COMPANY:

Allarity Therap

"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."

"Allarity Therapeutics, Inc...is pleased to announce that the Company has been invited to give a presentation at Biomarkers Europe 2023. The presentation will focus on Allarity’s development of drug-specific DRP^® companion diagnostics (CDx) for oncology therapeutics, featuring clinical validation for several exemplary DRP^® CDx....In addition to its presentation, Allarity is honored to participate in a panel discussion titled 'Prediction Of Drug Response Using An Ex Vivo Organ Culture (EVOC) On Oncology Patients, Clinical Trial Development And Patient Testing' at the same conference."

P=NA | N=135 | "Allarity Therapeutics...announced today the publication of its clinical validation of a novel drug-specific DRP®-companion diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a subgroup of advanced renal cell carcinoma (RCC) patients that have improved clinical benefit from treatment with dovitinib, as compared to unselected patients....In the study evaluating pre-treatment biopsies of 135 advanced RCC patients, the DRP® positive subgroup (indicating that the patient was likely to respond) (N=49) had a median overall survival of 15 months (96% CI 12.94-26.25), whereas the DRP® negative subgroup (N=86) had a median overall survival of 9.13 months (95% CI 7.49-13.2)."

"Allarity Therapeutics, Inc...announced today that the two companies have entered into a Clinical Collaboration Agreement. Under this agreement, Allarity will support FivepHusion’s future clinical development of Deflexifol™ for the treatment of solid tumors by using certain of Allarity’s drug-specific DRP^® companion diagnostics, including its validated DRP^®-5FU companion diagnostic, to potentially select patients for enrollment and treatment in clinical trials of Deflexifol™ as a monotherapy and in combination with other drugs....Under the terms of the Clinical Collaboration Agreement, Allarity will initially support FivepHusion’s planned Phase 1b/2a trial of DEFLOX plus bevacizumab in 1st line treatment of unresectable mCRC, which will be conducted at trial sites in Australia....Financial terms of the clinical collaboration, option and potential license are not disclosed."

P2 | N=176 | NCT00593827 | Sponsor: R-Pharm | "Allarity Therapeutics, Inc...announced initial results from its European Phase 2 clinical trial evaluating the efficacy of IXEMPRA^® in metastatic breast cancer (mBC) patients selected with the DRP^®-IXEMPRA^® companion diagnostic (CDx) candidate....Among the evaluable patients assessed up to the data evaluation cut-off, there were promising signs of clinical benefit in four out of four evaluable cases: One partial responder (PR) (tumor shrinkage of 66%). One partial responder (PR) (tumor shrinkage of 59%). One patient experienced 24 weeks of stable disease. One patient experienced 19 weeks of stable disease....The Company anticipates an additional interim data readout before the end of this year."

P1/2 | N=50 | NCT01861496 | Sponsor: Allarity Therapeutics | "Allarity Therapeutics, Inc...announced the results of a prospective Phase 2 clinical study of the Company’s proprietary DRP® technology that will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2023....Data from the poster presentation will show that the cisplatin-DRP^® identified all four mBC patients who demonstrated a partial response (PR) in the trial as likely responders to the LiPlaCis™ treatment regimen using a DRP80+ score as a cut-off for likely responders. In addition, the cisplatin-DRP^® also identified mBC patients demonstrating other efficacy signals, including improved progression-free survival. Based on these data, researchers concluded that the cisplatin-DRP^® companion diagnostic can differentiate, in a statistically significant way, clinical responders and non-responders to cisplatin administered as LiPlaCis™."

"Allarity Therapeutics, Inc...announced that an abstract on the Company’s proprietary DRP^® technology has been accepted for a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting....The poster shows the final data from a phase 2 study evaluating the ability of the DRP^® companion diagnostic for cisplatin to prospectively identify patients with metastatic breast cancer that are likely to respond to treatment with LiPlaCis^®, a targeted liposomal formulation of cisplatin."

"Following several weeks of analysis by Company leadership together with clinical and regulatory experts, Allarity has now filed a formal request with the FDA for a 'Type C' meeting to further discuss potential clinical paths to support approval of dovitinib, together with its DRP^®-Dovitinib companion diagnostic, in view of the FDA’s recent RTFs....The Company anticipates providing a further update on the outcome of its FDA meeting and the future of the dovitinib program before the end of the third quarter of this year."

"Allarity Therapeutics...announced that the...FDA has provided the Company with Refusal to File ('RTF') letters regarding the new drug application ('NDA') for dovitinib, and its accompanying pre-market approval ('PMA') application for the DRP®-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma ('mRCC'). Upon preliminary review, the FDA determined that the NDA, submitted on December 22, 2021, and the PMA application, submitted on April 2, 2021, were not sufficiently complete to permit substantive reviews....Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its accompanying DRP®-Dovitinib companion diagnostic towards approval."

"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..."

"Allarity Therapeutics, Inc...announced the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients....The Company’s NDA filing is supported by its prior PMA submission with the FDA for use of Dovitinib-DRP^®, the Company’s validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib."