stenoparib (2X-121)

"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

P2, N=30, Active, not recruiting, Allarity Therapeutics | Trial completion date: Oct 2022 --> May 2023 | Trial primary completion date: Oct 2022 --> Apr 2023

P2, N=30, Active, not recruiting, Allarity Therapeutics | Trial completion date: Oct 2021 --> Oct 2022 | Trial primary completion date: Oct 2021 --> Oct 2022

"Allarity Therapeutics, Inc...and Oncoheroes Biosciences, Inc...announced that they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancers...Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to fund and conduct further clinical development of both dovitinib and stenoparib in pediatric cancers...Allarity will support Oncoheroes’ pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP® companion diagnostic screening of pediatric patients for each drug...the Company is also planning a clinical trial of dovitnib in pediatric patients with osteosarcoma, in partnership with Oncoheroes..."

P2, N=30, Active, not recruiting, Allarity Therapeutics | Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2021 --> Oct 2021

P2, N=30, Active, not recruiting, Oncology Venture | Trial completion date: Dec 2020 --> Apr 2021 | Trial primary completion date: Dec 2020 --> Apr 2021

P2, N=30, Active, not recruiting, Oncology Venture | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2020 --> Dec 2020

The results support further clinical investigation of E7449 and its associated biomarker 2X-121 DRP.

P2; N=30; Recruiting; Sponsor: Oncology Venture