Stenoparib Shows Continued Benefit in Advanced Ovarian Cancer

Boston (June 25, 2024)—Allarity Therapeutics, Inc. (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company focused on personalized cancer treatments, announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have remained on treatment for over 30 weeks. This milestone underscores the durability of the clinical benefit previously noted by the company in early May 2024. At that time, Allarity reported that stenoparib had demonstrated significant tumor shrinkage and long-term disease stability in patients heavily pre-treated for ovarian cancer, who otherwise had limited life expectancy.

The promising outcomes have led the company to halt patient enrollment to concentrate on designing a follow-on trial aimed at expediting stenoparib's path to regulatory approval. Dr. Kathleen N. Moore, the Principal Investigator of the trial, remarked on the transformative potential of PARP inhibitors like stenoparib, especially for patients who do not respond to first-generation PARP inhibitors. She emphasized the promising tolerability of stenoparib and expressed anticipation for future trial designs to further explore its potential.

Thomas Jensen, CEO of Allarity Therapeutics, highlighted the enthusiasm surrounding stenoparib's benefits for patients with limited treatment options. He pointed out that the safety profile of stenoparib is favorable compared to both chemotherapies and first-generation PARP inhibitors, suggesting that stenoparib could serve as a next-generation option for advanced ovarian cancer patients. Jensen noted the company's aggressive efforts to advance stenoparib’s clinical progress toward FDA registration.

Following a thorough review of the trial data, Allarity concluded that the findings warrant presentation at a high-level scientific conference. The continued durability of clinical benefits and the favorable safety profile of stenoparib are expected to attract interest from oncologists, commercial partners, and other stakeholders. Future releases of clinical data will be structured to comply with the rules of scientific conferences.

The market for PARP inhibitors experienced a significant shift in 2022 with the withdrawal of rucaparib, olaparib, and niraparib for heavily pretreated ovarian cancer patients, highlighting the need for new and effective inhibitors with better safety profiles. The PARP inhibitor market is projected to reach $22 billion by 2028 and has seen substantial partnerships and acquisitions. Stenoparib, which is orally available, not only inhibits PARP1/2 but also Tankyrase 1 and 2 enzymes, targeting the WNT/Beta-catenin pathway—a pathway often overactive in ovarian and other solid cancers. This dual inhibitory action makes stenoparib a compelling therapeutic candidate.

The ongoing Phase 2 trial is a prospective, open-label, single-arm study conducted across multiple sites in the US and UK. Women with advanced, recurrent ovarian cancer were pre-screened using Allarity’s DRP® companion diagnostic, which identifies a complex signature of 414 mRNA biomarkers indicative of response or resistance to the drug. The revised protocol implemented in early 2023 involves a twice-daily dosing regimen to optimize daily drug exposure and target inhibition.

The enrolled patients, who have undergone multiple lines of therapy including platinum, taxanes, anti-angiogenesis inhibitors, and the ADC Elahere, have limited effective treatment options. Except for two, all patients had previously been treated with a PARP inhibitor.

Stenoparib, a dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 2, was originally developed by Eisai Co. Ltd. and is now under Allarity's exclusive global development and commercialization rights. The DRP® companion diagnostic platform used by Allarity helps in selecting patients more likely to benefit from specific drugs, thereby increasing the therapeutic benefit rate.

Allarity Therapeutics is dedicated to developing personalized cancer treatments and is focused on advancing stenoparib through its ongoing Phase 2 clinical trial. The company operates out of the U.S. with a research facility in Denmark.