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Allarity Therapeutics Moving Stenoparib to Registration-Directed Ovarian Cancer Trials

NEW YORK – Allarity Therapeutics said Tuesday that it is planning to launch registration-directed follow-on trials of its investigational agent stenoparib in advanced ovarian cancer. 

The Boston-based firm said its dual PARP/tankyrase inhibitor has shown clear benefit in a Phase II clinical trial by significantly shrinking advanced, recurrent ovarian cancer patients' tumors and providing long-term disease stability. Several patients have been receiving the treatment for more than 30 weeks now, which further convinced Allarity of the drug's benefit in this setting and reinforced its decision in May to halt patient enrollment in the Phase II study based on early data and focus its resources on a planned follow-on trial. The firm also said that stenoparib's safety profile appeared favorable compared to first-generation PAPP inhibitors. Allarity plans to present data from this trial at an upcoming scientific conference. 

According to Allarity, the follow-on trials are meant to accelerate stenoparib's path to regulatory approval. The firm plans to use its DRP (Drug Response Predictor) test as a companion diagnostic to identify best responders. The test gauges a transcriptomic signature comprising 414 messenger RNA biomarkers that Allarity has determined to be associated with drug response or resistance. In the Phase II trial, each advanced ovarian cancer patient received a DRP score, and only those with scores above 50 went on to receive stenoparib. 

"The promising results observed with stenoparib, particularly with the tolerability demonstrated so far, warrant further development of this drug," Kathleen Moore, the deputy director of the University of Oklahoma's Stephenson Cancer Center and the stenoparib trial's principal investigator, said in a statement. "I look forward to continuing the discussions with the team at Allarity to refine the future trial design and subsequently continue to investigate the potential of this novel PARP/tankyrase inhibitor."