Allarity Therapeutics and Oncoheroes Biosciences sign agreements to advance pediatric cancer development of dovitinib and stenoparib.

Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to fund and conduct further clinical development of both dovitinib and stenoparib in pediatric cancers. Oncoheroes will take responsibility for pediatric cancer clinical development activities for both clinical-stage therapeutics. Allarity will support Oncoheroes’ pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP companion diagnostic screening of pediatric patients for each drug.

Under the licenses, Oncoheroes will receive commercialization rights for pediatric cancers, subject to Allarity’s first buy-back option for each program, and Allarity will receive an undisclosed upfront license fee and regulatory milestones for each program. If Allarity does not re-acquire the pediatric field rights, it will further receive certain clinical/regulatory milestone payments and royalties on sales of stenoparib and dovitinib in the pediatric cancer market from Oncoheroes. Further financial terms of the licenses were not disclosed.

In December 2021, Allarity submitted an NDA, to the FDA, for marketing approval for dovitinib for the treatment of third line Renal Cell Carcinoma. In April 2021, the Company submitted a premarket approval (PMA) application for use of its Dovitinib-DRP companion diagnostic to select and treat patients most likely to respond to dovitinib.

In support of its NDA filing, and in accordance with FDA requirements, the Company is also planning a clinical trial of dovitnib in pediatric patients with osteosarcoma, in partnership with Oncoheroes, where the patients will be selected with the Dovitinib-DRP companion diagnostic. Allarity’s focus on pediatric osteosarcoma development is based on the results of two previously reported preclinical studies in which treatment with dovitinib, compared to control treatment (sucrose solution lacking dovitinib), increased the median survival time of mouse models of osteosarcoma by 50% and antitumor growth activity was observed for dovitinib as a single agent.