Allarity Therapeutics announced acceptance of its patent application for a companion diagnostic related to stenoparib in Australia.
Quiver AI Summary
Allarity Therapeutics, a Phase 2 clinical-stage pharmaceutical company, announced the acceptance of its patent application in Australia for the Drug Response Predictor (DRP®) companion diagnostic specific to its cancer treatment stenoparib, which is a dual inhibitor of PARP and WNT. This patent, which includes 40 claims, represents a significant step in Allarity's global strategy to protect its proprietary technology as it advances stenoparib through clinical trials toward U.S. regulatory approval. The patent will be advertised on June 26, 2025, followed by a three-month opposition period before it can be officially granted. CEO Thomas Jensen highlighted the importance of this achievement for securing international intellectual property protection. Allarity holds a European patent for the DRP® and has multiple granted patents in various countries.
Potential Positives
- Allarity Therapeutics has received formal acceptance of its patent application for the DRP® companion diagnostic specific to stenoparib from IP Australia, enhancing its intellectual property position.
- The patent acceptance covers 40 claims, indicating broad protection for its innovative diagnostic technology, which is crucial for the international commercialization of stenoparib.
- This step represents progress in Allarity's global strategy, reinforcing its commitment to securing intellectual property in key markets while advancing stenoparib through clinical trials.
Potential Negatives
- The patent for the Stenoparib DRP® is still pending in multiple key markets, including the U.S., raising concerns about the potential for delays or rejections that could impact commercialization efforts.
- The press release highlights risks associated with the patent grant, including the potential for opposition during the announced opposition period, which could jeopardize the intellectual property rights crucial for the company's strategy.
- Forward-looking statements in the release acknowledge multiple risks and uncertainties that could negatively affect plans for regulatory approval and commercialization of stenoparib, signaling potential volatility in the company's future prospects.
FAQ
What is the significance of the Australian patent for Allarity's DRP®?
The Australian patent acceptance is crucial for protecting Allarity's DRP® technology and supports global commercialization efforts.
What is stenoparib and its potential uses?
Stenoparib is a dual-targeted inhibitor aimed at treating various cancers, particularly ovarian cancer, by blocking PARP and the WNT pathway.
How does the Drug Response Predictor (DRP®) work?
The DRP® identifies patients likely to benefit from stenoparib based on gene expression signatures and prior clinical outcomes.
What are the next steps after the Australian patent acceptance?
If unopposed, the patent is expected to be granted within 20 working days after a three-month opposition period.
How many patents has Allarity secured for its DRP® technology?
Allarity has secured multiple patents, including 18 granted for drug-specific DRPs across various countries.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
TARPON SPRINGS, Fla., June 30, 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 that IP Australia, the Australian Government agency that administers intellectual property rights in the country, has formally accepted the Company’s patent application for its DRP ® companion diagnostic specific to stenoparib.
The acceptance covers 40 claims and marks a key step in Allarity’s global strategy to protect the potential international commercialization of its proprietary DRP ® platform alongside the clinical development of stenoparib. The granted patent will be officially advertised in the Australian Official Journal of Patents on June 26, 2025, followed by a three-month opposition period. If unopposed, the patent is expected to be granted within 20 working days thereafter.
Thomas Jensen, CEO of Allarity Therapeutics, commented: “This latest patent acceptance from Australia represents another important achievement in our efforts to secure international IP protection for our DRP ® technology. As we continue advancing stenoparib through Phase 2 trials toward U.S. regulatory approval, we are also building a robust intellectual property position in key global markets.”
Allarity previously secured a European patent for the Stenoparib DRP
®
and holds 18 granted patents for drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP
®
remain pending in the U.S., Canada, Japan, China, and India.
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 regarding the expected grant and scope of the Australian patent for the Stenoparib DRP®; the anticipated contribution of this patent to the Company’s global intellectual property strategy; and the Company’s ability to advance and commercialize stenoparib in Australia and other key markets. 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 potential for opposition to the patent grant; changes in regulatory timelines or requirements; failure to obtain regulatory approval for stenoparib or its companion diagnostic; and risks inherent in developing and commercializing biopharmaceutical products. 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:
[email protected]
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
[email protected]
Attachment