stenoparib (2X-121)

P2, N=40, Recruiting, Allarity Therapeutics | Active, not recruiting --> Recruiting

P1/2, N=166, Not yet recruiting, VA Office of Research and Development | Phase classification: P2 --> P1/2

These findings offer new insights into the molecular mechanisms of LUADBM and highlight potential therapeutic targets, including the XLOC_006941/miR-543/NPRL3 axis and GATA3-driven Th2 cell infiltration. The dual-target therapy combining E7449 with dupilumab shows promise for improving patient outcomes in LUADBM, warranting further clinical evaluation.

P2, N=20, Completed, Allarity Therapeutics | Active, not recruiting --> Completed | N=30 --> 20

"Allarity Therapeutics, Inc...announced that the European Patent Office (EPO) has issued a formal notice of its intention to grant a patent for Allarity’s Drug Response Predictor (DRP) companion diagnostic specific to stenoparib, the Company’s dual-targeted PARP/Tankyrase inhibitor. This patent represents a significant step forward in securing Allarity’s market position for stenoparib and the Stenoparib DRP companion diagnostic, which identifies patients most likely to derive clinical benefit from stenoparib treatment....Patent applications for the Stenoparib DRP companion diagnostic are also pending in the United States, Japan, China, Australia, and India."

P2 | N=60 | PREDICT 2X-121 (NCT03878849) | Sponsor: Allarity Therapeutics | "Allarity Therapeutics, Inc...announced that two patients enrolled in its Phase 2 clinical trial of stenoparib for advanced, recurrent ovarian cancer have now exceeded one year on therapy....This remarkably lengthy treatment period highlights the potential of stenoparib to provide durable clinical benefit, even in heavily pre-treated ovarian cancer patients who have limited treatment options. The trial continues to evaluate stenoparib’s safety and efficacy, showing a confirmed, complete response as well as long term disease stability for multiple patients."

P2, N=30, Active, not recruiting, Allarity Therapeutics | Trial completion date: May 2024 --> Aug 2024

P2, N=60, Active, not recruiting, Allarity Therapeutics | Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Sep 2024

"Allarity Therapeutics, Inc....announced a strategic pivot aimed at advancing its clinical-stage candidate stenoparib, a novel PARP/Tankyrase dual inhibitor, toward registration in advanced recurrent ovarian cancer, leveraging its DRP platform to identify and enroll only the patients most likely to derive clinical benefit....This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023....As part of this strategic shift, the Company will deprioritize the other clinical trials for dovitinib and IXEMPRA."

"Allarity Therapeutics, Inc...is pleased to announce that it has been invited to present at Biomarkers 2024. Thomas Jensen, CEO and co-founder of Allarity, will present the company's novel work in developing the drug-specific Drug Response Predictor (DRP) companion diagnostics (CDx) platform. This work spans from cancer cell line research to the validation of concepts through retrospective clinical data analysis and into the area of prospective clinical trials, notably an ongoing trial for ovarian cancer. This trial investigates how a DRP created specifically for the Company’s lead clinical asset, the dual PARP/Tankyrase inhibitor stenoparib, can be used to pre-select advanced ovarian cancer patients who are predicted to have a significant likelihood of clinical benefit from treatment for enrollment in this phase 2 monotherapy study, NCT03878849."

P2 | N=60 | PREDICT 2X-121 (NCT03878849) | Sponsor: Allarity Therapeutics | "Allarity Therapeutics, Inc...today announced encouraging initial results from its ongoing Phase 2 clinical trial evaluating the efficacy of its PARP inhibitor, stenoparib, in women with advanced ovarian cancer (AOC). Of the five evaluable patients included in the initial data analysis, one patient experienced a complete response and the other four demonstrated stable disease...Of the 22 patients screened with the DRP^®-Stenoparib CDx, 17 DRP^® positive patients were identified...One patient experienced a complete response (CR) by scan (to be confirmed by second scan) and by decreased levels of CA125 (a biomarker of AOC)....Allarity anticipates an interim data readout in Q1 2024."

P2, N=30, Active, not recruiting, Allarity Therapeutics | Trial completion date: May 2023 --> May 2024 | Trial primary completion date: Apr 2023 --> Apr 2024