Core Viewpoint - Allarity Therapeutics is advancing the clinical development of stenoparib, a dual PARP/Wnt pathway inhibitor, towards FDA approval for advanced ovarian cancer, utilizing its Drug Response Predictor (DRP) technology for patient selection [1][2][4]. Group 1: Clinical Development Plans - The new Phase 2 protocol aims to optimize the dose of stenoparib and refine DRP patient selection criteria to maximize clinical benefits [1][2]. - The trial will focus on patients with advanced, recurrent, platinum-resistant ovarian cancer, a group that has shown durable clinical benefits from stenoparib [2][4]. - Patient enrollment is expected to begin in the first half of 2025, pending final protocol review by regulatory authorities [5][6]. Group 2: Mechanism of Action and Therapeutic Potential - Stenoparib is a small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential implications for controlling the Wnt pathway, which is involved in various cancers [7]. - The trial is designed to enhance understanding of stenoparib's therapeutic mechanism, particularly its impact on the Wnt pathway [2][3]. Group 3: Drug Response Predictor (DRP) Technology - The DRP technology will be used to identify patients most likely to benefit from stenoparib, generating a robust data set to refine the DRP cut-off [3][9]. - The DRP platform has shown significant predictive ability for clinical outcomes in cancer patients across numerous studies [9]. Group 4: Company Background - Allarity Therapeutics is focused on developing personalized cancer treatments and has exclusive global rights for the development and commercialization of stenoparib [10]. - The company is headquartered in the U.S. and has a research facility in Denmark, addressing significant unmet medical needs in cancer treatment [10].
Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian Cancer