Drug Response Predictor (DRP) Companion Diagnostic

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Allarity Therapeutics Announces First Patient Enrolled in New Phase 2 Clinical Trial Protocol of Stenoparib in Advanced Ovarian Cancer
Globenewswireยท 2025-06-02 12:00
Core Viewpoint - Allarity Therapeutics has initiated a new Phase 2 clinical trial for stenoparib, targeting advanced, platinum-resistant or platinum-ineligible ovarian cancer, with the first patient enrolled [1][2]. Group 1: Clinical Development - The new trial protocol aims to accelerate the clinical development of stenoparib and its companion diagnostic, Drug Response Predictor (DRP), towards potential FDA approval [2][5]. - The updated study design includes an additional dosing level to explore optimal dosing for enhanced clinical benefit, aligning with FDA's Project Optimus initiative [4]. Group 2: Clinical Efficacy and Safety - Previous Phase 2 studies indicated that patients receiving twice-daily stenoparib experienced durable clinical benefits, with some patients remaining on treatment for over 20 months [2][3]. - The new trial will further assess the efficacy and safety of stenoparib while deepening the understanding of its modulation of the WNT signaling pathway, which is crucial in cancer progression [3][6]. Group 3: Drug Response Predictor (DRP) - The DRP is designed to select patients likely to benefit from stenoparib based on their cancer's gene expression signature, potentially enhancing therapeutic benefit rates [7][8]. - The DRP platform has shown significant predictive ability for clinical outcomes across various cancer studies [8]. Group 4: Company Overview - Allarity Therapeutics is focused on developing personalized cancer treatments, particularly stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients [9]. - The company is headquartered in the U.S. and has a research facility in Denmark, committed to addressing unmet medical needs in cancer treatment [9].