On April 2, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the submission of a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for DRP-Dovitinib, the Company’s validated companion diagnostic for the drug dovitinib (Press release, Allarity Therapeutics, APR 2, 2021, View Source [SID1234577544]). Dovitinib is a small molecule, pan-tyrosine kinase inhibitor licensed from Novartis, and is Allarity’s most advanced clinical asset. This milestone marks the first time that Allarity has sought regulatory approval for one of its drug-specific DRPs used to guide patient therapy.
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Allarity’s unique 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 of the individual patients are done based on a biopsy from the patients’ tumors. The DRP-Dovitinib 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 a New Drug Application ("NDA") with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA provides the anticipated premarket approval of the dovitinib DRP as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib to DRP-selected RCC patients as an effective new therapy to treat their disease. The DRP for dovitinib, if approved, will be the first complex, gene expression signature approved by the U.S. FDA as a companion diagnostic to guide patient selection for cancer therapy.
Allarity’s CEO, Steve Carchedi, noted "Our current goal for dovitinib is to make it available to the group of RCC patients for whom a treatment with this particular therapeutic will be the most efficacious treatment for their disease. Today, marks a milestone for the advancement of our unique DRP biomarker technology for dovitinib, and approval of our PMA will enable oncologists to select those patients who are high likelihood responders to this drug." Mr. Carchedi further stated: "Later this year, I look forward to announcing our expected filing of a New Drug Application for dovitinib itself. Ultimately, if both of these filings are approved by the FDA, our Company will be positioned to significantly change how treatment of RCC will be conducted in the future, and help realize the promise of personalized medicine for these patients."
Steen Knudsen, Ph.D., CSO and Co-Founder of the Company, further stated, "I am extremely pleased to reach the milestone event of our first regulatory approval application for a DRP companion diagnostic, following our extensive work, over the past 15 years, developing, validating, and perfecting our DRP technology. I look forward to our Company advancing dovitinib, in combination with the Dovitinib-DRP, through approval and to market, and to similarly advancing the rest of our oncology therapeutics pipeline with DRP companion diagnostics in a true personalize medicine approach."
In October 2020 Allarity announced that the United States Patent and Trademark Office (USPTO) had issued a notice of allowance to the Company on its patent application no 16/444,881 titled "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – directed to a DRP biomarker for dovitinib.
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.