Allarity Therapeutics Submits NDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma

Allarity Therapeutics, Inc. recently announced the submission of a new drug application (NDA) with the US 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.

Allarity’s CEO Steve Carchedi said “This NDA submission for dovitinib, in connection with the Dovitinib-DRP companion diagnostic, is a historic milestone for our company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options. Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP diagnostic technology to realize the promise of personalized cancer care for patients. We greatly look forward to the approval of dovitinib and to introducing the clinical value of DRP companion diagnostics to oncologists and their patients.”

Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical therapeutic candidate. The drug has previously shown clinical activity in a number of cancer indications, including RCC, gastrointestinal stromal tumors (GIST), endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma (HCC). The company expects to further evaluate the therapeutic benefit of dovitinib in one or more of these additional indications, either as a monotherapy or in combination with other oncology therapeutics.

“As a clinical oncologist looking for new therapies for my RCC patients, I am enthusiastic about Allarity’s NDA filing together with its Dovitinib-DRP(R) companion diagnostic,” stated Professor Roberto Pili, MD, Associate Dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. “These patients, and their treating oncologists, are greatly in need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders.  I look forward to working with Allarity to advance this new personalized cancer care approach for RCC patients.”

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, and only treating those patients with a sufficiently high DRP score, the therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA from patient biopsies.  The DRP platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA. The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer reviewed literature.

Allarity’s unique and clinically validated DRP companion diagnostics platform enables the prediction of whether a particular cancer patient is likely to respond to treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments for an individual patient are made based on a biopsy from the patient’s tumor. The Dovitinib-DRP companion diagnostic is intended to be used to identify patients with later-stage renal cell carcinoma (RCC) who, by the gene expression signature of their tumor, are identified as having a high likelihood of responding to dovitinib. By identifying and treating only those RCC patients most likely to respond to dovitinib, and avoiding treatment of those RCC patients likely to not respond to the drug, Allarity aims to improve treatment options for patients and their treating oncologist to improve therapeutic benefit.

Allarity Therapeutics, Inc. develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP platform. The company has a mature portfolio of five drug candidates, including: Stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; Dovitinib, a pan-TKI submitted for NDA review by the FDA for third line treatment of renal cell carcinoma; IXEMPRA (Ixabepilone), a microtubule inhibitor approved in the US for the treatment of second line metastatic breast cancer and in Phase 2 development, in Europe, for the treatment of the same indication; LiPlaCis, a liposomal formulation of cisplatin in Phase 2 development for metastatic breast cancer;  and 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM).  The LiPlaCis and 2X-111 programs are partnered, via out-license, to Smerud Medical Research International AS.  In 2021, Allarity sold the global rights to Irofulven, a DNA-damaging agent in Phase 2 for prostate cancer, back to Lantern Pharma, Inc.  The company maintains an R&D facility in Hoersholm, Denmark. For more information, visit www.Allarity.com.