Stenoparib shows clear clinical benefit and achieves significant milestone with early conclusion of phase II trial in advanced ovarian cancer

The patients enrolled in the trial had been pre-screened by Allarity’s unique Drug Response predictor (DRP ) companion diagnostic (CDx) in order to treat only patients with the highest likelihood of deriving clinical benefit.

The trial, evaluating stenoparib given twice daily, has shown clear clinical benefit, including tumor shrinkage and long-term disease stability, in heavily pre-treated ovarian cancer patients who otherwise have limited life expectancy. These results have provided sufficient clinical proof of concept for stenoparib as monotherapy, prompting Allarity to halt further enrollment in this trial to enable and accelerate the development of a follow-on trial with FDA regulatory intent.

"Based on the substantial clinical benefit observed in the early stages of the trial, we have achieved proof of concept results that surpassed our initial expectations and provided the critical insights we were seeking," stated Thomas Jensen, CEO of Allarity Therapeutics. "Concluding the trial now is the most effective way to re-allocate our financial resources to develop a follow-on trial with the fastest route to regulatory submission for stenoparib. The patients enrolled in this trial are heavily pretreated, having undergone multiple prior treatments, often including PARP inhibitors. It is highly noteworthy that stenoparib, used in patients selected with the DRP CDx, has delivered sustained clinical benefit for such very heavily pre-treated patients in the trial.”

The Company’s decision will not affect the ongoing treatment of current patients, as described in greater detail in Allarity’s March 27, 2024, press release.

Allarity is committed to rapidly analyzing the trial data and plans to present more comprehensive data as early as possible in a clinical update. This early trial conclusion marks a significant milestone in developing stenoparib, reflecting Allarity's dedication to advancing stenoparib to address the urgent needs of advanced ovarian cancer patients.

About Advanced, Recurrent Ovarian Cancer Advanced, recurrent ovarian cancer refers to the return of ovarian cancer after it has been treated. This condition typically occurs in the later stages of the disease, which are classified as stage III or IV at diagnosis. It is characterized by the cancer's resistance to treatment, making its management particularly challenging. The initial symptoms of ovarian cancer can be very subtle, leading to a late diagnosis in many cases.

The recurrence of ovarian cancer is not uncommon, and it significantly complicates the therapeutic landscape. The current main goals of treating advanced, recurrent ovarian cancer are to extend the patient's life while maintaining or improving their quality of life, as curative options are limited. Treatment strategies may involve a combination of surgery, chemotherapy, targeted therapy, and, in some cases, radiation therapy. However, the effectiveness of these treatments diminishes with each recurrence, highlighting the need for innovative approaches to manage the disease.

About the Drug Response Predictor – DRP Companion Diagnostic: Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients dozens of clinical studies (both retrospective and prospective). The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.