COMPANY:

Allarity Therap

P2 | N=40 | Recruiting | Sponsor: Allarity Therapeutics | Active, not recruiting ➔ Recruiting

"Allarity recently began patient enrollment under a new Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer."

"Allarity Therapeutics, Inc...today announced the signing of a new commercial agreement with a non-disclosed EU-based biotechnology company. The agreement provides the partner with a non-exclusive global license to a range of selected proprietary Allarity DRP® algorithms in breast cancer, alongside laboratory services from Allarity’s Medical Laboratory in Denmark."

"Allarity Therapeutics...announced that IP Australia...has formally accepted the Company’s patent application for its DRP companion diagnostic specific to stenoparib....The granted patent will be officially advertised in the Australian Official Journal of Patents on June 26, 2025, followed by a three-month opposition period. If unopposed, the patent is expected to be granted within 20 working days thereafter....Allarity previously secured a European patent for the Stenoparib DRP and holds 18 granted patents for drug-specific DRPs, including eight in the United States. Patent applications for the Stenoparib DRP remain pending in the U.S., Canada, Japan, China, and India."

"Allarity Therapeutics, Inc...today announced the Company’s CEO, Thomas Jensen, will deliver a company overview focused on stenoparib and the Company’s DRP® companion diagnostic platform and conduct one-on-one meetings at the Pharma Partnering Summit US. The event is a business development and licensing conference for executives of biotechnology and pharmaceutical companies, taking place May 14–15 in San Diego, CA."

"Allarity Therapeutics, Inc...announced the presentation of a poster containing data on a new DRP for the monoclonal antibody drug daratumumab....The daratumumab DRP was developed by correlating gene expression patterns with sensitivity to daratumumab-induced antibody-dependent cellular cytotoxicity (ADCC), based on published in vitro data from multiple myeloma and B-cell lymphoma cell lines. From this analysis, the Company identified a total of 53 genes—27 associated with sensitivity and 26 with resistance—which form the basis of this drug-specific DRP. Using single-cell RNA sequencing data and overall response information from bone marrow samples collected in the KYDAR trial (a study of multiple myeloma patients treated with daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone), the DRP was able to predict treatment outcomes and survival."

P2 | N=60 | PREDICT (NCT03878849) | Sponsor: Allarity Therapeutics | "The poster presents data from the first Phase 2 study of stenoparib in advanced ovarian cancer and the first stenoparib study ever to dose twice daily....First study to dose stenoparib twice daily optimizing inhibition of PARP and Tankyrase across every 24-hour period. First stenoparib study to show potential durable clinical benefit in platinum-resistant and refractory patients. Data continue to show that stenoparib is well-tolerated and does not elicit the bone marrow toxicity typical of first-generation PARP inhibitors. Study shows clinical benefit across distinct genetic backgrounds including in both BRCA-mutant patients and in BRCA wild-type (non-mutated) patients, a larger patient group than those with BRCA mutation."

"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."

"Allarity Therapeutics...announced the early discontinuation of its Phase 2 clinical trial of stenoparib, a novel PARP inhibitor, for the treatment of advanced recurrent 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."

"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."