Oncoheroes will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers. Allarity is preparing to file a first US new drug application (NDA) for approval of dovitinib in renal cell carcinoma (RCC), and has plans for an additional clinical trial of the drug in pediatric cancer, using the DRP® Companion Diagnostic for dovitinib Allarity is also currently conducting a Phase 2 trial of stenoparib in ovarian cancer using the DRP® Companion Diagnostic for the drug, and has explored potential expansion into a pediatric cancer indication
Horsholm, Denmark and Boston, MA, USA (14 June- 2021) – Allarity Therapeutics A/S (“Allarity”) and Oncoheroes Biosciences, Inc. (“Oncoheroes”) announced today 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.
Allarity is preparing to submit to the US Food and Drug Administration (FDA) an NDA to market dovitinib as a treatment for RCC later this year. Earlier this year, in April, the company filed its premarket application for approval (PMA) for the use of its Dovitinib-DRP® companion diagnostic to select and treat patients most likely to respond to the drug. In support of the NDA filing, and in compliance with FDA requirements, the company is also planning a clinical trial in pediatric osteosarcoma patients, in collaboration with Oncoheroes, where 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 with control treatment (sucrose solution without dovitinib), increased the median survival time of mouse models of osteosarcoma by 50% and antitumor growth activity was observed for dovitinib monotherapy.
Allarity is also currently evaluating stenoparib for the treatment of advanced ovarian cancer in a phase 2 clinical trial at Dana-Farber Cancer Institute (Boston, MA, USA) using the Stenoparib-DRP® companion diagnostic to guide patient enrollment and improve therapeutic outcomes. In previous clinical trials in more than 60 patients, stenoparib was well tolerated with a demonstrated acceptable safety profile. Through the use of DRP® patient selection, Allarity aims to provide a superior clinical benefit to ovarian cancer patients receiving stenoparib compared to other approved PARP inhibitors. In addition, there is mounting evidence pointing to the potential use of PARP inhibitors in the treatment of various cancers in children.
Steve R. Carchedic, CEO of Allarity Therapeutics, noted: “This is a promising opportunity to partner with Oncoheroes Biosciences, a pediatric cancer organization, allowing the two companies to build together on Allarity’s previous efforts to advance both dovitinib and stenoparib by unlocking the clinical potential of to further explore these drugs for the specific treatment of childhood cancer. We are thrilled to partner with Oncoheroes on these pediatric cancer programs to address historically undervalued, rare childhood cancers. By licensing these pediatric development programs, Allarity can focus remain on our top-priority adult cancer programs while leveraging Oncoheroes’ resources, capabilities and commitment to further clinically advance dovitinib and stenoparib in childhood cancers.”
Under the terms set forth in the Binding Terms Sheets, Oncoheroes will acquire worldwide, exclusive rights to fund and conduct the continued clinical development of both dovitinib and stenoparib in pediatric cancer. The full agreements are conditional on Oncoheroes allocating specific funds, within a specified time frame, to carry out the intended clinical development in children. Under the dovitinib termsheet, Oncoheroes will assume 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 an indication of pediatric cancer. Oncoheroes will not receive any pediatric field commercialization rights unless Allarity elects not to further develop the drug for pediatric indications. According to the stenoparib termsheet, Oncoheroes will receive commercialization rights for pediatric cancers, subject to Allarity’s first repurchase option, and Allarity will receive an undisclosed license fee. If Allarity does not reacquire the pediatric field rights, it will further receive certain clinical/regulatory milestone payments and royalties on sales of stenoparib in Oncoheroes’ pediatric cancer market. Allarity will support Oncoheroes’ pediatric clinical trials by providing a 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 have not been disclosed.
Caesarea broadswords, COO & Founder from Oncoheroes life sciences, further noted, “Oncoheroes is a mission-driven company committed to providing more effective and safer treatments for children and adolescents with cancer. We are excited to partner with Allarity on these joint development programs that fit our goal of become 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 deliver tangible benefits to younger cancer patients .
About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) is developing medicines for personalized cancer treatment based on its proprietary drug response prediction technology, the DRP® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration phase. The product portfolio includes: Stenoparib (2X-121), a Phase 2 PARP inhibitor for ovarian cancer; Dovitinib, a pan-TKI headed for a US NDA filing for renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubulin inhibitor approved in the US for the treatment of breast cancer; LiPlaCis®, a liposomal formulation of cisplatin in phase 2 studies for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin in production for stage 2 breast cancer; and Irofulven, a phase 2 DNA-damaging agent for prostate cancer. For more information, visit the company’s website at www.Allarity.com
About the Drug Response Predictor – DRP® Accompanying diagnosis
Allarity uses its drug-specific DRP® to select those patients who have a high probability of responding to the specific drug, based on the genetic characteristics of their cancer. By screening patients prior to treatment, the response can be significantly increased. The DRP® method builds on the comparison of susceptible versus resistant human cancer cell lines, including cell line genomic information combined with clinical tumor biology and previous clinical research results. DRP® is based on messenger RNA from patient biopsies. DRP® has demonstrated its ability to provide a statistically significant prediction of the clinical outcome of drug therapy in cancer patients in nearly 40 clinical trials examined, including an ongoing, prospective Phase 2 study. The DRP® platform can be used in all types of cancer and is patented for more than 70 cancer drugs.
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About Oncoheroes life sciences
Oncoheroes is a pioneering biotech company focused solely on the discovery and development of better medicines for children and young people with cancer. Our vision is to provide benefits to young cancer patients while creating value. The company is headquartered in Boston, USA, with a research laboratory in Barcelona, Spain. Oncoheroes is actively seeking licensing opportunities in pediatric oncology while working to generate new proprietary assets for a number of pediatric cancer indications with significant unmet medical needs. For more information, visit: oncoheroes.com
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This announcement contains forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond the control of Allarity and/or Oncoheroes, that could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements about Allarity’s and/or Oncoheroes’ plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautions and any other cautions that may accompany the forward-looking statements. Neither Allarity nor Oncoheroes undertakes any obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date, except as required by law.
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This information is information that Allarity A/S is required to disclose under the EU Market Abuse Regulation. The information has been submitted for: publication on 14 June- 2021.
Allarity Press Release_OncoHeroes