Allarity Therapeutics Announces Positive Data from Preclinical Study of Dovitinib in Osteosarcoma

- Treatment of animal osteosarcoma models with dovitinib increased the median survival time
by 50 % as compared to control animals.

Press release  

Hørsholm, Denmark (9 March 2021) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced 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. 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. 

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.”