On January 3, 2022 Allarity Therapeutics, Inc. (Nasdaq: ALLR) ("Allarity" or the "Company"), a clinical-stage biopharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, and Oncoheroes Biosciences, Inc. ("Oncoheroes"), a clinical-stage biotechnology company advancing new therapies for childhood cancers, reported that they have entered into licensing agreements under which Oncoheroes will acquire exclusive, global development rights to Allarity’s therapeutic candidates dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancers (Press release, Allarity Therapeutics, JAN 3, 2022, View Source [SID1234597973]).
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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.
Steve R. Carchedi, CEO of Allarity Therapeutics, commented, "We are very pleased to partner with Oncoheroes Biosciencesto advance both dovitinib and stenoparib as potential new therapeutic options for the personalized treatment ofchildren and adolescents with cancer. Oncoheroes is a leader in advancing new therapeutics to help address historically underserved, rare childhood cancers, and an ideal partner for Allarity in the pediatric cancer market. Our out-licensing of these pediatric development programs enables Allarity to remain focused on our top priority programs in adult cancers, while at the same time leveraging Oncoheroes’ resources, capabilities, and commitment to clinically advancing dovitinib and stenoparib in childhood cancers, together with our DRP companion diagnostics, in a true personalized cancer care approach."
In December 2021, Allarity submitted an NDA, to the U.S. Food and Drug Administration (FDA), for marketing approval for dovitinib for the treatment of third line RCC. 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.
Ricardo Garcia , C EO & Founder of Oncoheroes Biosciences, further commented, "Oncoheroes is a mission-driven company committed to deliver more effective and safer treatments for children and adolescents with cancer. We are excited to partner with Allarity on these co-development programs. These fit perfectly with our goal of becoming the partner of choice for life sciences companies with drug candidates that have the potential to treat pediatric cancers. We are confident that this collaborative model will create powerful synergies to accelerate pediatric drug development and bring tangible benefits to younger cancer patients."
Allarity is currently evaluating stenoparib for the treatment of advanced ovarian cancer in a Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.), and additional U.S. and European trial sites, using the Stenoparib-DRP companion diagnostic to guide patient enrollment and improve therapeutic outcome. In prior clinical testing of more than 60 patients, stenoparib was well tolerated with a demonstrated acceptable safety profile. Through use of DRP patient selection, Allarity aims to provide a superior clinical benefit to ovarian cancer patients receiving stenoparib as compared to other approved PARP inhibitors. Moreover, there is increasing evidence pointing to the potential use of PARP inhibitors in the treatment of various pediatric cancers.