitar patentes para el DRP de stenoparib en otros mercados clave, incluyendo Estados Unidos, Japón, China, Australia e India. Allarity ya ha obtenido 17 patentes para DRPs específicos de medicamentos, incluidas ocho en Estados Unidos. El CEO Thomas Jensen enfatizó la importancia de asegurar patentes en mercados clave para allanar el camino hacia una posible comercialización futura, especialmente a medida que avanzan en su programa clínico para el stenoparib.

Allarity Therapeutics (NASDAQ: ALLR)는 유럽 특허청(EPO)이 회사의 이중 표적 PARP/Tankyrase 억제제인 스텐로파립(stenoparib)에 특화된 약물 반응 예측기(DRP®) 동반 진단에 대한 특허를 부여할 의사를 밝혔습니다. 이 특허는 스텐로파립 및 해당 동반 진단의 시장 위치를 확보하는 데 중요한 단계로, 치료의 혜택을 가장 많이 받을 가능성이 있는 환자를 식별합니다.

회사는 또한 미국, 일본, 중국, 호주 및 인도를 포함한 다른 주요 시장에서 스텐로파립 DRP에 대한 특허 신청을 추진하고 있습니다. Allarity는 이미 약물 특정 DRP에 대해 17개의 특허를 부여받았으며, 그 중 8개는 미국에서 부여된 것입니다. CEO 토마스 옌센(Thomas Jensen)은 스텐로파립에 대한 임상 프로그램을 발전시키면서 향후 상업화 가능성을 위해 주요 시장에서의 특허 확보의 중요성을 강조했습니다.

Allarity Therapeutics (NASDAQ: ALLR) a annoncé que l'Office européen des brevets (EPO) a l'intention de délivrer un brevet pour son Drug Response Predictor (DRP®), un diagnostic compagnon spécifique au stenoparib, l'inhibiteur dual ciblé PARP/Tankyrase de la société. Ce brevet représente une étape importante pour sécuriser la position de marché d'Allarity pour le stenoparib et son diagnostic compagnon, qui identifie les patients les plus susceptibles de bénéficier d'un traitement par stenoparib.

La société poursuit également des demandes de brevet pour le DRP de stenoparib dans d'autres marchés clés, notamment les États-Unis, le Japon, la Chine, l'Australie et l'Inde. Allarity a déjà obtenu 17 brevets pour des DRP spécifiques à des médicaments, dont huit aux États-Unis. Le PDG Thomas Jensen a souligné l'importance de sécuriser des brevets dans des marchés clés pour ouvrir la voie à une éventuelle commercialisation future, en particulier alors qu'ils avancent dans leur programme clinique pour le stenoparib.

Allarity Therapeutics (NASDAQ: ALLR) hat bekannt gegeben, dass das Europäische Patentamt (EPO) beabsichtigt, ein Patent für seinen Drug Response Predictor (DRP®) als Begleitdiagnose für Stenoparib, den dual gezielten PARP/Tankyrase-Inhibitor des Unternehmens, zu erteilen. Dieses Patent ist ein bedeutender Schritt zur Sicherung der Marktposition von Allarity für Stenoparib und dessen Begleitdiagnose, die Patienten identifiziert, die am wahrscheinlichsten von einer Behandlung mit Stenoparib profitieren.

Das Unternehmen verfolgt auch Patent-anträge für den Stenoparib DRP in anderen wichtigen Märkten, einschließlich der Vereinigten Staaten, Japan, China, Australien und Indien. Allarity hat bereits 17 Patente für spezifische DRPs für Medikamente erhalten, darunter acht in den Vereinigten Staaten. CEO Thomas Jensen betonte die Bedeutung der Sicherung von Patenten in Schlüssel-märkten, um den Weg für eine mögliche zukünftige Kommerzialisierung zu ebnen, insbesondere während sie ihr klinisches Programm für Stenoparib vorantreiben.

Positive
  • European Patent Office intends to grant a patent for Allarity's Stenoparib DRP® companion diagnostic
  • Patent strengthens market position for stenoparib and its companion diagnostic
  • Patent applications pending in other key markets (US, Japan, China, Australia, India)
  • Company already holds 17 patents for drug-specific DRPs, including 8 in the US
Negative
  • None.

Insights

The EPO's intention to grant a patent for Allarity's Stenoparib DRP® companion diagnostic is a positive development for the company's intellectual property portfolio. This strengthens Allarity's position in the European market for personalized cancer treatments.

