On April 27, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its patent application covering the Company’s DRP companion diagnostic specific to stenoparib.
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Importantly, this Notice of Allowance covers multiple claims and represents a major step in Allarity’s global strategy to expand and protect the commercial potential of stenoparib when selecting patients using its proprietary stenoparib DRP test. The patent is expected to be formally granted within three months, subject to standard administrative procedures and would provide exclusivity at least into 2039 for stenoparib when used in concert with the DRP as a companion diagnostic.
Thomas Jensen, CEO of Allarity Therapeutics, commented: "This Notice of Allowance from the USPTO represents another successful milestone in our efforts to secure intellectual property protection for our DRP technology in the US, the world’s most important pharmaceutical market. Critically, this patent maximizes the marketing exclusivity in the US for stenoparib in patients selected using the stenoparib DRP test, which is especially important as we seek to accelerate stenoparib toward approval for Ovarian and other cancers."
The allowed claims include methods for predicting clinical benefit based on gene expression profiles derived from tumor samples and for selecting those patients most likely to benefit from stenoparib treatment.
Allarity previously secured a European and Australian patent for the Stenoparib DRP and holds 18 granted patents for other drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP remain pending in Canada, Japan, China, and India.
About Stenoparib/2X-121
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, Small Cell Lung Cancer and colorectal 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. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.
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.
(Press release, Allarity Therapeutics, APR 27, 2026, View Source [SID1234664809])