- Poster title: A novel drug response predictor (DRP®) mRNA biomarker for the multi tyrosine kinase inhibitor dovitinib

- Poster provides new details of the DRP® companion diagnostic for dovitinib, its lead oncology pipeline asset

Press release

Hørsholm, Denmark (29 April 2021) Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced 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.

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: https://www.eacr2021.org

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.

About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP^® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: Stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; Dovitinib, a pan-TKI advancing towards a U.S. NDA filing for renal cell carcinoma; IXEMPRA^® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer; LiPlaCis^®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer.

Follow us on social media:
Facebook: https://www.facebook.com/AllarityTx/
LinkedIn: https://www.linkedin.com/company/allaritytx/
Twitter: https://twitter.com/allaritytx

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning Allarity’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. Allarity undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Allarity’s clinical programs may be delayed or impacted by the ongoing global COVID-19 pandemic.

###

Investor Contact:
        Jens Knudsen, CFO        
        +45 8874 2415
        Email inquiries: InvestorRelations@allarity.com

Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390
        Email inquiries: tsp@carrotize.com

Certified Adviser:
Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732

This information is information that Allarity A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 29 April 2021.