• Oncoheroes will fund and advance clinical development of both dovitinib and stenoparib in pediatric cancers
• Allarity is preparing to file a first U.S. new drug application (NDA) for the approval of dovitinib in renal cell carcinoma (RCC), and has been planning for an additional clinical trial of the drug in a pediatric cancer, utilizing its DRP® companion diagnostic for dovitinib
• Allarity is also currently conducting a Phase 2 study of stenoparib in ovarian cancer utilizing its DRP® companion diagnostic for the drug, and has been exploring potential expansion into a pediatric cancer indication
  
  

Press release   

Hørsholm, Denmark and Boston, MA, U.S.A. (14 June 2021) – Allarity Therapeutics A/S (“Allarity”) and Oncoheroes Biosciences, Inc. (“Oncoheroes”) today announced 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 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.

About Allarity Therapeutics
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops drugs for personalized treatment of cancer guided by its proprietary drug response predictor technology, the DRP^® platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration stage. The product portfolio includes: Stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian cancer; Dovitinib, a pan-TKI advancing towards a U.S. NDA filing for renal cell carcinoma; IXEMPRA^® (Ixabepilone), a microtubulin inhibitor approved in the U.S. for the treatment of breast cancer; LiPlaCis^®, a liposomal formulation of cisplatin in Phase 2 trials for breast and prostate cancer; 2X-111, a liposomal formulation of doxorubicin under manufacturing for Phase 2 in breast cancer; and Irofulven, a DNA damaging agent in Phase 2 for prostate cancer. For more information, please visit the company’s website at www.Allarity.com        

About the Drug Response Predictor – DRP^® Companion Diagnostic

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, the response rate can be significantly increased. The DRP^® method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP^® is based on messenger RNA from the patient’s biopsies. DRP^® has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP^® platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

Follow Allarity on social media:
Facebook: https://www.facebook.com/AllarityTx/
LinkedIn: https://www.linkedin.com/company/allaritytx/
Twitter: https://twitter.com/allaritytx

About Oncoheroes Biosciences  
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, US, 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 please visit: oncoheroes.com

Follow Oncoheroes on social media:
Facebook: https://www.facebook.com/Oncoheroes
LinkedIn: https://www.linkedin.com/company/oncoheroes
Twitter: https://twitter.com/oncoheroesbio
Instagram: https://www.instagram.com/oncoheroesbio

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of Allarity’s and/or Oncoheroes’ control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning 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 cautionary statements and any other cautionary statements which may accompany the forward-looking statements. Neither Allarity or Oncoheroes undertakes any obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

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U.S. Media Contact:

        Mike Beyer
        Sam Brown, Inc.
        +1 312-961-2502
        mikebeyer@sambrown.com

EU Media Contact:

        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390
        tsp@carrotize.com

Certified Adviser:
Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732

This information is information that Allarity A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on 14 June 2021.