Allarity Therapeutics & Oncoheroes Biosciences Sign Agreements to Advance Pediatric Cancer Development of Dovitinib & Stenoparib

Allarity Therapeutics, Inc. and Oncoheroes Biosciences, Inc. recently announced 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.

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, said “We are very pleased to partner with Oncoheroes Biosciences to advance both dovitinib and stenoparib as potential new therapeutic options for the personalized treatment of children 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 US 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, CEO and Founder of Oncoheroes Biosciences, added “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), and additional US 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.

Allarity Therapeutics, Inc. develops drugs for personalized treatment of cancer guided by its proprietary and highly validated companion diagnostic technology, the DRP platform. The company has a mature portfolio of five drug candidates, including: Stenoparib, a PARP inhibitor in Phase 2 development for ovarian cancer; Dovitinib, a pan-TKI submitted for NDA review by the FDA for the third line treatment of renal cell carcinoma; IXEMPRA (Ixabepilone), a microtubule inhibitor approved in the US for the second line treatment of metastatic breast cancer and in Phase 2 development, in Europe, for the treatment of the same indication; LiPlaCis, a liposomal formulation of cisplatin in Phase 2 development for metastatic breast cancer; and 2X-111, a liposomal formulation of doxorubicin in Phase 2 development for metastatic breast cancer and/or glioblastoma multiforme (GBM). The LiPlaCis and 2X-111 programs are partnered, via out-license, to Smerud Medical Research International AS. In 2021, Allarity sold the global rights to Irofulven, a DNA-damaging agent in Phase 2 for prostate cancer, back to Lantern Pharma, Inc. The Company maintains an R&D facility in Hoersholm, Denmark. For more information, visit www.Allarity.com.

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, and only treating those patients with a sufficiently high DRP score, the therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP^® is based on messenger RNA from patient biopsies. The DRP platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of Stenoparib and IXEMPRA. The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in peer reviewed literature.

Oncoheroes is a ground-breaking biotech company exclusively focused on the discovery and development of better drugs for children and adolescents with cancer. Our vision is to deliver benefits to young cancer patients and create value in the process. The company is headquartered in Boston, MA, with a discovery lab in Barcelona, Spain. Oncoheroes is actively looking for in-licensing opportunities in the pediatric oncology space while working to generate new proprietary assets for a number of pediatric cancer indications with high unmet medical needs. For more information, visit oncoheroes.com.