On March 9, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported positive data from its preclinical assessment of dovitinib’s antitumor activity in osteosarcoma, the most common primary malignant bone tumor in children and young adults (Press release, Allarity Therapeutics, MAR 9, 2021, View Source,-Email%20Print%20Friendly&text=by%2050%20%25%20as%20compared%20to%20control%20animals. [SID1234576337]). The purpose of the study was to investigate the capacity of dovitinib alone, and in combination with a specific checkpoint inhibition strategy (anti-PD-1), for slowing the progression of experimental pulmonary metastases in animal models of osteosarcoma.

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Two separate studies, performed contemporaneously in a syngeneic, mouse model of experimental pulmonary osteosarcoma metastases in mice using the K7M2 cell line, generated the following key results:

Treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time by 50 %.
Antitumor growth activity was also observed for dovitinib as a single agent in this model.
In addition, it was found that no significant antitumor activity was observed in mice treated with single-agent anti-PD-1 antibody at the investigated dosage and dosing schedule. Furthermore, the combination of dovitinib and anti-PD-1 antibody did not generate additive or synergistic antitumor activities equal or greater than observed by dovitinib alone in the mouse osteosarcoma model.

Allarity is preparing for the submission of a new drug application (NDA) for marketing approval, by the U.S. FDA, for dovitinib as a treatment for renal cell carcinoma (RCC). In support of its NDA filing, and in accordance with FDA requirements, the company is also planning a clinical trial in pediatric patients with osteosarcoma, where the patients will be selected with the DRP companion diagnostic for Dovitinib. The FDA defines pediatric patients as persons aged 21 or younger.

Allarity Therapeutics has chosen osteosarcoma as the pediatric indication in which to evaluate the efficacy and safety of dovitinib on the basis of the reported preclinical study. A positive preclinical assessment, as announced today, is a part of the normal prerequisites for initiating a clinical trial in pediatric patients with osteosarcoma.

Allarity’s CEO, Steve Carchedi, noted "These data further demonstrates that dovitinib is a therapy that has a potential beyond RCC. We look forward to continuing our work towards regulatory approval of dovitinib, and ultimately realize its potential as a personalized cancer treatment by applying our unique DRP technology."

M.D., D.Sc., Marie Foegh, CMO of Allarity Therapeutics, further stated. "We are now ready to move forward towards initiating a pediatric clinical trial for dovitinib after receiving these excellent preclinical results. If we can show that dovitinib is also a potential treatment for patients with osteosarcoma, it will further strengthen the case for bringing this new therapy to the market."

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.