On April 29, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported at the Company has been selected for e-Poster presentation at the European Association for Cancer Research (EACR) 2021 Virtual Congress to be held from 9 – 12 June 2021 (Press release, Allarity Therapeutics, APR 29, 2021, View Source [SID1234578831]).
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The e-Poster provides new details of the Dovitinib-DRP companion diagnostic, which is used to select cancer patients most likely to respond to the pan-targeted kinase inhibitor (pan-TKI) dovitinib. The Dovitinib-DRP confirms many of the cell signaling pathways previously known to be targeted by the drug, as well as identifying additional, novel mechanisms of drug response.
Dovitinib is a post-Phase 3 small molecule, pan-TKI in-licensed from Novartis, and is Allarity’s most advanced clinical asset. Allarity plans to file a New Drug Application ("NDA") with the U.S. Food and Drug Administration (FDA) for the approval of dovitinib for the treatment of renal cell carcinoma (RCC, kidney cancer) during 2021. The Company previously submitted, in April 2021, a premarket approval application (PMA) to the U.S. FDA for use of the Dovitinib-DRP as a companion diagnostic to select RCC patients most likely to respond to dovitinib. The Dovitinib-DRP, if approved by the U.S. FDA, will be the first clinically validated, complex gene expression signature used as a companion diagnostic to select patients most likely to respond to a given cancer therapeutic.
Presentation details:
e-Poster title: A novel drug response predictor (DRP) mRNA biomarker for the multi tyrosine kinase inhibitor dovitinib
Presenter: Marie Foegh, M.D., D.Sc., Chief Medical Officer of Allarity Therapeutics
Date and Time: 9 – 12 June 2021
Additional information on the congress can be found on the EACR 2021 Virtual Congress website: View Source
The CEO of Allarity Therapeutics, Steve Carchedi, noted, "We are pleased every time that Allarity is given the opportunity to contribute to scientific conferences, particularly in the area of personalized cancer care and companion diagnostics. We are honored to be invited to present our poster at this important EACR conference, detailing our Dovitinib-DRP companion diagnostic, which aligns with our ongoing efforts to file a New Drug Application (NDA) for dovitinib, following our PMA filing for the Dovitinib-DRP earlier this year. We remain committed to improving therapeutic options for RCC patients by securing approval of dovitinib together with its DRP companion diagnostic to help realized the promise of personalized cancer care."
About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.