On June 14, 2021 Allarity Therapeutics A/S ("Allarity") and Oncoheroes Biosciences, Inc. ("Oncoheroes") reported that they have entered into binding term sheets for agreements under which Oncoheroes will acquire certain rights to dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, and assume responsibility for their further clinical development in pediatric cancer (Press release, Allarity Therapeutics, JUN 14, 2021, View Source [SID1234583965]).
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Allarity is preparing for the submission, to the U.S. Food and Drug Administration (FDA), of an NDA for marketing approval for dovitinib as a treatment for RCC later this year. Earlier this year, in April, the Company submitted the premarket approval (PMA) application for use of its Dovitinib-DRP companion diagnostic to select and treat patients most likely to respond to the drug. 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, 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.
Allarity is also 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.) 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 possible use of PARP inhibitors in the treatment of various pediatric cancers.
Steve R. Carchedi, CEO of Allarity Therapeutics, commented, "This is a promising opportunity to work with Oncoheroes Biosciences, a childhood cancer-focused organization, which will allow the two companies to build together on Allarity’s prior efforts to advance both dovitinib and stenoparib by further exploring the clinical potential of these drugs for the specific treatment of pediatric cancers. We are very pleased to partner with Oncoheroes on these pediatric cancer programs to help address historically underserved, rare childhood cancers. 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."
Under the terms outlined in the binding terms sheets, Oncoheroes will acquire global, exclusive rights to fund and conduct further clinical development of both dovitinib and stenoparib in pediatric cancer. The complete agreements are conditioned upon Oncoheroes allocating specific funds, within a specified timeframe, to conduct the contemplated pediatric clinical development. Under the dovitinib term sheet, Oncoheroes will take responsibility for pediatric cancer clinical development activities. Upon successful completion of the studies, Allarity will reimburse Oncoheroes for clinical development costs plus a fixed profit margin and pay an undisclosed milestone upon first regulatory approval for a pediatric cancer indication. Oncoheroes will not receive any pediatric field commercialization rights unless Allarity elects not to further develop the drug for pediatric indications. Under the stenoparib term sheet, Oncoheroes will receive commercialization rights for pediatric cancers, subject to Allarity’s first buy-back option, and Allarity will receive an undisclosed upfront license fee. 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 in the pediatric cancer market from Oncoheroes. Allarity will support Oncoheroes’ pediatric clinical trials by providing clinical-grade drug inventory at cost and by facilitating DRP companion diagnostic screening of patients for each drug. Further financial terms of the term sheets were not disclosed.
Cesare Spadoni, COO & 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.