Allarity Therapeutics, Inc. (NASDAQ: ALLR) has announced encouraging progress in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer. Two patients in the trial have now been on stenoparib treatment for over 14 months, demonstrating a sustained benefit in a heavily pretreated population.
Extended Treatment Duration in Phase 2 Trial
The ongoing Phase 2 trial evaluates stenoparib in women with advanced, recurrent ovarian cancer who have progressed through multiple lines of therapy, including prior PARP inhibitors. The extended treatment duration observed in these two patients highlights the potential of stenoparib as a valuable option for patients with limited effective treatment alternatives.
Thomas Jensen, CEO of Allarity Therapeutics, noted, "Seeing patients continue to benefit from stenoparib beyond 14 months is very encouraging... We are pleased to see the lasting clinical benefit in these very advanced patients and think this reflects stenoparib’s unique therapeutic mechanism of action."
Financial Stability to Support Further Development
Allarity Therapeutics reports a solid financial position with a cash balance of $18.5 million as of September 30, 2024. This financial strength will enable the company to initiate a follow-up trial to advance stenoparib towards potential FDA registration.
Expansion of Allarity Medical Laboratory
In addition to clinical advancements, Allarity's in-house medical laboratory has expanded its services to external biotech companies. The lab now offers Drug Response Predictor (DRP®) analysis and comprehensive gene expression services, generating revenue and further establishing Allarity's proprietary DRP® platform within the oncology field.
Jensen added, "I am also excited about our successful seamless expansion into the service provider space... In addition to generating meaningful revenue, this expansion further establishes our company, our brand and the DRP® platform within the oncology field."
Trial Design and Patient Selection
The Phase 2 trial is a prospective, open-label, single-arm study conducted at multiple sites in the US and the UK. Patients are prescreened using Allarity’s DRP® companion diagnostic (CDx), which analyzes a transcriptomic signature of 414 mRNA biomarkers to predict drug response. Patients with a DRP score above 50, indicating a higher likelihood of benefit, are selected to receive stenoparib. The dosing regimen was revised in Q1 2023 to 200 mg in the morning and 400 mg in the evening, aiming to optimize daily drug exposure and target inhibition.
About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. Tankyrases are emerging therapeutic targets in cancer due to their role in regulating the Wnt signaling pathway. By inhibiting PARP and blocking Wnt pathway activation, stenoparib's mechanism of action may offer a promising therapeutic approach. Allarity holds exclusive global rights for stenoparib's development and commercialization.