Key points to consider:

  • The patent covers a companion diagnostic for stenoparib, potentially giving Allarity a competitive edge in patient selection for this therapy.
  • Pending patent applications in other major markets (US, Japan, China, Australia, India) could further solidify Allarity's global IP position.
  • With 17 existing patents for drug-specific DRPs, including 8 in the US, Allarity is building a robust patent portfolio around its core technology.

While this patent grant is promising, investors should note that it doesn't guarantee regulatory approval or commercial success. The company still needs to demonstrate clinical efficacy and obtain regulatory approvals for both stenoparib and its companion diagnostic.

This patent news is a positive step for Allarity, but it's important to view it in the context of the broader oncology market:

  • The PARP inhibitor market is competitive, with established players like AstraZeneca's Lynparza and GSK's Zejula.
  • Allarity's dual PARP/Tankyrase inhibition approach could differentiate stenoparib, potentially addressing resistance mechanisms.
  • The companion diagnostic strategy aligns with the trend towards personalized medicine in oncology, which could enhance stenoparib's market positioning.

However, Allarity faces challenges:

  • As a small-cap company ($2.3M), funding for late-stage clinical trials and potential commercialization could be a concern.
  • The company needs to demonstrate superior efficacy or a better safety profile to compete with established PARP inhibitors.

Investors should monitor Allarity's clinical progress and cash position closely as these will be critical for realizing the potential value of this patent.


European Patent Office to grant a patent for DRP
® companion diagnostic for Allarity’s stenoparib cancer therapy


Patent applications for the Stenoparib DRP
® are also pending in the US, Japan, China, Australia, and India


Boston (October 22, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selection technology, today announced that the European Patent Office (EPO) has issued a formal notice of its intention to grant a patent for Allarity’s Drug Response Predictor (DRP®) companion diagnostic specific to stenoparib, the Company’s dual-targeted PARP/Tankyrase inhibitor.

This patent represents a significant step forward in securing Allarity’s market position for stenoparib and the Stenoparib DRP companion diagnostic, which identifies patients most likely to derive clinical benefit from stenoparib treatment.

Thomas Jensen, CEO of Allarity Therapeutics, commented, “As we advance our clinical program for stenoparib, we are also focused on securing patents in key markets to pave the way for potential future commercialization. Though our main focus is to first achieve regulatory approval in the US for both stenoparib and its DRP companion diagnostic, we strongly believe stenoparib has the potential to help ovarian cancer patients worldwide. Therefore, knowing that the EPO intends to grant us a European patent for the Stenoparib DRP is an important step towards securing the foundation for an international market position for stenoparib and its companion diagnostic."

Patent applications for the Stenoparib DRP companion diagnostic are also pending in the United States, Japan, China, Australia, and India. Allarity has previously been granted 17 patents for drug-specific DRPs, including eight in the United States.
        


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 also 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.

Follow Allarity on Social Media
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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 anticipated clinical advancement of stenoparib in treating advanced ovarian cancer, its potential to deliver meaningful clinical outcomes for patients, and the Company’s strategy to seek regulatory approval based on the results from ongoing clinical trials. 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, potential challenges in securing sufficient capital for continued clinical operations, uncertainties regarding the interpretation of clinical trial results, the risk that positive initial data may not be confirmed in larger studies, delays or failures in obtaining necessary regulatory approvals, and challenges in bringing stenoparib or other candidates to the market. 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.

###

Company Contact:         
        investorrelations@allarity.com

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

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FAQ

What patent has the European Patent Office (EPO) announced for Allarity Therapeutics (ALLR)?

The EPO has announced its intention to grant a patent for Allarity Therapeutics' Drug Response Predictor (DRP®) companion diagnostic specific to stenoparib, the company's dual-targeted PARP/Tankyrase inhibitor.

In which other countries is Allarity Therapeutics (ALLR) pursuing patent applications for the Stenoparib DRP?

Allarity Therapeutics is pursuing patent applications for the Stenoparib DRP in the United States, Japan, China, Australia, and India.

How many patents for drug-specific DRPs does Allarity Therapeutics (ALLR) currently hold?

Allarity Therapeutics has previously been granted 17 patents for drug-specific DRPs, including eight in the United States.

What is the significance of the EPO patent for Allarity Therapeutics (ALLR)?

The EPO patent represents a significant step in securing Allarity's market position for stenoparib and its companion diagnostic, paving the way for potential future commercialization in Europe.

Allarity Therapeutics, Inc.

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