Allarity Therapeutics, a clinical-stage pharmaceutical company, is set to advance the clinical development of stenoparib, a dual PARP/Wnt pathway inhibitor, towards potential FDA approval for advanced ovarian cancer. The company's refined Phase 2 protocol aims to optimize stenoparib's dosing and enhance patient selection using its proprietary Drug Response Predictor (DRP®) technology.
Phase 2 Trial Expansion
Building on the ongoing Phase 2 clinical trial data, Allarity's expanded protocol will focus on patients with advanced, recurrent, platinum-resistant ovarian cancer. This patient group has demonstrated durable clinical benefits from stenoparib in the current Phase 2 trial and has limited treatment options following standard chemotherapy.
Thomas Jensen, CEO of Allarity Therapeutics, stated, "Until now, patients receiving stenoparib have had diverse and often extensive treatment histories, with many being very heavily pretreated. Based on data we have gathered to date from our clinical trials, and through in-depth analysis and consultation with leading gynecologic oncologists, we have developed a new clinical trial protocol focused on a well-defined, commercially significant patient population in desperate need of newer, safer treatment options beyond more chemotherapy, which comes with well-documented side effects."
Patient enrollment is expected to begin in the first half of 2025, pending final protocol review by regulatory authorities. The trial will commence at leading U.S. sites, with potential expansion to the U.K.
Investigating Stenoparib's Mechanism of Action
In addition to expanding clinical data, the trial is designed to enhance the understanding of stenoparib's therapeutic mechanism, particularly its impact on the Wnt pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. A deeper understanding of stenoparib's role in modulating the Wnt pathway could further differentiate stenoparib in the $9B+ PARP inhibitor market.
Refining Patient Selection with DRP
The protocol will further refine Allarity’s understanding of the stenoparib-DRP® for identifying patients most likely to benefit from stenoparib treatment. A DRP score will be assessed for all enrolled patients to generate a more robust data set, necessary to refine the DRP cut-off that would ring-fence patients most likely to benefit from stenoparib. These data will be fundamental for supporting any regulatory approval for the stenoparib-DRP as a companion diagnostic (CDx) specific to stenoparib.
Stenoparib's Potential
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. 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. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd.
Allarity expects to pursue multiple advantaged regulatory pathways to expedite approval in the first half of 2025.
