Allarity Therapeutics Receives Acceptance & Review Notification from U.S. FDA for Pre-Market Approval Application for Dovitinib-DRP

Allarity Therapeutics A/S ("Allarity" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance and review notification for the Company's PMA application for its Dovitinib-DRP®, the Company's validated companion diagnostic for the drug dovitinib. Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity's most advanced clinical asset.

On 2 April, 2021, Allarity announced the filing of the PMA application. The FDA's acceptance of the Company's PMA application means that the FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Allarity's PMA application, to gain FDA approval to use the Dovitinib-DRP® as a companion diagnostic to select and treat patients likely to respond to dovitinib, supports the Company's imminent NDA filing for the drug, and is the Company's first PMA filing for a drug-specific DRP® companion diagnostic.

Allarity's CEO, Steve Carchedi, noted, "The FDA'sacceptance of our PMA filing for the Dovitinib-DRP® companion diagnostic is an important milestone for our Company. This marks a turning point for our DRP® technology, as it represents the first time in our Company's history that we have advanced towards regulatory approval for one of our drug-specific DRP® companion diagnostics."

Allarity's unique and clinically validated DRP® biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP® drug response assessments for individual patients are done based on a biopsy from the patients' tumor. The Dovitinib-DRP® companion diagnostic is intended to be used to identify patients suffering from renal cell carcinoma (RCC) who by the gene expression signature of their tumor are found to have a high likelihood of responding to dovitinib.

Allarity plans to file an NDA with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA, following the agency's complete review process, provides the anticipated PMA approval of the Dovitinib-DRP® as a companion diagnostic for dovitinib, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib in the U.S. to DRP®-selected RCC patients as an effective new therapy to treat their disease.  

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. 

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.