On March 28, 2023 Allarity Therapeutics, Inc. (NASDAQ: ALLR) ("Allarity" or "the Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported updates to its ongoing phase 2 clinical programs evaluating IXEMPRA and stenoparib as monotherapies (Press release, Allarity Therapeutics, MAR 28, 2023, View Source [SID1234629454]).
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For both IXEMPRA and stenoparib monotherapy trials, Allarity is taking steps to accelerate patient recruitment to support the goals for interim data readouts by the end of 2023. Due to slower than anticipated patient enrollment in both studies, owing in part to impacts of the COVID pandemic on trial site staffing, Allarity has expanded its collaboration with multiple contract research organizations (CROs) to substantially increase the number of active trial sites. The Company has also made changes to the clinical trial protocols to increase the availability of eligible participants for both monotherapy studies.
"Patient recruitment in oncology clinical trials is an ongoing challenge and has delayed target date readouts across our sector. I am optimistic that our ongoing efforts to address this challenge will make a positive impact on our goal of providing interim data readouts in our ongoing Phase 2 studies by year’s end," said James G. Cullem, Chief Executive Officer of Allarity Therapeutics. "Similarly, our trial protocol amendments reflect Allarity’s adaptability and commitment to seek optimal patient benefit in our clinical studies, guided by our unique DRP companion diagnostics, to select and treat most likely-to-respond patients."
Allarity is sponsoring an ongoing DRP-guided Phase 2 clinical trial evaluating IXEMPRA as a monotherapy in metastatic breast cancer in Europe. In addition to expanding its CRO partnerships, Allarity has implemented a trial protocol amendment that will lower the IXEMPRA-DRP companion diagnostic cut-off score, for enrollment, from 67% to 33%. As a result, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.
The Company is also evaluating stenoparib as a monotherapy in ovarian cancer in an ongoing DRP-guided Phase 2 clinical trial. Based on early data (unpublished) from this study and in consultation with trial investigators and the Company’s Scientific Advisory Board (SAB), Allarity has implemented a trial protocol amendment to change patient dosing from once daily dose to a BID regimen (twice daily). The aim is to improve therapeutic benefit by providing a consistent level of the drug in the patient throughout the treatment period. As a result of these efforts, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.
The dosing-related protocol amendment in the Phase 2 stenoparib monotherapy trial also aligns with the BID dosing strategy for Allarity’s recently initiated Phase 1b combination study of stenoparib and dovitinib for the treatment of advanced solid tumors.