The patent covers a gene-expression profiling method designed to identify patients most likely to respond to the investigational therapy stenoparib through 2042.
The United States Patent and Trademark Office has granted a patent to Allarity Therapeutics for its stenoparib-specific Drug Response Predictor (DRP) companion diagnostic, which is being developed for use with the investigational ovarian cancer therapy stenoparib, the company announced. The patent, which extends into April 2042, covers methods for predicting clinical benefit based on gene-expression profiles derived from tumor samples.
The diagnostic test is designed to select patients most likely to benefit from treatment with stenoparib, a dual PARP and WNT pathway inhibitor currently in Phase 2 clinical trials. The patent protects the use of the test for patient selection in the US, providing an intellectual property foundation for the drug and its associated diagnostic.
“With this US patent now granted and providing protection into 2042, we have established an important long-term intellectual property foundation for stenoparib and our DRP companion diagnostic,” says Thomas Jensen, CEO of Allarity Therapeutics, in a release. “Looking ahead, our goal is to use the stenoparib DRP to help identify the patients most likely to benefit from treatment. This patent provides the foundation for advancing a more precise, patient-selection-driven approach to ovarian cancer and accelerating stenoparib toward FDA approval.”
The DRP platform uses messenger RNA expression profiles from patient biopsies to predict clinical outcomes. The method builds on a comparison of sensitive versus resistant human cancer cell lines, combining transcriptomic information with clinical tumor biology filters and prior clinical trial results. By screening patients before treatment and only treating those with a high drug-specific score, the company aims to enhance therapeutic benefit rates.
Stenoparib is an orally available, small-molecule inhibitor of PARP1/2 and tankyrase 1/2. Tankyrases are emerging therapeutic targets due to their role in regulating the WNT signaling pathway, which is often implicated in the progression of drug-resistant cancers. Allarity Therapeutics is currently conducting a Phase 2 trial for the drug in platinum-resistant or platinum-ineligible ovarian cancer patients to support development toward Food and Drug Administration approval.
In addition to the US patent, the company has secured patent protection for the companion diagnostic in Europe and Australia through 2039. A separate Phase 2 trial is also evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer across multiple Veterans Affairs sites in the US.
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