Oncoheroes will lead the pediatric clinical development of dovitinib and stenoparib in childhood cancers, utilizing Allarity’s DRP® companion diagnostics
Oncoheroes is Allarity’s partner of choice to fulfill FDA’s requirements mandated by the RACE for Children Act
The RACE for Children Act authorizes the FDA to require pediatric clinical studies when a molecular target of an adult cancer drug is relevant to a children’s cancer
Boston, MA., January 3, 2022 —Oncoheroes Biosciences, Inc. (“Oncoheroes”), and Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”) have signed a worldwide, exclusive pediatric licensing agreement for dovitinib, a pan-targeted kinase inhibitor (pan-TKI), and stenoparib, a PARP inhibitor, both being developed by Allarity.
Under the terms of the licensing agreements, Oncoheroes acquires global, exclusive rights to both clinical-stage therapeutic compounds for pediatric cancer clinical development. Allarity will support Oncoheroes’ pediatric clinical trials by providing access to its DRP® companion diagnostic for the selection of patients that are most likely to respond to both drugs. Financial terms of the licenses were not disclosed.
“Oncoheroes is a leader in pediatric oncology and Allarity’s ideal pediatric-focused partner to advance both dovitinib and stenoparib as potential new therapeutic options for children and adolescents with cancer,” explained Steve R. Carchedi, CEO of Allarity Therapeutics. “We are very pleased to support Oncoheroes’ pediatric clinical development of our therapeutic candidates together with our DRP® companion diagnostics, in a true personalized cancer care approach.”
Dovitinib is a pan-tyrosine kinase inhibitor targeting fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR) and other receptor tyrosine kinases (RTKs). The drug was originally licensed by Allarity from Novartis and is currently under NDA submission to the U.S. FDA for treatment of renal cell carcinoma.
“This agreement fits very well with the requirements set forth in the Research and Accelerate Cures and Equity (RACE) for Children Act, requiring companies to test adult oncology drugs in pediatric patients too, when there is a scientific rationale,” said Ricardo Garcia, Oncoheroes’ co-founder and CEO. “ Allarity’s drug candidate dovitinib, initially developed for renal cell carcinoma, might provide significant benefit to osteosarcoma pediatric patients and Oncoheroes is excited to make this happen”.
The use of dovitinib in osteosarcoma patients is based on the results of preclinical studies suggesting a significant role of dovitinib in preventing metastases formation in the lungs. More in general, the potential of this class of multi-tyrosine kinase inhibitors for pediatric bone sarcomas, is suggested by several clinical studies demonstrating significant responses in subsets of patients.
Stenoparib is a unique, small molecule dual targeted inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and telomerase maintenance enzymes (Tankyrase 1 and 2), currently in a Phase 2 clinical trial for advanced ovarian cancer at Dana-Farber Cancer Institute (Boston, MA).
“Previous preclinical and clinical studies have demonstrated the potential of PARP inhibitors in pediatric oncology. We are excited to bring this class of molecules into Oncoheroes’ portfolio,” explained Cesare Spadoni, Oncoheroes’ co-founder and COO. “Stenoparib has the potential to be tested across many different pediatric cancers, including brain tumors. More importantly, for both licensed molecules, we would have a powerful tool in the DRP® companion diagnostic to select potential responders.”
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.
Allarity Therapeutics, Inc. (Nasdaq: ALLR) 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 3rd line renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in the U.S. for the treatment of 2nd line 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.
