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Allarity Therapeutics 'Retools' Pipeline to Focus on Stenoparib, Deprioritizes Ixempra, Dovitinib

NEW YORK – Allarity Therapeutics on Wednesday said it has pivoted its business to focus exclusively on advancing the PARP/tankyrase inhibitor stenoparib as a treatment for advanced ovarian cancer patients most likely to benefit based on its drug response predictor (DRP) platform.

The decision to focus solely on moving stenoparib — also known as E7449 and 2X-121 — toward regulatory approval comes after Allarity announced positive, albeit early, Phase II data for the agent in December 2023.

In that Phase II trial, Allarity said stenoparib's clinical benefit "exceeded expectations" among patients who previously received PARP inhibitors and were selected for enrollment in the study based on Allarity's 2X-121 DRP. Among five evaluable patients, all of whom were heavily pretreated, the firm said that one experienced a complete response and the other four had stable disease on stenoparib. The patient with a complete response has now been on treatment for 10 months, and all five patients have experienced a clinical benefit exceeding 20 weeks, according to Allarity.

Allarity believes that stenoparib has a unique mechanism of action, as it inhibits both PARP and the novel cancer target tankyrase. According to the firm, inhibiting tankyrase could restrain the WNT pathway, which is often upregulated in ovarian cancer and other solid tumors.

"Based on the favorable tolerability with stenoparib and the emerging clinical benefit evident in our patients so far, we have decided to focus on retooling our company to accelerate development of stenoparib toward registration as quickly as possible for these desperately ill patients," Allarity interim CEO Thomas Jensen said in a statement.

To funnel additional funds and internal resources to the stenoparib program, the Boston-based firm said it must deprioritize clinical development of its other candidates, Ixempra (ixabepilone) and dovitinib.

The strategic shift comes as Allarity, formerly known as Oncology Venture, tries to regain compliance with Nasdaq listing rules. The firm has until April 24 to achieve a stockholders' equity of at least $2.5 million and a minimum bid price of $1.00 per share for a minimum of 10 consecutive business days. To achieve these benchmarks, Allarity is reducing its operating costs and seeking "additional capital through separate sources of short-term and longer-term strategic financing."