Allarity Therapeutics Announces Phase 2 Trial of Stenoparib in Combination with Temozolomide for Recurrent Small Cell Lung Cancer Fully Funded by the US Veterans Administration

Core Viewpoint - Allarity Therapeutics is advancing a Phase 2 trial for stenoparib in combination with temozolomide to treat recurrent Small Cell Lung Cancer (SCLC), fully funded by the U.S. Veterans Administration, aiming to address significant unmet medical needs in this patient population [1][7][10]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a dual PARP/tankyrase inhibitor [13]. - The company is headquartered in the U.S. and has a research facility in Denmark, committed to addressing significant unmet medical needs in cancer treatment [13]. Clinical Study Design - The Phase 2 trial will enroll approximately 65 extensive-stage SCLC patients across 11 VA medical centers, assessing progression-free survival and determining the recommended Phase 2 dose during an initial safety lead-in phase [5]. Mechanism of Action - Stenoparib is a dual PARP and tankyrase inhibitor that enhances the efficacy of temozolomide by blocking DNA repair mechanisms, potentially increasing cancer cell death and addressing treatment resistance associated with SCLC [2][6][8]. - The combination aims to overcome resistance mechanisms such as the MGMT enzyme and mismatch repair deficiencies that limit the effectiveness of temozolomide [8]. Funding and Financial Considerations - The trial is fully funded by the U.S. Veterans Administration, ensuring that it will not impact Allarity's financial outlook or other clinical programs [10]. - Allarity's cash position is reported to support operations into 2026, indicating a stable financial foundation for ongoing and future projects [10]. Regulatory Status - Investigators are in the process of obtaining final regulatory approvals from the U.S. Food and Drug Administration, the VA, and the Institutional Review Board before patient enrollment can begin [9].